EMEA-003343-PIP01-22 - paediatric investigation plan

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

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
Contact for public enquiries

Alexion Europe SAS

E-mail: pip.enquiries.eu@alexion.com
Tel. +33 147100619

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

Decision

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