EMEA-002376-PIP01-18 - paediatric investigation plan

nadofaragene firadenovec

Key facts

• Active substance:
  nadofaragene firadenovec
• Therapeutic area:
  Oncology
• Decision number:
  P/0276/2018
• PIP number:
  EMEA-002376-PIP01-18
• Pharmaceutical form(s):
  Concentrate for suspension for infusion
• Condition(s) / indication(s):
  Treatment of mesothelioma
• Route(s) of administration:
  Intrapleural use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/09/2018
• Compliance check done:
  No

Decision

P/0276/2018: EMA decision of 12 September 2018 on the granting of a product specific waiver for nadofaragene firadenovec (EMEA-002376-PIP01-18)

Reference Number: EMA/539660/2018