Sabervel
irbesartan
Table of contents
Overview
The marketing authorisation for Sabervel has expired following the marketing authorisation holder's decision not to apply for a renewal.
Authorisation details
| Product details | |
|---|---|
| Name |
Sabervel
|
| Agency product number |
EMEA/H/C/002510
|
| Active substance |
irbesartan
|
| International non-proprietary name (INN) or common name |
irbesartan
|
| Therapeutic area (MeSH) |
Hypertension
|
| Anatomical therapeutic chemical (ATC) code |
C09CA04
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Pharmathen S.A.
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
13/04/2012
|
| Contact address |
6, Dervenakion
EL-15351 Pallini Attiki Greece |
Product information
04/09/2014 Sabervel - EMEA/H/C/002510 - A31/0005
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.