Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Enviage
Auth. number : EU/1/07/406
INN : aliskiren
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: C09X - Other agents acting on the renin-angiotensin system
Chemical subgroup: C09XA - Renin-inhibitors
Chemical substance: 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

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
24/08/2007 Centralised - Authorisation EMEA/H/C/850 (2007)4031 of 22/08/2007
11/07/2008 Centralised - Variation EMEA/H/C/850/II/27, 28 (2008)3615 of 09/07/2008
29/07/2008 Centralised - Variation EMEA/H/C/850/II/30
01/09/2008 Centralised - Variation EMEA/H/C/850/II/26 (2008)4741 of 28/08/2008
04/11/2008 Centralised - Variation EMEA/H/C/850/II/29
11/02/2009 Centralised - Variation EMEA/H/C/850/IA/37
11/02/2009 Centralised - Variation EMEA/H/C/850/IA/35
08/04/2009 Centralised - Variation EMEA/H/C/850/II/31, 32, 33 (2009)2722 of 03/04/2009
24/04/2009 Centralised - Variation EMEA/H/C/850/II/34 (2009)3189 of 22/04/2009
04/05/2009 Centralised - Variation EMEA/H/C/850/IB/36
04/05/2009 Centralised - Variation EMEA/H/C/850/IB/38
25/03/2010 Centralised - Variation EMEA/H/C/850/II/39 (2010)2020 of 23/03/2010
29/09/2010 Centralised - Withdrawal (2010)6784 of 27/09/2010