REPLENINE-VF 500 FOR INJECTION

Regulatory Information

HSA regulatory responsibility and product classification details

RegistrantEURO ASIA MEDICO PTE. LTD.

Licence HolderEURO ASIA MEDICO PTE. LTD.

Drug Type

Therapeutic

Forensic Class

Prescription Only

HSA Singapore Classification

Dosage Form

INJECTION, POWDER, FOR SOLUTION

Route of Administration

INTRAVENOUS

ATC Code

B02BD04

ATC Item Name

coagulation factor IX

Pharmaceutical Manufacturer

EURO ASIA MEDICO PTE. LTD.

Manufacturers

Siegfried Hameln GmbH (for WFI)

Bio Products Laboratory

Ingredient Name

COAGULATION FACTOR IX (HUMAN) (FREEZE-DRIED)

Strength

min 500 iu/vial