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Firmagon 80mg Injection (2012)

Active ingredients: Degarelix

Product Name and Form

FIRMAGON 80 mg powder and solvent for solution for injection.

Pharmaceutical form

Powder and solvent for solution for injection (Powder for injection and solvent).

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 a full list of excipients, see section 6.1.

Chemical substance
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

Vials of glass Type I with bromobutyl rubber stopper and aluminium flip-off seal.

1 vial containing 80 mg powder for solution for injection

1 vial containing 6 ml solvent

1 syringe (5 ml with dual-line marking 4.0 and 4.2 ml)

2 vial adapters

1 injection needle (25G 0.5 × 25 mm)

Pack sizes

1 pack containing 1 powder vial, 1 solvent vial, 1 syringe, 2 vial adapters and 1 needle.

3 pack containing 3x (1 powder vial, 1 solvent vial, 1 syringe, 2 vial adapters and 1 needle).

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
DK-2300 Copenhagen S
Denmark

Tel: +45 88 33 88 34

17/02/2009

Marketing authorization number:

EU/1/08/504/001

EU/1/08/504/003