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.

Desloratadine Actavis is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).

Desloratadine Actavis is a ‘generic medicine’. This means that Desloratadine Actavis is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aerius.

Desloratadine Actavis 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 5 mg once a day.

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

Because Desloratadine Actavis 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 Actavis 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 Actavis 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 Actavis be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine Actavis on 13 January 2012.

For more information about treatment with Desloratadine Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Desloratadine Actavis : EPAR - Summary for the public

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dansk (DA) (115.82 KB - PDF)
Deutsch (DE) (116.56 KB - PDF)
eesti keel (ET) (54.02 KB - PDF)
ελληνικά (EL) (150.42 KB - PDF)
français (FR) (56.44 KB - PDF)
italiano (IT) (54.88 KB - PDF)
latviešu valoda (LV) (139.45 KB - PDF)
lietuvių kalba (LT) (137.9 KB - PDF)
magyar (HU) (134.89 KB - PDF)
Malti (MT) (148.8 KB - PDF)
Nederlands (NL) (116.04 KB - PDF)
polski (PL) (81.02 KB - PDF)
português (PT) (114.33 KB - PDF)
română (RO) (137.64 KB - PDF)
slovenčina (SK) (138.72 KB - PDF)
slovenščina (SL) (135.83 KB - PDF)
Suomi (FI) (115.33 KB - PDF)
svenska (SV) (54.26 KB - PDF)

Product information

Desloratadine Actavis : EPAR - Product Information

български (BG) (418.93 KB - PDF)
español (ES) (382.13 KB - PDF)
čeština (CS) (406.77 KB - PDF)
dansk (DA) (447.36 KB - PDF)
Deutsch (DE) (475.26 KB - PDF)
eesti keel (ET) (358.92 KB - PDF)
ελληνικά (EL) (420.27 KB - PDF)
français (FR) (390.48 KB - PDF)
hrvatski (HR) (428.67 KB - PDF)
íslenska (IS) (350.03 KB - PDF)
italiano (IT) (380.33 KB - PDF)
latviešu valoda (LV) (408.29 KB - PDF)
lietuvių kalba (LT) (404.43 KB - PDF)
magyar (HU) (411.11 KB - PDF)
Malti (MT) (433.93 KB - PDF)
Nederlands (NL) (357.62 KB - PDF)
norsk (NO) (349.26 KB - PDF)
polski (PL) (431.71 KB - PDF)
português (PT) (399.11 KB - PDF)
română (RO) (412.2 KB - PDF)
slovenčina (SK) (422.69 KB - PDF)
slovenščina (SL) (404.53 KB - PDF)
Suomi (FI) (353.51 KB - PDF)
svenska (SV) (357.54 KB - PDF)

Latest procedure affecting product information: IG/1612

31/05/2023

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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).

Desloratadine Actavis : EPAR - All Authorised presentations

български (BG) (25.63 KB - PDF)
español (ES) (18.1 KB - PDF)
čeština (CS) (31.78 KB - PDF)
dansk (DA) (17.42 KB - PDF)
Deutsch (DE) (18.19 KB - PDF)
eesti keel (ET) (17.78 KB - PDF)
ελληνικά (EL) (40.77 KB - PDF)
français (FR) (18.75 KB - PDF)
hrvatski (HR) (25.35 KB - PDF)
íslenska (IS) (19.88 KB - PDF)
italiano (IT) (19.26 KB - PDF)
latviešu valoda (LV) (37.46 KB - PDF)
lietuvių kalba (LT) (38.75 KB - PDF)
magyar (HU) (32.34 KB - PDF)
Malti (MT) (32.23 KB - PDF)
Nederlands (NL) (20.14 KB - PDF)
norsk (NO) (19.19 KB - PDF)
polski (PL) (26.38 KB - PDF)
português (PT) (18.09 KB - PDF)
română (RO) (33.29 KB - PDF)
slovenčina (SK) (31.27 KB - PDF)
slovenščina (SL) (21.53 KB - PDF)
Suomi (FI) (18.29 KB - PDF)
svenska (SV) (17.26 KB - PDF)

Product details

Name of medicine
Desloratadine Actavis
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

Pharmacotherapeutic group

Antihistamines for systemic use

Therapeutic indication

Treatment of allergic rhinitis and urticaria.

Authorisation details

EMA product number
EMEA/H/C/002435

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.

Marketing authorisation holder
Actavis Group PTC ehf

Dalshraun 1
220 Hafnarfjörður
Iceland

Marketing authorisation issued
13/01/2012
Revision
16

Assessment history

Desloratadine Actavis : EPAR - Procedural steps taken and scientific information after authorisation

Desloratadine Actavis-H-C-PSUSA-00000962-202107: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Desloratadine Actavis-H-C-PSUSA-962-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Desloratadine Actavis : EPAR - Public assessment report

CHMP summary of positive opinion for Desloratadine Actavis

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