Budesonide/Formoterol Teva

budesonide / formoterol

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This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva. 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 Budesonide/Formoterol Teva.

For practical information about using Budesonide/Formoterol Teva, patients should read the package leaflet or contact their doctor or pharmacist.

What is Budesonide/Formoterol Teva and what is it used for?

Budesonide/Formoterol Teva is a medicine that contains the active substances budesonide and formoterol. It is used for the treatment of asthma in adults for whom a combination product is considered appropriate. It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists’ taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists’ taken by inhalation.

Budesonide/Formoterol Teva is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare–ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.

Budesonide/Formoterol Teva is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substances, but Budesonide/Formoterol Teva is given using a different inhaler. The reference medicine for Budesonide/Formoterol Teva is Symbicort Turbohaler.

How is Budesonide/Formoterol Teva used?

The medicine can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine. Budesonide/Formoterol Teva can be used for the regular treatment of asthma. It can also be used for the treatment of COPD.

For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma. For asthma reliever therapy, patients should take a separate ‘reliever inhaler’ to relieve their symptoms. If patients need to take more than 8 reliever inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.

For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.

For further information, see the package leaflet.

How does Budesonide/Formoterol Teva work?

The two active substances in Budesonide/Formoterol Teva are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.

Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cells. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.

Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2 receptors found in the muscles. When inhaled it mainly attaches to the receptors in the airways and causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.

What are the benefits and risks of Budesonide/Formoterol Teva?

Studies were carried out to show that Budesonide/Formoterol Teva is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way. The benefits and risks of Budesonide/Formoterol Teva are therefore taken to be the same as those of the reference medicine.

Why is Budesonide/Formoterol Teva approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler. Therefore, the CHMP’s view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk. The Committee recommended that Budesonide/Formoterol Teva be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Budesonide/Formoterol Teva?

A risk management plan has been developed to ensure that Budesonide/Formoterol Teva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide/Formoterol Teva, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Budesonide/Formoterol Teva

The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva on 19 November 2014.

For more information about treatment with Budesonide/Formoterol Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Summary for the public BG = bălgarski 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public ES = español 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public CS = čeština 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public DA = dansk 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public DE = Deutsch 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public ET = eesti keel 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public EL = elliniká 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public FR = français 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public IT = italiano 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public LV = latviešu valoda 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public LT = lietuvių kalba 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public HU = magyar 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public MT = Malti 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public NL = Nederlands 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public PL = polski 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public PT = português 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public RO = română 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public SK = slovenčina 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public SL = slovenščina 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public FI = suomi 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public SV = svenska 04/12/2014  
Budesonide/Formoterol Teva : EPAR - Summary for the public HR = Hrvatski 04/12/2014  
Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Risk-management-plan summary (English only) 04/12/2014  

This EPAR was last updated on 15/07/2016 .

Authorisation details

Product details

Product details for Budesonide/Formoterol Teva
NameBudesonide/Formoterol Teva
Agency product numberEMEA/H/C/003951
Active substance

budesonide / formoterol fumarate dihydrate

International non-proprietary name (INN) or common name

budesonide / formoterol

Therapeutic area AsthmaPulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03AK07

Publication details

Publication details for Budesonide/Formoterol Teva
Marketing-authorisation holder

Teva Pharma B.V.

Revision2
Date of issue of marketing authorisation valid throughout the European Union19/11/2014

Contact address:

Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands

Product information

Product information

06/07/2016  Budesonide/Formoterol Teva -EMEA/H/C/003951 -A31/0002

Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 04/12/2014 15/07/2016

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.


Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 04/12/2014  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only.

Asthma
Budesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:

  • in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
    or
  • in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

COPD
Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Procedural steps taken and scientific information after authorisation EN = English 09/10/2015 15/07/2016
Budesonide/Formoterol Teva-H-C-3951-A31-14165: EPAR - Assessment Report - Article 31 EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 15/07/2016  

Initial marketing-authorisation documents

Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Public assessment report EN = English 04/12/2014  
CHMP summary of positive opinion for Budesonide / Formoterol Teva EN = English 26/09/2014