Docaravimab-Miromavimab
| Product Overview | |
| Generic Name | Docaravimab-Miromavimab |
| Brand Name(s) | TWINRAB, VaxiRab-N |
| Form | sterile preservative-free liquid sol for wound infiltration and intra-musular inj |
| Strength | 300 IU/mL & 600 IU/mL |
| Therapeutic Class | Rabies post-exposure prophylaxis biologic (administered with rabies vaccine) |
| ATC Code | J06BB05 |
| Manufacturing & Regulatory | |
| Manufacturer | Zydus |
| Country | Inda |
| GMP Compliance | WHO-GMP certificate |
| DMF/CEP | Not publicly available |
| COFEPRIS | Not verifiable |
| Free Sale Certificate | Potentially available if exported via authorized channel |
| Logistics & Export | |
| MOQ | RFQ-Dependent, 100pcs |
| Shelf Life | 24 Months |
| Storage | 2–8 °C; do not freeze; do not shake; protect from light. |
| Incoterms | RFQ-dependent... |
| Lead Time | RFQ-dependent |
| Documentation | |
| Certificate of Analysis (COA) | Yes (typical) via manufacturer/authorized distributor as batch/lot CoA |
| SDS | available as GHS/CLP-style SDS |
| CTD Summary | Not publicly posted as CTD; however, a product information leaflet (PI) exists |
Description
Indicated in passive immunization for rabies post-exposure prophylaxis in suspected exposures; must be used with rabies vaccine. Dose: 40 IU/kg; infiltrate as much as anatomically feasible into/around wounds, remainder IM at a site distant from vaccine administration
Two ARV mAb products are currently registered for use in humans. • 17C7 (also known as RAB1, SIIRMAB or Rabisheld), a homologous human ARV mAb for adult and paediatric use. It is licensed in India and is also registered for use in Bahrain, Chad, Democratic Republic of the Congo, Ethiopia, Georgia, Kazakhstan, Kenya, Kyrgyzstan, Mozambique, Nepal, Oman, Tajikistan, Tanzania and Uzbekistan. • M777-16-3/62-71-3 (docaravimab and miromavimab, also known as Rabimab, Twinrab), a heterologous mix of two murine ARV mAbs for adult and paediatric use. It is licensed in India. Two other ARV mAbs are currently under clinical and/or regulatory evaluation.
