ERVEBO Solution for injection Ref.[27940] Active ingredients: Ebola vaccine

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Ervebo solution for injection.

Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live).

Pharmaceutical Form

Solution for injection.

The solution is a colourless to slightly brownish-yellow liquid.

Qualitative and quantitative composition

One dose (1 mL) contains: Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP1,2 live, attenuated) ≥72 million pfu3.

1 Recombinant Vesicular Stomatitis Virus (rVSV) strain Indiana with a deletion of the VSV envelope glycoprotein (G) replaced with the Zaire Ebola Virus (ZEBOV) Kikwit 1995 strain surface glycoprotein (GP)
2 Produced in Vero cells
3 pfu= plaque-forming units

This product contains genetically modified organisms (GMOs).
This vaccine contains a trace amount of rice protein. 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

Recombinant human serum albumin
Trometamol buffer
Water for injections
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)

Pack sizes and marketing

Solution for 1 dose in a vial (type I glass) with a stopper (chlorobutyl) and a flip-off plastic cap with aluminium seal.

Pack size of 10 vials.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/19/1392/001

Date of first authorisation: 11 November 2019
Date of latest renewal: 15 September 2020

Drugs

Drug Countries
ERVEBO Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland
 
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