🇪🇺 Vaxelis vaccine in European Union

EMA authorised Vaxelis vaccine on 15 February 2016

Marketing authorisation

EMA — authorised 15 February 2016

  • Application: EMEA/H/C/003982
  • Marketing authorisation holder: MCM Vaccine B.V.
  • Local brand name: Vaxelis
  • Indication: Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of Vaxelis should be in accordance with official recommendations.
  • Status: approved

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Other Immunology approved in European Union

Frequently asked questions

Is Vaxelis vaccine approved in European Union?

Yes. EMA authorised it on 15 February 2016.

Who is the marketing authorisation holder for Vaxelis vaccine in European Union?

MCM Vaccine B.V. holds the EU marketing authorisation.