INTEGRILIN Solution for infusion Ref.[8874] Active ingredients: Eptifibatide

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

INTEGRILIN 0.75 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless solution.

Qualitative and quantitative composition

Each ml of solution for infusion contains 0.75 mg of eptifibatide.

One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Eptifibatide

Eptifibatide is an inhibitor of platelet aggregation and belongs to the class of RGD (arginine-glycine-aspartate)-mimetics. Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to the glycoprotein (GP) IIb/IIIa receptors.

List of Excipients

Citric acid monohydrate
Sodium hydroxide
Water for injections

Pack sizes and marketing

One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

EU/1/99/109/001

Date of first authorisation: 01.07.1999
Date of latest renewal: 09.07.2009

Drugs

Drug Countries
INTEGRILIN Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa

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