Ypozane

osaterone acetate

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This 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 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 Ypozane?

Ypozane are round, white tablets that contain osaterone acetate as the active substance. The medicine is available as 1.875 mg, 3.75 mg, 7.5 mg or 15 mg tablets, which can be used for dogs of different weights (small, medium sized, large or very large dogs).

What is Ypozane used for?

Ypozane is used in male dogs for the treatment of “benign prostatic hypertrophy”, which means an increase of the size of the prostate gland that is not related to cancer (benign). The prostate is a gland that produces a fluid that is part of the semen. When it is enlarged, it can lead to abdominal pain, constipation and difficulties in urinating in the dogs affected.

Ypozane is given daily for 7 days. Its effect can be seen within about 2 weeks, and lasts for 5 months.

How does Ypozane work?

Osaterone acetate is a hormone that is chemically related to progesterone, and as such it has anti-androgen and progestagen activity. In male dogs, it blocks the transport of the male hormone testosterone into the prostate. By inhibiting testosterone, Ypozane helps the prostate to shrink back to its normal size.

How has Ypozane been studied?

Data were provided on the pharmaceutical quality of the product, the tolerance of Ypozane in dogs and the safety of the tablets when handled by humans.

The effectiveness of osaterone acetate was investigated in a large study undertaken in a number of veterinary practices across Europe. Dogs with enlarged prostates from various breeds, age groups and weights, were either treated with Ypozane or with another product, which is already authorised in the EU for this indication. The dogs received once a day for 7 days, one Ypozane tablet appropriate for their size to correspond to a daily dose of 0.25 – 0.5 mg osaterone acetate per kilogram bodyweight.

What benefit has Ypozane shown during the studies?

Treatment with Ypozane was effective in the treatment of benign prostatic hypertrophy. A clinical response to treatment (reduction of prostate volume) was seen within 14 days, which lasted for at least 5 months. After this time, the dog should be re-examined by a veterinarian and treatment might be repeated. Ypozane has no adverse effects on semen quality.

What is the risk associated with Ypozane?

Ypozane should be used with caution in dogs which have had liver problems.

The most common side effects are a transient increase in appetite, and changes in the behaviour of the dog (changes in activity levels, more sociable behaviour). Some dogs might also show vomiting, diarrhoea or increased thirst, or might develop a “feminisation syndrome”. This is when male dogs suddenly become attractive to other male dogs or the size of their mammary glands increases. All these effects disappear after a while without specific treatment.

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

This veterinary medicine has been developed especially for dogs and is not for use in humans. If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor. Wash hands after administration.

In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions. Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when handling the tablets.

Why has Ypozane been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ypozane exceed its risks for the treatment of benign prostatic hypertrophy (BPH) in male dogs and recommended that Ypozane be given a marketing authorisation. The benefitrisk balance may be found in module 6 of this EPAR.

Other information about Ypozane

The European Commission granted a marketing authorisation valid throughout the European Union, for Ypozane to Virbac S.A. on 11.01.2007. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Ypozane : EPAR - Summary for the public BG = bălgarski 18/01/2007  
Ypozane : EPAR - Summary for the public ES = español 18/01/2007  
Ypozane : EPAR - Summary for the public CS = čeština 18/01/2007  
Ypozane : EPAR - Summary for the public DA = dansk 18/01/2007  
Ypozane : EPAR - Summary for the public DE = Deutsch 18/01/2007  
Ypozane : EPAR - Summary for the public ET = eesti keel 18/01/2007  
Ypozane : EPAR - Summary for the public EL = elliniká 18/01/2007  
Ypozane : EPAR - Summary for the public EN = English 18/01/2007  
Ypozane : EPAR - Summary for the public FR = français 18/01/2007  
Ypozane : EPAR - Summary for the public IT = italiano 18/01/2007  
Ypozane : EPAR - Summary for the public LV = latviešu valoda 18/01/2007  
Ypozane : EPAR - Summary for the public LT = lietuvių kalba 18/01/2007  
Ypozane : EPAR - Summary for the public HU = magyar 18/01/2007  
Ypozane : EPAR - Summary for the public MT = Malti 18/01/2007  
Ypozane : EPAR - Summary for the public NL = Nederlands 18/01/2007  
Ypozane : EPAR - Summary for the public PL = polski 18/01/2007  
Ypozane : EPAR - Summary for the public PT = português 18/01/2007  
Ypozane : EPAR - Summary for the public RO = română 18/01/2007  
Ypozane : EPAR - Summary for the public SK = slovenčina 18/01/2007  
Ypozane : EPAR - Summary for the public SL = slovenščina 18/01/2007  
Ypozane : EPAR - Summary for the public FI = suomi 18/01/2007  
Ypozane : EPAR - Summary for the public SV = svenska 18/01/2007  

This EPAR was last updated on 05/01/2012 .

Authorisation details

Product details

Product details for Ypozane
NameYpozane
Agency product numberEMEA/V/C/000112
Active substance

osaterone acetate

International non-proprietary name (INN) or common name

osaterone acetate

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codeQG04CX90

Publication details

Publication details for Ypozane
Marketing-authorisation holder

Virbac S.A.

Revision1
Date of issue of marketing authorisation valid throughout the European Union11/01/2007

Contact address:

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

Product information

Product information

19/12/2011  Ypozane -EMEA/V/C/000112 -R/0001

Name Language First published Last updated
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012
Ypozane : EPAR - Product Information SV = svenska 18/01/2007 05/01/2012

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
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  
Ypozane : EPAR - All Authorised presentations SV = svenska 18/01/2007  

Pharmacotherapeutic group

Urologicals

Therapeutic indication

Treatment of benign prostatic hypertrophy (BPH) in male dogs.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ypozane : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 05/01/2012  

Initial marketing-authorisation documents

Name Language First published Last updated
Ypozane : EPAR - Procedural steps taken before authorisation SV = svenska 18/01/2007  
Ypozane : EPAR - Scientific Discussion SV = svenska 18/01/2007