🇪🇺 HAVRIX in European Union

EMA authorised HAVRIX on 21 March 2007

Marketing authorisations

EMA — authorised 21 March 2007

  • Application: EMEA/H/C/000706
  • Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
  • Local brand name: Daronrix
  • Indication: Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
  • Pathway: exceptional circumstances
  • Status: withdrawn

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EMA — authorised 1 June 2007

  • Application: EMEA/H/C/000758
  • Marketing authorisation holder: Seqirus GmbH
  • Local brand name: Optaflu
  • Indication: Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications. Optaflu should be used in accordance to official guidance.
  • Status: withdrawn

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EMA — authorised 26 September 2008

  • Application: EMEA/H/C/001015
  • Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
  • Local brand name: Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals
  • Indication: Active immunisation against H5N1 subtype of Influenza A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1). Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.
  • Status: withdrawn

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EMA — authorised 10 October 2009

  • Application: EMEA/H/C/001206
  • Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
  • Local brand name: Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
  • Indication: Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
  • Pathway: exceptional circumstances
  • Status: approved

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EMA — authorised 16 October 2009

  • Application: EMEA/H/C/001200
  • Marketing authorisation holder: Resilience Biomanufacturing Ireland Limited
  • Local brand name: Pandemic Influenza Vaccine H5N1 Baxter AG
  • Indication: Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
  • Pathway: exceptional circumstances
  • Status: withdrawn

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EMA — authorised 18 October 2009

  • Application: EMEA/H/C/001208
  • Marketing authorisation holder: Seqirus S.r.l.
  • Local brand name: Foclivia
  • Indication: Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
  • Pathway: exceptional circumstances
  • Status: approved

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EMA — authorised 8 June 2010

  • Application: EMEA/H/C/001202
  • Marketing authorisation holder: Sanofi Pasteur S.A.
  • Local brand name: Humenza
  • Indication: Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with Official Guidance.
  • Pathway: conditional
  • Status: withdrawn

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EMA — authorised 29 November 2010

  • Application: EMEA/H/C/002269
  • Marketing authorisation holder: Novartis Vaccines and Diagnostics S.r.l.
  • Local brand name: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
  • Indication: Active immunisation against H5N1 subtype of Influenza A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain. Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic should be used in accordance with official recommendations.
  • Status: withdrawn

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EMA — authorised 17 February 2012

  • Application: EMEA/H/C/002089
  • Marketing authorisation holder: Ology Bioservices Ireland LTD
  • Local brand name: Vepacel
  • Indication: Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Vepacel should be used in accordance with Official guidance.
  • Status: withdrawn

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EMA — authorised 12 December 2018

  • Application: EMEA/H/C/004814
  • Marketing authorisation holder: Seqirus Netherlands B.V.
  • Local brand name: Flucelvax Tetra
  • Indication: Prophylaxis of influenza in adults and children from 2 years of age. Flucelvax Tetra should be used in accordance with official recommendations.
  • Status: withdrawn

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EMA — authorised 20 May 2020

  • Application: EMEA/H/C/004993
  • Marketing authorisation holder: Seqirus Netherlands B.V.
  • Local brand name: Fluad Tetra
  • Indication: Prophylaxis of influenza in adults 50 years of age and older. Fluad Tetra should be used in accordance with official recommendations.
  • Status: withdrawn

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EMA — authorised 9 October 2023

  • Application: EMEA/H/C/006375
  • Marketing authorisation holder: Seqirus S.r.l.
  • Local brand name: Zoonotic Influenza Vaccine Seqirus
  • Indication: Zoonotic Influenza Vaccine Seqirus H5N8 is indicated for active immunisation against H5 subtype influenza A viruses in individuals 6 months of age and above. The use of this vaccine should be in accordance with official recommendations.
  • Status: approved

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EMA — authorised 19 April 2024

  • Application: EMEA/H/C/006051
  • Marketing authorisation holder: Seqirus Netherlands B.V.
  • Local brand name: Incellipan
  • Indication: Incellipan is indicated for active immunisation against influenza in an officially declared pandemic. Incellipan should be used in accordance with official recommendations.
  • Pathway: conditional
  • Status: approved

HAVRIX is an inactivated hepatitis A vaccine. On 19 April 2024, the European Medicines Agency (EMA) granted conditional marketing authorisation for HAVRIX in the European Union. The marketing authorisation holder is Seqirus Netherlands B.V. and the local brand name is HAVRIX.

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EMA — authorised 19 April 2024

  • Application: EMEA/H/C/006052
  • Marketing authorisation holder: Seqirus Netherlands B.V.
  • Local brand name: Celldemic
  • 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.
  • Status: approved

HAVRIX, a vaccine, has been granted marketing authorisation by the European Medicines Agency (EMA) for the active immunisation against the H5N1 subtype of Influenza A virus. The vaccine is indicated for use in adults and infants from 6 months of age and above. It should be administered in accordance with official recommendations.

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HAVRIX in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in European Union

Frequently asked questions

Is HAVRIX approved in European Union?

Yes. EMA authorised it on 21 March 2007; EMA authorised it on 1 June 2007; EMA authorised it on 26 September 2008.

Who is the marketing authorisation holder for HAVRIX in European Union?

GlaxoSmithKline Biologicals S.A. holds the EU marketing authorisation.