
Belimumab prefilled syringe
Form: Subcutaneous (SC) and intravenous (IV) Prefilled syringe
Strength: 200 mg/ten 1 mL for SQ; 10 mg/mL for IV
Reference Brands: Benlysta(US & EU)
Category: Immune Disorder
Belimumab, marketed as Benlysta, is approved in the US by the FDA and in the EU via EMA for treating active systemic lupus erythematosus (SLE). Regulatory approval requires a comprehensive dossier including clinical trial data, safety profiles, manufacturing processes, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and manufacturing information, while the EMA ensures regional compliance with safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring thorough regulatory compliance is essential for the safe, effective, and timely approval of belimumab prefilled syringe products worldwide, supporting advanced autoimmune disease management.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Related Products
Anakinra injection
Strength: 100 mg/mL
Form: Injection(SQ)
Reference Brands: Kinerso, Kineret(US)
View Details Get EnquiryIVIG (Intravenous Immunoglobulin) solution
Strength: 5% or 10%
Form: Intravenous infusion
Reference Brands: Gammagard (Gamunex-C, Flebogamma),Privigen, Octagam, Gamunex-C(US)
View Details Get EnquiryUstekinumab Injection
Strength: SQ:: 45 mg, 90 mg; IV: 130 mg/vial
Form: SQ and IV injection
Reference Brands: Stelara(US)
View Details Get EnquiryEverolimus tablets
Strength: 0.75 mg, 1.25 mg, 2.5 mg, 5 mg, 7.5 mg, 10 mg
Form: Tablet
Reference Brands: Zortress, Afinitor(US & EU)
View Details Get Enquiry