EMEA-002746-PIP01-20-M02 - paediatric investigation plan
Seltorexant
PIPHuman
Key facts
- Active Substance
- Seltorexant
- Therapeutic area
- Psychiatry
- Decision number
- P/0479/2023
- PIP number
- EMEA-002746-PIP01-20-M02
- Pharmaceutical form(s)
- Film-coated tablet
- Age-appropriate dosage form
- Condition(s) / indication(s)
- Treatment of major depressive disorder
- Route(s) of administration
- Oral use
- Contact for public enquiries
Janssen-Cilag International NV
E-mail: contact@janssen-emea.com
Tel: +40 744383413- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date