Rivaroxaban tablets

Form: Tablet

Strength: 10 mg, 15 mg, 20 mg

Reference Brands: Xarelto(US & EU)

Category: Blood Disorder

Rivaroxaban is a widely used oral anticoagulant regulated by the FDA in the US and the EMA in the EU. It requires a robust dossier demonstrating safety, efficacy, and manufacturing quality for approval. In the US, it is approved as Xarelto, with a focus on stroke prevention, DVT, and PE treatment. In the EU, similar approvals are granted through centralized procedures, ensuring compliance with regional standards. For expert guidance on dossier preparation, regulatory pathways, and market entry strategies, visit PharmaTradz. Ensuring regulatory compliance is critical for successful registration and commercialization of rivaroxaban products globally.