Bupropion SR/ ER Tablets
Form: Sustained-Release (SR) Tablets, Extended-Release (XL) Tablets
Strength: 100 mg, 150 mg, 200 mg (SR); 150 mg, 300 mg (XL)
Reference Brands: Wellbutrin® SR/XL(US); Zyban®(EU & US)
Category: Antipsychotropic Drugs
Bupropion sustained-release (SR) and extended-release (ER) tablets are FDA-approved in the United States for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD), and as an aid in smoking cessation under brand variations. U.S. regulations require Boxed Warnings regarding suicidal thoughts in young adults, seizure risk, and contraindications. Manufacturers must ensure GMP compliance, bioequivalence data, and post-marketing safety reporting. In the European Union, bupropion is authorized under national and centralized procedures for depression and smoking cessation. EU approval mandates a Risk Management Plan (RMP), Periodic Safety Update Reports (PSURs), and pharmacovigilance systems. For dossier-ready supply, visit Pharmatradz.com.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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