ORENCIA Solution for injection Ref.[6071] Active ingredients: Abatacept

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

Product name and form

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.

Qualitative and quantitative composition

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
Poloxamer 188
Sodium dihydrogen phosphate monohydrate
Disodium phosphate anhydrous
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

Marketing authorization dates and numbers

EU/1/07/389/004-010

Date of first authorisation: 21 May 2007
Date of latest Renewal: 21 May 2012

Drugs

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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