Summary
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EudraCT Number: | 2018-000739-28 |
Sponsor's Protocol Code Number: | AIFA-ICSLIFE-001 |
National Competent Authority: | Italy - Italian Medicines Agency |
Clinical Trial Type: | EEA CTA |
Trial Status: | Prematurely Ended |
Date on which this record was first entered in the EudraCT database: | 2021-01-05 |
Trial results |
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A. Protocol Information
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A.1 | Member State Concerned | Italy - Italian Medicines Agency | ||
A.2 | EudraCT number | 2018-000739-28 | ||
A.3 | Full title of the trial |
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A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
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A.3.2 | Name or abbreviated title of the trial where available |
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A.4.1 | Sponsor's protocol code number | AIFA-ICSLIFE-001 | ||
A.7 | Trial is part of a Paediatric Investigation Plan | No | ||
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information
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B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | AZIENDA OSPEDALIERO UNIVERSITARIA DI FERRARA |
B.1.3.4 | Country | Italy |
B.3.1 and B.3.2 | Status of the sponsor | Non-Commercial |
B.4 Source(s) of Monetary or Material Support for the clinical trial: | ||
B.4.1 | Name of organisation providing support | AIFA - Italian Medicines Agency |
B.4.2 | Country | Italy |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | CrosNT |
B.5.2 | Functional name of contact point | Fabio Gambini |
B.5.3 | Address: | |
B.5.3.1 | Street Address | Via Germania 2 |
B.5.3.2 | Town/ city | Verona |
B.5.3.3 | Post code | 37136 |
B.5.3.4 | Country | Italy |
B.5.4 | Telephone number | 0039045820266 |
B.5.5 | Fax number | 0039045820587 |
B.5.6 | icslife@crosnt.com |
D. IMP Identification
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D.IMP: 1 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | REVINTY ELLIPTA - 92 MICROGRAMMI/22 MICROGRAMMI - POLVERE PER INALAZIONE, PRE-DOSATA - USO INALATORIO - BLISTER (ALU) - 1 INALATORE DA 30 DOSI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GLAXO GROUP LIMITED |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | fluticasone furoato vilanterolo |
D.3.2 | Product code | [REVINTY ELLIPTA] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FLUTICASONE FUROATO |
D.3.9.1 | CAS number | 397864-44-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 92 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | VILANTEROLO |
D.3.9.1 | CAS number | 503070-58-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 22 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 2 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SPIRIVA RESPIMAT - 2.5 MCG SOLUZIONE PER INALAZIONE 2 INALATORI RESPIMAT + 2 CARTUCCE PE/PP DA 60 EROGAZIONI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BOEHRINGER INGELHEIM INTERNATIONAL GMBH |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | TIOTROPIO |
D.3.2 | Product code | [SPIRIVA RESPIMAT] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | TIOTROPIO |
D.3.9.1 | CAS number | 186691-13-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | ng nanogram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2500 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 3 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ONBREZ BREEZHALER - 150 MCG - POLVERE PER INALAZIONE, CAPSULE RIGIDE - USO INALATORIO - BLISTER (PA/ALU/PVC) 10 CAPSULE+ 1 INALATORE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | NOVARTIS EUROPHARM LTD |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | INDACATEROLO |
D.3.2 | Product code | [ONBREZ BREEZHALER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | INDACATEROLO |
D.3.9.1 | CAS number | 312753-06-3 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 150 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 4 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | LAVENTAIR - 55 MICROGRAMMI/22 MICROGRAMMI - POLVERE PER INALAZIONE, PRE-DOSATA - USO INALATORIO - BLISTER (ALU) - 1 INALATORE (7 DOSI) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GLAXO GROUP LIMITED |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | UMECLIDINIO VILANTEROLO |
D.3.2 | Product code | [LAVENTAIR] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | UMECLIDINIO |
D.3.9.1 | CAS number | 869185-19-3 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 55 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | VILANTEROLO |
