Overview
The marketing authorisation for Enzepi has been withdrawn at the request of the marketing authorisation holder.
Enzepi : EPAR - Summary for the public
Product information
Enzepi : EPAR - Product Information
Latest procedure affecting product information: T/01
02/09/2016
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Enzepi : EPAR - All Authorised presentations
Product details
- Name of medicine
- Enzepi
- Active substance
- pancreas powder
- International non-proprietary name (INN) or common name
- pancreas powder
- Therapeutic area (MeSH)
- Exocrine Pancreatic Insufficiency
- Anatomical therapeutic chemical (ATC) code
- A09AA02
Pharmacotherapeutic group
Digestives, incl. enzymesTherapeutic indication
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.
Assessment history
Enzepi : EPAR - Procedural steps taken and scientific information after authorisation