Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

HSA Approval

Elfabrio Concentrate for Solution for Infusion 2 mg/ml

Approval Number

SIN17186P

Drug Name

Elfabrio Concentrate for Solution for Infusion 2 mg/ml

Product Name

Elfabrio Concentrate for Solution for Infusion 2 mg/ml

Approval Date

February 20, 2025

Registrant

ORIENT EUROPHARMA PTE LTD

Regulatory Information

Registrant

ORIENT EUROPHARMA PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INFUSION, SOLUTION CONCENTRATE

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

A16AB20

Manufacturer Information

Pharmaceutical Manufacturer

ORIENT EUROPHARMA PTE LTD

Manufacturers

Chiesi Farmaceutici S.p.A.

Active Ingredients

Ingredient Name

Pegunigalsidase alfa

Strength

2 mg/ml

Drug MonographPegunigalsidase alfa

Documents

Package Inserts

Elfabrio Concentrate for Solution for Infusion PI.pdf

Approved: February 20, 2025

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy