Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Ferring Pharmaceuticals A/S, Amager Strandvej 405, 2770 Kastrup, Denmark, Tel: +45 88 33 88 34
FIRMAGON 80 mg powder and solvent for solution for injection.
FIRMAGON 120 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. |
FIRMAGON 80 mg powder and solvent for solution for injection: Each vial contains 80 mg degarelix (as acetate). After reconstitution, each ml of solution contains 20 mg of degarelix.
FIRMAGON 120 mg powder and solvent for solution for injection: Each vial contains 120 mg degarelix (as acetate). After reconstitution, each ml of solution contains 40 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 |
FIRMAGON 80 mg powder and solvent for solution for injection:
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).
FIRMAGON 120 mg powder and solvent for solution for injection:
Glass (type I) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 120 mg powder for solution for injection.
Pre-filled glass (type I) syringe with elastomer plunger stopper, tip cap and line-marking at 3 ml containing 3 ml solvent.
Plunger rods.
Vial adapters.
Injection needles (25G 0.5 × 25 mm).
FIRMAGON 80 mg powder and solvent for solution for injection:
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.
FIRMAGON 120 mg powder and solvent for solution for injection:
Pack-size of 2 trays containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters and 2 needles.
Not all pack sizes may be marketed.
Ferring Pharmaceuticals A/S, Amager Strandvej 405, 2770 Kastrup, Denmark, Tel: +45 88 33 88 34
FIRMAGON 80 mg powder and solvent for solution for injection:
EU/1/08/504/001
EU/1/08/504/003
FIRMAGON 120 mg powder and solvent for solution for injection:
EU/1/08/504/002
Date of first authorisation: 17/02/2009
Date of latest renewal: 13/11/2013
| 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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