EMEA-001411-PIP01-12-M04 - paediatric investigation plan
Sofosbuvir
ledipasvir
PIPHuman
Gilead Sciences International Ltd.
United Kingdom
Tel. +44 (0)1223 897300
Fax +44 (0)1223897284
E-mail: regulatory.pip@gilead.com
P/0063/2017: EMA decision of 17 March 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir / ledipasvir (Harvoni), (EMEA-001411-PIP01-12-M04)