Sulfadoxine + Pyrimethamine (SP) – tablets
Form: Tablet
Strength: 500 mg sulfadoxine + 25 mg pyrimethamine; 500 mg + 75 mg
Reference Brands: Generic formulations
Category: Medical Aid
Sulfadoxine + Pyrimethamine (SP) tablets are approved for malaria treatment and prophylaxis in the EU and US, mainly in endemic regions. In the EU, brands like Fansidar are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, approval is limited; primarily used in travel medicine and imported cases, with no specific brand approval. Both regions require detailed dossiers including clinical trial data, quality assurance, and pharmacovigilance plans for approval and safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support seamless market access for sulfadoxine/pyrimethamine, ensuring adherence to European and US standards for safe, effective malaria therapy.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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