Enzepi
pancreas powder
Table of contents
Overview
The marketing authorisation for Enzepi has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Enzepi
|
| Agency product number |
EMEA/H/C/002070
|
| 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
|
Additional monitoring |
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Allergan Pharmaceuticals International Ltd
|
| Revision |
1
|
| Date of issue of marketing authorisation valid throughout the European Union |
29/06/2016
|
| Contact address |
Clonshaugh Business Technology Park
Coolock Dublin D17 E400 Ireland |
Product information
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.
Pharmacotherapeutic group
Digestives, incl. enzymes
Therapeutic 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.