MHRA-100623-PIP01-22-M03 (update)

Key Facts

Active Substance
Active Substance:
  • NIRAPARIB TOSYLATE MONOHYDRATE
Invented Name
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
PIP Number MHRA-100623-PIP01-22-M03 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Tablet
  • Oral suspension
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoetic 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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100623-PIP01-22-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):NIRAPARIB TOSYLATE MONOHYDRATE.pdf
Published Date 10/04/2026