Enzepi
Withdrawn
This medicine's authorisation has been withdrawn
pancreas powder
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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Assessment Report (EPAR) for Enzepi is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
T/01
02/09/2016
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).
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. enzymesTherapeutic 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.
News on Enzepi
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