HALAVEN Solution for injection Ref.[8567] Active ingredients: Eribulin mesylate

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Eisai GmbH, Lyoner StraรŸe 36, 60528 Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net

Product name and form

HALAVEN 0.44 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless aqueous solution.

Qualitative and quantitative composition

One ml contains eribulin mesilate equivalent to 0.44 mg eribulin.

Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin.

Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Eribulin mesylate

Eribulin is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.

List of Excipients

Ethanol anhydrous
Water for injections
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)

Pack sizes and marketing

5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 ml of solution.

5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 3 ml of solution.

The pack sizes are cartons of 1 or 6 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Eisai GmbH, Lyoner StraรŸe 36, 60528 Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net

Marketing authorization dates and numbers

EU/1/11/678/001-004

Date of first authorisation: 17 March 2011
Date of latest renewal: 19 November 2015

Drugs

Drug Countries
HALAVEN Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, United Kingdom, United States, South Africa

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