Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Azomyr   
Auth. number : EU/1/00/157
INN : desloratadine
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R06 - Antihistamines for systemic use
Pharmacological subgroup: R06A - Antihistamines for systemic use
Chemical subgroup: R06AX - Other antihistamines for systemic use
Chemical substance: R06AX27 - Desloratadine
(See WHO ATC Index)
Indication: Azomyr is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with allergic rhinitis and urticaria
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
18/01/2001 Centralised - Authorisation EMEA/H/C/310 (2001)13 of 15/01/2001
08/08/2001 Centralised - Variation EMEA/H/C/310/II/1 (2001)2089 of 06/08/2001
24/09/2001 Centralised - Variation EMEA/H/C/310/II/2 (2001)2738 of 20/09/2001
13/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/I/8
16/04/2002 Centralised - Variation EMEA/H/C/310/II/7 (2002)1497 of 12/04/2002
18/04/2002 Centralised - Variation EMEA/H/C/310/X/5 (2002)1515 of 16/04/2002
18/04/2002 Centralised - Variation EMEA/H/C/310/X/4 (2002)1513 of 16/04/2002
22/05/2002 Centralised - Variation EMEA/H/C/310/II/6 (2002)1961 of 17/05/2002
22/07/2002 Centralised - Variation EMEA/H/C/310/II/9 (2002)2847 of 18/07/2002
30/08/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/I/12, 14
02/10/2002 Centralised - Variation EMEA/H/C/310/I/13 (2002)3641 of 30/09/2002
02/10/2002 Centralised - Variation EMEA/H/C/310/II/10, 11 (2002)3665 of 30/09/2002
19/03/2003 Centralised - Variation EMEA/H/C/310/II/16 (2003)863 of 17/03/2003
26/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/I/17
01/08/2003 Centralised - Variation EMEA/H/C/310/II/19, 20 (2003)2838 of 30/07/2003
16/02/2004 Centralised - Variation EMEA/H/C/310/II/21 (2004)511 of 12/02/2004
25/05/2004 Centralised - Notification EMEA/H/C/310/N/23
Updated with Decision(2004)3574 of 20/09/2004
22/09/2004 Centralised - Variation EMEA/H/C/310/II/22 (2004)3574 of 20/09/2004
12/01/2005 Centralised - Variation EMEA/H/C/310/II/24 (2005)58 of 10/01/2005
28/07/2005 Centralised - Notification EMEA/H/C/310/N/25
Updated with Decision(2006)39 of 09/01/2006
16/09/2005 Centralised - Notification EMEA/H/C/310/N/26
Updated with Decision(2006)39 of 09/01/2006
30/11/2005 Centralised - Notification EMEA/H/C/310/N/29
Updated with Decision(2006)157 of 20/01/2006
11/01/2006 Centralised - Variation EMEA/H/C/310/II/27 (2006)39 of 09/01/2006
24/01/2006 Centralised - Variation EMEA/H/C/310/II/30 (2006)157 of 20/01/2006
13/02/2006 Centralised - Renewal EMEA/H/C/310/R/28 (2006)448 of 09/02/2006
07/09/2006 Centralised - Variation EMEA/H/C/310/II/31 (2006)4078 of 01/09/2006
09/02/2007 Centralised - Notification EMEA/H/C/310/N/34
Updated with Decision(2007)1880 of 23/04/2007
25/04/2007 Centralised - Variation EMEA/H/C/310/X/32, 33 (2007)1880 of 23/04/2007
07/06/2007 Centralised - Variation EMEA/H/C/310/II/35 (2007)2486 of 05/06/2007
27/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/IB/37
10/08/2007 Centralised - Notification EMEA/H/C/310/N/36
Updated with Decision(2008)1276 of 31/03/2008
07/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/IA/41
09/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/IB/40
10/01/2008 Centralised - Notification EMEA/H/C/310/N/38
Updated with Decision(2008)1276 of 31/03/2008
31/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/IA/42
02/04/2008 Centralised - Variation EMEA/H/C/310/II/39 (2008)1276 of 31/03/2008
24/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/IA/44
11/12/2008 Centralised - Notification EMEA/H/C/310/N/43
Updated with Decision(2010)2048 of 23/03/2010
18/03/2009 Centralised - Notification EMEA/H/C/310/N/45
Updated with Decision(2010)2048 of 23/03/2010
14/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/IB/46
06/11/2009 Centralised - Variation EMEA/H/C/310/IA/48
Updated with Decision(2010)2048 of 23/03/2010
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/IA/49
23/03/2010 Centralised - Variation EMEA/H/C/310/IA/48 (2010)2048 of 23/03/2010
20/10/2010 Centralised - Notification EMEA/H/C/310/N/50
Updated with Decision(2011)6590 of 16/09/2011
01/02/2011 Centralised - Notification EMEA/H/C/310/N/51
Updated with Decision(2011)6590 of 16/09/2011
01/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/IA/53
11/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/310/IA/54/G
04/04/2011 Centralised - Notification EMEA/H/C/310/N/52
Updated with Decision(2011)6590 of 16/09/2011
21/09/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/310/T/53 (2011)6590 of 16/09/2011
13/02/2012 Centralised - Variation EMEA/H/C/310/IG/117/G
Updated with Decision(2012)894 of 09/02/2012
13/02/2012 Centralised - Variation (2012)894 of 09/02/2012
17/09/2012 Centralised - Notification EMEA/H/C/310/N/62
Updated with Decision(2014)6036 of 19/08/2014
04/02/2013 Centralised - Notification EMEA/H/C/310/N/65
Updated with Decision(2014)6036 of 19/08/2014
13/09/2013 Centralised - Variation EMEA/H/C/310/IB/68
Updated with Decision(2014)6036 of 19/08/2014
14/02/2014 Centralised - Notification EMEA/H/C/310/N/73
Updated with Decision(2014)6036 of 19/08/2014
26/06/2014 Centralised - Variation EMEA/H/C/310/II/71
Updated with Decision(2014)6036 of 19/08/2014
21/08/2014 Centralised - Yearly update (2014)6036 of 19/08/2014
29/08/2014 Centralised - Variation EMEA/H/C/310/IB/76
25/09/2014 Centralised - Variation EMEA/H/C/310/WS/587