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

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.