Dengue vaccine
Product Overview
| Generic Name | Dengue vaccine |
| Brand Name(s) | BUTANTAN-DV™ |
| Category | Vaccines |
| Form | 1, 2, 3, and 4, live attenuated, Vial, Sub-C Inject |
| Strength | Single Dose |
| Therapeutic Class | Vaccines; viral vaccines |
| ATC Code | J07BX04 |
Manufacturing & Regulatory
| Manufacturer | Instituto Butantan, São Paulo, Brazil |
| GMP Compliance | WHO-GMP |
| COFEPRIS | No CNIS clave identified / not yet listed |
| Free Sale Certificate | Government Procurement Only |
Logistics & Export
| MOQ | 10,000 Single Dose Vials |
| Shelf Life | 18 months |
| Storage | Refrigerated (2–8 °C) |
| Incoterms | EXW São Paulo, Brazil. HS-3002.41.99 |
| Lead Time | 45 days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Yes—lot-specific Certificate of Analysis |
| CTD Summary (PDF) | CTD available to regulators; summary available to qualified partners |
Special Notes
Butantan professional package insert lists the product as Butantan-DV™ vacina dengue 1, 2, 3 e 4 (atenuada), registered and produced by Instituto Butantan, with registration number 1.2234.0057, and states that the package insert was approved by ANVISA on 08/12/2025