Ventavis

RSS

iloprost

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

Overview

This is a summary of the European public assessment report (EPAR) for Ventavis. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ventavis.

This EPAR was last updated on 15/03/2019

Authorisation details

Product details
Name
Ventavis
Agency product number
EMEA/H/C/000474
Active substance
iloprost
International non-proprietary name (INN) or common name
iloprost
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
B01AC11
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Bayer AG
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
15/09/2003
Contact address
51368 Leverkusen
Germany

Product information

25/02/2019 Ventavis - EMEA/H/C/000474 - IB/0061

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

Antithrombotic agents

Therapeutic indication

Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.

Assessment history

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