Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
ORENCIA 250 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
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Powder for concentrate for solution for infusion. The powder is a white to off-white whole or fragmented cake. |
Each vial contains 250 mg of abatacept. Each mL contains 25 mg of abatacept, after reconstitution.
Abatacept is a fusion protein produced by recombinant DNA technology in Chinese hamster ovary cells.
Excipient with known effect: sodium: 0.375 mmol (8.625 mg) per vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Abatacept |
Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1). Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28. |
| List of Excipients |
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Maltose |
Powder in a vial (15 mL Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium) with a silicone-free syringe (polyethylene).
Pack of 1 vial and 1 silicone-free syringe, and multipacks containing 2, or 3 vials and 2, or 3 siliconefree syringes (2 or 3 packs of 1).
Not all pack-sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
EU/1/07/389/001-003
Date of first authorisation: 21 May 2007
Date of latest Renewal: 21 May 2012
| Drug | Countries | |
|---|---|---|
| ORENCIA | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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