EMEA-002268-PIP02-18-M01

Table of contents

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

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