EMEA-001032-PIP03-19
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) |
|
| 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 |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|