MHRA-102115-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Olomorasib
Invented Name
Not yet available
PIP Number MHRA-102115-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the central nervous system
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Olomorasib.pdf
Published Date 04/03/2026