Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lojuxta   
Auth. number : EU/1/13/851
Active substance : Lomitapide
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C10 - Lipid modifying agents
Pharmacological subgroup: C10A - Lipid modifying agents, plain
Chemical subgroup: C10AX - Other lipid modifying agents
Chemical substance: C10AX12 - Lomitapide
(See WHO ATC Index)
Indication: Lojuxta is indicated as an adjunct to a low fat diet and other lipid lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH).
Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded.
Marketing Authorisation Holder: Aegerion Pharmaceuticals Limited
Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, 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
05/08/2013 Centralised - Authorisation EMEA/H/C/2578 (2013)5153 of 31/07/2013
06/12/2013 Rectificative Decision (2013)8900 of 04/12/2013
11/12/2013 Corrigendum (2013)9148 of 09/12/2013
23/12/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2578/T/2 (2013)9744 of 18/12/2013
03/03/2014 Centralised - Variation EMEA/H/C/2578/IA/6/G
Updated with Decision(2014)8880 of 19/11/2014
02/06/2014 Centralised - Notification EMEA/H/C/2578/N/9
Updated with Decision(2014)8880 of 19/11/2014
21/11/2014 Centralised - Annual reassessment EMEA/H/C/2578/S/11
21/11/2014 PSUSA - Modification EMEA/H/C/2578/PSUV/8 (2014)8880 of 19/11/2014
01/04/2015 Centralised - 2-Monthly update EMEA/H/C/2578/II/14/G (2015)2315 of 30/03/2015
22/07/2015 Centralised - Variation EMEA/H/C/2578/IB/18
Updated with Decision(2016)1131 of 18/02/2016
19/11/2015 Centralised - Annual reassessment EMEA/H/C/2578/S/20
22/02/2016 Centralised - Variation EMEA/H/C/2578/X/16 (2016)1131 of 18/02/2016