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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Desloratadine ratiopharm   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Desloratadina ratiopharm (ES)
   - Desloratadina ratiopharm (IT)
   - Desloratadina ratiopharm (PT)
   - Desloratadină ratiopharm (RO)
   - Desloratadin ratiopharm (SK)
   - Desloratadin ratiopharm (SL)
Auth. number : EU/1/11/746
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: ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

  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
17/01/2012 Centralised - Authorisation EMEA/H/C/2404 (2012)185 of 13/01/2012
19/09/2013 Centralised - Variation EMEA/H/C/2404/IA/7
Updated with Decision(2014)6275 of 01/09/2014
23/09/2013 Centralised - Variation EMEA/H/C/2404/IB/7
Updated with Decision(2014)6275 of 01/09/2014
04/09/2014 Centralised - Variation (2014)6275 of 01/09/2014