Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
ORENCIA 50 mg solution for injection in pre-filled syringe.
ORENCIA 87.5 mg solution for injection in pre-filled syringe.
ORENCIA 125 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
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Solution for injection (injection) in pre-filled syringe. The solution is clear, colourless to pale yellow with a pH of 6.8 to 7.4. |
ORENCIA 50 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 50 mg of abatacept in 0.4 mL.
ORENCIA 87.5 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 87.5 mg of abatacept in 0.7 mL.
ORENCIA 125 mg solution for injection in pre-filled syringe: 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 |
|---|
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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 |
ORENCIA 50 mg solution for injection in pre-filled syringe:
0.4 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (white plunger).
Packs of 4 pre-filled syringes with needle guard.
ORENCIA 87.5 mg solution for injection in pre-filled syringe:
0.7 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (light blue plunger).
Packs of 4 pre-filled syringes with needle guard.
ORENCIA 125 mg solution for injection in pre-filled syringe:
One mL pre-filled syringe (type 1 glass) with flange extenders or one mL pre-filled syringe with an automatic needle safety guard and flange extenders (orange plunger).
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).
The type 1 glass syringe has a coated bromobutyl stopper and fixed stainless steel needle covered with a rigid needle shield.
Not all pack sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/07/389/004-010
EU/1/07/389/013-014
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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