Verapamil injection
Form: Injection
Strength: 5 mg/mL or 10 mg/mL
Reference Brands: Isoptin, Calan(US)
Category: Heart Disorder
Verapamil injection, used in acute arrhythmia management and hypertensive emergencies, is regulated in the US by the FDA and in the EU via EMA. Approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, FDA reviews clinical trial and manufacturing details, while the EMA verifies regional safety and quality compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory adherence supports timely approval, safe use, and global availability of verapamil injection, facilitating effective cardiovascular care across healthcare settings worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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