EMEA-003437-PIP01-23 - paediatric investigation plan

modified mRNA encoding human methylmalonyl-coenzyme A mutase containing a polymorphism at position 671 (mRNA-3705)

Key facts

• Active substance:
  modified mRNA encoding human methylmalonyl-coenzyme A mutase containing a polymorphism at position 671 (mRNA-3705)
• Therapeutic area:
  Endocrine disorders
• Decision number:
  P/0540/2023
• PIP number:
  EMEA-003437-PIP01-23
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Treatment of methylmalonic 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/0540/2023: EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for modified mRNA encoding human methylmalonyl-coenzyme A mutase containing a polymorphism at position 671 (mRNA-3705)

Reference Number: EMA/562327/2023