EMEA-003460-PIP01-23 - paediatric investigation plan

mannose-1-phosphate (GLM101)

Key facts

• Active substance:
  mannose-1-phosphate (GLM101)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0332/2024
• PIP number:
  EMEA-003460-PIP01-23
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of phosphomannomutase 2-congenital disorder of glycosylation
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0332/2024 : EMA decision of 13 September 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for mannose-1- phosphate (GLM101), (EMEA-003460-PIP01-23)

Adopted Reference Number: EMA/413936/2024