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 | Venclyxto |
D.2.1.1.2 | Name of the Marketing Authorisation holder | AbbVie Deutschland GmbH Co. KG |
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 | Film-coated tablet |
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 | VENETOCLAX |
D.3.9.1 | CAS number | 1257044-40-8 |
D.3.9.4 | EV Substance Code | SUB176260 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 200
to
400 |
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 | Dexamethasone |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Krka |
D.2.1.2 | Country which granted the Marketing Authorisation | Denmark |
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 | Dexamethasone |
D.3.4 | Pharmaceutical form | Tablet |
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 | DEXAMETHASONE |
D.3.9.1 | CAS number | 50-02-2 |
D.3.9.4 | EV Substance Code | SUB07017MIG |
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 | 4 |
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: 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 | Prevenar 13 |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Pfizer ApS |
D.2.1.2 | Country which granted the Marketing Authorisation | Denmark |
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 13 |
D.3.4 | Pharmaceutical form | Suspension for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intramuscular use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Pneumococcal polysaccharide serotype 1 conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 1 conjugated to CRM197 adsorbed on aluminium phosphate |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Pneumococcal polysaccharide serotype 1 conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 3 conjugated to CRM197 adsorbed on aluminium phosphate |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Pneumococcal polysaccharide serotype 4 conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 4 conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.4 | EV Substance Code | SUB25261 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Pneumococcal polysaccharide serotype 5 conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 5 conjugated to CRM197 adsorbed on aluminium phosphate |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Pneumococcal polysaccharide serotype 6A conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 6A conjugated to CRM197 adsorbed on aluminium phosphate |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.4 | EV Substance Code | SUB25344 |
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 | 4.4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Pneumococcal polysaccharide serotype 7F conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 7F conjugated to CRM197 adsorbed on aluminium phosphate |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.4 | EV Substance Code | SUB25342 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.4 | EV Substance Code | SUB25340 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Pneumococcal polysaccharide serotype 18C conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 18C conjugated to CRM197 adsorbed on aluminium phosphate |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Pneumococcal polysaccharide serotype 19A conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 19A conjugated to CRM197 adsorbed on aluminium phosphate |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.4 | EV Substance Code | SUB25366 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Pneumococcal polysaccharide serotype 23F conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.3 | Other descriptive name | Pneumococcal polysaccharide serotype 23F conjugated to CRM197 adsorbed on aluminium phosphate |
D.3.9.4 | EV Substance Code | SUB25347 |
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 | 2.2 |
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 | Pneumovax |
D.2.1.1.2 | Name of the Marketing Authorisation holder | MSD Danmark ApS |
D.2.1.2 | Country which granted the Marketing Authorisation | Denmark |
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 injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intramuscular use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 |
D.3.9.4 | EV Substance Code | SUB25373 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2 |
D.3.9.4 | EV Substance Code | SUB25372 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 |
D.3.9.4 | EV Substance Code | SUB25371 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 |
D.3.9.4 | EV Substance Code | SUB20576 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 |
D.3.9.4 | EV Substance Code | SUB25370 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B |
D.3.9.4 | EV Substance Code | SUB20577 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F |
D.3.9.4 | EV Substance Code | SUB25369 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 |
D.3.9.4 | EV Substance Code | SUB25357 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N |
D.3.9.4 | EV Substance Code | SUB25367 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V |
D.3.9.4 | EV Substance Code | SUB20578 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A |
D.3.9.4 | EV Substance Code | SUB25378 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A |
D.3.9.4 | EV Substance Code | SUB25365 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F |
D.3.9.4 | EV Substance Code | SUB25364 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 |
D.3.9.4 | EV Substance Code | SUB20579 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B |
D.3.9.4 | EV Substance Code | SUB25363 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F |
D.3.9.4 | EV Substance Code | SUB25362 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C |
D.3.9.4 | EV Substance Code | SUB20580 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A |
D.3.9.4 | EV Substance Code | SUB25361 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F |
D.3.9.4 | EV Substance Code | SUB20581 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20 |
D.3.9.4 | EV Substance Code | SUB25360 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F |
D.3.9.4 | EV Substance Code | SUB25359 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F |
D.3.9.4 | EV Substance Code | SUB20582 |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F |
D.3.9.4 | EV Substance Code | SUB25326 |
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 | 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) | 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 |