CLOPIXOL ACUPHASE Solution for injection Ref.[51054] Active ingredients: Zuclopenthixol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Lundbeck Limited, Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, United Kingdom

Product name and form

Clopixol-Acuphase 50 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, yellowish oil, practically free from particles.

Qualitative and quantitative composition

Zuclopenthixol acetate 50 mg/ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description

Zuclopenthixol is a potent neuroleptic of the thioxanthene series with a piperazine side-chain. The antipsychotic effect of neuroleptics is related to their dopamine receptor blocking effect.

List of Excipients

Thin vegetable oil (derived from coconuts)

Pack sizes and marketing

Clear glass ampoules containing 1 mL of zuclopenthixol acetate 5% w/v in thin vegetable oil.

The ampoules are packed in boxes of 5.

Marketing authorization holder

Lundbeck Limited, Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, United Kingdom

Marketing authorization dates and numbers

PL 00458/0063

Date of First Authorisation in the UK: 16 March 1990
Renewal of the Authorisation: 3 July 2008


Drug Countries
CLOPIXOL Australia, Brazil, Canada, Cyprus, Germany, Spain, France, Hong Kong, Ireland, Israel, Malta, Mexico, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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