Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rasilamlo   
Auth. number : EU/1/11/686
INN : aliskiren / amlodipine
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: C09XA53 - Aliskiren and amlodipine
(See WHO ATC Index)
Indication: Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.
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 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
18/04/2011 Centralised - Authorisation EMEA/H/C/2073 (2011)2790 of 14/04/2011
23/08/2011 Corrigendum
04/11/2011 Centralised - Variation EMEA/H/C/2073/WS/165, 167, 168, 169 (2011)7932 of 27/10/2011
13/12/2011 Centralised - Variation EMEA/H/C/2073/WS/145, 146, EMEA/H/C/2073/II/3 (2011)9387 of 09/12/2011
24/04/2012 Referral EMEA/H/C/2073/A-20/16 (2012)2820 of 20/04/2012
30/05/2012 Centralised - Variation EMEA/H/C/2073/WS/189 (2012)3576 of 25/05/2012
12/09/2012 Centralised - Variation EMEA/H/C/2073/WS/279 (2012)6381 of 10/09/2012
04/12/2012 Centralised - Variation EMEA/H/C/2073/WS/277, 278, 308 (2012)9105 of 30/11/2012
23/01/2013 Centralised - Variation EMEA/H/C/2073/WS/280, 309 (2013)365 of 21/01/2013
27/02/2013 Centralised - Variation EMEA/H/C/2073/WS/316, 327 (2013)1189 of 25/02/2013
24/04/2013 Centralised - Variation EMEA/H/C/2073/WS/287 (2013)2411 of 22/04/2013
01/07/2013 Centralised - Variation EMEA/H/C/2073/WS/374, 375 (2013)4191 of 27/06/2013
08/08/2013 Centralised - Variation EMEA/H/C/2073/WS/407 (2013)5294 of 05/08/2013
19/09/2013 Centralised - Variation EMEA/H/C/2073/WS/412
Updated with Decision(2013)8830 of 03/12/2013
17/10/2013 Centralised - Variation EMEA/H/C/2073/IB/82
Updated with Decision(2013)8830 of 03/12/2013
06/12/2013 Centralised - Variation EMEA/H/C/2073/WS/373 (2013)8830 of 03/12/2013
23/01/2014 Centralised - Variation EMEA/H/C/2073/WS/481
Updated with Decision(2014)4504 of 27/06/2014
09/07/2014 Centralised - Modification EMEA/H/C/2073/PSUV/90 (2014)4504 of 27/06/2014