🇪🇺 Tezspire in European Union

EMA authorised Tezspire on 19 September 2022

Marketing authorisation

EMA — authorised 19 September 2022

  • Application: EMEA/H/C/005588
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Tezspire
  • Indication: AsthmaTezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyps (CRSwNP) Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.
  • Status: approved

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Tezspire in other countries

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

Other Respiratory approved in European Union

Frequently asked questions

Is Tezspire approved in European Union?

Yes. EMA authorised it on 19 September 2022.

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

AstraZeneca AB holds the EU marketing authorisation.