Daliresp

roflumilast

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This is a summary of the European public assessment report (EPAR) for Daliresp. 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 Daliresp.

What is Daliresp?

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

What is Daliresp used for?

Daliresp 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.

Daliresp 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 Daliresp used?

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

How does Daliresp work?

The active substance in Daliresp, 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 Daliresp been studied?

Daliresp 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 Daliresp shown during the studies?

Daliresp 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 Daliresp had an average increase of 40 ml while those given placebo had an average decrease of 9 ml. In addition, the patients who took Daliresp 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 Daliresp?

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

Daliresp 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 Daliresp been approved?

The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daliresp 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 Daliresp’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Daliresp?

A risk management plan has been developed to ensure that Daliresp 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 Daliresp, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Daliresp 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 Daliresp 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 Daliresp

The European Commission granted a marketing authorisation valid throughout the European Union for Daliresp on 28 February 2011.

This authorisation was based on the authorisation granted to Daxas in 2010 (‘informed consent’).

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

Name Language First published Last updated
Daliresp : EPAR - Summary for the public BG = bălgarski 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public ES = español 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public CS = čeština 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public DA = dansk 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public DE = Deutsch 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public ET = eesti keel 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public EL = elliniká 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public EN = English 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public FR = français 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public IT = italiano 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public LV = latviešu valoda 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public LT = lietuvių kalba 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public HU = magyar 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public MT = Malti 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public NL = Nederlands 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public PL = polski 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public PT = português 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public RO = română 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public SK = slovenčina 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public SL = slovenščina 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public FI = suomi 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public SV = svenska 11/03/2011 30/06/2015
Daliresp : EPAR - Summary for the public HR = Hrvatski 11/03/2011 30/06/2015

This EPAR was last updated on 25/02/2016 .

Authorisation details

Product details

Product details for Daliresp
NameDaliresp
Agency product numberEMEA/H/C/002398
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 Daliresp
Marketing-authorisation holder

Takeda GmbH

Revision8
Date of issue of marketing authorisation valid throughout the European Union28/02/2011

Contact address:

Takeda GmbH
Byk-Gulden-Strasse 2
D-78467 Konstanz
Germany

Product information

Product information

17/12/2015  Daliresp -EMEA/H/C/002398 -WS/0768

Name Language First published Last updated
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016
Daliresp : EPAR - Product Information HR = Hrvatski 11/03/2011 25/02/2016

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
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  
Daliresp : EPAR - All Authorised presentations HR = Hrvatski 11/03/2011  

Name Language First published Last updated
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 11/03/2011  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Daliresp 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
Daliresp : EPAR - Public assessment report HR = Hrvatski 11/03/2011  
CHMP summary of positive opinion for Daliresp HR = Hrvatski 17/12/2010  

Authorised

This medicine is approved for use in the European Union