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.
Application details
Product details | |
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Name |
Dropcys
|
Active substance |
mercaptamine
|
International non-proprietary name (INN) or common name |
mercaptamine
|
Therapeutic area (MeSH) |
|
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 | |
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Marketing-authorisation applicant |
Lucane Pharma
|
Date of opinion |
01/04/2016
|
Date of refusal of marketing authorisation |
24/06/2016
|
Assessment history
News
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01/04/2016
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 201629/01/2016
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18/12/2015