Is Budesonide micronised authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Budesonide micronised: Kinpeygo.

Is Budesonide micronised authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 2 products containing Budesonide micronised, including CORTIMENT 9 MG, PROLONGED RELEASE TABLETS; KINPEYGO 4 MG MODIFIED-RELEASE HARD CAPSULES.

Active substance

Budesonide micronised

EMA 1
UK MHRA 2

Open in the medicines table

EMA European Union — centrally authorised medicines

Kinpeygo Stada Arzneimittel AG · Authorised · authorised 15 Jul 2022 · ATC A07EA06

Therapeutic indication (EMA)

Kinpeygo is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g).

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
CORTIMENT 9 MG, PROLONGED RELEASE TABLETS	PL 03194/0113	FERRING PHARMACEUTICALS LIMITED	POM
KINPEYGO 4 MG MODIFIED-RELEASE HARD CAPSULES	PLGB 17225/0027	GENUS PHARMACEUTICALS HOLDINGS LIMITED	POM

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.