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
E-mail: contact@nl.astellas.com

Decision type
W: decision granting a waiver in all age groups for all conditions or indications

Decision

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