Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
OPDIVO 600 mg solution for injection.
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Solution for injection. Clear to opalescent, colourless to yellow liquid, essentially free of visible particulates. The solution has a pH of 5.5-6.5 and an osmolality of 296-444 mOsm/kg. |
Each mL of solution for injection contains 120 mg of nivolumab.
One vial of 5 mL contains 600 mg of nivolumab.
Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
Excipient with known effect:
Each 5 mL vial of this this medicinal product contains 2.5 mg of polysorbate 80.
| List of Excipients |
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Recombinant human hyaluronidase (rHuPH20) |
Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic orange flip-off cap containing 5 mL of solution for injection.
Pack of one vial.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/15/1014/005
Date of first authorisation: 19 June 2015
Date of latest renewal: 23 April 2020
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