MVABEA Suspension for injection Ref.[50431] Active ingredients: Ebola vaccine

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

Mvabea suspension for injection.

Ebola vaccine (MVA-BN-Filo [recombinant]).

Pharmaceutical Form

Suspension for injection.

Light yellow, clear to milky suspension.

Qualitative and quantitative composition

One dose (0.5 mL) contains:

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

Not less than 0.7 × 108 infectious units (Inf.U)

* 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 (see section 4.3).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ebola vaccine

Ebola vaccine consists of a live, attenuated recombinant vesicular stomatitis virus-based vector expressing the envelope glycoprotein gene of Zaire Ebola virus (rVSV∆G-ZEBOV-GP). Immunisation of subjects with the vaccine results in an immune response and protection from Zaire Ebola Virus Disease (EVD).
List of Excipients

Sodium chloride
Trometamol
Water for injections
Hydrochloric acid (for pH adjustment)

Pack sizes and marketing

0.5 mL suspension in a single-dose Type I glass vial with a rubber stopper (chlorobutyl with fluoropolymer coated surface), aluminium crimp and yellow plastic cap.

Pack size of 20 single-dose vials.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization dates and numbers

EU/1/20/1445/001

Date of first authorisation: 01 July 2020

Drugs

Drug Countries
MVABEA Estonia, Croatia, Ireland, Italy, Lithuania, Poland
 
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