This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug FASLODEX contains one active pharmaceutical ingredient (API):
1
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UNII
22X328QOC4 - FULVESTRANT
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Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol. Fulvestrant blocks the trophic actions of estrogens without any partial agonist (estrogen-like) activity. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| FASLODEX 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 | |
|---|---|---|
| L02BA03 | Fulvestrant | L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents → L02BA Anti-estrogens |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 502301601151212, 502314100023503 |
| CA | Health Products and Food Branch | 02248624 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 878-MEE-0315 |
| EE | Ravimiamet | 1203264, 1501906 |
| ES | Centro de información online de medicamentos de la AEMPS | 03269001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 099215 |
| FR | Base de données publique des médicaments | 63545028 |
| GB | Medicines & Healthcare Products Regulatory Agency | 186712, 368014 |
| HK | Department of Health Drug Office | 57103 |
| IE | Health Products Regulatory Authority | 88501, 88793, 89030 |
| JP | 医薬品医療機器総合機構 | 4291421G1020 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1028397, 1059625 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 197M2005 |
| NL | Z-Index G-Standaard | 14921596 |
| NL | Z-Index G-Standaard, PRK | 74934 |
| NZ | Medicines and Medical Devices Safety Authority | 11807 |
| PL | Rejestru Produktów Leczniczych | 100125780 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W64402001, W64402002 |
| SG | Health Sciences Authority | 13216P |
| TN | Direction de la Pharmacie et du Médicament | 7973031H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699786950023, 8699786950030 |
| US | FDA, National Drug Code | 0310-0720 |
| ZA | Health Products Regulatory Authority | A38/21.12/0656 |
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