Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Tredaptive
Auth. number : EU/1/08/459
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: Tredaptive 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/889 (2008)3457 of 03/07/2008
07/10/2008 Centralised - Variation EMEA/H/C/889/IA/2
Updated with Decision(2009)4043 of 15/05/2009
18/12/2008 Centralised - Variation EMEA/H/C/889/IA/4
Updated with Decision(2009)4043 of 15/05/2009
18/12/2008 Centralised - Variation EMEA/H/C/889/IA/3
Updated with Decision(2009)4043 of 15/05/2009
19/02/2009 Centralised - Variation EMEA/H/C/889/IB/5
29/04/2009 Centralised - Variation EMEA/H/C/889/II/6
20/05/2009 Centralised - Variation (2009)4043 of 15/05/2009
29/06/2009 Centralised - Variation EMEA/H/C/889/IA/13
29/06/2009 Centralised - Variation EMEA/H/C/889/IA/12
29/06/2009 Centralised - Variation EMEA/H/C/889/IB/15
29/06/2009 Centralised - Variation EMEA/H/C/889/IA/9
29/06/2009 Centralised - Variation EMEA/H/C/889/IA/11
29/06/2009 Centralised - Variation EMEA/H/C/889/IA/10
10/08/2009 Centralised - Variation EMEA/H/C/889/II/7 (2009)6357 of 06/08/2009
01/09/2009 Centralised - Variation EMEA/H/C/889/II/8 (2009)6732 of 28/08/2009
27/10/2009 Centralised - Variation EMEA/H/C/889/II/14
25/11/2009 Centralised - Variation EMEA/H/C/889/II/17, 18
14/01/2010 Centralised - Variation EMEA/H/C/889/IA/20
27/01/2010 Centralised - Variation EMEA/H/C/889/II/19 (2010)519 of 25/01/2010
23/12/2010 Centralised - Variation EMEA/H/C/889/WS/54, 60 (2010)9618 of 20/12/2010
23/12/2010 Centralised - Variation EMEA/H/C/889/IG/27/G
Updated with Decision(2010)9618 of 20/12/2010
26/01/2011 Centralised - Variation EMEA/H/C/889/IB/WS/58 (2011)449 of 24/01/2011
26/04/2011 Centralised - Variation EMEA/H/C/889/N/21
Updated with Decision(2011)3708 of 23/05/2011
25/05/2011 Centralised - Variation EMEA/H/C/889/II/WS/118 (2011)3708 of 23/05/2011
30/08/2011 Centralised - Variation EMEA/H/C/889/IB/22
Updated with Decision(2011)6136 of 24/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/889/II/WS/123 (2011)6136 of 24/08/2011
25/04/2012 Centralised - Variation EMEA/H/C/889/II/WS/217 (2012)2811 of 20/04/2012
29/10/2012 Centralised - Variation EMEA/H/C/889/II/WS/301 (2012)7721 of 25/10/2012
18/01/2013 Referral EMEA/H/C/889/A-20/37 (2013)318 of 17/01/2013
26/03/2013 Referral EMEA/H/C/889/A-20/37 (2013)1840 of 22/03/2013
12/04/2013 Centralised - Withdrawal (2013)2127 of 10/04/2013