IMVANEX Suspension for injection Ref.[28029] Active ingredients: Smallpox, live attenuated

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Bavarian Nordic A/S, Philip Heymans Allé 3, DK-2900 Hellerup, Denmark

Product name and form

IMVANEX suspension for injection.

Smallpox vaccine (Live Modified Vaccinia Virus Ankara).

Pharmaceutical Form

Suspension for injection.

Light yellow to pale white, milky suspension.

Qualitative and quantitative composition

One dose (0.5 ml) contains: Modified Vaccinia Ankara – Bavarian Nordic Live virus1 no less than 5 × 107 Inf.U*

* infectious units
1 Produced in chick embryo cells

This vaccine contains trace residues of chicken protein, benzonase, gentamicin and ciprofloxacin (see section 4.3).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Smallpox, live attenuated

Smallpox vaccine is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

List of Excipients

Trometamol
Sodium chloride
Water for injections

Pack sizes and marketing

0.5 ml suspension in a vial (Type I glass) with stopper (bromobutyl rubber).

Pack size of 20.

Marketing authorization holder

Bavarian Nordic A/S, Philip Heymans Allé 3, DK-2900 Hellerup, Denmark

Marketing authorization dates and numbers

EU/1/13/855/001

Date of first authorisation: 31 July 2013
Date of the last renewal: 23 April 2018

Drugs

Drug Countries
IMVANEX Austria, Estonia, Ireland, Lithuania, Poland, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.