ALOXI Soft capsule Ref.[8703] Active ingredients: Palonosetron

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

Product name and form

Aloxi 500 micrograms soft capsules.

Pharmaceutical Form

Soft capsule.

Plain, light beige, opaque, round to oval, soft gelatine capsules, filled with a clear yellowish solution.

Qualitative and quantitative composition

Each capsule contains 500 micrograms palonosetron (as hydrochloride).

Excipient(s): Each capsule contains 7 mg sorbitol.

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

Capsule content:

Glycerol monocaprylocaproate (type I)
Polyglycerol oleate
Glycerol
Purified water
Butylhydroxyanisole

Capsule shell:

Gelatin
Sorbitol
Glycerol
Titanium dioxide

Pack sizes and marketing

Polyamide/aluminium/PVC blister containing one or five soft capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Helsinn Birex Pharmaceuticals Limited, Damastown, Mulhuddart, Dublin 15, Ireland

Marketing authorization dates and numbers

EU/1/04/306/003
EU/1/04/306/002

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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