Alglucosidase Alfa IV
Form: Lyophilized powder
Strength: 50 mg/vial
Reference Brands: Lumizyme®(US & EU)
Category: Orphan Drugs
Alglucosidase alfa, marketed as Lumizyme® and Myozyme®, is approved in the US and EU for Pompe disease. Regulatory dossiers include extensive clinical trial data, manufacturing standards, and safety profiles submitted to the FDA and EMA, supporting approval for intravenous use. Dossiers demonstrate its efficacy in improving muscle strength, breathing, and mobility. Dosing is individualized based on patient weight and disease severity. For detailed insights on regulatory processes, dossier submissions, and market approvals in the EU and US, visit PharmaTradz, your trusted source for pharmaceutical regulatory insights and industry updates.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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