Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Desloratadine Teva   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Desloratadina Teva (ES)
   - Desloratadina Teva (IT)
   - Desloratadină Teva (RO)
   - Desloratadin Teva (SK)
   - Desloratadin Teva (SL)
Auth. number : EU/1/11/732
Active substance : 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: Desloratadine Teva is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:
- allergic rhinitis
- urticaria
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
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
29/11/2011 Centralised - Authorisation EMEA/H/C/2419 (2011)8849 of 24/11/2011
02/07/2012 Centralised - Variation EMEA/H/C/2419/IB/1
Updated with Decision(2012)7870 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7870 of 29/10/2012
15/01/2013 Centralised - Notification EMEA/H/C/2419/N/2
Updated with Decision(2014)9298 of 01/12/2014
04/06/2014 Centralised - Notification EMEA/H/C/2419/N/5
Updated with Decision(2014)9298 of 01/12/2014
03/12/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2419/T/7 (2014)9298 of 01/12/2014
05/05/2015 Centralised - Variation EMEA/H/C/2419/IB/9
Updated with Decision(2016)2999 of 12/05/2016
11/06/2015 Centralised - Variation EMEA/H/C/2419/IB/10
Updated with Decision(2016)2999 of 12/05/2016
28/08/2015 Centralised - Variation EMEA/H/C/2419/IB/11
Updated with Decision(2016)2999 of 12/05/2016
30/10/2015 Centralised - Variation EMEA/H/C/2419/IB/12
Updated with Decision(2016)2999 of 12/05/2016
04/03/2016 Centralised - Variation EMEA/H/C/2419/IA/13
Updated with Decision(2016)2999 of 12/05/2016
17/05/2016 Centralised - Yearly update (2016)2999 of 12/05/2016