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 | No |
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.3.2 | Product code | QAW039, 150mg |
D.3.4 | Pharmaceutical form | Capsule |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | QAW039 |
D.3.9.3 | Other descriptive name | QAW039 |
D.3.9.4 | EV Substance Code | SUB32073 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg milligram(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 | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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 | 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 | ALK-prick SQ (SQ 106 139a/85a, SQ 108 141a/85a, SQ 113 142a/85a, SQ 225 148a/85a, SQ 231 150a/85a, SQ 299 151a/85a, SQ 312 152a/85a, SQ 360 405a/85a) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ALK-Abelló Arzneimittel GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
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.3.4 | Pharmaceutical form | Solution for skin-prick test |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Cutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ALDER |
D.3.9.3 | Other descriptive name | ALDER POLLEN |
D.3.9.4 | EV Substance Code | SUB49504 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | BIRCH |
D.3.9.3 | Other descriptive name | BIRCH |
D.3.9.4 | EV Substance Code | SUB61126 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HAZEL |
D.3.9.3 | Other descriptive name | HAZELNUT EXTRACT |
D.3.9.4 | EV Substance Code | SUB84550 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TIMOTHY |
D.3.9.3 | Other descriptive name | TIMOTHY GRASS POLLEN EXTRACT |
D.3.9.4 | EV Substance Code | SUB128744 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | RYE |
D.3.9.3 | Other descriptive name | RYE |
D.3.9.4 | EV Substance Code | SUB49373 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | GRASS MIXTURE |
D.3.9.3 | Other descriptive name | 13 GRASS POLLEN MIXTURE |
D.3.9.4 | EV Substance Code | SUB49502 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ARTEMISIA |
D.3.9.3 | Other descriptive name | ARTEMISIA |
D.3.9.4 | EV Substance Code | SUB90870 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PARIETARIA JUDAICA |
D.3.9.3 | Other descriptive name | PARIETARIA JUDAICA POLLEN EXTRACT |
D.3.9.4 | EV Substance Code | SUB84546 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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) | Yes |
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 | 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 | ALK-prick N (N 115 158a/85a, N 117 159a/85a, N 132 164a/85a, N 134 165a/85a, N 138 167a/85a, N 302 187a/85a, N 317 191a/85a, N 322 192a/85a, N 342 196a/85a, N 351 202a/85a, N 356 205a/85a) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ALK-Abelló Arzneimittel GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
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.3.4 | Pharmaceutical form | Solution for skin-prick test |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Cutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | BEECH |
D.3.9.3 | Other descriptive name | BEECH |
D.3.9.4 | EV Substance Code | SUB49365 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ASH |
D.3.9.3 | Other descriptive name | ASH POLLEN |
D.3.9.4 | EV Substance Code | SUB49505 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PLANE |
D.3.9.3 | Other descriptive name | PLANE POLLEN |
D.3.9.4 | EV Substance Code | SUB49667 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | POPLAR |
D.3.9.3 | Other descriptive name | POPLAR POLLEN |
D.3.9.4 | EV Substance Code | SUB55309 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | OAK |
D.3.9.3 | Other descriptive name | OAK POLLEN |
D.3.9.4 | EV Substance Code | SUB49638 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | RAGWEED |
D.3.9.3 | Other descriptive name | RAGWEED POLLEN |
D.3.9.4 | EV Substance Code | SUB49668 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | RAPE |
D.3.9.3 | Other descriptive name | RAPE POLLEN |
D.3.9.4 | EV Substance Code | SUB49669 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | CHENOPOD |
D.3.9.3 | Other descriptive name | CHENOPODIUM |
D.3.9.4 | EV Substance Code | SUB128558 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PLANTAIN |
D.3.9.3 | Other descriptive name | PLANTAIN POLLEN |
D.3.9.4 | EV Substance Code | SUB55308 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | DANDELION |
D.3.9.3 | Other descriptive name | DANDELION POLLEN |
D.3.9.4 | EV Substance Code | SUB88726 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | STINGING NETTLE |
D.3.9.1 | CAS number | 84012-40-8 |
D.3.9.3 | Other descriptive name | URTICA EXTRACT |
D.3.9.4 | EV Substance Code | SUB15673MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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) | Yes |
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 | 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 | ALK-prick N (N 402 224a/85, N 405 226a/85, N 417 233a/85, N 422 235a/85, N 430 240a/85, N 433 241a/85) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ALK-Abelló Arzneimittel GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
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.3.4 | Pharmaceutical form | Solution for skin-prick test |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Cutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ALTERNARIA ALTERNATA TENUIS |
