LC16 KMB
Product Overview
Type: Smallpox and Mpox vaccine
Commercial name: LC16 KMB (LC16m8 vaccine)
EUL holder: KM Biologics Co., Ltd
Country: Japan
Responsible NRA: Pharmaceutical and Medical Devices Agency (PMDA)
Country: Japan
WHO EUL recommendation
Effective date: 19 November 2024
Product description
Pharmaceutical Form: Freeze dried
Presentation: Vial
Number of doses: ≥
Route of administration: Percutaneous
Age indication: From 1 year of age
Shelf – life: 24 months
Storage temperature: 2°C to 8°C
Once the vaccine is transfered to refrigerated storage, it should be used without being returned to frozen storage confitions
Preservative: None
Diluent: Water for injection (containing 20 vol % glycerine)
Special storage conditions: Not applicable
Handling of opened multi-dose vials:
WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.
Packaging description
| Secondary Packaging: | Carton box containing 2 vials (one vaccine and one co-packed diluent) (Up to 250 doses/box). Dimensions: 45.5 x 29.2 x 14.5 cm |
| Tertiary Packaging: | Cardboard box of 200 carton boxes (50,000 doses). Dimensions: 45.5 x 29.2 x 14.5 cm. |