EMEA-001178-PIP01-11-M06 - paediatric investigation plan

regorafenib

Key facts

• Invented name:
  Stivarga
• Active Substance:
  regorafenib
• Therapeutic area:
  Oncology
• Decision number:
  P/0495/2021
• PIP number:
  EMEA-001178-PIP01-11-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Bayer AG

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2021

Decision

P/0495/2021: EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for regorafenib (Stivarga), (EMEA-001178-PIP01-11-M06)

AdoptedReference Number: EMA/616451/2021