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 | GARDASIL®9 (9vHPV vaccine) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | MSD VACCINS |
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 | 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 | HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 |
D.3.9.3 | Other descriptive name | HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA |
D.3.9.4 | EV Substance Code | SUB26773 |
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 | 30 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 |
D.3.9.3 | Other descriptive name | HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA |
D.3.9.4 | EV Substance Code | SUB26763 |
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 | 40 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 |
D.3.9.3 | Other descriptive name | HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA |
D.3.9.4 | EV Substance Code | SUB26769 |
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 | 60 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 |
D.3.9.3 | Other descriptive name | HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA |
D.3.9.4 | EV Substance Code | SUB26771 |
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 | 40 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 |
D.3.9.3 | Other descriptive name | HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA |
D.3.9.4 | EV Substance Code | SUB177597 |
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 | 20 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 |
D.3.9.3 | Other descriptive name | HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA |
D.3.9.4 | EV Substance Code | SUB177598 |
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 | 20 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 |
D.3.9.3 | Other descriptive name | HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA |
D.3.9.4 | EV Substance Code | SUB177599 |
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 | 20 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 |
D.3.9.3 | Other descriptive name | HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA |
D.3.9.4 | EV Substance Code | SUB177600 |
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 | 20 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 |
D.3.9.3 | Other descriptive name | HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA |
D.3.9.4 | EV Substance Code | SUB177601 |
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 | 20 |
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 | 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: 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 | mRNA-1273 SARS-CoV-2 vaccine |
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 | Dispersion 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 | Elasomeran |
D.3.9.3 | Other descriptive name | Elasomeran |
D.3.9.4 | EV Substance Code | SUB207171 |
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 | 50 |
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 |