Product overview
Type:
Ebola vaccine (Ad26.ZEBOV-GP [recombinant])
Commercial Name:
Zabdeno
Manufacturer:
Janssen Cilag International N.V.
Country:
Netherlands
URL:
Responsible NRA:
European Medicines Agency
Country:
Netherlands
Prequalification
Prequalification Status:
Current
Effective Date:
27/04/2021
Product description
Pharmaceutical Form:
Liquid: ready to use
Presentation:
Vial
Number of Doses:
1
Diluent:
Not Applicable
Route of Administration:
Intramuscular
Shelf Life:
48 months
Vaccine Vial Monitor:
none
Secondary Packaging:
20 vials per folding box (vials are packaged per ten vials in a blister: two blisters are packaged into one folding box) [Dimension: 97 x 38 x 133 mm]
Tertiary Packaging:
Each shipper contains 60 folding boxes, corresponding to 60 x 20 = 1200 vials [Dimension: 380 x 272 x 297 mm]
Cold Chain Volume
cm3/dose (in secondary packaging)
24.51
Preservative:
none
Handling of opened multi-dose vials:
Not Applicable.
Attachments
Remark:
- Shelf-life is 48 months at storage temperature: -85°C to -55°C (the vaccine should be transported frozen at -25°C to -15°C)
- Ad26.ZEBOV-GP [recombinant] is to be given as part of a prophylactic 2-dose heterologous prime-boost vaccine regimen consisting of a single dose of Ad26.ZEBOV-GP [recombinant] followed by a single dose of MVA-BN-Filo [recombinant] given approximately 8 weeks later.