EMEA-001904-PIP02-17 - paediatric investigation plan

Brincidofovir

Key facts

• Active Substance:
  Brincidofovir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0348/2018
• PIP number:
  EMEA-001904-PIP02-17
• Pharmaceutical form(s):
  • Oral suspension
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of adenovirus in immunocompromised patients
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  SymBio Pharmaceuticals Limited

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/11/2018

Decision

P/0348/2018: EMA decision of 16 November 2018 on the agreement of a paediatric investigation plan and on the granting of a waiver for brincidofovir (EMEA-001904-PIP02-17)

AdoptedReference Number: EMA/784346/2018