CLOPIXOL Solution for injection Ref.[8463] 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 200 mg/ml solution for injection.

Clopixol Conc. 500 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, yellowish oil, practically free from particles.

Qualitative and quantitative composition

Clopixol Injection: Zuclopenthixol decanoate 200 mg/ml.

Clopixol Conc. Injection: Zuclopenthixol decanoate 500 mg/ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Zuclopenthixol

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

Pack sizes and marketing

Clopixol Injection

Ampoules containing 1 ml of 200 mg/ml zuclopenthixol decanoate in thin vegetable oil.

Pack size: 10 ampoules per box. 10 ml clear glass vials with a rubber stopper secured with an aluminium collar having a fliptop cap. Pack size: 1 vial per box.

Clopixol Conc. Injection

Ampoules containing 1 ml of 500 mg/ml zuclopenthixol decanoate in thin vegetable oil.

Pack size: 5 ampoules per box.

Marketing authorization holder

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

Marketing authorization dates and numbers

Clopixol Injection: PL 00458/0017
Clopixol Conc. Injection: PL 00458/0060

Date of First Authorisation in the UK:

Clopixol Injection: 15 May 1978
Clopixol Conc. Injection: 21 November 1988

Renewal of the Authorisation:

Clopixol Injection: 3 July 2008
Clopixol Conc. Injection: 3 July 2008

Drugs

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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