ZOFRAN Suppositories Ref.[7028] Active ingredients: Ondansetron

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Product name and form

Zofran Suppositories 16 mg.

Pharmaceutical Form
White torpedo shaped suppositories.

Qualitative and quantitative composition

Each suppository contains 16 mg of ondansetron.

Active Ingredient	Description
Ondansetron	Ondansetron is a potent, highly selective 5HT₃ receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known.

List of Excipients
Witepsol S58.

Pack sizes and marketing

Each suppository is in an individually sealed cavity enclosed in a perforated cardboard mount and packed into a carton.

Marketing authorization holder

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Marketing authorization dates and numbers

PL 00101/0979

Date of first authorisation: 16 January 1997
Date of latest renewal: 15 January 2002

Drugs

Drug	Countries
ZOFRAN	Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, Poland, Singapore, Turkey, United Kingdom, United States, South Africa

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