Mesna Injection

Mesna Injection

Form: Injection

Strength: 100 mg/mL

Reference Brands: Mesnex(US)

Category: Blood Disorder

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.

Get Enquiry Back to Listing
Disclaimer: By continuing to browse, you agree to the terms of use of this website and the Trade Marks displayed, in compliance with the provisions of the Trademark Act, 1999, Section 30 and 30(1) under 'Fair use.'

The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.

Related Products

Anti-Inhibitor Coagulant Complex (AICC) Lyophilized Powder

Strength: 500 units, 1000 units, and 2500 units

Form: Lyophilized Powder (Reconstituted for IV infusion)

Reference Brands: FEIBA(US)

View Details Get Enquiry
Prothrombin Complex Concentrate (PCC) injection

Strength: 250 IU to 300 IU

Form: Injection

Reference Brands: Kcentra (4-factor PCC), Bebulin VH (3-factor PCC)(US)

View Details Get Enquiry
Leucovorin tablets/Capsule

Strength: 15 mg, 50 mg

Form: Tablet/Capsules

Reference Brands: Folvite(US & EU)

View Details Get Enquiry
Pegfilgrastim injection

Strength: 6 mg per single-use syringe

Form: Injection

Reference Brands: Neulasta, Pelgraz(US)

View Details Get Enquiry

Subscribe to Our Newsletter

Stay updated on pharma trends and marketplace opportunities.