EMEA-000601-PIP01-09-M06 - paediatric investigation plan

pazopanib

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. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/09/2019
• Compliance procedure number:
  EMEA-C-000601-PIP01-09-M06
• Compliance opinion date:
  24/07/2020
• Compliance outcome:
  Positive

Decision

P/0333/2019: EMA decision of 11 September 2019 on the acceptance of a modification of an agreed paediatric investigation plan for pazopanib (Votrient), (EMEA-000601-PIP01-09-M06)

AdoptedReference Number: EMA/439197/2019