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.3.1 | Product name | Human Papilloma Virus (HPV) type 16 E6/E7 synthetic long peptide (SLP®) vaccine |
D.3.2 | Product code | ISA101b |
D.3.4 | Pharmaceutical form | Powder and solvent for suspension for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Subcutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Aspartyl-L-lysyl-L-cysteinyl-L-leucyl-L-lysyl- L-phenylalanyl –L-tyrosyl-L-seryl-L-lysyl-L isoleucyl-L-seryl-L-glutamyl-L-tyrosyl-L-arginyl-L-histid |
D.3.9.1 | CAS number | 1218771-50-6 |
D.3.9.2 | Current sponsor code | D-3082-L Trifluoroacetate or D-3082-L |
D.3.9.3 | Other descriptive name | D-3082-L TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124635 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Leucyl-L-tyrosyl-L-cysteinyl-L-tyrosyl-L-glutamyl-L-glutaminyl-L-leucyl-L-asparaginyl-L-aspartyl-L-seryl-L-seryl-L-glutamyl-L-glutamyl-L-glutamyl-L- |
D.3.9.1 | CAS number | 1218907-64-2 |
D.3.9.2 | Current sponsor code | L-3972-T Trifluoroacetate or L-3972-T |
D.3.9.3 | Other descriptive name | L-3972-T TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124637 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Methionyl-L-histidyl-glycyl-L-aspartyl-L-threonyl-L-prolyl-L-threonyl-L-leucyl-L-histidyl-L glutamyl-L-tyrosyl-L-methionyl-L-leucyl-L-aspartyl-L-leu |
D.3.9.1 | CAS number | 1218907-32-4 |
D.3.9.2 | Current sponsor code | M-4148-E Trifluoroacetate or M-4148-E |
D.3.9.3 | Other descriptive name | M-4148-E TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124638 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-L-Arginyl-L-cysteinyl-L-isoleucyl-L-asparaginyl-L-cysteinyl-L-glutaminyl-L-lysyl-L-prolyl-L-leucyl-L-cysteinyl-L-prolyl-L-glutamyl-L-glutamyl-L-lysy |
D.3.9.1 | CAS number | 1218907-21-1 |
D.3.9.2 | Current sponsor code | R-4019-T Trifluoroacetate or R-4019-T |
D.3.9.3 | Other descriptive name | R-4019-T TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124639 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Threonyl-L-leucyl-L-arginyl-L-leucyl-L-cysteinyl-L-valyl-L-glutaminyl-L-seryl-L-threonyl-L-histidyl-L-valyl-L-aspartyl-L-isoleucyl-L-arginyl-L-threo |
D.3.9.1 | CAS number | 1218908-02-1 |
D.3.9.2 | Current sponsor code | T-3853-P Trifluoroacetate or T-3853-P |
D.3.9.3 | Other descriptive name | T-3853-P TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124640 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Aspartyl-L-lysyl-L-lysyl-L-glutaminyl-L-arginyl-L-phenylalanyl-L-histidyl-L-asparaginyl-L-isoleucyl-L-arginyl-glycyl-L-arginyl-L-tryptophanyl-L-thre |
D.3.9.1 | CAS number | 1218907-24-4 |
D.3.9.2 | Current sponsor code | D-3954-L Trifluoroacetate or D-3954-L |
D.3.9.3 | Other descriptive name | D-3954-L TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124641 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Histidyl-L-tyrosyl-L-cysteinyl-L-tyrosyl-L-seryl-L-leucyl-L-tyrosyl-glycyl-L-threonyl-L-threonyl-L leucyl-L-glutamyl-L-glutaminyl-L-glutaminyl-L-tyr |
D.3.9.1 | CAS number | 1218771-56-2 |
D.3.9.2 | Current sponsor code | H-3035-R Trifluoroacetate or H-3035-R |
D.3.9.3 | Other descriptive name | H-3035-R TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124642 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Lysyl-L-glutaminyl-L-glutaminyl-L-leucyl-L-leucyl-L-arginyl-L-arginyl-L-glutamyl-L-valyl-L-tyrosyl-L-aspartyl-L-phenylalanyl-L-alanyl-L-phenylalanyl |
D.3.9.1 | CAS number | 1218771-40-4 |
D.3.9.2 | Current sponsor code | K-3118-N Trifluoroacetate or K-3118-N |
D.3.9.3 | Other descriptive name | K-3118-N TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124643 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Leucyl-L-prolyl-L-glutaminyl-L-leucyl-L-cysteinyl-L-threonyl-L-glutamyl-L-leucyl-L-glutaminyl-L threonyl-L-threonyl-L-isoleucyl-L-histidyl-L-asparty |
D.3.9.1 | CAS number | 1218907-04-0 |
