FIRMAGON Powder and solvent for solution for injection Ref.[8332] Active ingredients: Degarelix

Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, DK-2300, Copenhagen S, Denmark, Tel: +45 88 33 88 34

Product name and form

FIRMAGON 80 mg powder and solvent for solution for injection.

Pharmaceutical Form
Powder and solvent for solution for injection. Powder: White to off-white powder. Solvent: Clear, colourless solution.

Qualitative and quantitative composition

Each vial contains 80 mg degarelix (as acetate). After reconstitution, each ml of solution contains 20 mg of degarelix.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Degarelix	Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes.

List of Excipients
Powder: Mannitol (E421) Solvent: Water for injections

Pack sizes and marketing

Glass (type I) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 80 mg powder for solution for injection.

Pre-filled glass (type I) syringe with elastomer plunger stopper, tip cap and line-marking at 4 ml containing 4.2 ml solvent.

Plunger rod.

Vial adapter.

Injection needle (25G 0.5 × 25 mm).

Pack sizes

FIRMAGON is available in 2 pack-sizes:

Pack-size of 1 tray containing: 1 powder vial, 1 solvent pre-filled syringe, 1 plunger rod, 1 vial adapter and 1 needle.
Pack-size of 3 trays containing: 3 powder vials, 3 solvent pre-filled syringes, 3 plunger rods, 3 vial adapters and 3 needles.

Not all pack sizes may be marketed.

Marketing authorization holder

Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, DK-2300, Copenhagen S, Denmark, Tel: +45 88 33 88 34

Marketing authorization dates and numbers

EU/1/08/504/001
EU/1/08/504/003

Date of first authorisation: 17/02/2009
Date of latest renewal: 19/09/2013

Drugs

Drug	Countries
FIRMAGON	Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, United Kingdom, South Africa

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