Enzepi

Withdrawn

This medicine's authorisation has been withdrawn

pancreas powder

Overview

On 19 July 2017, the European Commission withdrew the marketing authorisation for Enzepi (pancreas powder) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Allergan Pharmaceuticals International Ltd, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Enzepi was granted marketing authorisation in the EU on 29 June 2016 as an enzyme replacement treatment for exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. The marketing authorisation was initially valid for a 5-year period. There is no impact on patients expected as Enzepi was not commercially available in Europe. 

The European Public Assessment Report (EPAR) for Enzepi is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Enzepi : EPAR - Summary for the public

Reference Number: EMA/340098/2016

Product information

Enzepi : EPAR - Product Information

Enzepi : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Enzepi
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002070
• Marketing authorisation holder:
  Allergan Pharmaceuticals International Limited

  Clonshaugh Industrial Estate; Coolock; Dublin 17; Ireland

• Marketing authorisation issued:
  29/06/2016
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Enzepi : EPAR - Procedural steps taken and scientific information after authorisation

Reference Number: EMA/609014/2016

Initial marketing authorisation documents

Enzepi : EPAR - Public assessment report

Adopted Reference Number: EMA/340098/2016

CHMP summary of opinion for Enzepi

Adopted Reference Number: EMA/CHMP/291219/2016