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