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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Desloratadine ratiopharm   

   This product is authorised under a different brand name in the EU in the following 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
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 ratiopharm 5 mg film-coated tablets is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:
- allergic rhinitis
- urticaria
Marketing Authorisation Holder: ratiopharm GmbH
Graf-Arco-Straße 3, 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
4/09/2014 Centralised - Yearly update (2014)6275 of 1/09/2014
27/04/2015 Centralised - Variation EMEA/H/C/2404/IB/9/G
Updated with Decision(2016)2545 of 21/04/2016
15/06/2015 Centralised - Variation EMEA/H/C/2404/IB/11
Updated with Decision(2016)2545 of 21/04/2016
8/10/2015 Centralised - Variation EMEA/H/C/2404/IB/12
Updated with Decision(2016)2545 of 21/04/2016
2/03/2016 Centralised - Variation EMEA/H/C/2404/IA/13
Updated with Decision(2016)2545 of 21/04/2016
8/03/2016 Centralised - Variation EMEA/H/C/2404/IB/14
Updated with Decision(2016)2545 of 21/04/2016
25/04/2016 Centralised - Yearly update (2016)2545 of 21/04/2016
10/08/2016 Centralised - Renewal EMEA/H/C/2404/R/15 (2016)5260 of 8/08/2016
23/05/2017 PSUSA - Modification EMEA/H/C/2404/PSUSA/962/201607 (2017)3542 of 18/05/2017
29/11/2017 Centralised - Variation EMEA/H/C/2404/IAIN/18