EMEA-000601-PIP01-09-M06

Table of contents

Key facts

Invented name
Votrient
Active substance
pazopanib
Therapeutic area
Oncology
Decision number
P/0333/2019
PIP number
EMEA-000601-PIP01-09-M06
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral formulation
Condition(s) / indication(s)
  • Treatment of Ewing sarcoma family of tumours
  • Treatment of non-rhabdomyosarcoma soft tissue sarcoma
  • Treatment of rhabdomyosarcoma
Route(s) of administration
Oral use
Contact for public enquiries
Novartis Europharm Limited
Switzerland
Tel. +41 613241111
E-mail: paediatric.enquiries@novartis.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000601-PIP01-09-M06
Compliance opinion date
24/07/2020
Compliance outcome
positive

Decision

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