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Community Register of medicinal products
Community list of not active medicinal products for human use |
WITHDRAWN |
Product information |
| Invented name: | Tekturna |
| Auth. number : | EU/1/07/408 |
| INN : | aliskiren |
| ATC: | C - Cardiovascular system C09 - Agents acting on the renin-angiotensin system C09X - Other agents acting on the renin-angiotensin system C09XA - Renin-inhibitors C09XA02 - Aliskiren (See WHO ATC Index) |
| Indication: | Treatment of essential hypertension |
| Marketing Authorisation Holder: | Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, 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 |
| 24/08/2007 | Centralised - Authorisation | EMEA/H/C/852 | (2007)4036 of 22/08/2007 | |||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IA/16 | ||||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IB/18 | ||||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IA/13 | ||||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IA/19 | ||||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IB/1 | ||||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IA/17 | ||||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IB/2 | ||||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IA/15 | ||||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IA/14 | ||||
| 16/11/2007 | Centralised - Variation | EMEA/H/C/852/IA/20 | ||||
| 01/02/2008 | Centralised - Variation | EMEA/H/C/852/IB/12 | ||||
| 11/07/2008 | Centralised - Variation | EMEA/H/C/852/II/27, 28 | (2008)3612 of 09/07/2008 | |||
| 29/07/2008 | Centralised - Variation | EMEA/H/C/852/II/30 | ||||
| 01/09/2008 | Centralised - Variation | EMEA/H/C/852/II/26 | (2008)4748 of 28/08/2008 | |||
| 04/11/2008 | Centralised - Variation | EMEA/H/C/852/II/29 | ||||
| 11/02/2009 | Centralised - Variation | EMEA/H/C/852/IA/35 | ||||
| 11/02/2009 | Centralised - Variation | EMEA/H/C/852/IA/37 | ||||
| 08/04/2009 | Centralised - Variation | EMEA/H/C/852/II/31, 32, 33 | (2009)2719 of 03/04/2009 | |||
| 24/04/2009 | Centralised - Variation | EMEA/H/C/852/II/34 | (2009)3191 of 22/04/2009 | |||
| 04/05/2009 | Centralised - Variation | EMEA/H/C/852/IB/38 | ||||
| 04/06/2009 | Centralised - Variation | EMEA/H/C/852/IB/36 | ||||
| 07/09/2009 | Centralised - Withdrawal | - | (2009)6831 of 02/09/2009 |