EMEA-000978-PIP01-10-M01 - paediatric investigation plan

vemurafenib

Key facts

• Invented name:
  • Zelboraf
  • Zelboraf
• Active substance:
  vemurafenib
• Therapeutic area:
  Oncology
• Decision number:
  P/0210/2016
• PIP number:
  EMEA-000978-PIP01-10-M01
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/08/2016
• Compliance check done:
  Nej

Decision

P/0210/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for vemurafenib (Zelboraf), (EMEA-000978-PIP01-10-M01)

Adopted Reference Number: EMA/513271/2016