Angiox 250mg powder for concentrate for solution for injection or infusion

Active ingredients: Bivalirudin

Product name and form

Angiox 250 mg powder for concentrate for solution for injection or infusion.

Pharmaceutical Form

Powder for concentrate for solution for injection or infusion.

White to off-white lyophilised powder.

Qualitative and quantitative composition

Each vial contains 250 mg bivalirudin.

After reconstitution 1 ml contains 50 mg bivalirudin.

After dilution 1 ml contains 5 mg bivalirudin.

For a full list of excipients see section 6.1.

Active Ingredient
Description

Bivalirudin is a direct and specific thrombin inhibitor that binds both to the catalytic site and the anion-binding exosite of fluid-phase and clot-bound thrombin.

List of Excipients

Mannitol
Sodium hydroxide solution (for pH adjustment)

Pack sizes and marketing

Angiox is supplied as a lyophilised powder in 10 ml single use glass vials (Type 1) closed with a butyl rubber stopper and sealed with a crimped aluminum seal.

Angiox is available in packs of 10 vials.

Marketing Authorization Holder
Authorization Dates

The Medicines Company UK Ltd
115L Milton Park
Abingdon
Oxfordshire
OX14 4SA
UNITED KINGDOM

20.09.2004/20.09.2009

Marketing authorization number:

EU/1/04/289/001

Drugs

Drug
Countries
Lithuania