Enzepi

RSS

pancreas powder

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Enzepi has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 17/02/2021

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 monitoringAdditional 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

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Product information documents contain:

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.

Assessment history

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