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 125 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection) in pre-filled syringe. The solution is clear, colorless to pale yellow with a pH of 6.8 to 7.4. |
Each pre-filled syringe contains 125 mg of abatacept in one mL.
Abatacept is a fusion protein produced by recombinant DNA technology in Chinese hamster ovary cells.
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 |
|---|
|
Sucrose |
One mL pre-filled syringe (Type 1 glass) with flange extenders or one mL pre-filled syringe with a passive needle safety guard and flange extenders. The Type 1 glass syringe has a coated stopper and fixed stainless steel needle covered with a rigid needle shield.
Packs of 1 or 4 pre-filled syringes and multipack containing 12 pre-filled syringes (3 packs of 4).
Packs of 1, 3 or 4 pre-filled syringes with needle guard and multipack containing 12 pre-filled syringes with needle guard (3 packs of 4).
Not all pack-sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
EU/1/07/389/004-010
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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