Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Trevaclyn
Auth. number : EU/1/08/458
INN : nicotinic acid / laropiprant
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C10 - Lipid modifying agents
Pharmacological subgroup: C10A - Lipid modifying agents, plain
Chemical subgroup: C10AD - Nicotinic acid and derivatives
Chemical substance: C10AD52 - Nicotinic acid, combinations
(See WHO ATC Index)
Indication: Trevaclyn is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia (heterozygous familial and non familial)
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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
07/07/2008 Centralised - Authorisation EMEA/H/C/897 (2008)3458 of 03/07/2008
07/10/2008 Centralised - Variation EMEA/H/C/897/IA/2
Updated with Decision(2009)4041 of 15/05/2009
18/12/2008 Centralised - Variation EMEA/H/C/897/IA/3
Updated with Decision(2009)4041 of 15/05/2009
18/12/2008 Centralised - Variation EMEA/H/C/897/IA/4
Updated with Decision(2009)4041 of 15/05/2009
19/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/IB/5
29/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/II/6
20/05/2009 Centralised - Variation (2009)4041 of 15/05/2009
29/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/IA/13
29/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/IB/15
29/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/IA/12
29/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/IA/10
29/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/IA/9
29/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/IA/11
10/08/2009 Centralised - Variation EMEA/H/C/897/II/7 (2009)6354 of 06/08/2009
01/09/2009 Centralised - Variation EMEA/H/C/897/II/8 (2009)6731 of 28/08/2009
27/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/II/14
25/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/II/17, 18
14/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/897/IA/20
27/01/2010 Centralised - Variation EMEA/H/C/897/II/19 (2010)516 of 25/01/2010
12/10/2010 Centralised - Notification EMEA/H/C/897/N/21
Updated with Decision(2010)9619 of 20/12/2010
23/12/2010 Centralised - Variation EMEA/H/C/897/IG/27/G
Updated with Decision(2010)9619 of 20/12/2010
23/12/2010 Centralised - Variation EMEA/H/C/897/II/WS/54, 60 (2010)9619 of 20/12/2010
26/01/2011 Centralised - Variation EMEA/H/C/897/IB/WS/58 (2011)451 of 24/01/2011
26/04/2011 Centralised - Notification EMEA/H/C/897/N/22
Updated with Decision(2011)3709 of 23/05/2011
25/05/2011 Centralised - Variation EMEA/H/C/897/II/WS/118 (2011)3709 of 23/05/2011
30/08/2011 Centralised - Variation EMEA/H/C/897/IB/23
Updated with Decision(2011)6137 of 24/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/897/II/WS/123 (2011)6137 of 24/08/2011
25/04/2012 Centralised - Variation EMEA/H/C/897/II/WS/217 (2012)2812 of 20/04/2012
29/10/2012 Centralised - Variation EMEA/H/C/897/II/WS/301 (2012)7719 of 25/10/2012
18/01/2013 Referral EMEA/H/C/897/A-20/38 (2013)317 of 17/01/2013
26/03/2013 Referral EMEA/H/C/897/A-20/38 (2013)1841 of 22/03/2013
12/04/2013 Centralised - Withdrawal (2013)2128 of 10/04/2013