EMEA-001032-PIP02-17 - paediatric investigation plan
Macitentan
PIPHuman
Actelion Registration Ltd
Tel. +41 615656565
E-mail: clinical-trials-disclosure@its.jnj.com
P/0215/2017: EMA decision of 9 August 2017 on the granting of a product-specific waiver for macitentan (Opsumit), (EMEA-001032-PIP02-17)