Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pravafenix   
Auth. number : EU/1/11/679
INN : fenofibrate / pravastatin
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C10 - Lipid modifying agents
Pharmacological subgroup: C10B - Lipid modifying agents, combinations
Chemical subgroup: C10BA - HMG CoA reductase inhibitors in combination with other lipid modifying agents
Chemical substance: C10BA03 - Pravastatin and fenofibrate
(See WHO ATC Index)
Indication: Treatment of high coronary heart disease (CHD) -risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol levels whose LDL-C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy.
Marketing Authorisation Holder: LABORATOIRES SMB SA
26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België

  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
19/04/2011 Centralised - Authorisation EMEA/H/C/1243 (2011)2799 of 14/04/2011
20/07/2012 Centralised - Variation EMEA/H/C/1243/IB/4
Updated with Decision(2012)7927 of 29/10/2012
04/09/2012 Centralised - Variation EMEA/H/C/1243/II/3 (2012)6150 of 30/08/2012
06/11/2012 Centralised - Variation (2012)7927 of 29/10/2012
21/12/2012 Centralised - Variation EMEA/H/C/1243/IB/8
Updated with Decision(2014)997 of 11/02/2014
17/01/2013 Centralised - Variation EMEA/H/C/1243/N/7
Updated with Decision(2014)997 of 11/02/2014
21/02/2013 Centralised - Variation EMEA/H/C/1243/II/5
Updated with Decision(2014)997 of 11/02/2014
23/01/2014 Centralised - Variation EMEA/H/C/1243/N/10
Updated with Decision(2014)997 of 11/02/2014
13/02/2014 Centralised - Variation (2014)997 of 11/02/2014
23/04/2014 Centralised - Variation EMEA/H/C/1243/N/11