EMEA-001857-PIP02-20
Key facts
| Active substance |
Elafibranor
|
| Therapeutic area |
Gastroentology-Hepatology
|
| Decision number |
P/0295/2020
|
| PIP number |
EMEA-001857-PIP02-20
|
| Pharmaceutical form(s) |
Film-coated tablet
|
| Condition(s) / indication(s) |
Treatment of primary biliary cholangitis
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Ipsen Pharma
E-mail: elafibranor.enquiries@ipsen.com |
| Decision type |
W: decision granting a waiver in all age groups for all conditions or indications
|