EMEA-003309-PIP01-22 - paediatric investigation plan

Single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation (mRNA-1345)

Key facts

• Active Substance:
  Single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation (mRNA-1345)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0195/2023
• PIP number:
  EMEA-003309-PIP01-22
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Prevention of lower respiratory tract infection caused by respiratory syncytial virus
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  MODERNA BIOTECH SPAIN, S.L.

  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:
  15/05/2023

Decision

P/0195/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stab

AdoptedReference Number: EMA/210025/2023