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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Edarbi
|
| Auth. number : | EU/1/11/734 |
| INN : | azilsartan medoxomil |
| ATC: | C - Cardiovascular system C09 - Agents acting on the renin-angiotensin system C09C - Angiotensin II antagonists, plain C09CA - Angiotensin II antagonists, plain C09CA09 - Azilsartan medoxomil (See WHO ATC Index) |
| Indication: | Edarbi 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 procedures
| 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 |