Dropcys

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mercaptamine

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

Overview

On 17 December 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dropcys, intended to prevent and treat the build-up of the amino acid cystine in the cornea (the transparent layer in front of the eye).The company that applied for authorisation in the EU is Lucane Pharma.

The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 1 April 2016.

This EPAR was last updated on 25/07/2016

Application details

Product details
Name
Dropcys
Active substance
mercaptamine
International non-proprietary name (INN) or common name
mercaptamine
Therapeutic area (MeSH)
  • Corneal Diseases
  • Cystinosis
Anatomical therapeutic chemical (ATC) code
S01XA21
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Application details
Marketing-autorisation applicant
Lucane Pharma
Date of opinion
31/03/2016
Date of refusal of marketing authorisation
23/06/2016

Assessment history

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