EMEA-001824-PIP01-15
Key facts
| Active substance |
(R)-N-({5-[3-(2,5-Difluorophenyl)-2-(2,3-dihydro-1H-benzimidazol-2-ylidene)-3- oxopropanoyl]-2-fluorophenyl}sulfonyl)-2-hydroxypropanimidamide
|
| Therapeutic area |
Endocrinology, -gynacology-fertility-metabolism
|
| Decision number |
P/0292/2015
|
| PIP number |
EMEA-001824-PIP01-15
|
| Pharmaceutical form(s) |
Film-coated tablet
|
| Condition(s) / indication(s) |
Treatment of endometriosis
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Astellas Pharma Europe B.V.
Tel. +31 7154 55878 |
| Decision type |
W: decision granting a waiver in all age groups for all conditions or indications
|