Table of contents
The marketing authorisation for Enzepi has been withdrawn at the request of the marketing authorisation holder.
Enzepi : EPAR - Summary for the public (PDF/539.75 KB)
First published: 19/07/2016
Last updated: 19/07/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Exocrine Pancreatic Insufficiency
|Anatomical therapeutic chemical (ATC) code||
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
Allergan Pharmaceuticals International Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
Clonshaugh Business Technology Park
02/09/2016 Enzepi - EMEA/H/C/002070 - T/01
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Digestives, incl. enzymes
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.