On 16 November 2006, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mycograb 2 mg/ml powder for solution for injection intended for the treatment of invasive candidiasis in adult patients, in combination with amphotericin B or a lipid formulation of amphotericin B. The company that applied for authorisation is NeuTec Pharma plc. The applicant requested a reexamination of the opinion. After having considered the grounds for this request, the CHMP reexamined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2007.
Questions and answers on the recommendation for the refusal of the marketing authorization for Mycograb (PDF/34.38 KB)
First published: 21/03/2007
Last updated: 21/03/2007
recombinant human monoclonal antibody to hsp
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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.
NeuTec Pharma plc
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