D.3.9.1 | CAS number | 503070-58-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 22 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 5 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ALIFLUS - DISKUS 50/500 POLVERE PER INALAZIONE 1 INALATORE 28 DOSI 50 MCG + 500 MCG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | FLUTICASONE PROPIONATO SALMETEROLO |
D.3.2 | Product code | [ALIFLUS - DISKUS] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FLUTICASONE PROPIONATO |
D.3.9.1 | CAS number | 80474-14-2 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | SALMETEROLO |
D.3.9.1 | CAS number | 89365-50-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 1000 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 6 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ALABASTER - 100 MCG/6 MCG EROGAZIONE SOLUZIONE PRESSURIZZATA PER INALAZIONE 1 CONTENITORE DA 120 EROGAZIONI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | MASTER PHARMA S.R.L. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | BECLOMETASONE DUPROPIONATO FORMOTEROLO |
D.3.2 | Product code | [ALABASTER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | BECLOMETASONE DIPROPIONATO |
D.3.9.1 | CAS number | 5534-09-8 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 400 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 43229-80-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 24 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 7 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | TOVANOR BREEZHALER - 44 MICROGRAMMI - POLVERE PER INALAZIONE, CAPSULA RIGIDA-USO INALATORIO-BLISTER(ALU/ALU)-6X1 CAPSULA(DOSE UNITARIA)+ 1 INALATORE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | NOVARTIS EUROPHARM LTD |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | GLICOPIRRONIO |
D.3.2 | Product code | [TOVANOR BREEZHALER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | GLICOPIRRONIO |
D.3.9.1 | CAS number | 51186-83-5 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 44 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 8 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | FOBULER - "160 MICROGRAMMI/4,5 MICROGRAMMI/INALAZIONE, POLVERE PER INALAZIONE" 1 INALATORE DA 60 DOSI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ORION CORPORATION |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | BUDESONIDE FORMOTEROLO |
D.3.2 | Product code | [FOBULER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | BUDESONIDE |
D.3.9.1 | CAS number | 51333-22-3 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 640 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 43229-80-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 18 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 9 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | BRETARIS GENUAIR - 322 MICROGRAMMI - POLVERE PER INALAZIONE-USO INALATORIO-INALATORE (PLASTICA/ACCIAIO INOSSIDABILE) - 1 INALATORE CON 60 SOMMINISTRAZIONI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ALMIRALL S.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | ACLIDINIO |
D.3.2 | Product code | [BRETARIS GENUAIR] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | ACLIDINIO |
D.3.9.1 | CAS number | 320345-99-1 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 644 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 10 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | INCRUSE - 55 MCG - POLVERE PER INALAZIONE, PREDOSATA - USO INALATORIO - BLISTER (ALU) - 1 INALATORE (7 DOSI) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GLAXO GROUP LIMITED |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | UMECLIDINIO |
D.3.2 | Product code | [INCRUSE] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | UMECLIDINIO |
D.3.9.1 | CAS number | 0869113-09-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 55 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 11 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | LEVOVENT - 12 MCG POLVERE PER INALAZIONE, CAPSULE RIGIDE 60 CAPSULE + EROGATORE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GENETIC S.P.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | FORMOTEROLO |
D.3.2 | Product code | [LEVOVENT] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO |
D.3.9.1 | CAS number | 73573-87-2 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 24 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 12 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ULTIBRO BREEZHALER - 85 MCG/43 MCG POLVERE PER INALAZIONE CAPSULA RIGIDA - USO INALATORIO - BLISTER (PA/ALU/PVC-ALU) 90(3 CONFEZIONI DI 30X1) CAPSULE + 3 INALATORI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | NOVARTIS EUROPHARM LTD |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | INDACATEROLO GLICOPIRRONIO |
