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REOPRO Solution for injection or infusion (2016)

Active ingredients: Abciximab

Product Name and Form

ReoPro 2 mg/mL solution for injection or infusion.

Pharmaceutical form

Solution for injection or infusion.

ReoPro is a colourless and clear liquid.

Qualitative and Quantitative Composition

ReoPro 2 mg/mL contains 10 mg abciximab in 5 mL water for injection.

Abciximab is the Fab fragment of a chimeric IgG1 monoclonal antibody manufactured from a recombinant cell line cultured by continuous perfusion.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Abciximab

Abciximab is the Fab fragment of the chimeric monoclonal antibody 7E3. It is directed against the glycoprotein (GP) IIb/IIIa (αIIbβ3) receptor located on the surface of human platelets. Abciximab inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor, and other adhesive molecules to GPIIb/IIIa receptor sites on activated platelets.

List of excipients

Water for injection
Disodium phosphate dihydrate
Sodium dihydrogen phosphate monohydrate
Sodium chloride
Polysorbate 80

Pack sizes and Marketing

ReoPro is supplied as a 5 mL solution in a type I borosilicate glass vial with a Teflon-coated rubber stopper and an aluminium crimp protected by a plastic cap in a pack size of one.

Marketing authorization holder
Authorization dates

Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands

Date of first authorisation: 23 March 1995
Date of last renewal of the authorisation: 22 March 2010

Marketing authorization number:

PL 08563/0015