Galsulfase IV
Form: Lyophilized powder for IV
Strength: 1mg/ml
Reference Brands: Vimizim®(US & EU)
Category: Orphan Drugs
Galsulfase, marketed as Vimizim®, is approved in the US and EU for mucopolysaccharidosis type IVA (Morquio A syndrome). Regulatory dossiers include comprehensive clinical trial data, manufacturing practices, and safety profiles submitted to FDA and EMA, supporting its approval. Dossiers demonstrate its efficacy in reducing symptoms and improving mobility. Administered via IV infusion, dosing is individualized according to patient weight. For in-depth insights on regulatory submissions, dossier requirements, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry insights.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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