Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Desloratadine Teva   

   This product is authorized 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
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: Relief of symptoms associated with allergic rhinitis, urticaria.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, 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 - Variation EMEA/H/C/2419/N/2
04/06/2014 Centralised - Variation EMEA/H/C/2419/N/5