DECAPEPTYL SR Powder for suspension for injection Ref.[8222] Active ingredients: Triptorelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, United Kingdom

Product name and form

Decapeptyl SR 3 mg, powder for suspension for injection.

Pharmaceutical Form

Powder for suspension for injection, sustained release formulation.

Qualitative and quantitative composition

Triptorelin (I.N.N.) 4.2 mg, as triptorelin acetate.

The vial contains an overage to ensure that a dose of 3 mg is administered to the patient.

For a full list of excipients, see section 6.1.

Active Ingredient Description

Triptorelin is a decapeptide analogue of GnRH which initially stimulates release of pituitary gonadotropins.

List of Excipients

D,L-lactide/glycolide copolymer
Carmellose sodium
Polysorbate 80

Pack sizes and marketing

A type I, 5 mL capacity glass vial with an elastomer stopper and an aluminium cap containing the powder.

Type I, 3 mL capacity glass ampoule containing 2 mL of the suspension vehicle.

Box containing 1 vial and 1 ampoule with 1 syringe and 2 needles.

Marketing authorization holder

Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, United Kingdom

Marketing authorization dates and numbers

PL 34926/0002

Date of first authorisation: 29 December 1994
Date of last renewal: 13 September 2001


Drug Countries
DECAPEPTYL Austria, Australia, Ecuador, Spain, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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