CYD-TDV
| Product Overview | |
| Generic Name | CYD-TDV |
| Brand Name(s) | Dengvaxia® (CYD‑TDV) |
| Form | Live‑attenuated, injectable suspension |
| Strength | Standard prefilled dose; one vial per dose |
| Therapeutic Class | Viral vaccine, live attenuated (prophylactic) |
| ATC Code | J07BX03 |
| Manufacturing & Regulatory | |
| Manufacturer | Sanofi Pasteur |
| Country | France (global HQ); manufacturing worldwide |
| GMP Compliance | WHO‑prequalified; produced in GMP‑certified plants |
| DMF/CEP | CAD‑030088 (CDER) for U.S. |
| COFEPRIS | Approved (Clave used in tenders) |
| Free Sale Certificate | Issued by WHO/Sanofi for export |
| Logistics & Export | |
| MOQ | 5,000 doses |
| Shelf Life | ~24 months refrigerated |
| Storage | 2 – 8 °C refrigeration |
| Incoterms | FOB (exports) / EXW / FCA depending on supplier |
| Lead Time | 3–6 months (production slots) |
| Documentation | |
| Certificate of Analysis (COA) | Issued by manufacturer (Sanofi Pasteur) |
| SDS | Provided by manufacturer on request (standard viral vaccine document) |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Indications & Usage: Live‑attenuated tetravalent dengue vaccine; indicated for individuals 9 – 45 years with prior dengue seropositivity; three-dose regimen (months 0,6,12); reduces symptomatic dengue and hospitalization; requires pre‑vaccination screening due to risk in seronegatives.
