Elelyso

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taliglucerase alfa

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 3 July 2012, the Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of a marketing authorisation for the medicinal product Elelyso, intended for the treatment of type 1 Gaucher disease.

Following the CHMP recommendation, on 25 October 2012, the European Commission adopted a decision refusing the granting of a marketing authorisation.

This EPAR was last updated on 23/11/2012

Application details

Product details
Name
Elelyso
Active substance
Taliglucerase alfa
International non-proprietary name (INN) or common name
taliglucerase alfa
Therapeutic area (MeSH)
Gaucher Disease
Anatomical therapeutic chemical (ATC) code
A16AB11
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Application details
Marketing-autorisation applicant
Pfizer Ltd.   
Date of opinion
03/07/2012
Date of refusal of marketing authorisation
25/10/2012

Assessment history

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