Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 16 April 2018

Indication(s)

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.

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More information

Category Value
Agency product number EMEA/H/C/002739
Orphan designation No
Date First Approved 20-08-2015
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder CSL Behring GmbH
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions