Nilotinib capsules
Form: Capsules
Strength: 150 mg and 200 mg
Reference Brands: Tasigna(US & EU)
Category: Orphan Drugs
Nilotinib capsules, marketed as Tasigna, are approved in the US by the FDA and in the EU via EMA for treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML). Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. The FDA reviews clinical trial and manufacturing data for timely approval, 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 to regional requirements supports swift approval, safe use, and worldwide availability, enabling effective long-term disease management for CML patients across regions.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Related Products
Galsulfase IV
Strength: 1mg/ml
Form: Lyophilized powder for IV
Reference Brands: Vimizim®(US & EU)
View Details Get Enquiry
Alglucosidase Alfa IV
Strength: 50 mg/vial
Form: Lyophilized powder
Reference Brands: Lumizyme®(US & EU)
View Details Get Enquiry
Nitisinone tablets
Strength: 2 mg and 5 mg
Form: Tablets
Reference Brands: Orfadin®
View Details Get Enquiry
Treprostinil IV or SC
Strength: 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL)
Form: SC or Intravenous (IV)
Reference Brands: Remodulin®(US & EU)
View Details Get Enquiry