EMEA-003419-PIP01-23 - paediatric investigation plan

modified messenger ribonucleic acid encoding human propionyl-coenzyme a carboxylase alpha and beta subunits encapsulated into lipid nanoparticles (mRNA-3927)

Key facts

• Active substance:
  modified messenger ribonucleic acid encoding human propionyl-coenzyme a carboxylase alpha and beta subunits encapsulated into lipid nanoparticles (mRNA-3927)
• Therapeutic area:
  Endrocrine disorders
• Decision number:
  P/0521/2023
• PIP number:
  EMEA-003419-PIP01-23
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Treatment of propionic acidaemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0521/2023 : EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for modified messenger ribonucleic acid encoding human propionyl-coenzyme a carboxylase alpha.......(EMEA-003419-PIP01-23)

Reference Number: EMA/553376/2023