Enzepi

RSS
Withdrawn

This medicine's authorisation has been withdrawn

pancreas powder
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Enzepi has been withdrawn at the request of the marketing authorisation holder.

Enzepi : EPAR - Summary for the public

Reference Number: EMA/340098/2016

English (EN) (539.75 KB - PDF)

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български (BG) (621.78 KB - PDF)

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español (ES) (540.43 KB - PDF)

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čeština (CS) (604.89 KB - PDF)

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dansk (DA) (536.24 KB - PDF)

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Deutsch (DE) (543.01 KB - PDF)

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eesti keel (ET) (535.46 KB - PDF)

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ελληνικά (EL) (625.77 KB - PDF)

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français (FR) (541.13 KB - PDF)

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hrvatski (HR) (559.2 KB - PDF)

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italiano (IT) (540.18 KB - PDF)

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latviešu valoda (LV) (594.41 KB - PDF)

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lietuvių kalba (LT) (562 KB - PDF)

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magyar (HU) (597.75 KB - PDF)

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Malti (MT) (606.17 KB - PDF)

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Nederlands (NL) (1003.58 KB - PDF)

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polski (PL) (603.85 KB - PDF)

First published: 19/07/2016Last updated: 19/07/2016
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português (PT) (540.48 KB - PDF)

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română (RO) (564.35 KB - PDF)

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slovenčina (SK) (603.73 KB - PDF)

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slovenščina (SL) (597.53 KB - PDF)

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Suomi (FI) (535.49 KB - PDF)

First published: 19/07/2016Last updated: 19/07/2016
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svenska (SV) (537.16 KB - PDF)

First published: 19/07/2016Last updated: 19/07/2016
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Product information

Enzepi : EPAR - Product Information

English (EN) (903.05 KB - PDF)

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български (BG) (1.75 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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español (ES) (931.36 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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čeština (CS) (1.44 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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dansk (DA) (906.51 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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Deutsch (DE) (930.41 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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eesti keel (ET) (976.01 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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ελληνικά (EL) (1.83 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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français (FR) (935.97 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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hrvatski (HR) (973.31 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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íslenska (IS) (912.11 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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italiano (IT) (925.82 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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latviešu valoda (LV) (1.51 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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lietuvių kalba (LT) (1012.36 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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magyar (HU) (1.45 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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Malti (MT) (1.5 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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Nederlands (NL) (1.53 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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norsk (NO) (952.94 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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polski (PL) (1.49 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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português (PT) (913.38 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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română (RO) (1.02 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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slovenčina (SK) (1.45 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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slovenščina (SL) (1.41 MB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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Suomi (FI) (901.4 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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svenska (SV) (907.25 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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Latest procedure affecting product information: T/01
02/09/2016
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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).

Enzepi : EPAR - All Authorised presentations

English (EN) (519.69 KB - PDF)

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български (BG) (596.25 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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español (ES) (520.37 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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čeština (CS) (561.4 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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dansk (DA) (514.95 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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Deutsch (DE) (527.99 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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eesti keel (ET) (520.86 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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ελληνικά (EL) (565.89 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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français (FR) (536.94 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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hrvatski (HR) (551.61 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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íslenska (IS) (522.31 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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italiano (IT) (519.21 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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latviešu valoda (LV) (567.89 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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lietuvių kalba (LT) (562.34 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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magyar (HU) (584.06 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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Malti (MT) (561.52 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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Nederlands (NL) (975.32 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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norsk (NO) (509.71 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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polski (PL) (559.86 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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português (PT) (521.29 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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română (RO) (548.73 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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slovenčina (SK) (583.82 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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slovenščina (SL) (542.36 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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Suomi (FI) (516.06 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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svenska (SV) (512.27 KB - PDF)

First published: 19/07/2016Last updated: 14/08/2017
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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 Ltd

Clonshaugh Business Technology Park
Coolock
Dublin
D17 E400
Ireland

Marketing authorisation issued
29/06/2016
Revision
1

Assessment history

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

Reference Number: EMA/609014/2016

English (EN) (519.71 KB - PDF)

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Enzepi : EPAR - Public assessment report

AdoptedReference Number: EMA/340098/2016

English (EN) (2.93 MB - PDF)

First published:
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CHMP summary of opinion for Enzepi

AdoptedReference Number: EMA/CHMP/291219/2016

English (EN) (537.39 KB - PDF)

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More information on Enzepi

Public statement on Enzepi: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/473867/2017

English (EN) (64.83 KB - PDF)

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