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SUPREFACT Injection (2018)

Active ingredients: Buserelin

Product Name and Form

Suprefact Injection.

Pharmaceutical form

Injection.

Qualitative and Quantitative Composition

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

1.00mg buserelin is equivalent to 1.05mg buserelin acetate.

Suprefact Injection also contains 10mg benzyl alcohol in 1ml aqueous solution.

For full list of excipients, see section 6.1.

Chemical substance
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
Sodium dihydrogen phosphate
Sodium hydroxide
Benzyl alcohol
Water for injections

Pack sizes and Marketing

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

Pack size: 2 individual cardboard boxes are wrapped together in a clear plastic outer.

Marketing authorization holder
Authorization dates

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

16 June 2006

Marketing authorization number:

PL 04425/0268