EMEA-002566-PIP01-19-M01 - paediatric investigation plan
(R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one (SAR442168)
PIPHuman
Key facts
- Active Substance
- (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one (SAR442168)
- Therapeutic area
- Nervous system disorders
- Decision number
- P/0019/2024
- PIP number
- EMEA-002566-PIP01-19-M01
- Pharmaceutical form(s)
- Film-coated tablet
- Condition(s) / indication(s)
- Treatment of multiple sclerosis
- Route(s) of administration
- Oral use
- Contact for public enquiries
Sanofi Winthrop Industrie
Email: eumedinfo.gz@sanofi.com
Tel. +31 (0)202453917- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date