ABILIFY Solution for injection Ref.[7426] Active ingredients: Aripiprazole

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

Product name and form

ABILIFY 7.5 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless, aqueous solution.

Qualitative and quantitative composition

Each ml contains 7.5 mg of aripiprazole. Each vial contains 9.75 mg aripiprazole.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Aripiprazole

It has been proposed that aripiprazole’s efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism of serotonin 5-HT2A receptors.

List of Excipients

Sulfobutylether β-cyclodextrin (SBECD)
Tartaric acid
Sodium hydroxide
Water for injections

Pack sizes and marketing

Each carton contains one single-use type I glass vial with a rubber butyl stopper and a “tear-off” aluminium seal.

Marketing authorization holder

Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/04/276/036

Date of first authorisation: 04 June 2004
Date of latest renewal: 04 June 2009

Drugs

Drug Countries
ABILIFY Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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