D.3.2 | Product code | [ULTIBRO BREEZHALER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | INDACATEROLO MALEATO |
D.3.9.1 | CAS number | 312753-06-3 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 85 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | GLICOPIRRONIO BROMURO |
D.3.9.1 | CAS number | 596-51-0 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 43 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 13 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | RELVAR ELLIPTA - 92 MICROGRAMMI/22 MICROGRAMMI - POLVERE PER INALAZIONE, PRE-DOSATA - USO INALATORIO - BLISTER (ALU) - 1 INALATORE X 30 DOSI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GLAXO GROUP LIMITED |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | FLUTICASONE FUROATO VILANTEROLO |
D.3.2 | Product code | [RELVAR ELLIPTA] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FLUTICASONE FUROATO |
D.3.9.1 | CAS number | 397864-44-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 92 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | VILANTEROLO |
D.3.9.1 | CAS number | 503070-58-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 22 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 14 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | FORMODUAL - 100 MCG/6 MCG PER EROGAZIONE SOLUZIONE PRESSURIZZATA PER INALAZIONE 1 CONTENITORE DA 120 EROGAZIONI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | PROMEDICA S.R.L. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | BECLOMETASONE DIPROPIONATO FORMOTEROLO |
D.3.2 | Product code | [FORMODUAL] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | BECLOMETASONE DIPROPIONATO |
D.3.9.1 | CAS number | 5534-09-8 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 400 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 43229-80-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 24 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 15 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SERETIDE - DISKUS 50/500 1 INALATORE 28 DOSI POLV PER INALAZ |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GLAXOSMITHKLINE S.P.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | FLUTICASONE PROPIONATO SALMETEROLO |
D.3.2 | Product code | [SERETIDE] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FLUTICASONE PROPIONATO |
D.3.9.1 | CAS number | 80474-14-2 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | SALMETEROLO |
D.3.9.1 | CAS number | 89365-50-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 1000 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 16 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | FOSTER - 100/6 MICROGRAMMI PER EROGAZIONE SOLUZIONE PRESSURIZZATA PER INALAZIONE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | CHIESI FARMACEUTICI S.P.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | BECLOMETASONE DIPROPIONATO FORMOTEROLO |
D.3.2 | Product code | [FOSTER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | BECLOMETASONE DIPROPIONATO |
D.3.9.1 | CAS number | 5534-09-8 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 400 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 43229-80-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 24 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 17 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | INUVER - 100/6 MICROGRAMMI PER EROGAZIONE SOLUZIONE PRESSURIZZATA PER INALAZIONE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | CHIESI FARMACEUTICI S.P.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | BECLOMETASONE DIPROPIONATO FORMOTEROLO |
D.3.2 | Product code | [INUVER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | BECLOMETASONE DIPROPIONATO |
D.3.9.1 | CAS number | 5534-09-8 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 200 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 43229-80-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 12 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 18 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SYMBICORT - TURBOHALER18 INALATORI 60 DOSI 160/4.5 MCG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ASTRAZENECA S.P.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | BUDESONIDE FORMOTEROLO |
D.3.2 | Product code | [SYMBICORT] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | BUDESONIDE |
D.3.9.1 | CAS number | 51333-22-3 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 640 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 43229-80-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 18 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 19 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SINESTIC - TURBOHALER 1 INALATORE 60 DOSI 160/4.5 MCG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ASTRAZENECA S.P.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | BUDESONIDE FORMOTEROLO |
