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 | Information not present in EudraCT |
D.2.1.1.1 | Trade name | PREVENAR |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Wyeth Lederle Vaccines S.A. |
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.3.1 | Product name | PREVENAR |
D.3.2 | Product code | N/A |
D.3.4 | Pharmaceutical form | Suspension for injection |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intramuscular use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 4 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.3 | Concentration number | 2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 6B |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.3 | Concentration number | 4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 9V |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.3 | Concentration number | 2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 14 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.3 | Concentration number | 2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 18C |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.3 | Concentration number | 2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 19F |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.3 | Concentration number | 2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 23F |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.3 | Concentration number | 2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | Each polysaccharide conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.3 | Concentration number | 0.5 |
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) | Information not present in EudraCT |
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 | 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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.8 | Extractive medicinal product | Information not present in EudraCT |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.2.1.1.1 | Trade name | Pneumovax II |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Sanofi Pasteur 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.3.1 | Product name | PNEUMOVAX II Vial |
D.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intramuscular use Subcutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | Pneumococcal serotypes 1,3,4,5,6B,7F,8,9N,9V,10A,11A,12F,14,15B,17F,18C,19F,19A,20,22F,23F,33F |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.3 | Concentration number | 25 of each |
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) | Information not present in EudraCT |
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 | 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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.8 | Extractive medicinal product | Information not present in EudraCT |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
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 |