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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Enzepi has been withdrawn at the request of the marketing authorisation holder.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 02/09/2016

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

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating