Tovanor Breezhaler

RSS

glycopyrronium bromide

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

Overview

An overview of Tovanor Breezhaler and why it is authorised in the EU

Tovanor Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Tovanor Breezhaler is used for maintenance (regular) treatment.

Tovanor Breezhaler contains the active substance glycopyrronium bromide.

This EPAR was last updated on 07/09/2018

Authorisation details

Product details
Name
Tovanor Breezhaler
Agency product number
EMEA/H/C/002690
Active substance
Glycopyrronium bromide
International non-proprietary name (INN) or common name
glycopyrronium bromide
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03BB06
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
28/09/2012
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

09/07/2018 Tovanor Breezhaler - EMEA/H/C/002690 - T/0030

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

Drugs for obstructive airway diseases

Therapeutic indication

Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Assessment history

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