Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Edarbi   
Auth. number : EU/1/11/734
INN : azilsartan medoxomil
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: C09CA09 - Azilsartan medoxomil
(See WHO ATC Index)
Indication: Edarbi is indicated for the treatment of essential hypertension in adults.
Marketing Authorisation Holder: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark

  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
09/12/2011 Centralised - Authorisation EMEA/H/C/2293 (2011)9280 of 07/12/2011
10/05/2012 Centralised - Variation EMEA/H/C/2293/IB/1/G
Updated with Decision(2012)5017 of 12/07/2012
10/05/2012 Centralised - Variation EMEA/H/C/2293/IG/164/G
Updated with Decision(2012)5017 of 12/07/2012
17/07/2012 Centralised - Variation (2012)5017 of 12/07/2012
20/09/2013 Centralised - Variation EMEA/H/C/2293/WS/405
Updated with Decision(2013)7954 of 11/11/2013
12/11/2013 Centralised - Modification EMEA/H/C/2293/PSU/8 (2013)7954 of 11/11/2013
24/02/2014 Centralised - Variation EMEA/H/C/2293/IG/408
Updated with Decision(2014)3943 of 06/06/2014
11/06/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2293/T/12 (2014)3943 of 06/06/2014
11/09/2014 Referral EMEA/H/C/2293/A-31/1370 (2014)6475 of 09/09/2014