Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Dasselta   
Auth. number : EU/1/11/739
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: Dasselta is indicated in adults and adolescents aged 12 years and older for the relief of symptoms
associated with:
- allergic rhinitis
- urticaria
Marketing Authorisation Holder: Krka d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
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
30/11/2011 Centralised - Authorisation EMEA/H/C/2310 (2011)8964 of 28/11/2011
22/03/2012 Centralised - Notification EMEA/H/C/2310/N/1
Updated with Decision(2014)6090 of 22/08/2014
2/07/2013 Centralised - Notification EMEA/H/C/2310/N/3
Updated with Decision(2014)6090 of 22/08/2014
12/09/2013 Centralised - Variation EMEA/H/C/2310/IB/4
Updated with Decision(2014)6090 of 22/08/2014
26/08/2014 Centralised - Yearly update (2014)6090 of 22/08/2014
28/04/2015 Centralised - Variation EMEA/H/C/2310/IB/7
Updated with Decision(2016)2544 of 21/04/2016
11/06/2015 Centralised - Variation EMEA/H/C/2310/IB/8
Updated with Decision(2016)2544 of 21/04/2016
7/10/2015 Centralised - Variation EMEA/H/C/2310/IB/9
Updated with Decision(2016)2544 of 21/04/2016
25/04/2016 Centralised - Yearly update (2016)2544 of 21/04/2016
18/08/2016 Centralised - Renewal EMEA/H/C/2310/R/12 (2016)5403 of 16/08/2016
23/05/2017 PSUSA - Modification EMEA/H/C/2310/PSUSA/962/201607 (2017)3544 of 18/05/2017
7/02/2018 Centralised - Variation EMEA/H/C/2310/IB/16
12/03/2018 Centralised - Variation EMEA/H/C/2310/IB/17