Desloratadine Teva

desloratadine

Overview
Authorisation details
Product information
Assessment history

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 Teva. 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 Teva.

: Desloratadine Teva is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).
Desloratadine Teva is a ‘generic medicine’. This means that Desloratadine Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aerius.

: Desloratadine Teva is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
The medicine can only be obtained with a prescription.

: The recommended dose for adults and adolescents (12 years of age and over) is one tablet once a day.

: The active substance in Desloratadine Teva, desloratadine, is an antihistamine. It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

: Because Desloratadine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

: Because Desloratadine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

: The CHMP concluded that, in accordance with EU requirements, Desloratadine Teva has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the CHMP’s view was that, as for Aerius, the benefit outweighs the identified risk. The Committee recommended that Desloratadine Teva be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine Teva on 24 November 2011.
For more information about treatment with Desloratadine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

List item

Desloratadine Teva : EPAR - Summary for the public (PDF/53.75 KB)

First published: 08/12/2011
Last updated: 08/12/2011
EMA/CHMP/654268/2011
- Bulgarian
  (PDF/89.32 KB)
- Czech
  (PDF/80.14 KB)
- Danish
  (PDF/54.15 KB)
- Dutch
  (PDF/54.11 KB)
- Estonian
  (PDF/53.42 KB)
- Finnish
  (PDF/53.59 KB)
- French
  (PDF/54.42 KB)
- German
  (PDF/116.77 KB)
- Greek
  (PDF/150.47 KB)
- Hungarian
  (PDF/135.08 KB)
- Italian
  (PDF/56.31 KB)
- Latvian
  (PDF/80.02 KB)
- Lithuanian
  (PDF/78.46 KB)
- Maltese
  (PDF/80.63 KB)
- Polish
  (PDF/81.16 KB)
- Portuguese
  (PDF/70.33 KB)
- Romanian
  (PDF/78.06 KB)
- Slovak
  (PDF/76.76 KB)
- Slovenian
  (PDF/75.98 KB)
- Spanish
  (PDF/54.7 KB)
- Swedish
  (PDF/54.4 KB)

This EPAR was last updated on 09/06/2022

Authorisation details

Product details
Name	Desloratadine Teva
Agency product number	EMEA/H/C/002419
Active substance	desloratadine
International non-proprietary name (INN) or common name	desloratadine
Therapeutic area (MeSH)	Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal
Anatomical therapeutic chemical (ATC) code	R06AX27
Generic	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	Teva B.V
Revision	18
Date of issue of marketing authorisation valid throughout the European Union	24/11/2011
Contact address	Swensweg 5 2031GA Haarlem The Netherlands

Product information

30/05/2022 Desloratadine Teva - EMEA/H/C/002419 - PSUSA/00000962/202107

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Desloratadine Teva : EPAR - Product information (PDF/190.92 KB)

First published: 08/12/2011
Last updated: 09/06/2022
- Bulgarian
  (PDF/293.11 KB)
- Croatian
  (PDF/344.48 KB)
- Czech
  (PDF/264.06 KB)
- Danish
  (PDF/316.8 KB)
- Dutch
  (PDF/313.96 KB)
- Estonian
  (PDF/315.84 KB)
- Finnish
  (PDF/397.9 KB)
- French
  (PDF/205.22 KB)
- German
  (PDF/341.36 KB)
- Greek
  (PDF/406.44 KB)
- Hungarian
  (PDF/375.71 KB)
- Icelandic
  (PDF/313.99 KB)
- Italian
  (PDF/330.64 KB)
- Latvian
  (PDF/498.75 KB)
- Lithuanian
  (PDF/378.02 KB)
- Maltese
  (PDF/374.91 KB)
- Norwegian
  (PDF/315.7 KB)
- Polish
  (PDF/269.39 KB)
- Portuguese
  (PDF/311.14 KB)
- Romanian
  (PDF/250.92 KB)
- Slovak
  (PDF/240.31 KB)
- Slovenian
  (PDF/242.64 KB)
- Spanish
  (PDF/315.57 KB)
- Swedish
  (PDF/314.7 KB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

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.

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Desloratadine Teva : EPAR - All Authorised presentations (PDF/13.86 KB)

First published: 08/12/2011
Last updated: 19/10/2015
- Bulgarian
  (PDF/14.46 KB)
- Croatian
  (PDF/27.82 KB)
- Czech
  (PDF/21.46 KB)
- Danish
  (PDF/13.36 KB)
- Dutch
  (PDF/15.78 KB)
- Estonian
  (PDF/28.11 KB)
- Finnish
  (PDF/12.52 KB)
- French
  (PDF/12.29 KB)
- German
  (PDF/14.13 KB)
- Greek
  (PDF/32.88 KB)
- Hungarian
  (PDF/26.27 KB)
- Icelandic
  (PDF/14.31 KB)
- Italian
  (PDF/15.3 KB)
- Latvian
  (PDF/30.5 KB)
- Lithuanian
  (PDF/34.52 KB)
- Maltese
  (PDF/32.03 KB)
- Norwegian
  (PDF/14.13 KB)
- Polish
  (PDF/36.96 KB)
- Portuguese
  (PDF/13.56 KB)
- Romanian
  (PDF/29.41 KB)
- Slovak
  (PDF/19.15 KB)
- Slovenian
  (PDF/27.14 KB)
- Spanish
  (PDF/12.9 KB)
- Swedish
  (PDF/14.22 KB)

Desloratadine Teva

Table of contents

Overview

Desloratadine Teva : EPAR - Summary for the public (PDF/53.75 KB)

Authorisation details

Product information

Desloratadine Teva : EPAR - Product information (PDF/190.92 KB)

Desloratadine Teva : EPAR - All Authorised presentations (PDF/13.86 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Desloratadine Teva : EPAR - Procedural steps taken and scientific information after authorisation (PDF/168.26 KB)

Desloratadine Teva-H-C-PSUSA-00000962-202107 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/128.84 KB)

Desloratadine Teva-H-C-PSUSA-00000962-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/101.36 KB)

Initial marketing-authorisation documents

Desloratadine Teva : EPAR - Public assessment report (PDF/235.18 KB)

CHMP summary of positive opinion for Desloratadine Teva (PDF/53.03 KB)

More information on Desloratadine Teva

Questions and answers on generic medicines (PDF/66.45 KB)

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