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 | Libtayo |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Regeneron Ireland Designated Activity Company |
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.3.1 | Product name | cemiplimab |
D.3.2 | Product code | REGN2810 |
D.3.4 | Pharmaceutical form | 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 | CEMIPLIMAB |
D.3.9.2 | Current sponsor code | REGN2810 |
D.3.9.4 | EV Substance Code | SUB189482 |
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 | 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) | 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 |
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 | 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 Type 16 E6/E7 synthetic long peptides vaccine |
D.3.2 | Product code | ISA101b |
D.3.4 | Pharmaceutical form | Powder 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 | H-Asp-Lys-Cys-Leu-Lys-Phe-Tyr-Ser-Lys-Ile-Ser-Glu-Tyr-Arg-His-Tyr-Cys-Tyr-Ser-Leu-Tyr-Gly-Thr-Thr-Leu-OH, trifluoroacetate salt |
D.3.9.1 | CAS number | 1218771-50-6 |
D.3.9.2 | Current sponsor code | D-3082-L TFA |
D.3.9.3 | Other descriptive name | D-3082-L TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124635 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Leu-Tyr-Cys-Tyr-Glu-Gln-Leu-Asn-Asp-Ser-Ser-Glu-Glu-Glu-Asp-Glu-Ile-Asp-Gly-Pro-Ala-Gly-Gln-Ala-Glu-Pro-Asp-Arg-Ala-His-Tyr-Asn-Ile-Val-Thr-OH, trif |
D.3.9.1 | CAS number | 1218907-64-2 |
D.3.9.2 | Current sponsor code | L-3972-T TFA |
D.3.9.3 | Other descriptive name | L-3972-T TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124637 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Met-His-Gly-Asp-Thr-Pro-Thr-Leu-His-Glu-Tyr-Met-Leu-Asp-Leu-Gln-Pro-Glu-Thr-Thr-Asp-Leu-Tyr-Cys-Tyr-Glu-Gln-Leu-Asn-Asp-Ser-Ser-Glu-Glu-Glu-OH, trif |
D.3.9.1 | CAS number | 1218907-32-4 |
D.3.9.2 | Current sponsor code | M-4148-E TFA |
D.3.9.3 | Other descriptive name | M-4148-E TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124638 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Arg-Cys-Ile-Asn-Cys-Gln-Lys-Pro-Leu-Cys-Pro-Glu-Glu-Lys-Gln-Arg-His-Leu-Asp-Lys-Lys-Gln-Arg-Phe-His-Asn-Ile-Arg-Gly-Arg-Trp-Thr-OH, trifluoroacetate |
D.3.9.1 | CAS number | 1218907-21-1 |
D.3.9.2 | Current sponsor code | R-4019-T TFA |
D.3.9.3 | Other descriptive name | R-4019-T TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124639 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Thr-Leu-Arg-Leu-Cys-Val-Gln-Ser-Thr-His-Val-Asp-Ile-Arg-Thr-Leu-Glu-Asp-Leu-Leu-Met-Gly-Thr-Leu-Gly-Ile-Val-Cys-Pro-Ile-Cys-Ser-Gln-Lys-Pro-NH2, tri |
D.3.9.1 | CAS number | 1218908-02-1 |
D.3.9.2 | Current sponsor code | T-3853-P TFA |
D.3.9.3 | Other descriptive name | T-3853-P TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124640 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Asp-Lys-Lys-Gln-Arg-Phe-His-Asn-Ile-Arg-Gly-Arg-Trp-Thr-Gly-Arg-Cys-Met-Ser-Cys-Cys-Arg-Ser-Ser-Arg-Thr-Arg-Arg-Glu-Thr-Gln-Leu-OH, trifluoroacetate |
D.3.9.1 | CAS number | 1218907-24-4 |
D.3.9.2 | Current sponsor code | D-3954-L TFA |
D.3.9.3 | Other descriptive name | D-3954-L TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124641 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-His-Tyr-Cys-Tyr-Ser-Leu-Tyr-Gly-Thr-Thr-Leu-Glu-Gln-Gln-Tyr-Asn-Lys-Pro-Leu-Cys-Asp-Leu-Leu-Ile-Arg-OH, trifluoroacetate salt |
D.3.9.1 | CAS number | 1218771-56-2 |
D.3.9.2 | Current sponsor code | H-3035-R TFA |
D.3.9.3 | Other descriptive name | H-3035-R TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124642 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Lys-Gln-Gln-Leu-Leu-Arg-Arg-Glu-Val-Tyr-Asp-Phe-Ala-Phe-Arg-Asp-Leu-Cys-Ile-Val-Tyr-Arg-Asp-Gly-Asn-OH, trifluoroacetate salt |
D.3.9.1 | CAS number | 1218771-40-4 |
D.3.9.2 | Current sponsor code | K-3118-N TFA |
D.3.9.3 | Other descriptive name | K-3118-N TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124643 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Leu-Pro-Gln-Leu-Cys-Thr-Glu-Leu-Gln-Thr-Thr-Ile-His-Asp-Ile-Ile-Leu-Glu-Cys-Val-Tyr-Cys-Lys-Gln-Gln-Leu-Leu-Arg-Arg-Glu-Val-Tyr-OH, trifluoroacetate |
D.3.9.1 | CAS number | 1218907-04-0 |
D.3.9.2 | Current sponsor code | L-3863-Y TFA |
D.3.9.3 | Other descriptive name | L-3863-Y TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124644 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Met-His-Gln-Lys-Arg-Thr-Ala-Met-Phe-Gln-Asp-Pro-Gln-Glu-Arg-Pro-Arg-Lys-Leu-Pro-Gln-Leu-Cys-Thr-Glu-Leu-Gln-Thr-Thr-Ile-His-Asp-OH, trifluoroacetate |
D.3.9.1 | CAS number | 1218907-00-6 |
D.3.9.2 | Current sponsor code | M-3878-D TFA |
D.3.9.3 | Other descriptive name | M-3878-D TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124645 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Arg-Asp-Leu-Cys-Ile-Val-Tyr-Arg-Asp-Gly-Asn-Pro-Tyr-Ala-Val-Cys-Asp-Lys-Cys-Leu-Lys-Phe-Tyr-Ser-Lys-Ile-OH, trifluoroacetate salt |
D.3.9.1 | CAS number | 1218771-49-3 |
D.3.9.2 | Current sponsor code | R-3083-I TFA |
D.3.9.3 | Other descriptive name | R-3083-I TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124646 |
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 | 100 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | H-Tyr-Gly-Thr-Thr-Leu-Glu-Gln-Gln-Tyr-Asn-Lys-Pro-Leu-Cys-Asp-Leu-Leu-Ile-Arg-Cys-Ile-Asn-Cys-Gln-Lys-Pro-Leu-Cys-Pro-Glu-Glu-Lys-OH, trifluoroacetate |
D.3.9.1 | CAS number | 1218907-20-0 |
D.3.9.2 | Current sponsor code | Y-3755-K TFA |
D.3.9.3 | Other descriptive name | Y-3755-K TRIFLUOROACETATE |
D.3.9.4 | EV Substance Code | SUB124647 |
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 | 100 |
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 |