This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, Spain, Tunisia, Turkey, UK.
The drug ZOLADEX contains one active pharmaceutical ingredient (API):
1
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UNII
6YUU2PV0U8 - GOSERELIN ACETATE
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Goserelin is a synthetic analogue of naturally occurring LHRH. On chronic administration goserelin results in inhibition of pituitary LH secretion leading to a fall in serum testosterone concentrations in males and serum estradiol concentrations in females. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ZOLADEX Implant, in pre-filled syringe | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L02AE03 | Goserelin | L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02A Hormones and related agents → L02AE Gonadotropin releasing hormone analogues |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 1454M, 8093Y |
| BR | Câmara de Regulação do Mercado de Medicamentos | 502320020033607, 502320020033707 |
| CA | Health Products and Food Branch | 02049325, 02225905 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 21.293-1-07-04, 6060-MEE-0321 |
| EE | Ravimiamet | 1002621 |
| ES | Centro de información online de medicamentos de la AEMPS | 58603, 61367, R-7832 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 005363, 412049 |
| FR | Base de données publique des médicaments | 66669173, 67037162 |
| GB | Medicines & Healthcare Products Regulatory Agency | 147364, 180698, 186210, 200328, 24811, 24817, 368902, 369183, 369185, 373940, 373952, 379748 |
| HK | Department of Health Drug Office | 31178, 42691 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-247320153, HR-H-936480409 |
| IE | Health Products Regulatory Authority | 88000, 88230, 88231, 88325, 88392, 88423, 88962 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 4312, 4313 |
| JP | 医薬品医療機器総合機構 | 2499406G1025, 2499406G2021, 2499406G3028 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1002049, 1002050 |
| MT | Medicines Authority | MA046/02801, MA046/02802 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 537M89 |
| NG | Registered Drug Product Database | A4-5399 |
| NL | Z-Index G-Standaard | 14304198, 14304201 |
| NL | Z-Index G-Standaard, PRK | 26786, 41319 |
| NZ | Medicines and Medical Devices Safety Authority | 4650, 4652 |
| PL | Rejestru Produktów Leczniczych | 100074722, 100084413 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W65081001, W65082001 |
| SG | Health Sciences Authority | 01506P, 09793P |
| TN | Direction de la Pharmacie et du Médicament | 5683091H, 5683092H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699786880016, 8699786880023 |
| US | FDA, National Drug Code | 50090-3466, 70720-950, 70720-951 |
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