Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tracleer   
Auth. number : EU/1/02/220
Active substance : bosentan
Orphan status based on designation EU/3/01/019 added on 17/05/2002
10 years of market exclusivity
Orphan status based on designation EU/3/03/139 added on 11/06/2007
10 years of market exclusivity
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C02 - Antihypertensives
Pharmacological subgroup: C02K - Other antihypertensives
Chemical subgroup: C02KX - Other antihypertensives
Chemical substance: C02KX01 - Bosentan
(See WHO ATC Index)
Indication: Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in:
• Primary (idiopathic and heritable) pulmonary arterial hypertension
• Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
• Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology
Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II.
Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Marketing Authorisation Holder: Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, 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
17/05/2002 Centralised - Authorisation EMEA/H/C/401 (2002)1937 of 15/05/2002
21/10/2002 Centralised - Variation EMEA/H/C/401/I/1 (2002)4056 of 17/10/2002
30/06/2003 Centralised - Variation EMEA/H/C/401/II/2 (2003)2124 of 26/06/2003
08/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/I/5
24/09/2003 Centralised - Variation EMEA/H/C/401/I/6 (2003)3424 of 22/09/2003
28/10/2003 Centralised - Annual reassessment EMEA/H/C/401/S/4 (2003)4007 of 24/10/2003
30/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/I/12
15/12/2003 Centralised - Variation EMEA/H/C/401/IB/11
Updated with Decision(2004)3332 of 23/08/2004
23/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/II/13
25/08/2004 Centralised - Variation (2004)3332 of 23/08/2004
15/09/2004 Centralised - Variation EMEA/H/C/401/II/14 (2004)3520 of 13/09/2004
02/12/2004 Centralised - Annual reassessment EMEA/H/C/401/S/15 (2004)4699 of 30/11/2004
18/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/17
03/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/19
03/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/18
20/06/2005 Centralised - Variation EMEA/H/C/401/II/16 (2005)1875 of 16/06/2005
28/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/22
02/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/II/20
22/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IB/23
22/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IB/21
21/10/2005 Centralised - Variation EMEA/H/C/401/II/24 (2005)4165 of 19/10/2005
18/11/2005 Centralised - Variation EMEA/H/C/401/II/25 (2005)4496 of 15/11/2005
08/12/2005 Centralised - Variation EMEA/H/C/401/IB/26
Updated with Decision(2006)3002 of 26/06/2006
08/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/30
08/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/31
28/06/2006 Centralised - Variation (2006)3002 of 26/06/2006
14/08/2006 Centralised - Variation EMEA/H/C/401/II/28 (2006)3715 of 10/08/2006
11/09/2006 Centralised - Variation EMEA/H/C/401/IA/32
Updated with Decision(2006)5256 of 27/10/2006
31/10/2006 Centralised - Variation EMEA/H/C/401/II/27 (2006)5256 of 27/10/2006
08/06/2007 Centralised - Variation EMEA/H/C/401/II/29 (2007)2519 of 07/06/2007
11/06/2007 Centralised - Variation EMEA/H/C/401/II/29 (2007)2520 of 07/06/2007
15/06/2007 Centralised - Renewal EMEA/H/C/401/R/33 (2007)2599 of 13/06/2007
02/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/36
07/11/2007 Centralised - Variation EMEA/H/C/401/II/35 (2007)5430 of 31/10/2007
19/12/2007 Centralised - Variation EMEA/H/C/401/II/34 (2007)6730 of 18/12/2007
20/12/2007 Centralised - Variation EMEA/H/C/401/II/34 (2007)6729 of 18/12/2007
14/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/38
31/07/2008 Centralised - Variation EMEA/H/C/401/II/37 (2008)4170 of 29/07/2008
19/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/42
22/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/45
03/07/2009 Centralised - Variation EMEA/H/C/401/II/41 (2009)5425 of 01/07/2009
03/07/2009 Centralised - Variation EMEA/H/C/401/X/39 (2009)5424 of 01/07/2009
07/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IB/46
09/07/2009 Centralised - Variation EMEA/H/C/401/II/40 (2009)5591 of 07/07/2009
05/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IB/48
20/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/II/43
22/01/2010 Centralised - Variation EMEA/H/C/401/II/47 (2010)403 of 20/01/2010
26/04/2010 Centralised - Variation EMEA/H/C/401/II/49 (2010)2639 of 22/04/2010
15/06/2010 Centralised - Variation EMEA/H/C/401/IA/52/G
Updated with Decision(2010)6441 of 16/09/2010
20/09/2010 Centralised - Variation (2010)6441 of 16/09/2010
11/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/401/IA/53/G
03/03/2011 Centralised - Variation EMEA/H/C/401/II/51 (2011)1490 of 28/02/2011
21/12/2011 Centralised - Variation EMEA/H/C/401/II/54/G (2011)9951 of 19/12/2011
26/04/2012 Centralised - Renewal EMEA/H/C/40/R/55 (2012)2853 of 20/04/2012
17/05/2012 Centralised - (orphan status)
12/11/2012 Centralised - Variation EMEA/H/C/401/II/56 (2012)7755 of 25/10/2012
13/11/2012 Centralised - Variation EMEA/H/C/401/IAin/61/G
Updated with Decision(2013)9482 of 13/12/2013
27/11/2012 Centralised - Variation EMEA/H/C/401/II/59 (2012)8710 of 22/11/2012
19/09/2013 Centralised - Variation EMEA/H/C/401/II/62
Updated with Decision(2013)9482 of 13/12/2013
17/12/2013 Centralised - Yearly update (2013)9482 of 13/12/2013
04/04/2014 Centralised - (orphan status)
14/01/2015 Centralised - 2-Monthly update EMEA/H/C/401/II/66 (2015)113 of 12/01/2015
10/02/2015 Corrigendum (2015)746 of 06/02/2015
08/06/2015 Centralised - Notification EMEA/H/C/401/N/0069