Rasilez

aliskiren

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

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

: Rasilez is a medicine that contains the active substance aliskiren. It is available as tablets (150 and 300 mg).

: Rasilez is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

: The recommended dose of Rasilez is 150 mg once a day. Rasilez may be taken alone or in combination with other medicines for hypertension, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors’ or ‘angiotensin receptor blockers’ (ARBs) in patients with diabetes, or moderate or severe kidney impairment. Rasilez should not be taken together with fruit juice or drinks containing plant extracts such as herbal teas. The dose of Rasilez may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.

: The active substance in Rasilez, aliskiren, is a renin inhibitor. It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body. Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall. This causes vasodilation (widening of the blood vessels), so that the blood pressure drops. This may reduce the risks associated with high blood pressure, such as having a stroke.

: Rasilez has been studied in 14 main studies involving over 10,000 patients with essential hypertension. Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension. In five of the studies, the effects of Rasilez taken alone were compared with those of placebo (a dummy treatment). Rasilez, taken alone or in combination with other medicines, was also compared with other medicines for hypertension. Combination studies looked at Rasilez used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide). The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (‘diastolic’) or when the chambers of the heart were contracting (‘systolic’). The blood pressure was measured in ‘millimetres of mercury’ (mmHg).

: Rasilez on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure. When the results of the five studies comparing Rasilez taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Rasilez, from an average of 99.4 mmHg at the start of the study. This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the patients taking placebo.
Larger falls were seen in patients aged 65 years or over and those taking higher doses of Rasilez. Rasilez also reduced blood pressure in patients with diabetes and patients who were overweight. The medicine’s effects were maintained for up to a year in two of the studies.
The studies with Rasilez taken in combination with other medicines showed additional decreases in blood pressure compared with the decreases produced by these medicines alone.

: The most common side effects with Rasilez (seen in between 1 and 10 patients in 100) are dizziness, diarrhoea, arthralgia (joint pain) and hyperkalaemia (high blood potassium levels). For the full list of all side effects reported with Rasilez, see the package leaflet.
Rasilez must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, or in women who are more than three months pregnant. Its use during the first three months of pregnancy and in women planning to become pregnant is not recommended. Rasilez must also not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors’ (such as quinidine). Rasilez in combination with an ACE inhibitor or an ARB must not be used in patients with diabetes, or moderate or severe kidney impairment. Rasilez is for use in adults only; it must not be used in children aged less than 2 years and is not recommended for older children. For the full list of restrictions, see the package leaflet.

: The CHMP noted that Rasilez is effective in reducing blood pressure when used alone or in combination. The CHMP therefore decided that the benefits of Rasilez are greater than its risks and recommended that it be given marketing authorisation. However, in February 2012, following the review of a study called ALTITUDE, the CHMP recommended that Rasilez should not be used together with an ACE inhibitor or ARB in patients with diabetes or with moderate or severe kidney impairment because of an increase in the risk of cardiovascular and kidney problems.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rasilez have also been included in the summary of product characteristics and the package leaflet.

: The European Commission granted a marketing authorisation valid throughout the European Union for Rasilez on 22 August 2007.
For more information about treatment with Rasilez, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

List item

Rasilez : EPAR - Summary for the public (PDF/78.75 KB)

First published: 07/05/2009
Last updated: 18/08/2016
- Bulgarian
  (PDF/106.39 KB)
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  (PDF/78.54 KB)
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- Estonian
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- Finnish
  (PDF/78.28 KB)
- French
  (PDF/80.05 KB)
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- Greek
  (PDF/109.35 KB)
- Hungarian
  (PDF/100.04 KB)
- Italian
  (PDF/79.09 KB)
- Latvian
  (PDF/102.95 KB)
- Lithuanian
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- Maltese
  (PDF/106.66 KB)
- Polish
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  (PDF/79.74 KB)
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  (PDF/101.76 KB)
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  (PDF/105.2 KB)
- Slovenian
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- Spanish
  (PDF/79.37 KB)
- Swedish
  (PDF/78.88 KB)

More detail is available in the summary of product characteristics

This EPAR was last updated on 21/01/2019

Authorisation details

Product details
Name	Rasilez
Agency product number	EMEA/H/C/000780
Active substance	aliskiren
International non-proprietary name (INN) or common name	aliskiren
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09XA02

Publication details
Marketing-authorisation holder	Noden Pharma DAC
Revision	24
Date of issue of marketing authorisation valid throughout the European Union	22/08/2007
Contact address	D'Olier Chambers 16A D'Olier Street Dublin 2 Ireland

