MHRA-100024-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • LAROTRECTINIB
Invented Name
VITRAKVI
PIP Number MHRA-100024-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Oral solution
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Malignant neoplasms (except CNS tumours, haematopoietic and lymphoid tissue neoplasms
Route(s) of administration
  • Oral use
  • Gastric 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
09/10/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100024-PIP01-21-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LAROTRECTINIB.pdf
Published Date 14/04/2026