Mycograb

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efungumab

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

Overview

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.

This EPAR was last updated on 20/03/2007

Application details

Product details
Name
Mycograb
Active substance
recombinant human monoclonal antibody to hsp
International non-proprietary name (INN) or common name
efungumab
Therapeutic area (MeSH)
Candidiasis
Anatomical therapeutic chemical (ATC) code
J02
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
NeuTec Pharma plc
Date of opinion
19/03/2007
Date of refusal of marketing authorisation
21/05/2007

Assessment history

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