Cortavance (hydrocortisone aceponate) - QD07AC

CORTAVANCE

EPAR summary for the public

This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Cortavance?

Cortavance is a spray containing a solution of the active substance hydrocortisone aceponate.

What is Cortavance used for?

Cortavance is used to treat inflamed and itchy skin conditions in dogs. Cortavance is given once a day for 7 days. It is sprayed on the affected area, avoiding the eyes. The pump delivers in two sprays enough medicine to treat an area of about 100 cm2. If no improvement is seen after 7 days, the treatment should be re-evaluated by a veterinarian.

How does Cortavance work?

The active substance in Cortavance, hydrocortisone aceponate, is a steroid which is a type of substance that helps to reduce inflammation. The steroid is in a special chemical form (a diester) that makes it effective at low doses in skin conditions as the medicine is able to get into and remain longer in the outer layer of the skin.

How has Cortavance been studied?

The clinical part of the dossier consisted of studies to determine the dose and of one field trial. The field trial consisted of a multi-site study comparing treatment of dogs with itchy skin conditions with Cortavance to treatment with a different steroid-containing product. Fifty-four dogs were treated with Cortavance and 51 with this other product.

What benefit has Cortavance shown during the studies?

The studies to determine the dose generally supported the chosen dose and the length of treatment. Significant improvement of the skin condition was demonstrated in several studies under controlled conditions, whereas significant reduction of itching was demonstrated in only one of these laboratory studies in which the dogs received treatment against external parasites at the same time. Results from the field trial indicated comparable efficacy between Cortavance and the comparator product.

What is the risk associated with Cortavance?

There are no side effects reported in animals who have been treated with Cortavance. The treatment area should not normally exceed an area corresponding to the two flanks of the animal. Before treatment, any other existing skin conditions (such as an infection) must be treated and Cortavance should not be used on skin ulcers. The medicine should not normally be used in dogs suffering from Cushing’s syndrome (a disorder where the body produces too much natural steroid), and in young animals (under 7 months of age) as steroids are known to slow growth.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Wash hands after use. In case of accidental contact (skin, eye), wash thoroughly with water. In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician.

Spray preferably in a well ventilated area. The spray is flammable and should not be used next to a naked flame or any incandescent material. Do not smoke when applying this product.

Why has Cortavance been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Cortavance exceed the risks for the treatment of inflamed and itchy skin conditions and recommended that Cortavance be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Cortavance:

The European Commission granted a marketing authorisation valid throughout the European Union, for Cortavance to Virback S.A. on 09/01/2007. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated on 09/01/2007.

EMEA 2006

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