SUPRECUR Solution for injection Ref.[28032] Active ingredients: Buserelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom

Product name and form

Suprecur Injection.

Pharmaceutical Form

Solution for Injection.

Qualitative and quantitative composition

Suprecur Injection contains 1.00mg buserelin as buserelin acetate in 1ml aqueous solution.

1.00mg buserelin is equivalent to 1.05mg buserelin acetate.

Suprecur Injection also contains 10mg benzyl alcohol in 1ml aqueous solution. For full list of excipients, see section 6.1.

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 Ph.Eur.
Sodium dihydrogen phosphate BP.
Sodium hydroxide BP.
Benzyl alcohol BP.
Water for Injections Ph. Eur.

Pack sizes and marketing

Box of 2 × 5.5 ml multidose vials each containing 1.05 mg buserelin acetate per 1 ml, corresponding to 1.00 mg buserelin per 1 ml.

Marketing authorization holder

Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom

Marketing authorization dates and numbers

PL 45043/0051

23 April 2002

Drugs

Drug Countries
SUPRECUR Austria, Estonia, Japan, Malta, United Kingdom

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