DECAPEPTYL SR Powder and solvent for suspension for injection Ref.[8219] Active ingredients: Triptorelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Ipsen Limited, 190 Bath Road, Slough SL1 3XE, United Kingdom

Product name and form

Decapeptyl SR 22.5 mg powder and solvent for suspension for injection.

Pharmaceutical Form

Powder and solvent for suspension for injection, sustained release formulation.

Powder: White to off-white powder.

Solvent: Clear solution.

Qualitative and quantitative composition

Triptorelin (I.N.N) 28 mg as triptorelin pamoate.

The vial contains an overage to ensure that a dose of 22.5 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


Poly (d,l-lactide-co-glycolide)
Carmellose sodium
Polysorbate 80


Water for injections

Pack sizes and marketing

6 mL septum vial with bromobutyl stopper and aluminium flip-off cap.

Ampoule containing 2 mL of sterile solvent for suspension.

Box of: 1 vial, 1 ampoule and 1 blister containing 1 injection syringe and 2 injection needles.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 34926/0013

14 Sept 2010


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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