Product/Composition:- | Mesna Injection |
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Strength:- | 100 mg/mL |
Form:- | Injection |
Reference Brands:- | Mesnex(US) |
MOQ | As per the manufacturer batch size |
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Mesna inactivates harmful metabolites of cyclophosphamide and ifosfamide, reducing the risk of hemorrhagic cystitis. It binds to acrolein in the urinary bladder, protecting the lining. Benefits include preventing bladder toxicity, supporting continuous chemotherapy, and ensuring patient safety during high-dose cyclophosphamide or ifosfamide treatment.
Mesna injection, marketed as Mesnex, is approved in the US by the FDA and in the EU via EMA to prevent hemorrhagic cystitis during chemotherapy. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA conducts a comprehensive review, while the EMA assesses compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and successful market access, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of mesna injection worldwide, supporting optimal patient care in oncology treatments.