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, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom

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