EMEA-001619-PIP03-16-M02 - paediatric investigation plan
filgotinib
PIPHuman
Key facts
- Active Substance
- filgotinib
- Therapeutic area
- Gastrointestinal disorders
- Decision number
- P/0526/2023
- PIP number
- EMEA-001619-PIP03-16-M02
- Pharmaceutical form(s)
- Film-coated tablet
- Condition(s) / indication(s)
- Treatment of ulcerative colitis
- Route(s) of administration
- Oral use
- Contact for public enquiries
Alfasigma S.p.A.
E-mail: medicalinfo@glpg.com
Tel: +32 15342900- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date