EMEA-003343-PIP01-22 - paediatric investigation plan

recombinant human tissue nonspecific alkaline phosphatase (TNSALP) fragment crystallizable (Fc) deca aspartate fusion protein (ALXN1850)

Key facts

• Active substance:
  recombinant human tissue nonspecific alkaline phosphatase (TNSALP) fragment crystallizable (Fc) deca aspartate fusion protein (ALXN1850)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0390/2023
• PIP number:
  EMEA-003343-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hypophosphatasia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0390/2023: EMA decision of 8 September 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant human tissue nonspecific alkaline phosphatase (TNSALP) fragment crystallizable (Fc) deca aspartate fusion..

Adopted Reference Number: EMA/351271/2023