MHRA-100609-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • LENVATINIB MESILATE
Invented Name
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
PIP Number MHRA-100609-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of papillary thyroid cancer and follicular thyroid cancer
  • Treatment of osteosarcoma
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
18/10/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100609-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LENVATINIB MESILATE.pdf
Published Date 01/05/2026