Product Details

Zabdeno suspension for injection**

Ebola vaccine
see Composition
Suspension for injection

ROA

Intramuscular

Applicant Name

J & J Company West Africa Limited

NRN

A6-100111

Status

Active


Composition

Ebola vaccine (Ad26.ZEBOV-GP [recombinant]). Each single dose (0.5 mL) contains: Not less than 8.75 log10 infectious units (Inf.U) of Adenovirus type 26 encoding the Zaire ebolavirus (EBOV) Mayinga variant glycoprotein (GP)* * Produced in PER.C6 cells and by recombinant DNA technology. This product contains genetically modified organisms (GMOs). Excipients with known effect: Each dose (0.5 mL) contains 0.10 mg of polysorbate-80  

ATC Code

J07BX02  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

0.5 mL x 20's (in single-dose vials)  

Product Description

Suspension for injection. Colourless to slightly yellow, clear to very opalescent suspension

Manufacturer Name

IDT Biologika GmbH

Manufacturer Country

GERMANY  

Approval Date

2023-05-31  

Expiry Date

2028-05-30