D.3.2 | Product code | [SINESTIC - TURBOHALER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | BUDESONIDE |
D.3.9.1 | CAS number | 51333-22-3 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 640 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 43229-80-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 18 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 20 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | DUORESP SPIROMAX - 160 MCG/4,5 MCG - POLVERE PER INALAZIONE - USO INALATORIO - INALATORE - 1 INALATORE (120 DOSI) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | TEVA PHARMA B.V. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | BUDESONIDE FORMOTEROLO |
D.3.2 | Product code | [DUORESP SPIROMAX] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | BUDESONIDE |
D.3.9.1 | CAS number | 51333-22-3 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 640 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 43229-80-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 18 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 21 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ALIFLUS - DISKUS 50/250 POLVERE PER INALAZIONE 1 INALATORE 28 DOSI 50 MCG + 250 MCG |
D.2.1.1.2 | Name of the Marketing Authorisation holder | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | FLUTICASONE PROPIONATO SALMETEROLO |
D.3.2 | Product code | [ALIFLUS - DISKUS] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FLUTICASONE PROPIONATO |
D.3.9.1 | CAS number | 80474-14-2 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | SALMETEROLO |
D.3.9.1 | CAS number | 89365-50-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 500 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 22 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SERETIDE - DISKUS 50/250 1 INALATORE 28 DOSI POLV PER INALAZ |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GLAXOSMITHKLINE S.P.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | FLUTICASONE PROPIONATO SALMETEROLO |
D.3.2 | Product code | [SERETIDE - DISKUS] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FLUTICASONE PROPIONATO |
D.3.9.1 | CAS number | 80474-14-2 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | SALMETEROLO |
D.3.9.1 | CAS number | 89365-50-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 500 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 23 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SPIRIVA - 10 CAPSULE IN BLISTER AL/PVC/AL DA 18 MCG CON DISPOSITIVO HANDIHALER |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BOEHRINGER INGELHEIM INTERNATIONAL GMBH |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | TIOTROPIO |
D.3.2 | Product code | [SPIRIVA] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | TIOTROPIO BROMURO |
D.3.9.1 | CAS number | 186691-13-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 18 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 24 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | BRALTUS - "10 MICROGRAMMI POLVERE PER INALAZIONE, CAPSULA RIGIDA" 30 CAPSULE IN FLACONE HDPE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | TEVA ITALIA S.R.L. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | TIOTROPIO |
D.3.2 | Product code | [BRALTUS] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | TIOTROPIO BROMURO |
D.3.9.1 | CAS number | 186691-13-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 25 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SEEBRI BREEZHALER - 44 MCG - POLVERE PER INALAZIONE, CAPSULA RIGIDA - USO INALATORIO - BLISTER (ALU/ALU) 30X1 CAPSULA (DOSE UNITARIA) + 1 INALATORE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | NOVARTIS EUROPHARM LTD |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | GLICOPIRRONIO |
D.3.2 | Product code | [SEEBRI BREEZHALER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | GLICOPIRRONIO BROMURO |
D.3.9.1 | CAS number | 51186-83-5 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 44 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 26 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | EKLIRA GENUAIR - 322 MICROGRAMMI - POLVERE PER INALAZIONE-USO INALATORIO- INALATORE (PLASTICA/ACCIAIO INOSSIDABILE) 1 INALATORE CON 30 SOMMINISTRAZIONI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ALMIRALL S.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | ACLIDINIO |
D.3.2 | Product code | [EKLIRA GENUAIR] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | ACLIDINIO BROMURO |
