Is Pancreas powder authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Pancreas powder.

Is Pancreas powder authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 2 products containing Pancreas powder, including NORZYME 10,000 GASTRO-RESISTANT CAPSULES, HARD; NORZYME 25,000 GASTRO-RESISTANT CAPSULES, HARD.

Active substance

Pancreas powder

EMA 1
UK MHRA 2

Open in the medicines table

EMA European Union — centrally authorised medicines

Enzepi Allergan Pharmaceuticals International Limited · Withdrawn · authorised 29 Jun 2016 · ATC A09AA02

Therapeutic indication (EMA)

Pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).Enzepi is indicated in infants, children, adolescents and adults.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
NORZYME 10,000 GASTRO-RESISTANT CAPSULES, HARD	PL 55789/0001	NORDMARK PHARMA GMBH	P
NORZYME 25,000 GASTRO-RESISTANT CAPSULES, HARD	PL 55789/0002	NORDMARK PHARMA GMBH	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.