EMEA-002376-PIP02-20 - paediatric investigation plan

Nadofaragene firadenovec

Key facts

• Active Substance:
  Nadofaragene firadenovec
• Therapeutic area:
  Oncology
• Decision number:
  P/0149/2021
• PIP number:
  EMEA-002376-PIP02-20
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of malignant bladder neoplasms
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Ferring Pharmaceuticals A/S

  Tel.: [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/04/2021

Decision

P/0149/2021: EMA decision of 16 April 2021 on the granting of a product specific waiver for nadofaragene firadenovec, (EMEA-002376-PIP02-20)

AdoptedReference Number: EMA/152090/2021