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||
Clonshaugh Business Technology Park
02/09/2016 Enzepi - EMEA/H/C/002070 - T/01
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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).
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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.