Epoprostenol injection

Form: Injection

Strength: 1.5 mg/via;

Reference Brands: Flolan®(Us & Eu)

Category: Orphan Drugs

Epoprostenol infusion solution, marketed as Flolan® in the US and EU, is approved for pulmonary arterial hypertension. Regulatory dossiers include extensive clinical data, manufacturing details, and safety profiles submitted to FDA and EMA, supporting its approval for continued use. The solution is administered via continuous IV infusion, with dosing tailored individually. These dossiers ensure high-quality standards and efficacy. For in-depth insights into regulatory submissions, dossier requirements, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry insights.