Bavarian Nordic A/S (BVNRY.PK) announced Friday that Health Canada has granted a Notice of Compliance approving Imvamune for active immunization against smallpox in a public health emergency.
Imvamune is indicated for persons 18 years of age and older who are contraindicated to replicating smallpox vaccines. This includes individuals with immune deficiencies and skin disorders.
Health Canada is the second regulatory body to approve the company's smallpox vaccine which earlier this year was approved by the European Commission for use in the general adult population in all 28 EU countries and Iceland, Liechtenstein and Norway, where it is marketed under the trade name Imvanex.
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