EMEA-002463-PIP01-18-M02 - paediatric investigation plan
dostarlimab
PIPHuman
Key facts
- Invented name
- Jemperli
- Active Substance
- dostarlimab
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0260/2024
- PIP number
- EMEA-002463-PIP01-18-M02
- Pharmaceutical form(s)
- Solution for infusion
- Condition(s) / indication(s)
- Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
GlaxoSmithKline (Ireland) Limited
E-mail: eu.paediatric-plans@gsk.com
Tel: +1 4388998201- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date