Cortavance

hydrocortisone aceponate

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This is a summary of the European public assessment report (EPAR). 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 summary 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 seven 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 seven 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 multisite 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 the 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 seven 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 9 January 2007. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Cortavance : EPAR - Summary for the public BG = bălgarski 2007-08-02  
Cortavance : EPAR - Summary for the public ES = español 2007-08-02  
Cortavance : EPAR - Summary for the public CS = čeština 2007-08-02  
Cortavance : EPAR - Summary for the public DA = dansk 2007-08-02  
Cortavance : EPAR - Summary for the public DE = Deutsch 2007-08-02  
Cortavance : EPAR - Summary for the public ET = eesti keel 2007-08-02  
Cortavance : EPAR - Summary for the public EL = elliniká 2007-08-02  
Cortavance : EPAR - Summary for the public EN = English 2007-08-02  
Cortavance : EPAR - Summary for the public FR = français 2007-08-02  
Cortavance : EPAR - Summary for the public IT = italiano 2007-08-02  
Cortavance : EPAR - Summary for the public LV = latviešu valoda 2007-08-02  
Cortavance : EPAR - Summary for the public LT = lietuvių kalba 2007-08-02  
Cortavance : EPAR - Summary for the public HU = magyar 2007-08-02  
Cortavance : EPAR - Summary for the public NL = Nederlands 2007-08-02  
Cortavance : EPAR - Summary for the public PL = polski 2007-08-02  
Cortavance : EPAR - Summary for the public PT = português 2007-08-02  
Cortavance : EPAR - Summary for the public RO = română 2007-08-02  
Cortavance : EPAR - Summary for the public SK = slovenčina 2007-08-02  
Cortavance : EPAR - Summary for the public SL = slovenščina 2007-08-02  
Cortavance : EPAR - Summary for the public FI = suomi 2007-08-02  
Cortavance : EPAR - Summary for the public SV = svenska 2007-08-02  

This EPAR was last updated on 24/01/2017 .

Authorisation details

Product details

Product details for Cortavance
NameCortavance
Agency product numberEMEA/V/C/000110
Active substance

hydrocortisone aceponate

International non-proprietary name (INN) or common name

hydrocortisone

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QD07AC








Publication details

Publication details for Cortavance
Marketing-authorisation holder

Virbac S.A.

Revision5
Date of issue of marketing authorisation valid throughout the European Union09/01/2007

Contact address:

Virbac S.A.
1ère Avenue 2065 M
06516 Carros
France

Product information

Product information

21/12/2016  Cortavance -EMEA/V/C/000110 -IG/0724

Name Language First published Last updated
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24
Cortavance : EPAR - Product Information SV = svenska 2007-09-17 2017-01-24

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07
Cortavance : EPAR - All Authorised presentations SV = svenska 2007-08-02 2013-10-07

Pharmacotherapeutic group

Corticosteroids, dermatological preparations

Therapeutic indication

For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Cortavance : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2007-08-02 2017-01-24

Initial marketing-authorisation documents

Name Language First published Last updated
Cortavance : EPAR - Procedural steps taken before authorisation SV = svenska 2007-01-30  
Cortavance : EPAR - Scientific Discussion SV = svenska 2007-01-30