EMEA-002783-PIP01-20 - paediatric investigation plan

neratinib

Key facts

• Invented name:
  Nerlynx
• Active substance:
  neratinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0246/2020
• PIP number:
  EMEA-002783-PIP01-20
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of breast 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:
  15/07/2020
• Compliance check done:
  Ne

Decision

P/0246/2020: EMA decision of 15 July 2020 on the granting of a product specific waiver for neratinib (Nerlynx), (EMEA-002783-PIP01-20)

Adopted Reference Number: EMA/316758/2020