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EMA Product

Foclivia

Product approved by European Medicines Agency (EU)

Basic Information

Foclivia

Regulatory Information

EMEA/H/C/001208

Authorised

October 18, 2009

July 23, 2009

13

October 3, 2023

Company Information

Italy

Via del Pozzo 3/A S. Martino 53035 Monteriggioni (SI)

SEQIRUS SRL

Drug Classification

Exceptional Circumstances

Active Substances Detail

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1)

Detailed Information

Therapeutic Indication

### Therapeutic indication Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.

Overview Summary

Foclivia is a vaccine used in adults to protect against flu when a ‘pandemic’ has been officially declared by the World Health Organization (WHO) or the European Union (EU). A flu pandemic occurs when a new type (strain) of flu virus can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. Foclivia would be given according to official recommendations. Foclivia contains some parts of inactivated (killed) influenza (flu) virus. It contains a flu strain called A/Vietnam/1194/2004 (H5N1).

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