
Hydralazine tablets
Form: Tablets
Strength: 10 mg, 25 mg, 50 mg, 100 mg
Reference Brands: Apresoline(US & Eu)
Category: Hypertension
Hydralazine tablets, marketed as Apresoline, are approved in the US by the FDA and in the EU via EMA for managing severe hypertension and heart failure. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed 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. Adequate regional adherence supports timely approval, safe medication use, and worldwide availability, helping healthcare providers manage cardiovascular risks effectively across regions.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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