EMEA-002125-PIP01-17 - paediatric investigation plan

osimertinib (as mesilate)

Key facts

• Invented name:
  • Tagrisso
  • Tagrisso
• Active substance:
  osimertinib (as mesilate)
• Therapeutic area:
  Oncology
• Decision number:
  P/0222/2017
• PIP number:
  EMEA-002125-PIP01-17
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of lung carcinoma (small cell and non-small cell carcinoma)
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/08/2017
• Compliance check done:
  Ne

Decision

P/0222/2017: EMA decision of 9 August 2017 on the granting of a product-specific waiver for osimertinib (as mesylate) (Tagrisso), (EMEA-002125- PIP01-17)

Adopted Reference Number: EMA/431229/2017