KENGREXAL Powder for concentrate solution Ref.[6492] Active ingredients: Cangrelor

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Chiesi Farmaceutici S.p.A., Via Palermo, 26/A, 43122, Parma, Italy

Product name and form

Kengrexal 50 mg powder for concentrate for solution for injection/infusion.

Pharmaceutical Form

Powder for concentrate for solution for injection/infusion.

White to off-white lyophilised powder.

Qualitative and quantitative composition

Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor. After reconstitution 1 mL of concentrate contains 10 mg cangrelor. After dilution 1 mL of solution contains 200 micrograms cangrelor.

Excipient with known effect: Each vial contains 52.2 mg sorbitol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cangrelor

Cangrelor is a direct P2Y12 platelet receptor antagonist that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation in vitro and ex vivo. Cangrelor binds selectively and reversibly to the P2Y12 receptor to prevent further signalling and platelet activation.

List of Excipients

Mannitol
Sorbitol
Sodium hydroxide (for pH-adjustment)

Pack sizes and marketing

Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed with crimped aluminium seal.

Kengrexal is available in packs of 10 vials.

Marketing authorization holder

Chiesi Farmaceutici S.p.A., Via Palermo, 26/A, 43122, Parma, Italy

Marketing authorization dates and numbers

EU/1/15/994/001

Date of first authorisation: 23 March 2015

Drugs

Drug Countries
KENGREXAL Austria, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom

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