Overview

The marketing authorisation for Sabervel has expired following the marketing authorisation holder's decision not to apply for a renewal.

Sabervel : EPAR - Summary for the public

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română (RO) (540.91 KB - PDF)
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slovenščina (SL) (561.53 KB - PDF)
Suomi (FI) (514.99 KB - PDF)
svenska (SV) (514.36 KB - PDF)

Product information

Sabervel : EPAR - Product Information

български (BG) (2.82 MB - PDF)
español (ES) (1.28 MB - PDF)
čeština (CS) (2.06 MB - PDF)
dansk (DA) (1.27 MB - PDF)
Deutsch (DE) (1.36 MB - PDF)
eesti keel (ET) (1.24 MB - PDF)
ελληνικά (EL) (2.99 MB - PDF)
français (FR) (1.33 MB - PDF)
hrvatski (HR) (1.36 MB - PDF)
íslenska (IS) (1.33 MB - PDF)
italiano (IT) (1.35 MB - PDF)
latviešu valoda (LV) (2.27 MB - PDF)
lietuvių kalba (LT) (1.4 MB - PDF)
magyar (HU) (2.23 MB - PDF)
Malti (MT) (2.4 MB - PDF)
Nederlands (NL) (1.27 MB - PDF)
norsk (NO) (1.32 MB - PDF)
polski (PL) (2.32 MB - PDF)
português (PT) (1.27 MB - PDF)
română (RO) (1.51 MB - PDF)
slovenčina (SK) (2.05 MB - PDF)
slovenščina (SL) (2.09 MB - PDF)
Suomi (FI) (1.29 MB - PDF)
svenska (SV) (1.23 MB - PDF)

Latest procedure affecting product information: A31/0005

04/09/2014

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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).

Sabervel : EPAR - All Authorised presentations

български (BG) (532.52 KB - PDF)
español (ES) (492.54 KB - PDF)
čeština (CS) (510.59 KB - PDF)
dansk (DA) (490.33 KB - PDF)
Deutsch (DE) (492 KB - PDF)
eesti keel (ET) (491.88 KB - PDF)
ελληνικά (EL) (529.29 KB - PDF)
français (FR) (490.14 KB - PDF)
hrvatski (HR) (49.33 KB - PDF)
íslenska (IS) (489.46 KB - PDF)
italiano (IT) (489.59 KB - PDF)
latviešu valoda (LV) (521.99 KB - PDF)
lietuvių kalba (LT) (509.52 KB - PDF)
magyar (HU) (516.86 KB - PDF)
Malti (MT) (513.99 KB - PDF)
Nederlands (NL) (490.31 KB - PDF)
norsk (NO) (489.55 KB - PDF)
polski (PL) (510.69 KB - PDF)
português (PT) (490.96 KB - PDF)
română (RO) (505.31 KB - PDF)
slovenčina (SK) (511.15 KB - PDF)
slovenščina (SL) (508.86 KB - PDF)
Suomi (FI) (490.89 KB - PDF)
svenska (SV) (489.37 KB - PDF)

Product details

Name of medicine
Sabervel
Active substance
irbesartan
International non-proprietary name (INN) or common name
irbesartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09CA04

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Sabervel is indicated in adults for the treatment of essential hypertension.

It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

Authorisation details

EMA product number
EMEA/H/C/002510

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Pharmathen S.A.

6, Dervenakion
EL-15351 Pallini Attiki
Greece

Marketing authorisation issued
13/04/2012
Revision
2

Assessment history

Sabervel : EPAR - Procedural steps taken and scientific information after authorisation

Sabervel-H-C-2510-A31-05 : EPAR - Assessment Report - Article 31

Sabervel-H-C-2510-A31-05 : 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 recommenda...

български (BG) (683.64 KB - PDF)
español (ES) (532.13 KB - PDF)
čeština (CS) (630.73 KB - PDF)
dansk (DA) (528.78 KB - PDF)
Deutsch (DE) (539.55 KB - PDF)
eesti keel (ET) (530.74 KB - PDF)
ελληνικά (EL) (692.25 KB - PDF)
français (FR) (535.83 KB - PDF)
hrvatski (HR) (567.58 KB - PDF)
italiano (IT) (532.43 KB - PDF)
latviešu valoda (LV) (632.02 KB - PDF)
lietuvių kalba (LT) (568.53 KB - PDF)
magyar (HU) (613.41 KB - PDF)
Malti (MT) (634.18 KB - PDF)
Nederlands (NL) (531.92 KB - PDF)
polski (PL) (629.52 KB - PDF)
português (PT) (530.27 KB - PDF)
română (RO) (581.26 KB - PDF)
slovenčina (SK) (629.29 KB - PDF)
slovenščina (SL) (638.59 KB - PDF)
Suomi (FI) (529.08 KB - PDF)
svenska (SV) (531.48 KB - PDF)

Sabervel : EPAR - Public assessment report

CHMP summary of positive opinion for Sabervel

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