Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Glybera   
Auth. number : EU/1/12/791
INN : Alipogene tiparvovec
Orphan status based on designation EU/3/04/194 added on 29/10/2012
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: C10AX10 - Alipogene tiparvovec
(See WHO ATC Index)
Indication: Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions. The diagnosis of LPLD has to be confirmed by genetic testing. The indication is restricted to patients with detectable levels of LPL protein.
Marketing Authorisation Holder: uniQure biopharma B.V.
Meibergdreef 61, NL-1105 BA Amsterdam, Nederland

  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
29/10/2012 Centralised - Authorisation EMEA/H/C/2145 (2012)7708 of 25/10/2012
06/11/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2145 (2012)8008 of 31/10/2012
21/12/2012 Centralised - Variation EMEA/H/C/2145/IA/1
Updated with Decision(2013)9656 of 17/12/2013
03/01/2013 Centralised - Variation EMEA/H/C/2145/IA/2
Updated with Decision(2013)9656 of 17/12/2013
27/06/2013 Centralised - Variation EMEA/H/C/2145/II/4
Updated with Decision(2013)9656 of 17/12/2013
27/06/2013 Centralised - Variation EMEA/H/C/2145/II/3
Updated with Decision(2013)9656 of 17/12/2013
27/06/2013 Centralised - Variation EMEA/H/C/2145/II/8
Updated with Decision(2013)9656 of 17/12/2013
27/06/2013 Centralised - Variation EMEA/H/C/2145/II/7
Updated with Decision(2013)9656 of 17/12/2013
25/07/2013 Centralised - Variation EMEA/H/C/2145/II/6
Updated with Decision(2013)9656 of 17/12/2013
23/09/2013 Centralised - Variation EMEA/H/C/2145/IAin/14
Updated with Decision(2013)9656 of 17/12/2013
19/12/2013 Centralised - Variation (2013)9656 of 17/12/2013
19/12/2013 Centralised - Variation
Updated with Decision(2014)2913 of 28/04/2014
20/03/2014 Centralised - Variation EMEA/H/C/2145/II/25
30/04/2014 Centralised - Annual reassessment EMEA/H/C/2145/S/27 (2014)2913 of 28/04/2014
26/06/2014 Centralised - Variation EMEA/H/C/2145/II/05