Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Aerinaze   
Auth. number : EU/1/07/399
INN : desloratadine; pseudoephedrine sulphate
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: Aerinaze is indicated in adults and adolescents 12 years and older for the symptomatic treatment of
seasonal allergic rhinitis when accompanied by nasal congestion.
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
01/08/2007 Centralised - Authorisation EMEA/H/C/772 (2007)3763 of 30/07/2007
13/11/2007 Centralised - Notification EMEA/H/C/772/N/1
Updated with Decision(2009)2475 of 27/03/2009
07/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/772/IA/3
09/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/772/IB/2
13/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/772/IB/4
20/08/2008 Centralised - Variation EMEA/H/C/772/IB/5
Updated with Decision(2009)2475 of 27/03/2009
01/04/2009 Centralised - Variation (2009)2475 of 27/03/2009
24/04/2009 Centralised - Notification EMEA/H/C/772/N/6
Updated with Decision(2010)1838 of 15/03/2010
25/09/2009 Centralised - Notification EMEA/H/C/772/N/7
Updated with Decision(2010)1838 of 15/03/2010
17/03/2010 Centralised - Variation EMEA/H/C/772/II/8 (2010)1838 of 15/03/2010
08/02/2011 Centralised - Notification EMEA/H/C/772/N/9
Updated with Decision(2011)7148 of 30/09/2011
11/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/772/IG/54
05/04/2011 Centralised - Notification EMEA/H/C/772/N/10
Updated with Decision(2011)7148 of 30/09/2011
04/10/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/772/T/11 (2011)7148 of 30/09/2011
21/11/2011 Centralised - Variation EMEA/H/C/772/IG/117/G
Updated with Decision(2012)1187 of 17/02/2012
21/02/2012 Centralised - Variation (2012)1187 of 17/02/2012
25/05/2012 Centralised - Renewal EMEA/H/C/772/R/14 (2012)3462 of 22/05/2012
25/09/2012 Centralised - Notification EMEA/H/C/772/N/17
Updated with Decision(2014)6175 of 26/08/2014
22/01/2013 Centralised - Notification EMEA/H/C/772/N/20
Updated with Decision(2014)6175 of 26/08/2014
09/09/2013 Centralised - Variation EMEA/H/C/772:/IA/23
Updated with Decision(2014)6175 of 26/08/2014
13/09/2013 Centralised - Variation EMEA/H/C/772/IB/21
Updated with Decision(2014)6175 of 26/08/2014
28/08/2014 Centralised - Yearly update (2014)6175 of 26/08/2014
02/10/2014 Centralised - Notification EMEA/H/C/772/N/27