🇪🇺 Alpha 1-Antitrypsin in European Union

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EMA authorised Alpha 1-Antitrypsin on 23 June 2017

Marketing authorisation

EMA — authorised 23 June 2017

Application: EMEA/H/C/003934
Marketing authorisation holder: Kamada BioPharma Limited at Fieldfisher LLP
Local brand name: Infinia
Indication: Treatment and maintenance therapy of adult patients with congenital deficiency of alpha-1 antitrypsin and lung disease with clinical evidence of emphysema and airway obstruction (FEV1/SVC<70%)
Pathway: orphan
Status: withdrawn

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Frequently asked questions

Is Alpha 1-Antitrypsin approved in European Union?

Yes. EMA authorised it on 23 June 2017.

Who is the marketing authorisation holder for Alpha 1-Antitrypsin in European Union?

Kamada BioPharma Limited at Fieldfisher LLP holds the EU marketing authorisation.