Desloratadine Actavis

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desloratadine

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 11/10/2019

Authorisation details

Product details
Name
Desloratadine Actavis
Agency product number
EMEA/H/C/002435
Active substance
desloratadine
International non-proprietary name (INN) or common name
desloratadine
Therapeutic area (MeSH)
  • Rhinitis, Allergic, Perennial
  • Urticaria
  • Rhinitis, Allergic, Seasonal
Anatomical therapeutic chemical (ATC) code
R06AX27
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Actavis Group PTC ehf
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
13/01/2012
Contact address
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

08/08/2019 Desloratadine Actavis - EMEA/H/C/002435 - IAIN/0016/G

Contents

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Pharmacotherapeutic group

Antihistamines for systemic use

Therapeutic indication

Treatment of allergic rhinitis and urticaria.

Assessment history

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