MHRA-100623-PIP01-22-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
Invented Name
  • Zejula
  • Zejula
  • Zejula
  • Zejula
PIP Number MHRA-100623-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Film coated tablet
  • Capsule, hard
  • Age appropriate oral liquid formulation
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
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
Compliance Check Decision Date
Compliance opinion date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):NIRAPARIB TOSYLATE MONOHYDRATE.pdf
Published Date 07/12/2022