Elfabrio Concentrate for Solution for Infusion 2 mg/ml

Regulatory Information

HSA regulatory responsibility and product classification details

RegistrantORIENT EUROPHARMA PTE LTD

Drug Type

Therapeutic

Forensic Class

Prescription Only

HSA Singapore Classification

Dosage Form

INFUSION, SOLUTION CONCENTRATE

Route of Administration

INTRAVENOUS

ATC Code

A16AB20

Pharmaceutical Manufacturer

ORIENT EUROPHARMA PTE LTD

Manufacturers

Chiesi Farmaceutici S.p.A.

Ingredient Name

Pegunigalsidase alfa

Strength

2 mg/ml

Elfabrio Concentrate for Solution for Infusion PI.pdf

Approved: February 20, 2025