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
|