MHRA-101078-PIP01-23-M03 (update)

Key Facts

Active Substance
Active Substance:
  • OLAPARIB
Invented Name
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
PIP Number MHRA-101078-PIP01-23-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Tablet Age-appropriate oral solid dosage form
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).
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
18/08/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101078-PIP01-23-M03-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):OLAPARIB.pdf
Published Date 04/09/2026