Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cholib   
Auth. number : EU/1/13/866
Active substance : fenofibrate / simvastatin
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: C10BA04 - Simvastatin and fenofibrate
(See WHO ATC Index)
Indication: Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL C levels when LDL C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.
Marketing Authorisation Holder: Mylan Products Limited
20 Station Close, Potters Bar, EN6 ITL, 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
28/08/2013 Centralised - Authorisation EMEA/H/C/2559 (2013)5597 of 26/08/2013
19/12/2013 Centralised - Variation EMEA/H/C/2559/IB/2/G
Updated with Decision(2015)228 of 15/01/2015
03/02/2014 Centralised - Variation EMEA/H/C/2559/IAin/3
Updated with Decision(2015)228 of 15/01/2015
22/08/2014 Centralised - Variation EMEA/H/C/2559/IB/6
Updated with Decision(2015)228 of 15/01/2015
19/01/2015 Centralised - Yearly update (2015)228 of 15/01/2015
12/03/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2559/T/9 (2015)1683 of 10/03/2015
21/04/2015 Centralised - Variation EMEA/H/C/2559/IB/10
Updated with Decision(2016)2274 of 13/04/2016
27/07/2015 Centralised - Variation EMEA/H/C/2559/IAin/12
Updated with Decision(2016)2274 of 13/04/2016
15/10/2015 Centralised - Variation EMEA/H/C/2559/N/15
Updated with Decision(2016)2274 of 13/04/2016
15/04/2016 Centralised - Yearly update (2016)2274 of 13/04/2016
25/10/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2559/T/15 (2016)6878 of 21/10/2016