D.3.9.2 | Current sponsor code | L-3863-Y Trifluoroacetate or L-3863-Y |
D.3.9.3 | Other descriptive name | L-3863-Y TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124644 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Methionyl-L-histidyl-L-glutaminyl-L-lysyl-L-arginyl-L-threonyl-L-alanyl-L-methionyl-L phenylalanyl-L-glutaminyl-L-aspartyl-L-prolyl-L-glutaminyl-L-g |
D.3.9.1 | CAS number | 1218907-00-6 |
D.3.9.2 | Current sponsor code | M-3878-D Trifluoroacetate or M-3878-D |
D.3.9.3 | Other descriptive name | M-3878-D TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124645 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Arginyl-L-aspartyl-L-leucyl-L-cysteinyl-L-isoleucyl-L-valyl-L-tyrosyl-L-arginyl-L-aspartyl-glycyl-L asparaginyl-L-prolyl-L-tyrosyl-L-alanyl-L-valyl- |
D.3.9.1 | CAS number | 1218771-49-3 |
D.3.9.2 | Current sponsor code | R-3083-I Trifluoroacetate or R-3083-I |
D.3.9.3 | Other descriptive name | R-3083-I TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124646 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-Tyrosyl-glycyl-L-threonyl-L-threonyl-L-leucyl-L-glutamyl-L-glutaminyl-L-glutaminyl-L-tyrosyl-L asparaginyl-L-lysyl-L-prolyl-L-leucyl-L-cysteinyl-L-a |
D.3.9.1 | CAS number | 1218907-20-0 |
D.3.9.2 | Current sponsor code | Y-3755-K Trifluoroacetate or Y-3755-K |
D.3.9.3 | Other descriptive name | Y-3755-K TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124647 |
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 | PegIntron |
D.2.1.1.2 | Name of the Marketing Authorisation holder | MSD |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Powder and solvent for solution for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Subcutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PEGINTERFERON ALFA-2B |
D.3.9.3 | Other descriptive name | PEGINTERFERON ALFA-2B |
D.3.9.4 | EV Substance Code | SUB12549MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/kg microgram(s)/kilogram |
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 | Yes |
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 | Yes |
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 | Paclitaxel 6 mg/ml concentrate for solution for infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Fresenius Kabi |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Concentrate for solution for infusion |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PACLITAXEL |
D.3.9.1 | CAS number | 33069-62-4 |
D.3.9.4 | EV Substance Code | SUB09583MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg/m2 milligram(s)/square meter |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 175 |
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: 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 | Carboplatin 10 mg/ml concentrate for solution for infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Fresenius Kabi Ltd |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Concentrate for solution for infusion |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | carboplatin |
D.3.9.3 | Other descriptive name | CARBOPLATIN |
D.3.9.4 | EV Substance Code | SUB06614MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 900 |
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: 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 | Avastin |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Roche Registration Limited |
D.2.1.2 | Country which granted the Marketing Authorisation | European Union |
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 | Concentrate for solution for infusion |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | BEVACIZUMAB |
D.3.9.1 | CAS number | 216974-75-3 |
D.3.9.4 | EV Substance Code | SUB16402MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 25 |
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) | 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 | Yes |
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 |