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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Desloratadine Actavis   

   This product is authorised under a different brand name in the EU in the following languages:
   - Desloratadin Actavis (DE)
   - Desloratadina Actavis (ES)
   - Desloratadina Actavis (PT)
   - Desloratadină Actavis (RO)
   - Desloratadin Actavis 5 mg filmsko obložene tablete (SL)
Auth. number : EU/1/11/745
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 Actavis is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:
- allergic rhinitis
- urticaria
Marketing Authorisation Holder: Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland
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/2435 (2012)183 of 13/01/2012
10/03/2014 Centralised - Variation EMEA/H/C/2435/IB/1
Updated with Decision(2015)1918 of 16/03/2015
27/08/2014 Centralised - Notification EMEA/H/C/2435/N/2
Updated with Decision(2015)1918 of 16/03/2015
18/03/2015 Centralised - Yearly update (2015)1918 of 16/03/2015
30/04/2015 Centralised - Variation EMEA/H/C/2435/IB/4
Updated with Decision(2016)2954 of 11/05/2016
4/06/2015 Centralised - Variation EMEA/H/C/2435/IB/5
Updated with Decision(2016)2954 of 11/05/2016
14/10/2015 Centralised - Variation EMEA/H/C/2435/IB/6
Updated with Decision(2016)2954 of 11/05/2016
2/02/2016 Centralised - Notification EMEA/H/C/2435/N/7
Updated with Decision(2016)2954 of 11/05/2016
13/05/2016 Centralised - Yearly update (2016)2954 of 11/05/2016
15/11/2016 Centralised - Renewal EMEA/H/C/2435/R/8 (2016)7411 of 11/11/2016
17/02/2017 Centralised - Variation EMEA/H/C/2435/IAIN/11
Updated with Decision(2017)3543 of 18/05/2017
16/05/2017 Centralised - Variation EMEA/H/C/2435/IB/12
Updated with Decision(2018)2585 of 23/04/2018
23/05/2017 PSUSA - Modification EMEA/H/C/2435/PSUSA/962/201607 (2017)3543 of 18/05/2017
29/11/2017 Centralised - Variation EMEA/H/C/2435/IAIN/13
Updated with Decision(2018)2585 of 23/04/2018
21/03/2018 Centralised - Notification EMEA/H/C/2435/N/14
Updated with Decision(2018)2585 of 23/04/2018
25/04/2018 Centralised - Yearly update (2018)2585 of 23/04/2018