Clonidine Patch

Form: transdermal patch

Strength: 0.1 mg/24 hours, 0.2 mg/24 hours, 0.3 mg/24 hours

Reference Brands: Catapres(US)

Category: Hypertension

Clonidine patches, marketed as Catapres-TTS and generic versions, are approved in the US by the FDA and in the EU via EMA for hypertension management. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and quality data, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and global availability of clonidine patches, facilitating blood pressure control and improving patient adherence worldwide.