This is a summary of the European public assessment report (EPAR) for Respreeza. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Respreeza. For practical information about using Respreeza, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
B02AB02
ATC Item
alfa1 antitrypsin
Pharmacotherapeutic Group
Antihemorrhagics
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Human alpha1-proteinase inhibitor | N/A | human alpha 1-proteinase inhibitor |
EMA Name
Respreeza
Medicine Name
Respreeza
Aliases
N/A