LARGACTIL Solution for injection Ref.[6918] Active ingredients: Chlorpromazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Ltd, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Largactil 25mg/ml Solution for Injection.

Pharmaceutical Form

Sterile solution for injection.

A clear, colourless or almost colourless solution.

Qualitative and quantitative composition

25mg/ml chlorpromazine hydrochloride.

For full list of excipients see section 6.1

Active Ingredient Description
Chlorpromazine

Chlorpromazine is a phenothiazine neuroleptic. Chlorpromazine has depressant actions on the Central Nervous System, with alpha-adrenergic blocking and anticholinergic activities. It has anti-emetic, anti-puritic, serotonin-blocking and weak anti-histamine properties and slight ganglion blocking activity.

List of Excipients

Sodium sulphite anhydrous (E221)
Sodium citrate
Sodium metabisulphite (E223)
Sodium chloride
Water for injections

Pack sizes and marketing

Largactil Injection 2.5% w/v is supplied in boxes containing 10 × 1 ml or 10 × 2 ml in glass ampoules.

Marketing authorization holder

Aventis Pharma Ltd, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0582

Date of First Authorisation: 24 April 2007

Drugs

Drug Countries
LARGACTIL Australia, Estonia, Spain, France, Lithuania, Malta, New Zealand, Tunisia, Turkey, United Kingdom

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