Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Sprimeo HCT
Auth. number : EU/1/11/683
Active substance : aliskiren / hydrochlorothiazide
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: C09XA52 - Aliskiren and hydrochlorothiazide
(See WHO ATC Index)
Indication: Treatment of essential hypertension in adults.Sprimeo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.Sprimeo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
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
28/06/2011 Centralised - Authorisation EMEA/H/C/2421 (2011)4639 of 23/06/2011
04/11/2011 Centralised - Variation EMEA/H/C/2421/WS/165, 168, 169 (2011)7942 of 27/10/2011
24/04/2012 Referral EMEA/H/C/2421/A-20/11 (2012)2842 of 20/04/2012
01/06/2012 Centralised - Variation EMEA/H/C/2421/WS/189, EMEA/H/C/2421/II/12/G (2012)3641 of 25/05/2012
02/07/2012 Centralised - Variation EMEA/H/C/2421/WS/173 (2012)4563 of 28/06/2012
10/07/2012 Centralised - Withdrawal (2012)4852 of 06/07/2012