Ranibizumab 0.5mg/0.05 mL
| Product Overview | |
| Generic Name | Ranibizumab 0.5mg/0.05 mL |
| Brand Name(s) | Lucentis® |
| Form | Solution for intravitreal injection; marketed in vial and pre-filled syringe configurations |
| Strength | 10 mg/mL / 0.165 mL pre-filled syringe / 0.23 mL vial containing 2.3 mg/0.23 mL. |
| Therapeutic Class | Humanised monoclonal antibody fragment (Fab), VEGF-A inhibitor / anti-neovascularisation agent |
| ATC Code | S01LA04 |
| Manufacturing & Regulatory | |
| Manufacturer | Novartis |
| Country | Switzerland |
| COFEPRIS | 010.000.5236.00.00 |
| Free Sale Certificate | upon manufacturer/distributor request |
| Logistics & Export | |
| Shelf Life | 36 months |
| Storage | Store refrigerated at 2°C–8°C; do not freeze; protect from light |
| Incoterms | EXW/FCA/CIP/CIF/DDP depending on route and temperature-control responsibility, |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Normally yes upon supply |
| CTD Summary | regulatory-quality summary exists through the EMA EPAR / product information, |
Description
Ranibizumab (Lucentis®) is an intravitreal anti-VEGF biologic indicated for the treatment of neovascular retinal disorders, including wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy, macular oedema secondary to retinal vein occlusion, and certain forms of choroidal neovascularisation
