EMEA-002042-PIP01-16 - paediatric investigation plan

Erdafitinib

Key facts

• Active substance:
  Erdafitinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0126/2017
• PIP number:
  EMEA-002042-PIP01-16
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of urothelial 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:
  05/05/2017
• Compliance check done:
  Ei

Decision

P/0126/2017: EMA decision of 5 May 2017 on the granting of a product-specific waiver for erdafitinib (EMEA-002042-PIP01-16)

Adopted Reference Number: EMA/224407/2017