EMEA-001119-PIP03-19-M03 - paediatric investigation plan
Lenvatinib
PIPHuman
Key facts
Invented name
Kisplyx
Lenvima
Active Substance
Lenvatinib
Therapeutic area
Oncology
Decision number
P/0528/2022
PIP number
EMEA-001119-PIP03-19-M03
Pharmaceutical form(s)
Capsule (hard)
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thyroid cancer, follicular thyroid cancer and osteosarcoma
PM: decision on the application for modification of an agreed PIP
Decision date
Decision
P/0528/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (Lenvima, Kisplyx), (EMEA-001119-PIP03-19-M03)