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Therapeutic Ipilimumab antibody from the original Yervoy® commercial drug.
Showing all 2 results
ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
CTLA-4 |
Monoclonal Antibody |
Yervoy® |
5 mg/mL |
yes |
2 mg |
-80°C |
09/2024 |
848,00 € |
||
CTLA-4 |
Monoclonal Antibody |
Yervoy® |
5 mg/mL |
yes |
2 mg |
-80°C |
08/2021 |
763,20 € |
| Drug name | Yervoy® |
| INN | Ipilimumab |
| API type | Ipilimumab is a fully human anti-CTLA-4 monoclonal antibody (IgG1κ) produced in Chinese hamster ovary cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Antineoplastic agents, monoclonal antibodies |
| ATC code | L01XC11 |
| Target of antibody | CD152-CTLA4 |
| General function | Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a key regulator of T-cell activity. Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells. CTLA-4 blockade can also reduce T-regulatory cell function, which may contribute to an anti-tumour immune response. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Ipilimumab is an Antineoplastic agent, and may selectively deplete T-regulatory cells at the tumour site, leading to an increase in the intratumoral T-effector/ T-regulatory cell ratio which drives tumour cell death. |
| Original license holder | Bristol-Myers Squibb Pharma EEIG |
| Marketing authorisation numbers | EU/1/11/698/001-002 |
| Marketing authorisation holder | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland |
| Name of the manufacturer of the biological active substance | Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 United States Samsung Biologics Co. Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Korea |
| Name and address of the manufacturer(s) responsible for batch release | CATALENT ANAGNI S.R.L. Loc. Fontana del Ceraso snc Strada Provinciale 12 Casilina, 41 03012 Anagni (FR) Italy Swords Laboratories T/A Bristol-Myers Squibb Cruiserath Biologics Cruiserath Road, Mulhuddart Dublin 15, D15 H6EF Ireland |
| Max shelf life | 3 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Tris hydrochloride (2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride) Sodium chloride Mannitol (E421) Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80 Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment) |
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