EMEA-002908-PIP01-20 - paediatric investigation plan

Posoleucel

Key facts

• Active Substance:
  Posoleucel
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0533/2022
• PIP number:
  EMEA-002908-PIP01-20
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of bacterial community-acquired pneumonia
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Nabriva Therapeutics DAC

  email: [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:
  30/12/2022

Decision

P/0533/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan for posoleucel (EMEA-002908-PIP01-20)

AdoptedReference Number: EMA/930300/2022