Basic Information
REPLAGAL CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML
INFUSION, SOLUTION CONCENTRATE
Regulatory Information
SIN16197P
May 17, 2021
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
May 30, 2025
XA16AB03
Company Information
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
Active Ingredients
Agalsidase alfa
Strength: 1.0 mg/mL
Detailed Information
Contraindications
**4.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
Indication Information
**4.1 Therapeutic indications** Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency).