EMEA-000781-PIP01-09 - paediatric investigation plan

sorafenib tosilate

Key facts

• Invented name:
  • Nexavar
  • Nexavar
• Active substance:
  sorafenib tosilate
• Therapeutic area:
  Oncology
• Decision number:
  P/68/2010
• PIP number:
  EMEA-000781-PIP01-09
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Differentiated thyroid cancer
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/05/2010
• Compliance check done:
  No

Decision

P/68/2010: European Medicines Agency decision on the granting of a product specific waiver for sorafenib (as tosylate) (Nexavar) (EMEA-000781-PIP01-09)

Adopted Reference Number: EMA/264450/2010