Desloratadine Actavis

Authorised

This medicine is authorised for use in the European Union

desloratadine

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.

What is 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.

What is Desloratadine Actavis used for?

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.

How is Desloratadine Actavis used?

The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.

How does Desloratadine Actavis work?

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.

How has Desloratadine Actavis been studied?

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.

What are the benefits and risks of Desloratadine Actavis?

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.

Why has Desloratadine Actavis been approved?

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.

Other information about Desloratadine Actavis

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

Adopted

Product information

Desloratadine Actavis : EPAR - Product Information

Desloratadine Actavis : EPAR - All Authorised presentations

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

Changes since initial authorisation of medicine

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

Reference Number: EMA/567651/2022

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

Reference Number: EMA/333803/2017

Initial marketing authorisation documents

Desloratadine Actavis : EPAR - Public assessment report

AdoptedReference Number: EMA/11666/2012

CHMP summary of positive opinion for Desloratadine Actavis

AdoptedReference Number: EMA/CHMP/796881/2011