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Nivolumab / Opdivo®

   
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Opdivo

10 mg/ml
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Opdivo

10 mg/ml
Note: For full product details, please login.

Opdivo

10 mg/ml
Note: For full product details, please login.

Opdivo

10 mg/ml
Note: For full product details, please login.

Drug name: Opdivo®

INN: Nivolumab

API type: Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology.

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies

ATC code: L01XC17

General function:

Short description:

Original license holder:

Marketing authorisation numbers: EU/1/15/1014/001 - 002

Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG; Uxbridge Business Park; Sanderson Road Uxbridge UB8 1DH; United Kingdom

Name of the manufacturer of the biological active substance: Bristol-Myers Squibb Company; 6000 Thompson Road; East Syracuse, New York 13057; USA
Samsung Biologics Co. Ltd.; 125, Cheomdan-daero; Yeonsu-gu, Incheon, 21987; Korea

Name and address of the manufacturer responsible for batch release: Bristol-Myers Squibb S.r.l.; Loc. Fontana del Ceraso; 03012 Anagni (FR); Italy

Max shelf life: 24 months

Storage conditions: 2°C – 8°C

List of excipients: Sodium citrate dihydrate, Sodium chloride, Mannitol (E421), Pentetic acid (diethylenetriaminepentaacetic acid),Polysorbate 80, Sodium hydroxide (for pH adjustment), Hydrochloric acid (for pH adjustment), Water for injections