D.3.9.1 | CAS number | 52B29REC7H |
D.3.9.3 | Other descriptive name | ALTERNARIA TENUIS |
D.3.9.4 | EV Substance Code | SUB32848 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ASPERGILLUS FUMIGATUS |
D.3.9.3 | Other descriptive name | ASPERGILLUS FUMIGATUS |
D.3.9.4 | EV Substance Code | SUB29591 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | CLADOSPORIUM HERBARUM |
D.3.9.3 | Other descriptive name | CLADOSPORIUM HERBARUM |
D.3.9.4 | EV Substance Code | SUB129494 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | MUCOR MUCEDO |
D.3.9.3 | Other descriptive name | MUCOR MUCEDO |
D.3.9.4 | EV Substance Code | SUB128185 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PENICILLIUM EXPANSUM |
D.3.9.3 | Other descriptive name | PENICILLIUM EXPANSUM |
D.3.9.4 | EV Substance Code | SUB29599 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PENICILLIUM NOTATUM |
D.3.9.3 | Other descriptive name | PENICILLIUM NOTATUM |
D.3.9.4 | EV Substance Code | SUB29600 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5 |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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) | Yes |
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 | ALK-prick SQ (SQ 503 220a/85a, SQ 504 221a/85a) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ALK-Abelló Arzneimittel GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
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.3.4 | Pharmaceutical form | Solution for skin-prick test |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Cutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | DERMATOPHAGOIDES PTERONYSSINUS |
D.3.9.3 | Other descriptive name | DERMATOPHAGOIDES PTERONYSSINUS |
D.3.9.4 | EV Substance Code | SUB25740 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | DERMATOPHAGOIDES FARINAE |
D.3.9.3 | Other descriptive name | DERMATOPHAGOIDES FARINAE |
D.3.9.4 | EV Substance Code | SUB29199 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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) | Yes |
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 | ALK-prick SQ (SQ 552 207a/85a, SQ 553 208a/85a, SQ 555 209a/85a) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ALK-Abelló Arzneimittel GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
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.3.4 | Pharmaceutical form | Solution for skin-prick test |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Cutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HORSE HAIR |
D.3.9.3 | Other descriptive name | HORSE HAIR |
D.3.9.4 | EV Substance Code | SUB49530 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | DOG HAIR |
D.3.9.3 | Other descriptive name | DOG HAIR |
D.3.9.4 | EV Substance Code | SUB49529 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | CAT HAIR |
D.3.9.3 | Other descriptive name | CAT HAIR EXTRACT |
D.3.9.4 | EV Substance Code | SUB34688 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | Other |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 HEP |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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) | Yes |
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 | 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 | ALK-prick N (N 521 265a/85, N 522 266a/85,N 523 267a/85, N 524 268a/85, N 554 211a/85b, N 556 212a/85b, N 557 213a/85b, N 560 215a/85b, N 563 217a/85b) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ALK-Abelló Arzneimittel GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
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.3.4 | Pharmaceutical form | Solution for skin-prick test |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Cutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | GOOSE FEATHERS |
D.3.9.3 | Other descriptive name | GOOSE FEATHERS |
D.3.9.4 | EV Substance Code | SUB49571 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | CHICKEN FEATHERS |
D.3.9.3 | Other descriptive name | CHICKEN FEATHERS |
D.3.9.4 | EV Substance Code | SUB49527 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | BUDGERIGAR FEATHERS |
D.3.9.3 | Other descriptive name | BUDGERIGAR FEATHERS |
D.3.9.4 | EV Substance Code | SUB49525 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Duck Feathers |
D.3.9.3 | Other descriptive name | MIXED FEATHERS |
D.3.9.4 | EV Substance Code | SUB49629 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | COW HAIR |
D.3.9.3 | Other descriptive name | COW HAIR |
D.3.9.4 | EV Substance Code | SUB49717 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | GUINEA PIG HAIR |
D.3.9.3 | Other descriptive name | GUINEA PIG HAIR |
D.3.9.4 | EV Substance Code | SUB49575 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | RAT HAIR |
D.3.9.3 | Other descriptive name | RAT HAIR |
D.3.9.4 | EV Substance Code | SUB49698 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HAMSTER HAIR |
D.3.9.3 | Other descriptive name | HAMSTER HAIR |
D.3.9.4 | EV Substance Code | SUB49576 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Rabbit hair |
D.3.9.3 | Other descriptive name | RABBIT FUR |
D.3.9.4 | EV Substance Code | SUB49697 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
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) | Yes |
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 |