Key facts

Invented name
Zejula
Active Substance
Niraparib (tosilate monohydrate)
Therapeutic area
Oncology
Decision number
P/0184/2021
PIP number
EMEA-002268-PIP02-18-M01
Pharmaceutical form(s)
  • Film-coated tablet
  • Capsule (hard)
  • Age appropriate oral liquid formulation
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
Route(s) of administration
Oral use
Contact for public enquiries

GlaxoSmithKline (Ireland) Limited

E-mail: eu.paediatric-plans@gsk.com
Tel: +1 4388998201

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0184/2021 : EMA decision of 10 May 2021 on the acceptance of a modification of an agreed paediatric investigation plan for niraparib (tosylate monohydrate), (Zejula), (EMEA-002268-PIP02-18-M01)

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