Dafiro

amlodipine / valsartan

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

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Dafiro?

Dafiro is a medicine that contains two active substances, amlodipine and valsartan. It is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).

What is Dafiro used for?

Dafiro is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘Essential’ means that the hypertension has no obvious cause.

The medicine can only be obtained with a prescription.

How is Dafiro used?

Dafiro is taken by mouth as one tablet once a day with some water. The dose of Dafiro to be used depends on the doses of amlodipine or valsartan that the patient was taking before. The patient may need to take separate tablets or capsules before switching to the combination tablet.

How does Dafiro work?

Dafiro contains two active substances, amlodipine and valsartan. Both are anti‑hypertensive medicines that have been available separately in the European Union (EU) since the mid‑1990s. They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.

Valsartan is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen.

How has Dafiro been studied?

Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.

Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out. Two studies (involving almost 3,200 patients) compared amlodipine, valsartan or a combination of both substances with placebo (a dummy treatment). Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan. The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats). The blood pressure was measured in ‘millimetres of mercury’ (mmHg).

The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Dafiro and people taking the separate medicines.

What benefit has Dafiro shown during the studies?

The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone. In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively. Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.

What is the risk associated with Dafiro?

The most common side effects with Dafiro (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes. For the full list of all side effects reported with Dafiro, see the package leaflet.

Dafiro must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives’ class, to valsartan, or to any of the other ingredients. It must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Dafiro must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure). Dafiro must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment. For the full list of restrictions, see the package leaflet.

Why has Dafiro been approved?

The CHMP decided that Dafiro’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Dafiro

The European Commission granted a marketing authorisation valid throughout the EU for Dafiro on 16 January 2007.

Name Language First published Last updated
Dafiro : EPAR - Summary for the public BG = bălgarski 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public ES = español 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public CS = čeština 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public DA = dansk 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public DE = Deutsch 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public ET = eesti keel 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public EL = elliniká 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public EN = English 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public FR = français 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public IT = italiano 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public LV = latviešu valoda 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public LT = lietuvių kalba 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public HU = magyar 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public MT = Malti 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public NL = Nederlands 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public PL = polski 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public PT = português 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public RO = română 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public SK = slovenčina 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public SL = slovenščina 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public FI = suomi 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public SV = svenska 2009-05-05 2015-07-10
Dafiro : EPAR - Summary for the public HR = Hrvatski 2009-05-05 2015-07-10

This EPAR was last updated on 14/05/2018 .

Authorisation details

Product details

Product details for Dafiro
NameDafiro
Agency product numberEMEA/H/C/000776
Active substance

amlodipine / valsartan

International non-proprietary name (INN) or common name

amlodipine / valsartan

Therapeutic area Hypertension
Anatomical therapeutic chemical (ATC) code C09DB01

Publication details

Publication details for Dafiro
Marketing-authorisation holder

Novartis Europharm Ltd.

Revision22
Date of issue of marketing authorisation valid throughout the European Union16/01/2007

Contact address:

Novartis Europharm Limited
Frimley Business Park
Camberley
GU16 7SR
United Kingdom

Product information

Product information

17/04/2018  Dafiro -EMEA/H/C/000776 -IG/0910

Name Language First published Last updated
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14
Dafiro : EPAR - Product Information HR = Hrvatski 2009-05-05 2018-05-14

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
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05
Dafiro : EPAR - All Authorised presentations HR = Hrvatski 2008-05-20 2010-08-05

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Dafiro : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-05-05 2018-05-14
Dafiro-H-C-776-A31-69 : EPAR - Assessment Report - Article 31 HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-A31-69 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation HR = Hrvatski 2014-10-01  
Dafiro-H-C-776-WS-360 : EPAR - Assessment Report - Variation HR = Hrvatski 2013-12-12  
CHMP post-authorisation summary of positive opinion for Dafiro HR = Hrvatski 2013-06-28  
Dafiro-H-C-776-WS-100-G : EPAR - Assessment Report - Variation HR = Hrvatski 2011-09-07  

Initial marketing-authorisation documents

Name Language First published Last updated
Dafiro : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2007-02-21  
Dafiro : EPAR - Scientific Discussion HR = Hrvatski 2007-02-21  

Authorised

This medicine is approved for use in the European Union

More information on Dafiro