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ORENCIA Solution for injection (2017)

Active ingredients: Abatacept

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.

Chemical substance
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
Authorization dates

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

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

Marketing authorization number:

EU/1/07/389/004-010