Product Details

Mvabea suspension for injection**

Ebola vaccine
see Composition
Suspension for injection

ROA

Intramuscular

Applicant Name

J & J Company West Africa Limited

NRN

A6-100118

Status

Active


Composition

Ebola vaccine (MVA-BN-Filo [recombinant]). Each single dose (0.5 mL) contains: Not less than 0.7 x 10^8 infectious units (Inf.U) of modified Vaccinia Ankara Bavarian Nordic Virus* encoding the: - Zaire ebolavirus (EBOV) Mayinga variant glycoprotein (GP) - Sudan ebolavirus Gulu variant GP - Taï Forest ebolavirus nucleoprotein - Marburg Marburgvirus Musoke variant GP * Produced in chicken embryo fibroblast cells and by recombinant DNA technology. This product contains genetically modified organisms (GMOs). This vaccine contains trace residues of gentamicin Excipients: Sodium chloride, trometamol, water for injections, hydrochloric acid (for pH adjustment)  

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. Light yellow, clear to milky suspension

Manufacturer Name

IDT Biologika GmbH

Manufacturer Country

GERMANY  

Approval Date

2023-05-30  

Expiry Date

2028-05-29