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.
Therapeutic Indication
N/A
Therapeutic Area (MeSH)
ATC Code
A16AB11
ATC Item
taliglucerase alfa
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| taliglucerase alfa | N/A | Taliglucerase alfa |
EMA Name
Elelyso
Medicine Name
Elelyso
Aliases
N/ANo risk management plan link.
