EMA/PE/0000221511 - paediatric investigation plan

recombinant human apolipoprotein A-I

Key facts

• Active substance:
  recombinant human apolipoprotein A-I
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000221511
• PIP number:
  EMA/PE/0000221511
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of lecithin-cholesterol acyltransferase deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000221511 : EMA decision of 6 December 2024 on the granting of a product specific waiver for recombinant human apolipoprotein A-I

Adopted Reference Number: EMADOC-1700519818-1793267