This brand name is authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, South Africa, Spain, UK.
The drug FIRMAGON contains one active pharmaceutical ingredient (API):
1
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UNII
I18S89P20R - DEGARELIX ACETATE
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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. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| FIRMAGON Powder and solvent for solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L02BX02 | Degarelix | L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents → L02BX Other hormone antagonists and related agents |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 2784M, 2785N |
| BR | Câmara de Regulação do Mercado de Medicamentos | 521416070006103, 521416070006203 |
| CA | Health Products and Food Branch | 02337029, 02337037 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 4693-MEE-0419, 4791-MEE-0819 |
| EE | Ravimiamet | 1400599, 1400601, 1500398 |
| ES | Centro de información online de medicamentos de la AEMPS | 08504001, 08504002 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 040239, 040251 |
| FR | Base de données publique des médicaments | 63329030, 69784330 |
| GB | Medicines & Healthcare Products Regulatory Agency | 165924, 165927, 368020, 374374, 376648, 380745, 381339 |
| HK | Department of Health Drug Office | 61178, 61179 |
| IE | Health Products Regulatory Authority | 88363, 88364, 89093 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6672, 6673 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1036403, 1036404, 1058059 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 143M2009 |
| NL | Z-Index G-Standaard, PRK | 90328 |
| PL | Rejestru Produktów Leczniczych | 100102795, 100149220 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W54154001, W54155001 |
| SG | Health Sciences Authority | 14350P, 14351P |
| ZA | Health Products Regulatory Authority | 43/21.12/0918, 43/21.12/0920 |
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