Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Dynastat   
Auth. number : EU/1/02/209
INN : Parecoxib
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M01 - Antiinflammatory and antirheumatic products
Pharmacological subgroup: M01A - Antiinflammatory and antirheumatic products, non-steroids
Chemical subgroup: M01AH - Coxibs
Chemical substance: M01AH04 - Parecoxib
(See WHO ATC Index)
Indication: For the short-term treatment of postoperative pain. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the
individual patient's overall risks (see sections 4.3 and 4.4).
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
26/03/2002 Centralised - Authorisation EMEA/H/C/381 (2002)1295 of 22/03/2002
31/07/2002 Centralised - Variation EMEA/H/C/381/I/1
25/11/2002 Centralised - Variation EMEA/H/C/381/I/2
08/04/2003 Centralised - Variation EMEA/H/C/381/I/4
08/04/2003 Centralised - Variation EMEA/H/C/381/I/7
08/04/2003 Centralised - Variation EMEA/H/C/381/I/5
11/04/2003 Centralised - Variation EMEA/H/C/381/II/3 (2003)1251 of 09/04/2003
16/05/2003 Centralised - Variation EMEA/H/C/381/I/6
16/05/2003 Centralised - Variation EMEA/H/C/381/I/8
20/04/2004 Centralised - Variation EMEA/H/C/381/IA/12
Updated with Decision(2004)4845 of 06/12/2004
04/05/2004 Centralised - Variation EMEA/H/C/381/II/11 (2004)1685 of 22/04/2004
06/07/2004 Centralised - Variation EMEA/H/C/381/IA/14
07/09/2004 Centralised - Variation EMEA/H/C/381/N/15
Updated with Decision(2004)4845 of 06/12/2004
08/12/2004 Centralised - Variation EMEA/H/C/381/II/13 (2004)4849 of 06/12/2004
08/12/2004 Centralised - Variation (2004)4845 of 06/12/2004
01/02/2005 Centralised - Variation EMEA/H/C/381/II/16, 17 (2005)233 of 26/01/2005
14/06/2005 Centralised - Variation EMEA/H/C/381/II/19 (2005)1804 of 10/06/2005
07/10/2005 Referral EMEA/H/C/381/A-18/633 (2005)3796 of 05/10/2005
30/01/2006 Centralised - Variation EMEA/H/C/381/II/21 (2006)223 of 25/01/2006
11/05/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/381/T/18 (2006)1955 of 05/05/2006
06/07/2006 Centralised - Variation EMEA/H/C/381/II/22 (2006)3141 of 04/07/2006
13/07/2006 Centralised - Variation EMEA/H/C/381/IA/23
18/01/2007 Centralised - Variation EMEA/H/C/381/IA/26
25/01/2007 Centralised - Variation EMEA/H/C/381/IA/27
Updated with Decision(2007)1533 of 29/03/2007
02/04/2007 Centralised - Variation EMEA/H/C/381/II/25 (2007)1533 of 29/03/2007
25/04/2007 Centralised - Renewal EMEA/H/C/381/R/24 (2007)1884 of 23/04/2007
06/06/2007 Centralised - Variation EMEA/H/C/381/IA/28
Updated with Decision(2008)442 of 31/01/2008
06/06/2007 Centralised - Variation EMEA/H/C/381/IA/29
10/09/2007 Centralised - Variation EMEA/H/C/381/IB/30
14/09/2007 Centralised - Variation EMEA/H/C/381/IB/30
09/11/2007 Centralised - Variation EMEA/H/C/381/IA/31
04/02/2008 Centralised - Variation (2008)442 of 31/01/2008
10/11/2008 Centralised - Variation EMEA/H/C/381/IA/33
27/02/2009 Centralised - Variation EMEA/H/C/381/II/32 (2009)1381 of 25/02/2009
16/07/2009 Centralised - Variation EMEA/H/C/381/II/35 (2009)5747 of 14/07/2009
28/07/2009 Centralised - Variation EMEA/H/C/381/II/36 (2009)5906 of 23/07/2009
08/12/2009 Centralised - Variation EMEA/H/C/381/IA/39
Updated with Decision(2010)1790 of 15/03/2010
09/12/2009 Centralised - Variation EMEA/H/C/381/IA/38
17/03/2010 Centralised - Variation (2010)1790 of 15/03/2010
02/08/2010 Centralised - Variation EMEA/H/C/381/II/41 (2010)5391 of 28/07/2010
08/09/2010 Centralised - Variation EMEA/H/C/381/II/40 (2010)6227 of 06/09/2010
29/11/2010 Centralised - Variation EMEA/H/C/381/IA/43
23/02/2011 Centralised - Variation EMEA/H/C/381/II/42 (2011)1184 of 21/02/2011
02/03/2011 Centralised - Variation EMEA/H/C/381/IG/44/G
28/06/2011 Centralised - Variation EMEA/H/C/381/II/44 (2011)4635 of 23/06/2011
24/11/2011 Centralised - Variation EMEA/H/C/381/II/46 (2011)8696 of 22/11/2011
26/01/2012 Centralised - Renewal EMEA/H/C/381/R/45 (2012)483 of 24/01/2012
18/07/2012 Centralised - Variation EMEA/H/C/381/IB/50/G
Updated with Decision(2012)7210 of 10/10/2012
12/10/2012 Centralised - Variation (2012)7210 of 10/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/381/II/47 (2012)7661 of 24/10/2012
03/12/2012 Centralised - Variation EMEA/H/C/381/II/55
Updated with Decision(2013)8839 of 03/12/2013
21/03/2013 Centralised - Variation EMEA/H/C/381/II/52
Updated with Decision(2013)8839 of 03/12/2013
06/12/2013 Centralised - Variation (2013)8839 of 03/12/2013