This is a summary of the European public assessment report (EPAR) for Desloratadine Actavis. 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 Desloratadine Actavis.
Desloratadine Actavis : EPAR - Summary for the public (PDF/115.86 KB)Adopted
First published: 25/01/2012
Last updated: 25/01/2012
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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.
Actavis Group PTC ehf
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Reykjavíkurvegur 76 - 78
30/05/2022 Desloratadine Actavis - EMEA/H/C/002435 - PSUSA/00000962/202107
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Antihistamines for systemic use
Treatment of allergic rhinitis and urticaria.