Regulatory PathRegulatory requirements compared

Active substance

Buserelin

Open in the medicines table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
SUPREFACT022251661 MG / MLSOLUTION · SUBCUTANEOUSCHEPLAPHARM ARZNEIMITTEL GMBH

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
BUSERELIN 1 MG/ML SOLUTION FOR INJECTIONPL 45043/0051NEON HEALTHCARE LIMITEDPOM
SUPRECUR INJECTION 1 MG/ML SOLUTION FOR INJECTIONPL 45043/0051NEON HEALTHCARE LIMITEDPOM
SUPREFACT 1MG/ML INJECTIONPL 45043/0050NEON HEALTHCARE LIMITEDPOM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.