SUPREFACT Nasal spray Ref.[6712] Active ingredients: Buserelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, 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

Suprefact Nasal Spray.

Pharmaceutical Form

Nasal spray.

Qualitative and quantitative composition

Suprefact nasal spray contains 100 micrograms buserelin as buserelin acetate in 1 spray dose of aqueous solution containing benzalkonium chloride as preservative.

100 micrograms buserelin is equivalent to 105 micrograms buserelin acetate.

Active Ingredient Description
Buserelin

Buserelin is a synthetic peptide. It is a superactive analogue of natural gonadotrophin releasing hormone (gonadorelin, LHRH or GNRH). After an initial stimulation of gonadotrophin release, it down-regulates the hypothalanic-pituitary-gonadal axis.

List of Excipients

Sodium chloride
Citric acid monohydrate
Sodium citrate dihydrate
Benzalkonium chloride
Water for injections

Pack sizes and marketing

Box of 4 bottles each containing 10g solution and 4 spray pumps.

Marketing authorization holder

Aventis Pharma Limited, 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 04425/0279

16 June 2006

Drugs

Drug Countries
SUPREFACT Austria, Brazil, Canada, Spain, Netherlands, Singapore, United Kingdom, South Africa

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