ALOXI Solution for injection Ref.[8704] Active ingredients: Palonosetron

Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland

Product name and form

Aloxi 250 micrograms solution for injection.

Pharmaceutical Form
Solution for injection. Clear, colourless solution.

Qualitative and quantitative composition

Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).

Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Palonosetron	Palonosetron is a selective high-affinity receptor antagonist of the 5HT₃ receptor.

List of Excipients
Mannitol Disodium edetate Sodium citrate Citric acid monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections

Pack sizes and marketing

Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap.

Available in packs of 1 vial containing 5 ml of solution.

Marketing authorization holder

Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland

Marketing authorization dates and numbers

EU/1/04/306/001

Date of first authorisation: 22 March 2005
Date of latest renewal: 23 March 2010

Drugs

Drug	Countries
ALOXI	Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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