Hyoscine Butylbromide tablet

Form: Tablets

Strength: 10 mg

Reference Brands: Buscopan(EU)

Category: Gastrointestinal Drugs

Hyoscine Butylbromide tablets, marketed as Buscopan, are approved in the EU for relief of bowel and stomach spasms. In the US, it is available as a generic for short-term spasm relief. Regulatory approval requires dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The EU’s EMA evaluates safety and quality, while the FDA reviews clinical trial and manufacturing information for US approval. For dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance supports timely approval, safe use, and global availability, helping patients manage gastrointestinal spasms effectively across regions worldwide.