Mycograb

Refused

This medicine has been refused authorisation

efungumab

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.

Questions and answers on the recommendation for the refusal of the marketing authorization for Mycograb

Product details

• Name of medicine:
  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

Pharmacotherapeutic group

Antimycotics for systemic use

Application details

• EMA product number:
  EMEA/H/C/000658
• Marketing authorisation applicant:
  NeuTec Pharma plc
• Opinion adopted:
  20/03/2007
• Refusal of marketing authorisation:
  22/05/2007

Assessment history

Mycograb : EPAR - Refusal public assessment report