Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sabervel   
Auth. number : EU/1/12/765
INN : Irbesartan
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: C09C - Angiotensin II antagonists, plain
Chemical subgroup: C09CA - Angiotensin II antagonists, plain
Chemical substance: C09CA04 - Irbesartan
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
17/04/2012 Centralised - Authorisation EMEA/H/C/2510 (2012)2543 of 13/04/2012
06/07/2012 Centralised - Variation EMEA/H/C/2510/N/2
Updated with Decision(2012)7880 of 29/10/2012
14/09/2012 Centralised - Variation EMEA/H/C/2510/IB/3/G
Updated with Decision(2012)7880 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7880 of 29/10/2012
11/12/2012 Centralised - Variation
Updated with Decision(2013)9843 of 20/12/2013
30/08/2013 Centralised - Variation EMEA/H/C/2510/N/6
Updated with Decision(2013)9843 of 20/12/2013
24/12/2013 Centralised - Variation (2013)9843 of 20/12/2013