Mesterolone tablets

Form: Tablet

Strength: 25 mg

Reference Brands: Proviron(US)

Category: Sexual Wellness

Mesterolone tablets, marketed as Proviron, are approved in the EU and used in some countries as an androgen supplement. However, they are not approved by the FDA in the US. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the EU, approval is overseen by EMA, while in the US, lack of FDA approval means legal clearance is limited. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper compliance ensures timely approval, safe use, and international availability, supporting hormone therapy and performance enhancement needs worldwide.