D.3.9.1 | CAS number | 320345-99-1 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 644 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 27 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SEREVENT - 50 MCG POLVERE PER INALAZIONE INALATORE DA 60 DOSI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GLAXOSMITHKLINE S.P.A. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | SALMETEROLO |
D.3.2 | Product code | [SEREVENT] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | SALMETEROLO |
D.3.9.1 | CAS number | 89365-50-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 100 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 28 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ONBREZ BREEZHALER - 300 MCG - POLVERE PER INALAZIONE, CAPSULE RIGIDE - USO INALATORIO - BLISTER (PA/ALU/PVC) 30 X ( 10 CAPSULE + 1 INALATORE) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | NOVARTIS EUROPHARM LTD |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | INDACATEROLO |
D.3.2 | Product code | [ONBREZ BREEZHALER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | INDACATEROLO MALEATO |
D.3.9.1 | CAS number | 753498-25-8 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 300 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 29 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | HIROBRIZ BREEZHALER - 150 MCG-POLVERE PER INALAZIONE ,CAPSULE RIGIDE-USO INALATORIO-BLISTER (PA/ALU/PVC) 30 CAPSULE +1 INALATORE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | NOVARTIS EUROPHARM LTD |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | INDACATEROLO |
D.3.2 | Product code | [HIROBRIZ BREEZHALER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | INDACATEROLO MALEATO |
D.3.9.1 | CAS number | 753498-25-8 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 150 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 30 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | HIROBRIZ BREEZHALER - 300 MCG-POLVERE PER INALAZIONE ,CAPSULE RIGIDE-USO INALATORIO-BLISTER (PA/ALU/PVC) 30 CAPSULE +1 INALATORE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | NOVARTIS EUROPHARM LTD |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | INDACATEROLO |
D.3.2 | Product code | [HIROBRIZ BREEZHALER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | INDACATEROLO MALEATO |
D.3.9.1 | CAS number | 753498-25-8 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 300 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 31 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | FORADIL - 12 MCG POLVERE PER INALAZIONE CAPSULE RIGIDE 60 CAPSULE +EROGATORE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | NOVARTIS EUROPHARM LTD |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | FORMOTEROLO |
D.3.2 | Product code | [FORADIL] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 73573-87-2 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 24 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 32 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | ANORO - 55 MICROGRAMMI/22 MICROGRAMMI - POLVERE PER INALAZIONE, PRE-DOSATA - USO INALATORIO - BLISTER (ALU) - 1 INALATORE (30 DOSI) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GLAXO GROUP LIMITED |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | UMECLIDINIO VILANTEROLO |
D.3.2 | Product code | [ANORO] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | UMECLIDINIO BROMURO |
D.3.9.1 | CAS number | 869113-09-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 55 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | VILANTEROLO |
D.3.9.1 | CAS number | 503070-58-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 22 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 33 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | XOTERNA BREEZHALER - 85 MCG/43MCG POLVERE PER INALAZIONE, CAPSULA RIGIDA - USO INALATORIO - BLISTER (PA/ALU/PVC-ALU) - 30X1 CAPSULE + 1 INALATORE |
D.2.1.1.2 | Name of the Marketing Authorisation holder | NOVARTIS EUROPHARM LTD |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | INDACATEROLO GLICOPIRRONIO |
D.3.2 | Product code | [XOTERNA BREEZHALER] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | INDACATEROLO MALEATO |
D.3.9.1 | CAS number | 753498-25-8 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 85 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | 00326700 |
D.3.9.1 | CAS number | 596-51-0 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 43 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 34 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | SPIOLTO RESPIMAT - " 2,5 MICROGRAMMI/2,5 MICROGRAMMI, SOLUZIONE PER INALAZIONE" 1 INALATORE RESPIMAT + 1 CARTUCCIA PE/PP DA 60 EROGAZIONI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BOEHRINGER INGELHEIM INTERNATIONAL GMBH |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | TIOTROPIO OLODATEROLO |
