PHENERGAN Solution for injection Ref.[7736] Active ingredients: Promethazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Product name and form

Phenergan 25mg/ml Solution for Injection.

Pharmaceutical Form

Solution for injection.

Phenergan Injection is a clean, bright, colourless or almost colourless solution.

Qualitative and quantitative composition

Each ampoule contains 25mg/ml of the active substance Promethazine hydrochloride.

Also contains 0.5mg of sodium sulphite anhydrous (E221) and 0.7mg of sodium metabisulphite (E223).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Promethazine

Promethazine is a potent, long acting, antihistamine with additional anti-emetic central sedative and anti-cholinergic properties.

List of Excipients

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

Pack sizes and marketing

Cardboard carton containing either 10 × 1 ml ampoules or 10 × 2 ml ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization dates and numbers

PL 04425/0648

Date of first authorisation: 16 March 1973
Date of latest renewal: 29 July 2002

Drugs

Drug Countries
PHENERGAN France, Ireland, Israel, Malta, New Zealand, Tunisia, United Kingdom, United States

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