Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ipreziv   
Auth. number : EU/1/11/735
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: Ipreziv is indicated for the treatment of essential hypertension in adults.
Marketing Authorisation Holder: Takeda Global Research and Development Centre (Europe) Ltd
61 Aldwych, London WC2B 4AE, United Kingdom

  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 continues to be 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 Centralised - Modification EMEA/H/C/2517/PSU/8 (2013)7955 of 11/11/2013
24/02/2014 Centralised - Variation EMEA/H/C/2517/IG/408