BUSCOPAN Solution for injection Ref.[50883] Active ingredients: Butylscopolamine

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France

Product name and form

Buscopan Ampoules 20 mg/ml Solution for Injection.

Pharmaceutical Form
Solution for Injection. A colourless or almost colourless, clear solution.

Qualitative and quantitative composition

Each 1 ml ampoule contains 20 mg Hyoscine Butylbromide.

For a full list of excipients, see section 6.1.

Active Ingredient	Description
Butylscopolamine	Butylscopolamine is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.

List of Excipients
Sodium chloride Water for injections

Pack sizes and marketing

1 ml clear glass (Ph. Eur. Type I) ampoules with coloured identification rings, marketed in cartons containing 10 ampoules.

Marketing authorization holder

Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France

Marketing authorization dates and numbers

PA23180/016/001

Date of first authorisation: 1^st April 1979
Date of last renewal: 1^st April 2009

Drugs

Drug	Countries
BUSCOPAN	Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Finland, Hong Kong, Croatia, Ireland, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom

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