EnCyzix

RSS

enclomifene

Refused
This medicine was refused authorisation for use in the European Union.

Overview

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.

This EPAR was last updated on 26/01/2018

Application details

Product details
Name
EnCyzix
Active substance
enclomifene citrate
International non-proprietary name (INN) or common name
enclomifene
Therapeutic area (MeSH)
Hypogonadism
Anatomical therapeutic chemical (ATC) code
G03X
Application details
Marketing-authorisation applicant
Renable Pharma Limited
Date of opinion
25/01/2018
Date of refusal of marketing authorisation
06/04/2018

Assessment history

How useful was this page?

Add your rating