Antithymocyte Globulin (ATG) powder for injection
Form: Lyophilized powder
Strength: 250mg/5ml
Reference Brands: Thymoglobulin(US & EU)
Category: Hypertension
Antithymocyte Globulin (ATG) powder for injection, marketed as Thymoglobulin, is approved in the US by the FDA and in the EU via EMA for preventing and treating graft rejection in organ transplantation. Regulatory approval requires a comprehensive dossier, including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. The FDA reviews detailed clinical trial and manufacturing information, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports timely approval, safe use, and broad availability, helping improve transplant outcomes and patient safety worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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