Product information

18/10/2018 Rasilez - EMEA/H/C/000780 - WS/1371

List item

Rasilez : EPAR - Product Information (PDF/305.91 KB) (updated)

First published: 08/06/2009
Last updated: 21/01/2019
- Bulgarian
  (PDF/436.24 KB)
- Croatian
  (PDF/358.25 KB)
- Czech
  (PDF/398.56 KB)
- Danish
  (PDF/283.4 KB)
- Dutch
  (PDF/304.39 KB)
- Estonian
  (PDF/263.47 KB)
- Finnish
  (PDF/283.75 KB)
- French
  (PDF/349.74 KB)
- German
  (PDF/264.04 KB)
- Greek
  (PDF/479.47 KB)
- Hungarian
  (PDF/438.77 KB)
- Icelandic
  (PDF/271.76 KB)
- Italian
  (PDF/303.31 KB)
- Latvian
  (PDF/378.44 KB)
- Lithuanian
  (PDF/492.23 KB)
- Maltese
  (PDF/449.84 KB)
- Norwegian
  (PDF/325.16 KB)
- Polish
  (PDF/392.65 KB)
- Portuguese
  (PDF/272.99 KB)
- Romanian
  (PDF/366.48 KB)
- Slovak
  (PDF/382.42 KB)
- Slovenian
  (PDF/384.4 KB)
- Spanish
  (PDF/303.19 KB)
- Swedish
  (PDF/261.47 KB)

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.

List item

Rasilez : EPAR - All Authorised presentations (PDF/209.9 KB)

First published: 03/09/2007
Last updated: 02/10/2014
- Bulgarian
  (PDF/222.33 KB)
- Croatian
  (PDF/217.86 KB)
- Czech
  (PDF/217.13 KB)
- Danish
  (PDF/210.11 KB)
- Dutch
  (PDF/208.86 KB)
- Estonian
  (PDF/210.25 KB)
- Finnish
  (PDF/212.22 KB)
- French
  (PDF/213 KB)
- German
  (PDF/211.6 KB)
- Greek
  (PDF/224.47 KB)
- Hungarian
  (PDF/225.6 KB)
- Icelandic
  (PDF/211.48 KB)
- Italian
  (PDF/212.13 KB)
- Latvian
  (PDF/219.1 KB)
- Lithuanian
  (PDF/219.09 KB)
- Maltese
  (PDF/218.49 KB)
- Norwegian
  (PDF/212.18 KB)
- Polish
  (PDF/212.48 KB)
- Portuguese
  (PDF/210.54 KB)
- Romanian
  (PDF/215.46 KB)
- Slovak
  (PDF/215.56 KB)
- Slovenian
  (PDF/214.23 KB)
- Spanish
  (PDF/210.45 KB)
- Swedish
  (PDF/210.28 KB)

Pharmacotherapeutic group

Agents acting on the renin angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Assessment history

Changes since initial authorisation of medicine

List item

Rasilez : EPAR - Procedural steps taken and scientific information after authorisation (PDF/388.94 KB) (updated)

First published: 18/06/2009
Last updated: 21/01/2019
List item

Rasilez-H-C-780-P46-0039 : EPAR - Assessment Report (PDF/1.6 MB)

Adopted

First published: 18/04/2016
Last updated: 18/04/2016
EMA/262230/2016
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Rasilez-H-C-780-PSUSA-00000089-201409 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/72.74 KB)

First published: 07/07/2015
Last updated: 07/07/2015
EMA/CHMP/333074/2015
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Rasilez-H-C-780-A31-85 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 02/10/2014
Last updated: 02/10/2014
EMA/PRAC/294920/2014
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Rasilez-H-C-780-A31-85 : 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 recommendati... (PDF/48.81 KB)

First published: 02/10/2014
Last updated: 02/10/2014
- Bulgarian
  (PDF/87.49 KB)
- Croatian
  (PDF/80.12 KB)
- Czech
  (PDF/82.81 KB)
- Danish
  (PDF/49.01 KB)
- Dutch
  (PDF/49.82 KB)
- Estonian
  (PDF/50.6 KB)
- Finnish
  (PDF/49.15 KB)
- French
  (PDF/51.91 KB)
- German
  (PDF/53.54 KB)
- Greek
  (PDF/89.54 KB)
- Hungarian
  (PDF/68.7 KB)
- Italian
  (PDF/51.13 KB)
- Latvian
  (PDF/81.63 KB)
- Lithuanian
  (PDF/82.54 KB)
- Maltese
  (PDF/84.23 KB)
- Polish
  (PDF/83.62 KB)
- Portuguese
  (PDF/49.74 KB)
- Romanian
  (PDF/88.19 KB)
- Slovak
  (PDF/81.5 KB)
- Slovenian
  (PDF/79.79 KB)
- Spanish
  (PDF/50.51 KB)
- Swedish
  (PDF/50.18 KB)
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Rasilez-H-C-780-PSUV-90 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/68.46 KB)

