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 | |
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Marketing-authorisation applicant |
Renable Pharma Limited
|
Date of opinion |
25/01/2018
|
Date of refusal of marketing authorisation |
06/04/2018
|