EMEA-002268-PIP02-18

Key facts

Invented name
Zejula
Active substance
Niraparib (tosylate monohydrate)
Therapeutic area
Oncology
Decision number
P/0313/2019
PIP number
EMEA-002268-PIP02-18
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

Tel.: +44 2089903836
E-mail: eu.paediatric-plans@gsk.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

How useful was this page?

Add your rating