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This medicine was refused authorisation for use in the European Union.
On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product EnCyzix, intended for the treatment of hypogonadotropic hypogonadism in men.
The company that applied for authorisation is Renable Pharma Limited. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) (PDF/72.65 KB)Adopted
First published: 26/01/2018
Last updated: 20/04/2018
This EPAR was last updated on 26/01/2018
|International non-proprietary name (INN) or common name||
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Renable Pharma Limited
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|Date of refusal of marketing authorisation||