Respreeza
alpha1-proteinase inhibitor (human)
Table of contents
Overview
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.
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Respreeza : EPAR - Summary for the public (PDF/76.69 KB)
First published: 16/09/2015
Last updated: 03/10/2016 -
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Respreeza : EPAR - Risk-management-plan summary (PDF/93.96 KB)
First published: 16/09/2015
Last updated: 16/09/2015
Authorisation details
Product details | |
---|---|
Name |
Respreeza
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Agency product number |
EMEA/H/C/002739
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Active substance |
Human alpha1-proteinase inhibitor
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International non-proprietary name (INN) or common name |
alpha1-proteinase inhibitor (human)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
B02AB02
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
CSL Behring GmbH
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Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
20/08/2015
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Contact address |
Emil-von-Behring-Straße 76 |
Product information
06/12/2021 Respreeza - EMEA/H/C/002739 - N/0058
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antihemorrhagics
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.