Desloratadine ratiopharm

Authorised

This medicine is authorised for use in the European Union

desloratadine

Overview

Desloratadine ratiopharm is a medicine used in adults to relieve the symptoms of the following conditions:

• allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example hay fever or allergy to dust mites).
• chronic idiopathic urticaria (a recurrent skin condition with symptoms including itching and hives) as diagnosed by a doctor. ‘Idiopathic’ means that the cause of the disease is unknown.

Desloratadine ratiopharm contains the active substance desloratadine and is a ‘generic medicine’. This means that Desloratadine ratiopharm contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Aerius. For more information on generic medicines, see the question-and-answer document below.

How is Desloratadine ratiopharm used?

Desloratadine ratiopharm can be obtained without a prescription. The medicine is available as tablets.

 

The recommended dose is one tablet once a day. The duration of treatment depends on the condition being treated.

If symptoms persist for more than 7 days or worsen, patients should seek medical advice. For more information about using Desloratadine ratiopharm, see the package leaflet or contact your doctor or pharmacist.

How does Desloratadine ratiopharm work?

The active substance in Desloratadine ratiopharm, 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 ratiopharm been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Aerius, and do not need to be repeated for Desloratadine ratiopharm.

As for every medicine, the company provided studies on the quality of Desloratadine ratiopharm.

The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Desloratadine ratiopharm?

Because Desloratadine ratiopharm 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 is Desloratadine ratiopharm authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Desloratadine ratiopharm has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the Agency’s view was that, as for Aerius, the benefits of Desloratadine ratiopharm outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Desloratadine ratiopharm?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Desloratadine ratiopharm have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Desloratadine ratiopharm are continuously monitored. Side effects reported with Desloratadine ratiopharm are carefully evaluated and any necessary action taken to protect patients.

Other information about Desloratadine ratiopharm

Desloratadine ratiopharm received a marketing authorisation valid throughout the EU on 13 January 2012.

Desloratadine ratiopharm : EPAR - Medicine overview

Reference Number: EMA/11520/2021

Desloratadine ratiopharm : EPAR - Risk-management-plan summary

Product information

Desloratadine ratiopharm : EPAR - Product Information

Desloratadine ratiopharm : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Desloratadine ratiopharm
• 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

Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:

• allergic rhinitis
• chronic idiopathic urticaria as initially diagnosed by a physician

Authorisation details

• EMA product number:
  EMEA/H/C/002404
• 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:
  Ratiopharm GmbH

  Graf-Arco-Str. 3; D-89079 Ulm; Germany

• Opinion adopted:
  17/11/2011
• Marketing authorisation issued:
  13/01/2012
• Revision:
  12

Assessment history

Changes since initial authorisation of medicine

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

Desloratadine ratiopharm-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 ratiopharm-H-C-2404-II-0023-G : EPAR - Assessment report - Variation

AdoptedReference Number: EMA/592592/2020

CHMP post-authorisation summary of positive opinion for Desloratadine ratiopharm (II-23-G)

AdoptedReference Number: EMA/CHMP/114257/2020

Desloratadine ratiopharm-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 ratiopharm : EPAR - Public assessment report

AdoptedReference Number: EMA/41222/2012

CHMP summary of positive opinion for Desloratadine ratiopharm

AdoptedReference Number: EMA/CHMP/614374/2011