
Artemether + Lumefantrine tablet
Form: Tablet
Strength: 20 mg/120 mg per tablet
Reference Brands: Coartem(EU)
Category: Medical Aid
Artemether + Lumefantrine tablets, marketed as Coartem, are approved in some EU countries for uncomplicated Plasmodium falciparum malaria. In the EU, brands are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards, though approval status varies. In the US, the combination is not approved for malaria treatment, but importation for travel use is permitted. Both regions require detailed dossiers, clinical trial data, quality assurance, and pharmacovigilance plans for approval and ongoing safety monitoring. For expert regulatory support, dossier preparation, and compliance, visit PharmaTradz. We facilitate seamless market access, 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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