DEPIXOL Solution for injection Ref.[8630] Active ingredients: Flupentixol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Lundbeck Limited, Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, UK

Product name and form

Depixol Low Volume 200 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, yellowish oil, practically free from particles.

Oily solution for deep intramuscular injection.

Qualitative and quantitative composition

200 mg/ml flupentixol decanoate in thin vegetable oil.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Flupentixol
List of Excipients

Thin vegetable oil ‘Viscoleo’ (fractionated coconut oil)

Pack sizes and marketing

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

Pack size: 5 ampoules per carton.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 0458/0065

Date of First Authorisation in the UK: 23 October 1991
Renewal of the Authorisation: 09 November 2010

Drugs

Drug Countries
DEPIXOL Ireland, Malta, New Zealand, United Kingdom

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