D.3.2 | Product code | [SPIOLTO RESPIMAT] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | TIOTROPIO BROMURO |
D.3.9.1 | CAS number | 186691-13-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 10 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | OLODATEROLO |
D.3.9.1 | CAS number | 868049-49-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 10 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 35 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | DUAKLIR GENUAIR - 340 MICROGRAMMI/12 MICROGRAMMI - POLVERE PER INALAZIONE - USO INALATORIO - INALATORE (PLASTICA/ACCIAIO INOSSIDABILE) - 1 INALATORE CON 30 DOSI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ASTRAZENECA AB |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | ACLIDINIO FORMOTEROLO |
D.3.2 | Product code | [DUAKLIR GENUAIR] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | ACLIDINIO |
D.3.9.1 | CAS number | 320345-99-1 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 680 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 73573-87-2 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 24 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 36 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | BRIMICA GENUAIR - 340 MICROGRAMMI/12 MICOGRAMMI - POLVERE PER INALAZIONE - USO INALATORIO - INALATORE (PLASTICA/ACCIAIO INOSSIDABILE) - 3 INALATORI CON 60 DOSI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ASTRAZENECA AB |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | ACLIDINIO FORMOTEROLO |
D.3.2 | Product code | [BRIMICA GENUAIR] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | ACLIDINIO |
D.3.9.1 | CAS number | 320345-99-1 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 680 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FORMOTEROLO FUMARATO |
D.3.9.1 | CAS number | 43229-80-7 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 24 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 37 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | STRIVERDI RESPIMAT - 2,5 MICROGRAMMI/DOSE SOLUZIONE PER INALAZIONE 1 INALATORE CON CARTUCCIA IN PE/PP DA 30 DOSI |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BOEHRINGER INGELHEIM INTERNATIONAL GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | OLODATEROLO |
D.3.2 | Product code | [STRIVERDI RESPIMAT] |
D.3.4 | Pharmaceutical form | Inhalation powder |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Inhalation use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | OLODATEROLO |
D.3.9.1 | CAS number | 868049-49-4 |
D.3.9.2 | Current sponsor code | NON APPLICABILE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 5 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.8 Information on Placebo
|
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E. General Information on the Trial
|
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
E.1 Medical condition or disease under investigation | |||||||||||||||||
E.1.1 | Medical condition(s) being investigated |
|
|||||||||||||||
E.1.1.1 | Medical condition in easily understood language |
|
|||||||||||||||
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] | |||||||||||||||
MedDRA Classification | |||||||||||||||||
E.1.2 Medical condition or disease under investigation | |||||||||||||||||
|
|||||||||||||||||
E.1.3 | Condition being studied is a rare disease | No | |||||||||||||||
E.2 Objective of the trial | |||||||||||||||||
E.2.1 | Main objective of the trial |
|
|||||||||||||||
E.2.2 | Secondary objectives of the trial |
|
|||||||||||||||
E.2.3 | Trial contains a sub-study | No | |||||||||||||||
E.3 | Principal inclusion criteria |
|
|||||||||||||||
E.4 | Principal exclusion criteria |
|
|||||||||||||||
E.5 End points | |||||||||||||||||
E.5.1 | Primary end point(s) |
|
|||||||||||||||
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
|||||||||||||||
E.5.2 | Secondary end point(s) |
|
|||||||||||||||
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
|||||||||||||||
E.6 and E.7 Scope of the trial | |||||||||||||||||
E.6 | Scope of the trial | ||||||||||||||||
E.6.1 | Diagnosis | No | |||||||||||||||
E.6.2 | Prophylaxis | No | |||||||||||||||
E.6.3 | Therapy | Yes | |||||||||||||||
E.6.4 | Safety | Yes | |||||||||||||||
E.6.5 | Efficacy | Yes | |||||||||||||||
E.6.6 | Pharmacokinetic | No | |||||||||||||||
E.6.7 | Pharmacodynamic | No | |||||||||||||||
E.6.8 | Bioequivalence | No | |||||||||||||||
E.6.9 | Dose response | No | |||||||||||||||
