Cladribine tablets

Form: Tablet

Strength: 10 mg

Reference Brands: Mavenclad(US & EU)

Category: Multiple sclerosis

Cladribine tablets, marketed as Mavenclad, are approved in the US by the FDA and in the EU via EMA for relapsing multiple sclerosis (MS). Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical trial and manufacturing data, while the EMA ensures compliance with regional safety, efficacy, and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional compliance is essential for timely approval, safe use, and worldwide availability of cladribine tablets, supporting optimal MS treatment outcomes.