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EMA Product

Incellipan

Product approved by European Medicines Agency (EU)

Basic Information

Incellipan

Regulatory Information

EMEA/H/C/006051

Authorised

April 19, 2024

February 22, 2024

May 2, 2024

Company Information

the netherlands

Paasheuvelweg 28 1105 BJ Amsterdam

Seqirus Netherlands B.V.

Drug Classification

Conditional ApprovalAdditional Monitoring

Active Substances Detail

Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen

Detailed Information

Therapeutic Indication

### Therapeutic indication Incellipan is indicated for active immunisation against influenza in an officially declared pandemic. Incellipan should be used in accordance with official recommendations.

Overview Summary

Incellipan is a [pandemic preparedness vaccine](https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/pandemic-influenza/vaccines-pandemic-influenza) used to protect adults and children against influenza (flu). It can only be used during a pandemic declared officially by the World Health Organization (WHO) or within the European Union (EU). A pandemic occurs when a strain of flu can spread easily from person to person because people have no immunity (protection) against it. Incellipan contains small amounts of proteins from the influenza virus. The virus has been inactivated so that it does not cause any disease in people who receive the vaccine.

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