Ypozane (osaterone acetate) - QG04CX90

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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 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.