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 21/03/2007
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
|
| Application details | |
|---|---|
| Marketing-authorisation applicant |
NeuTec Pharma plc
|
| Date of opinion |
20/03/2007
|
| Date of refusal of marketing authorisation |
22/05/2007
|
Assessment history
-
List item
Mycograb : EPAR - Refusal public assessment report (PDF/370.81 KB)
First published: 22/10/2007
Last updated: 22/10/2007 -
List item
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 -