EMEA-001032-PIP02-17
Key facts
| Invented name |
Opsumit
|
| Active substance |
Macitentan
|
| Therapeutic area |
Cardiovascular diseases
|
| Decision number |
P/0215/2017
|
| PIP number |
EMEA-001032-PIP02-17
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Actelion Registration Ltd
Tel. +41 615656565
E-mail: clinical-trials-disclosure@its.jnj.com |
| Decision type |
W: decision granting a waiver in all age groups for all conditions or indications
|