E.6.10 | Pharmacogenetic | No | |||||||||||||||
E.6.11 | Pharmacogenomic | No | |||||||||||||||
E.6.12 | Pharmacoeconomic | No | |||||||||||||||
E.6.13 | Others | No | |||||||||||||||
E.7 | Trial type and phase | ||||||||||||||||
E.7.1 | Human pharmacology (Phase I) | No | |||||||||||||||
E.7.1.1 | First administration to humans | No | |||||||||||||||
E.7.1.2 | Bioequivalence study | No | |||||||||||||||
E.7.1.3 | Other | No | |||||||||||||||
E.7.1.3.1 | Other trial type description | ||||||||||||||||
E.7.2 | Therapeutic exploratory (Phase II) | No | |||||||||||||||
E.7.3 | Therapeutic confirmatory (Phase III) | No | |||||||||||||||
E.7.4 | Therapeutic use (Phase IV) | Yes | |||||||||||||||
E.8 Design of the trial | |||||||||||||||||
E.8.1 | Controlled | Yes | |||||||||||||||
E.8.1.1 | Randomised | Yes | |||||||||||||||
E.8.1.2 | Open | Yes | |||||||||||||||
E.8.1.3 | Single blind | No | |||||||||||||||
E.8.1.4 | Double blind | No | |||||||||||||||
E.8.1.5 | Parallel group | Yes | |||||||||||||||
E.8.1.6 | Cross over | No | |||||||||||||||
E.8.1.7 | Other | No | |||||||||||||||
E.8.2 | Comparator of controlled trial | ||||||||||||||||
E.8.2.1 | Other medicinal product(s) | Yes | |||||||||||||||
E.8.2.2 | Placebo | No | |||||||||||||||
E.8.2.3 | Other | No | |||||||||||||||
E.8.2.4 | Number of treatment arms in the trial | 2 | |||||||||||||||
E.8.3 | The trial involves single site in the Member State concerned | No | |||||||||||||||
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes | |||||||||||||||
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 | |||||||||||||||
E.8.5 | The trial involves multiple Member States | No | |||||||||||||||
E.8.6 Trial involving sites outside the EEA | |||||||||||||||||
E.8.6.1 | Trial being conducted both within and outside the EEA | No | |||||||||||||||
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT | |||||||||||||||
E.8.7 | Trial has a data monitoring committee | Yes | |||||||||||||||
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial |
|
|||||||||||||||
E.8.9 Initial estimate of the duration of the trial | |||||||||||||||||
E.8.9.1 | In the Member State concerned years | 1 | |||||||||||||||
E.8.9.1 | In the Member State concerned months | 6 | |||||||||||||||
E.8.9.1 | In the Member State concerned days | 0 | |||||||||||||||
E.8.9.2 | In all countries concerned by the trial years | 1 | |||||||||||||||
E.8.9.2 | In all countries concerned by the trial months | 6 | |||||||||||||||
E.8.9.2 | In all countries concerned by the trial days | 0 |
F. Population of Trial Subjects
|
||||
---|---|---|---|---|
F.1 Age Range | ||||
F.1.1 | Trial has subjects under 18 | No | ||
F.1.1.1 | In Utero | No | ||
F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | No | ||
F.1.1.3 | Newborns (0-27 days) | No | ||
F.1.1.4 | Infants and toddlers (28 days-23 months) | No | ||
F.1.1.5 | Children (2-11years) | No | ||
F.1.1.6 | Adolescents (12-17 years) | No | ||
F.1.2 | Adults (18-64 years) | Yes | ||
F.1.2.1 | Number of subjects for this age range: | 105 | ||
F.1.3 | Elderly (>=65 years) | Yes | ||
F.1.3.1 | Number of subjects for this age range: | 927 | ||
F.2 Gender | ||||
F.2.1 | Female | Yes | ||
F.2.2 | Male | Yes | ||
F.3 Group of trial subjects | ||||
F.3.1 | Healthy volunteers | No | ||
F.3.2 | Patients | Yes | ||
F.3.3 | Specific vulnerable populations | No | ||
F.3.3.1 | Women of childbearing potential not using contraception | No | ||
F.3.3.2 | Women of child-bearing potential using contraception | No | ||
F.3.3.3 | Pregnant women | No | ||
F.3.3.4 | Nursing women | No | ||
F.3.3.5 | Emergency situation | No | ||
F.3.3.6 | Subjects incapable of giving consent personally | No | ||
F.3.3.7 | Others | No | ||
F.4 Planned number of subjects to be included | ||||
F.4.1 | In the member state | 1032 | ||
F.4.2 | For a multinational trial | |||
F.4.2.1 | In the EEA | 1032 | ||
F.4.2.2 | In the whole clinical trial | 1032 | ||
F.5 | Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition) |
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G. Investigator Networks to be involved in the Trial
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N. Review by the Competent Authority or Ethics Committee in the country concerned
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N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2018-06-26 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
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N. | Date of Ethics Committee Opinion | 2018-04-18 |
P. End of Trial
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P. | End of Trial Status | Prematurely Ended |
P. | Date of the global end of the trial | 2022-10-26 |