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||
Allergan Pharmaceuticals International Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
02/09/2016 Enzepi - EMEA/H/C/002070 - T/01
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.