Product overview
Vaccine type
Smallpox and Mpox vaccine (Live Modified Vaccinia Virus Ankara)
Commercial Name
Imvanex® (also approved under the name of JYNNEOS by the USFDA)
Manufacturer
Bavarian Nordic A/S
Manufacturer Country
Denmark
Responsible NRA
European Medicines Agency
Country
Netherlands
Prequalification
Prequalification Status
Current
Product description
Pharmaceutical Form
Suspension for injection
Presentation
Vial
Number of Doses
1
Diluent
Not Applicable
Route of Administration
Subcutaneous
Shelf Life
3 years when stored at -20°C +/-5°C, 5 years when stored at -50°C +/-10°C, 9 years when stored at -80°C +/-10°C
Vaccine Vial Monitor
none
Secondary Packaging
A. Carton of 10 single dose vials (10 doses). Dimensions: 3.8 x 5.4 x 9.3 cm. B. Carton of 20 single dose vials (20 doses). Dimensions: 4.5 x 9.7 x 12.6 cm.
Tertiary Packaging
A. Box containing 48 secondary cartons (480 vials/ 480 doses). Dimensions: 12.4 x 24.6 x 39.2 cm. B. Box containing 70 secondary cartons (1400 vials/ 1400 doses). Dimensions: 26.4 x 33.1 x 49.7 cm.
Multidose Vial Policy
Not applicable
Vaccine Preservative
none
Cold Chain Volume
A. 19.08 and B. 27.50 cm3/dose (in secondary packaging)