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ORENCIA Powder for concentrate for solution for infusion (2017)

Active ingredients: Abatacept

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.

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

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
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/1/07/389/001-003