Enzepi

pancreas powder

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The marketing authorisation for Enzepi has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Enzepi : EPAR - Summary for the public BG = bălgarski 2016-07-19  
Enzepi : EPAR - Summary for the public ES = español 2016-07-19  
Enzepi : EPAR - Summary for the public CS = čeština 2016-07-19  
Enzepi : EPAR - Summary for the public DA = dansk 2016-07-19  
Enzepi : EPAR - Summary for the public DE = Deutsch 2016-07-19  
Enzepi : EPAR - Summary for the public ET = eesti keel 2016-07-19  
Enzepi : EPAR - Summary for the public EL = elliniká 2016-07-19  
Enzepi : EPAR - Summary for the public EN = English 2016-07-19  
Enzepi : EPAR - Summary for the public FR = français 2016-07-19  
Enzepi : EPAR - Summary for the public IT = italiano 2016-07-19  
Enzepi : EPAR - Summary for the public LV = latviešu valoda 2016-07-19  
Enzepi : EPAR - Summary for the public LT = lietuvių kalba 2016-07-19  
Enzepi : EPAR - Summary for the public HU = magyar 2016-07-19  
Enzepi : EPAR - Summary for the public MT = Malti 2016-07-19  
Enzepi : EPAR - Summary for the public NL = Nederlands 2016-07-19  
Enzepi : EPAR - Summary for the public PL = polski 2016-07-19  
Enzepi : EPAR - Summary for the public PT = português 2016-07-19  
Enzepi : EPAR - Summary for the public RO = română 2016-07-19  
Enzepi : EPAR - Summary for the public SK = slovenčina 2016-07-19  
Enzepi : EPAR - Summary for the public SL = slovenščina 2016-07-19  
Enzepi : EPAR - Summary for the public FI = suomi 2016-07-19  
Enzepi : EPAR - Summary for the public SV = svenska 2016-07-19  
Enzepi : EPAR - Summary for the public HR = Hrvatski 2016-07-19  

This EPAR was last updated on 19/07/2016 .

Authorisation details

Product details

Product details for Enzepi
NameEnzepi
Agency product numberEMEA/H/C/002070
Active substance

pancreas powder

International non-proprietary name (INN) or common name

pancreas powder

Therapeutic area Exocrine Pancreatic Insufficiency
Anatomical therapeutic chemical (ATC) code A09AA02
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Enzepi
Marketing-authorisation holder

Allergan Pharmaceuticals International Ltd

Revision1
Date of issue of marketing authorisation valid throughout the European Union29/06/2016

Contact address:

Clonshaugh Business & Technology Park
Coolock
Dublin
D17 E400
Ireland

Product information

Product information

02/09/2016  Enzepi -EMEA/H/C/002070 -T/01

Name Language First published Last updated
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2017-08-14

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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.


Name Language First published Last updated
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2017-08-14

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Enzepi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-09-16  

Initial marketing-authorisation documents

Name Language First published Last updated
Enzepi : EPAR - Public assessment report HR = Hrvatski 2016-07-19  
CHMP summary of opinion for Enzepi HR = Hrvatski 2016-04-29  

Withdrawn

This medicine is now withdrawn from use in the European Union

Related information

More information on Enzepi