Daxas

roflumilast

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This is a summary of the European Public Assessment Report (EPAR) for Daxas. 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 Daxas.

What is Daxas?

Daxas is a medicine that contains the active substance roflumilast. It is available as tablets (500 micrograms).

What is Daxas used for?

Daxas is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.

Daxas is not used on its own but as an ‘add-on’ to treatment with bronchodilators (medicines that widen the airways in the lungs).

The medicine can only be obtained with a prescription.

How is Daxas used?

The recommended dose of Daxas is one tablet once a day. The tablets should be swallowed with water at the same time each day. Patients may need to take Daxas for several weeks before it starts to have an effect.

How does Daxas work?

The active substance in Daxas, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors’. It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD. By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient’s symptoms or to prevent them from getting worse.

How has Daxas been studied?

Daxas has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year. The patients could continue to receive treatment with a bronchodilator during the study. The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment. FEV1 is the most air a person can breathe out in one second.

What benefit has Daxas shown during the studies?

Daxas was shown to be more effective than placebo at treating COPD. At the beginning of the study, both groups of patients had an FEV1 of around 1 litre (1,000 ml). After a year, the patients who took Daxas had an average increase of 40 ml while those given placebo had an average decrease of 9 ml. In addition, the patients who took Daxas had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.

What is the risk associated with Daxas?

The most common side effects with Daxas (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).

Because patients taking Daxas may lose weight, they are advised to weigh themselves on a regular basis. The doctor may stop treatment with Daxas if the patient loses too much weight. For the full list of all side effects reported with Daxas, see the package leaflet.

Daxas must not be used in patients who have moderate or severe problems with their liver. For the full list of restrictions, see the package leaflet.

Why has Daxas been approved?

The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas in patients with severe COPD. This benefit was seen on top of the effects of the treatments that the patients were already receiving. After considering all of the available data on the effects of the medicine, the Committee decided that Daxas’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Daxas?

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

In addition, the company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine’s side effects and how it should be used. The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Daxas is appropriate for them. The card will include an area where patients can record their weight.

The company is also carrying out an observational study on the long-term safety of the medicine.

Other information about Daxas

The European Commission granted a marketing authorisation valid throughout the EU for Daxas on 5 July 2010.

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

Name Language First published Last updated
Daxas : EPAR - Summary for the public BG = bălgarski 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public ES = español 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public CS = čeština 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public DA = dansk 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public DE = Deutsch 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public ET = eesti keel 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public EL = elliniká 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public EN = English 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public FR = français 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public IT = italiano 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public LV = latviešu valoda 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public LT = lietuvių kalba 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public HU = magyar 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public MT = Malti 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public NL = Nederlands 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public PL = polski 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public PT = português 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public RO = română 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public SK = slovenčina 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public SL = slovenščina 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public FI = suomi 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public SV = svenska 2010-07-28 2015-06-04
Daxas : EPAR - Summary for the public HR = Hrvatski 2010-07-28 2015-06-04

This EPAR was last updated on 21/11/2016 .

Authorisation details

Product details

Product details for Daxas
NameDaxas
Agency product numberEMEA/H/C/001179
Active substance

roflumilast

International non-proprietary name (INN) or common name

roflumilast

Therapeutic area Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03DX07
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Daxas
Marketing-authorisation holder

AstraZeneca AB

Revision11
Date of issue of marketing authorisation valid throughout the European Union05/07/2010

Contact address:

AstraZeneca AB
SE-151 85 Södertälje
Sweden
 

Product information

Product information

18/11/2016  Daxas -EMEA/H/C/001179 -T/0034

Name Language First published Last updated
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21
Daxas : EPAR - Product Information HR = Hrvatski 2010-07-28 2016-11-21

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
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17
Daxas : EPAR - All Authorised presentations HR = Hrvatski 2010-07-28 2012-01-17

Name Language First published Last updated
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  
Daxas : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-07-28  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Daxas : EPAR - Public assessment report HR = Hrvatski 2010-07-28  
CHMP positive summary of opinion for Daxas HR = Hrvatski 2010-04-23  

Authorised

This medicine is approved for use in the European Union