Product/Composition:- | Hyoscine Butylbromide tablet |
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Strength:- | 10 mg |
Form:- | Tablets |
Reference Brands:- | Buscopan(EU) |
MOQ | As per the manufacturer batch size |
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Hyoscine Butylbromide tablets are antispasmodics that block parasympathetic nerve signals, relaxing smooth muscles in the gastrointestinal tract. They effectively reduce stomach and bowel spasms, relieving cramps, pain, and discomfort associated with gastrointestinal motility disorders. Benefits include symptom relief and improved digestive comfort.
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.