EMEA-001304-PIP03-17
Key facts
| Invented name |
Ocaliva
|
| Active substance |
Obeticholic acid
|
| Therapeutic area |
Gastroentology-Hepatology
|
| Decision number |
P/0104/2018
|
| PIP number |
EMEA-001304-PIP03-17
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of non-alcoholic steatohepatitis (NASH)
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Intercept Pharma Ltd.
Tel.: +1 6195417227
E-mail: reginfo@interceptpharma.com |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|