EnCyzix

enclomifene

Opinion

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.

Key facts

Name
EnCyzix
International non-proprietary name (INN) or common name
  • enclomifene
Active substance
  • enclomifene citrate
Therapeutic area
Hypogonadism
Date opinion adopted
25/01/2018
Company name
Renable Pharma Limited
Status
Negative
Application type
Initial authorisation

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