
Tizanidine tablets/capsules
Form: Oral Capsules/Tablets
Strength: 2 mg and 4 mg
Reference Brands: Zanaflex (US)
Category: Multiple sclerosis
Tizanidine tablets, marketed as Zanaflex, are approved in the US by the FDA and in the EU via EMA for relief of spasticity associated with neurological conditions. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical trial and manufacturing data, while the EMA ensures regional safety and quality compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance is essential for timely approval, safe use, and global availability of tizanidine tablets, supporting effective management of spasticity worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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