Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
HALAVEN 0.44 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless aqueous solution. |
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 |
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.
Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
EU/1/11/678/001-004
Date of first authorisation: 17 March 2011
Date of latest renewal: 19 November 2015
| 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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