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HSA Approval

STRENSIQ SOLUTION FOR INJECTION 100 MG/ML

SIN17126P

STRENSIQ SOLUTION FOR INJECTION 100 MG/ML

STRENSIQ SOLUTION FOR INJECTION 100 MG/ML

October 29, 2024

ASTRAZENECA SINGAPORE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantASTRAZENECA SINGAPORE PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SOLUTION

SUBCUTANEOUS

Medical Information

A16AB13

Manufacturer Information

ASTRAZENECA SINGAPORE PTE LTD

Alexion Pharma International Operations Limited (AAMF)

Patheon Italia S.p.A

Active Ingredients

asfotase alfa

100mg/mL

Asfotase alfa

Documents

Package Inserts

Strensiq Approved PI.pdf

Approved: October 29, 2024

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STRENSIQ SOLUTION FOR INJECTION 100 MG/ML - HSA Approval | MedPath