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EMA Product

Celldemic

Product approved by European Medicines Agency (EU)

Basic Information

Celldemic

Regulatory Information

EMEA/H/C/006052

Authorised

April 19, 2024

February 22, 2024

1

January 29, 2025

Company Information

the netherlands

Paasheuvelweg 28 1105 BJ Amsterdam

Seqirus Netherlands B.V.

Drug Classification

Additional Monitoring

Active Substances Detail

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

Detailed Information

Therapeutic Indication

### Therapeutic indication Celldemic is indicated for active immunisation against H5N1 subtype of Influenza A virus in adults and infants from 6 months of age and above. Celldemic should be used in accordance with official recommendations.

Overview Summary

Celldemic is a vaccine used to protect adults and children from 6 months of age against influenza (flu) caused by the H5N1 subtype of the influenza A virus (sometimes called ‘bird flu’ or ‘avian flu’). Celldemic contains small amounts of proteins from an H5N1 strain of the influenza A virus. The virus has been inactivated so that it does not cause any disease in people who receive the vaccine.

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