ZOLADEX

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

Active ingredients

The drug ZOLADEX contains one active pharmaceutical ingredient (API):

1 Goserelin
UNII 6YUU2PV0U8 - GOSERELIN ACETATE

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.

Read about Goserelin

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
ZOLADEX Implant, in pre-filled syringe Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L02AE03 Goserelin L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02A Hormones and related agents → L02AE Gonadotropin releasing hormone analogues
Discover more medicines within L02AE03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 1454M, 8093Y
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 502320020033607, 502320020033707
Country: CA Health Products and Food Branch Identifier(s): 02049325, 02225905
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 21.293-1-07-04, 6060-MEE-0321
Country: EE Ravimiamet Identifier(s): 1002621
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 58603, 61367, R-7832
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 005363, 412049
Country: FR Base de données publique des médicaments Identifier(s): 66669173, 67037162
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 147364, 180698, 186210, 200328, 24811, 24817, 368902, 369183, 369185, 373940, 373952, 379748
Country: HK Department of Health Drug Office Identifier(s): 31178, 42691
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-247320153, HR-H-936480409
Country: IE Health Products Regulatory Authority Identifier(s): 88000, 88230, 88231, 88325, 88392, 88423, 88962
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 4312, 4313
Country: JP 医薬品医療機器総合機構 Identifier(s): 2499406G1025, 2499406G2021, 2499406G3028
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1002049, 1002050
Country: MT Medicines Authority Identifier(s): MA046/02801, MA046/02802
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 537M89
Country: NG Registered Drug Product Database Identifier(s): A4-5399
Country: NL Z-Index G-Standaard Identifier(s): 14304198, 14304201
Country: NL Z-Index G-Standaard, PRK Identifier(s): 26786, 41319
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 4650, 4652
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100074722, 100084413
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W65081001, W65082001
Country: SG Health Sciences Authority Identifier(s): 01506P, 09793P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 5683091H, 5683092H
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699786880016, 8699786880023
Country: US FDA, National Drug Code Identifier(s): 50090-3466, 70720-950, 70720-951

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