First published: 02/10/2014
Last updated: 02/10/2014
EMA/554060/2014
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Rasilez-H-C-780-WS-37 : EPAR - Assessment Report - Variation (PDF/2.82 MB)

First published: 21/09/2012
Last updated: 21/09/2012
EMA/CHMP/479605/2012
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Rasilez-H-C-780-A20-63 : EPAR - Assessment Report - Variation (PDF/269.03 KB)

First published: 21/09/2012
Last updated: 21/09/2012
EMA/139311/2012
List item

Rasilez-H-C-780-WS-69 : EPAR - Assessment Report - Variation (PDF/88.46 KB)

Adopted

First published: 01/03/2012
Last updated: 01/03/2012
EMA/74385/2012

Rasilez

Table of contents

Overview

Rasilez : EPAR - Summary for the public (PDF/78.75 KB)

Authorisation details

Product information

Rasilez : EPAR - Product Information (PDF/305.91 KB) (updated)

Contents

Rasilez : EPAR - All Authorised presentations (PDF/209.9 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Rasilez : EPAR - Procedural steps taken and scientific information after authorisation (PDF/388.94 KB) (updated)

Rasilez-H-C-780-P46-0039 : EPAR - Assessment Report (PDF/1.6 MB)

Rasilez-H-C-780-PSUSA-00000089-201409 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/72.74 KB)

Rasilez-H-C-780-A31-85 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Rasilez-H-C-780-A31-85 : 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 recommendati... (PDF/48.81 KB)

Rasilez-H-C-780-PSUV-90 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/68.46 KB)

Rasilez-H-C-780-WS-37 : EPAR - Assessment Report - Variation (PDF/2.82 MB)

Rasilez-H-C-780-A20-63 : EPAR - Assessment Report - Variation (PDF/269.03 KB)

Rasilez-H-C-780-WS-69 : EPAR - Assessment Report - Variation (PDF/88.46 KB)

Initial marketing-authorisation documents

Rasilez : EPAR - Scientific Discussion (PDF/414.81 KB)

Rasilez : EPAR - Procedural steps taken before authorisation (PDF/26.26 KB)

News

More information on Rasilez

Questions and answers on the review aliskiren-containing medicines (PDF/60.98 KB)

Rasilez - Product information as approved by the CHMP on 16 February 2012, pending endorsement by the European Commission (PDF/434.19 KB)

Questions and answers on ongoing review of aliskiren-containing medicines (PDF/65.3 KB)

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Rasilez

Table of contents

Overview

Rasilez : EPAR - Summary for the public (PDF/78.75 KB)

Authorisation details

Product information

Rasilez : EPAR - Product Information (PDF/305.91 KB) (updated)

Contents

Rasilez : EPAR - All Authorised presentations (PDF/209.9 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Rasilez : EPAR - Procedural steps taken and scientific information after authorisation (PDF/388.94 KB) (updated)

Rasilez-H-C-780-P46-0039 : EPAR - Assessment Report (PDF/1.6 MB)

Rasilez-H-C-780-PSUSA-00000089-201409 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/72.74 KB)

Rasilez-H-C-780-A31-85 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Rasilez-H-C-780-A31-85 : 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 recommendati... (PDF/48.81 KB)

Rasilez-H-C-780-PSUV-90 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/68.46 KB)

Rasilez-H-C-780-WS-37 : EPAR - Assessment Report - Variation (PDF/2.82 MB)

Rasilez-H-C-780-A20-63 : EPAR - Assessment Report - Variation (PDF/269.03 KB)

Rasilez-H-C-780-WS-69 : EPAR - Assessment Report - Variation (PDF/88.46 KB)

Initial marketing-authorisation documents

Rasilez : EPAR - Scientific Discussion (PDF/414.81 KB)

Rasilez : EPAR - Procedural steps taken before authorisation (PDF/26.26 KB)

News

More information on Rasilez

Questions and answers on the review aliskiren-containing medicines (PDF/60.98 KB)

Rasilez - Product information as approved by the CHMP on 16 February 2012, pending endorsement by the European Commission (PDF/434.19 KB)

Questions and answers on ongoing review of aliskiren-containing medicines (PDF/65.3 KB)

Related content

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