Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Ipreziv
Auth. number : EU/1/11/735
Active substance : 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: Ipreziv 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/2517 (2011)9281 of 07/12/2011
10/05/2012 Centralised - Variation EMEA/H/C/2517/IB/1/G
Updated with Decision(2012)5018 of 12/07/2012
10/05/2012 Centralised - Variation EMEA/H/C/2517/IA/164
Updated with Decision(2012)5018 of 12/07/2012
17/07/2012 Centralised - Variation (2012)5018 of 12/07/2012
20/09/2013 Centralised - Variation EMEA/H/C/2517/WS/405
Updated with Decision(2013)7955 of 11/11/2013
12/11/2013 PSUSA - Modification EMEA/H/C/2517/PSU/8 (2013)7955 of 11/11/2013
24/02/2014 Centralised - Variation EMEA/H/C/2517/IG/408
Updated with Decision(2014)3530 of 22/05/2014
27/05/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2517/T/12 (2014)3530 of 22/05/2014
11/09/2014 Referral EMEA/H/C/2517/A-31/1370 (2014)6472 of 09/09/2014
29/10/2014 Centralised - Withdrawal (2014)8184 of 27/10/2014