Enzepi Withdrawal of the marketing authorisation in the European Union
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Assessment Report (EPAR) for Enzepi will be updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
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The validation period between submission date and start date is usually sixteen calendar days. (**) Comments from PRAC and CHMP members are not made available to Marketing Authorisation Holders. (***) An updated AR is optional and dependent on the co
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Oct 7, 2016 - Applications by marketing authorisation holders (MAHs). Guidance for ... Issues identified during validation will be notified to the MAH via email.
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