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

Key Facts

Active Substance
Active Substance:
  • NIRAPARIB TOSYLATE MONOHYDRATE
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
Yes
Compliance Check Decision Date
Compliance opinion date
03/10/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100623-PIP01-22-M01-C1

Decision Document

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