Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Neoclarityn   
Auth. number : EU/1/00/161
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: Neoclarityn 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/314 (2001)12 of 15/01/2001
08/08/2001 Centralised - Variation EMEA/H/C/314/II/1 (2001)2088 of 06/08/2001
24/09/2001 Centralised - Variation EMEA/H/C/314/II/2 (2001)2739 of 20/09/2001
13/03/2002 Centralised - Variation EMEA/H/C/314/I/8
16/04/2002 Centralised - Variation EMEA/H/C/314/II/7 (2002)1496 of 12/04/2002
18/04/2002 Centralised - Variation EMEA/H/C/314/X/5 (2002)1516 of 16/04/2002
18/04/2002 Centralised - Variation EMEA/H/C/314/X/4 (2002)1508 of 16/04/2002
22/05/2002 Centralised - Variation EMEA/H/C/314/II/6 (2002)1962 of 17/05/2002
22/07/2002 Centralised - Variation EMEA/H/C/314/II/9 (2002)2849 of 18/07/2002
30/08/2002 Centralised - Variation EMEA/H/C/314/I/12, 14
02/10/2002 Centralised - Variation EMEA/H/C/314/I/12 (2002)3646 of 30/09/2002
02/10/2002 Centralised - Variation EMEA/H/C/314/II/10, 11 (2002)3664 of 30/09/2002
19/03/2003 Centralised - Variation EMEA/H/C/314/II/16 (2003)861 of 17/03/2003
26/03/2003 Centralised - Variation EMEA/H/C/314/I/17
01/08/2003 Centralised - Variation EMEA/H/C/314/II/19, 20 (2003)2841 of 30/07/2003
16/02/2004 Centralised - Variation EMEA/H/C/314/II/21 (2004)510 of 12/02/2004
25/05/2004 Centralised - Variation EMEA/H/C/314/N/23
Updated with Decision(2004)3576 of 20/09/2004
22/09/2004 Centralised - Variation EMEA/H/C/314/II/22 (2004)3576 of 20/09/2004
12/01/2005 Centralised - Variation EMEA/H/C/314/II/24 (2005)60 of 10/01/2005
28/07/2005 Centralised - Variation EMEA/H/C/314/N/25
Updated with Decision(2006)41 of 09/01/2006
11/01/2006 Centralised - Variation EMEA/H/C/314/II/26 (2006)41 of 09/01/2006
24/01/2006 Centralised - Variation EMEA/H/C/314/II/28 (2006)160 of 20/01/2006
13/02/2006 Centralised - Renewal EMEA/H/C/314/R/27 (2006)447 of 09/02/2006
07/09/2006 Centralised - Variation EMEA/H/C/314/II/29 (2006)4063 of 01/09/2006
09/02/2007 Centralised - Variation EMEA/H/C/314/N/32
Updated with Decision(2007)1881 of 23/04/2007
25/04/2007 Centralised - Variation EMEA/H/C/314/X/30, 31 (2007)1881 of 23/04/2007
07/06/2007 Centralised - Variation EMEA/H/C/314/II/33 (2007)2488 of 05/06/2007
27/07/2007 Centralised - Variation EMEA/H/C/314/IB/34
07/01/2008 Centralised - Variation EMEA/H/C/314/IA/38
09/01/2008 Centralised - Variation EMEA/H/C/314/IB/37
10/01/2008 Centralised - Variation EMEA/H/C/314/N/35
Updated with Decision(2008)1272 of 31/03/2008
31/01/2008 Centralised - Variation EMEA/H/C/314/IA/39
02/04/2008 Centralised - Variation EMEA/H/C/314/II/36 (2008)1272 of 31/03/2008
24/10/2008 Centralised - Variation EMEA/H/C/314/IA/41
11/12/2008 Centralised - Variation EMEA/H/C/314/N/40
Updated with Decision(2010)2047 of 23/03/2010
18/03/2009 Centralised - Variation EMEA/H/C/314/N/42
Updated with Decision(2010)2047 of 23/03/2010
14/07/2009 Centralised - Variation EMEA/H/C/314/IB/43
06/11/2009 Centralised - Variation EMEA/H/C/314/IA/45
Updated with Decision(2010)2047 of 23/03/2010
04/01/2010 Centralised - Variation EMEA/H/C/314/IA/46
23/03/2010 Centralised - Variation EMEA/H/C/314/II/44 (2010)2047 of 23/03/2010
21/10/2010 Centralised - Variation EMEA/H/C/314/N/47
Updated with Decision(2011)6588 of 16/09/2011
01/03/2011 Centralised - Variation EMEA/H/C/314/IA/53
11/03/2011 Centralised - Variation EMEA/H/C/314/IA/54/G
11/04/2011 Centralised - Variation EMEA/H/C/314/N/48
Updated with Decision(2011)6588 of 16/09/2011
21/09/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/314/T/49 (2011)6588 of 16/09/2011
22/02/2012 Centralised - Variation EMEA/H/C/314/I/117/G
Updated with Decision(2012)1195 of 17/02/2012
22/02/2012 Centralised - Variation (2012)1195 of 17/02/2012
17/09/2012 Centralised - Variation EMEA/H/C/314/N/58
Updated with Decision(2014)6038 of 19/08/2014
04/02/2013 Centralised - Variation EMEA/H/C/314/N/61
Updated with Decision(2014)6038 of 19/08/2014
13/09/2013 Centralised - Variation EMEA/H/C/314/IB/64
Updated with Decision(2014)6038 of 19/08/2014
26/06/2014 Centralised - Variation EMEA/H/C/314/II/67
Updated with Decision(2014)6038 of 19/08/2014
21/08/2014 Centralised - Variation (2014)6038 of 19/08/2014
29/08/2014 Centralised - Variation EMEA/H/C/314/IB/71