This is a summary of the European public assessment report (EPAR) for Dasselta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dasselta.
Dasselta : EPAR - Summary for the public (PDF/53.66 KB)
First published: 15/12/2011
Last updated: 15/12/2011
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Krka, d.d., Novo mesto
|Date of issue of marketing authorisation valid throughout the European Union||
12/03/2018 Dasselta - EMEA/H/C/002310 - IB/0017
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Antihistamines for systemic use
Dasselta is indicated for the relief of symptoms associated with:
- allergic rhinitis;