- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Sabervel (irbesartan) expired on 17 April 2017 following the decision of the marketing authorisation holder, Pharmathen S.A., not to apply for a renewal of the marketing authorisation. Pharmathen S.A. confirmed that it did not apply for renewal of the authorisation due to commercial reasons.
Sabervel was granted marketing authorisation in the European Union (EU) on 17 April 2012 for the treatment of essential hypertension and the treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen. The marketing authorisation was valid for a 5-year period. Sabervel is a generic medicine of Aprovel. There are other generic medicinal products of Aprovel authorised and marketed in the EU.
The European Public Assessment Report (EPAR) for Sabervel is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Sabervel : EPAR - Summary for the public
English (EN) (513.87 KB - PDF)
български (BG) (592 KB - PDF)
español (ES) (515.58 KB - PDF)
čeština (CS) (567.92 KB - PDF)
dansk (DA) (514.61 KB - PDF)
Deutsch (DE) (577.63 KB - PDF)
eesti keel (ET) (514.44 KB - PDF)
ελληνικά (EL) (596.82 KB - PDF)
français (FR) (517.66 KB - PDF)
italiano (IT) (517.72 KB - PDF)
latviešu valoda (LV) (570.36 KB - PDF)
lietuvių kalba (LT) (540.99 KB - PDF)
magyar (HU) (562.94 KB - PDF)
Malti (MT) (566.99 KB - PDF)
Nederlands (NL) (529.5 KB - PDF)
polski (PL) (568.46 KB - PDF)
português (PT) (530.4 KB - PDF)
română (RO) (540.91 KB - PDF)
slovenčina (SK) (563.69 KB - PDF)
slovenščina (SL) (561.53 KB - PDF)
Suomi (FI) (514.99 KB - PDF)
svenska (SV) (514.36 KB - PDF)
Product information
Sabervel : EPAR - Product Information
English (EN) (1.21 MB - PDF)
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)
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
English (EN) (491.51 KB - PDF)
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 systemTherapeutic 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
- Expiry of marketing authorisation
- 17/04/2017
- Revision
- 2
Assessment history
Sabervel : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (542.15 KB - PDF)
Sabervel-H-C-2510-A31-05 : EPAR - Assessment Report - Article 31
English (EN) (977.48 KB - PDF)
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...
English (EN) (527.93 KB - PDF)
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
English (EN) (770.39 KB - PDF)
CHMP summary of positive opinion for Sabervel
English (EN) (504.48 KB - PDF)