EMEA-001032-PIP01-10-M04
Key facts
| Invented name |
Opsumit
|
| Active substance |
Macitentan
|
| Therapeutic area |
Cardiovascular diseases
|
| Decision number |
P/0480/2021
|
| PIP number |
EMEA-001032-PIP01-10-M04
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Janssen-Cilag International NV
Email: clinical-trials-disclosure@actelion.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|