Rasilez HCT

RSS
Withdrawn

This medicine's authorisation has been withdrawn

aliskiren / hydrochlorothiazide
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Rasilez HCT has been withdrawn at the request of the marketing-authorisation holder.

Rasilez HCT : EPAR - Medicine overview

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български (BG) (768.25 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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español (ES) (670.49 KB - PDF)

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čeština (CS) (750.7 KB - PDF)

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dansk (DA) (668.78 KB - PDF)

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Deutsch (DE) (673.35 KB - PDF)

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eesti keel (ET) (667.58 KB - PDF)

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ελληνικά (EL) (779.38 KB - PDF)

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français (FR) (677.62 KB - PDF)

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hrvatski (HR) (692.82 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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italiano (IT) (669.57 KB - PDF)

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latviešu valoda (LV) (753.72 KB - PDF)

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lietuvių kalba (LT) (698.69 KB - PDF)

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magyar (HU) (740.98 KB - PDF)

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Malti (MT) (759.64 KB - PDF)

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Nederlands (NL) (669.39 KB - PDF)

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polski (PL) (746.01 KB - PDF)

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português (PT) (670.4 KB - PDF)

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română (RO) (706.3 KB - PDF)

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slovenčina (SK) (745.79 KB - PDF)

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slovenščina (SL) (737.22 KB - PDF)

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Suomi (FI) (667.7 KB - PDF)

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svenska (SV) (668.64 KB - PDF)

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Product information

Rasilez HCT : EPAR - Product Information

English (EN) (1.65 MB - PDF)

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български (BG) (4.37 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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español (ES) (1.73 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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čeština (CS) (3.41 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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dansk (DA) (1.67 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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Deutsch (DE) (1.76 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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eesti keel (ET) (1.72 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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ελληνικά (EL) (4.48 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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français (FR) (1.58 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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hrvatski (HR) (1.8 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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íslenska (IS) (1.66 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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italiano (IT) (1.91 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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latviešu valoda (LV) (3.58 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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lietuvių kalba (LT) (2.02 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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magyar (HU) (3.46 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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Malti (MT) (3.48 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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Nederlands (NL) (1.77 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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norsk (NO) (1.73 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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polski (PL) (3.52 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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português (PT) (1.67 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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Suomi (FI) (1.68 MB - PDF)

First published: 05/06/2009Last updated: 20/05/2022
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Latest procedure affecting product information:
20/12/2021
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Rasilez HCT : EPAR - All Authorised presentations

English (EN) (887.22 KB - PDF)

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български (BG) (1021.35 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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español (ES) (744.52 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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čeština (CS) (977.93 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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dansk (DA) (740.68 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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Deutsch (DE) (895.25 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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eesti keel (ET) (901.89 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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ελληνικά (EL) (1.02 MB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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français (FR) (949.45 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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hrvatski (HR) (950.76 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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íslenska (IS) (935.58 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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italiano (IT) (943.34 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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latviešu valoda (LV) (987.16 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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lietuvių kalba (LT) (946.05 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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magyar (HU) (988.5 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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Malti (MT) (1.05 MB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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Nederlands (NL) (893.12 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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norsk (NO) (900.08 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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polski (PL) (974.73 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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português (PT) (902.63 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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română (RO) (904.92 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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slovenčina (SK) (1021.14 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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slovenščina (SL) (979.15 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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Suomi (FI) (901.15 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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svenska (SV) (936.86 KB - PDF)

First published: 09/02/2009Last updated: 20/05/2022
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Product details

Name of medicine
Rasilez HCT
Active substance
  • aliskiren
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
  • aliskiren
  • hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09XA52

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension in adults.

Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.

Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.

Authorisation details

EMA product number
EMEA/H/C/000964
Marketing authorisation holder
Noden Pharma DAC

D'Olier Chambers
16A D'Olier Street
Dublin 2
Ireland

Marketing authorisation issued
16/01/2009
Revision
17

Assessment history

Rasilez HCT : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (1.4 MB - PDF)

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Rasilez-H-C-964-PSUSA-00000089-201409 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/333074/2015

English (EN) (657.38 KB - PDF)

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Rasilez HCT-H-C-964-A31-0053 : 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 recomm...

English (EN) (646.34 KB - PDF)

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Rasilez HCT-H-C-964-PSUV-0060 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/554712/2014

English (EN) (648.5 KB - PDF)

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Rasilez HCT-H-C-964-A31-0053 : EPAR - Assessment Report - Article 31

AdoptedReference Number: EMA/PRAC/294920/2014

English (EN) (1.07 MB - PDF)

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Rasilez HCT-H-C-964-WS-0037 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/479605/2012

English (EN) (3.41 MB - PDF)

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Rasilez HCT-H-C-964-A20-0026 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/391210/2012

English (EN) (1 MB - PDF)

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Rasilez-HCT-964-WS-0069 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/74385/2012

English (EN) (695.37 KB - PDF)

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Rasilez HCT : EPAR - Public assessment report

English (EN) (1.65 MB - PDF)

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CHMP summary of positive opinion for Rasilez HCT

Reference Number: EMEA/CHMP/599453/2008

English (EN) (609.57 KB - PDF)

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More information on Rasilez HCT

Questions and answers on the review aliskiren-containing medicines

Reference Number: EMA/113677/2012

English (EN) (60.98 KB - PDF)

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Questions and answers on ongoing review of aliskiren-containing medicines

Reference Number: EMA/990270/2011

English (EN) (65.3 KB - PDF)

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Public statement on Rasilez HCT : Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/266975/2022

English (EN) (91.88 KB - PDF)

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