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HSA Approval

STRENSIQ SOLUTION FOR INJECTION 100 MG/ML

Approval Number

SIN17126P

Drug Name

STRENSIQ SOLUTION FOR INJECTION 100 MG/ML

Product Name

STRENSIQ SOLUTION FOR INJECTION 100 MG/ML

Approval Date

October 29, 2024

Registrant

ASTRAZENECA SINGAPORE PTE LTD

Regulatory Information

Registrant

ASTRAZENECA SINGAPORE PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION

Route of Administration

SUBCUTANEOUS

Medical Information

ATC Code

A16AB13

Manufacturer Information

Pharmaceutical Manufacturer

ASTRAZENECA SINGAPORE PTE LTD

Manufacturers

Alexion Pharma International Operations Limited (AAMF)

Patheon Italia S.p.A

Active Ingredients

Ingredient Name

asfotase alfa

Strength

100mg/mL

Drug MonographAsfotase alfa

Documents

Package Inserts

Strensiq Approved PI.pdf

Approved: October 29, 2024

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