🇪🇺 Zemaira in European Union

EMA authorised Zemaira on 20 August 2015

Marketing authorisation

EMA — authorised 20 August 2015

  • Application: EMEA/H/C/002739
  • Marketing authorisation holder: CSL Behring GmbH
  • Local brand name: Respreeza
  • Indication: Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ). Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
  • Status: approved

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Zemaira in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Zemaira approved in European Union?

Yes. EMA authorised it on 20 August 2015.

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

CSL Behring GmbH holds the EU marketing authorisation.