Respreeza

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alpha1-proteinase inhibitor (human)

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 15/10/2018

Authorisation details

Product details
Name
Respreeza
Agency product number
EMEA/H/C/002739
Active substance
alpha1-proteinase inhibitor (human)
International non-proprietary name (INN) or common name
alpha1-proteinase inhibitor (human)
Therapeutic area (MeSH)
  • Genetic Diseases, Inborn
  • Lung Diseases
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
Marketing-authorisation holder
CSL Behring GmbH
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
20/08/2015
Contact address
Emil-von-Behring-Straße 76
35041 Marburg
Germany

Product information

01/10/2018 Respreeza - EMEA/H/C/002739 - IB/0025/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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