ORENCIA Powder for concentrate for solution for infusion Ref.[6045] 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 250 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

The powder is a white to off-white whole or fragmented cake.

Qualitative and quantitative composition

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

Maltose
Sodium dihydrogen phosphate monohydrate
Sodium chloride

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/07/389/001-003

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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