EMEA-001032-PIP03-19

Table of contents

Key facts

Invented name
Opsumit
Active substance
Macitentan
Therapeutic area
Cardiovascular diseases
Decision number
P/0242/2021
PIP number
EMEA-001032-PIP03-19
Pharmaceutical form(s)
  • Film-coated tablet
  • Dispersible tablet
Condition(s) / indication(s)
Treatment of functional single ventricle heart disease with total cavo-pulmonary connection
Route(s) of administration
Oral use
Contact for public enquiries
Janssen-Cilag International N.V.

E-mail:clinical-trials-disclosure@its.jnj.com 
Tel. +41 615656565

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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