Refused
This medicine was refused authorisation for use in the European Union.
Overview
On 26 April 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Genasense 30 mg/ml concentrate for solution for infusion, intended for the treatment of advanced or metastatic melanoma.
The company that applied for authorisation is Genta Development Limited. The applicant requested a re-examination of the opinion.
After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 July 2007.
This EPAR was last updated on 31/12/2009
Application details
Product details | |
---|---|
Name |
Genasense
|
Active substance |
oblimersen
|
International non-proprietary name (INN) or common name |
oblimersen
|
Therapeutic area (MeSH) |
Melanoma
|
Application details | |
---|---|
Marketing-authorisation applicant |
Genta Development Ltd. c/o Ross Craig
|
Date of opinion |
19/07/2007
|
Date of refusal of marketing authorisation |
15/10/2007
|
Assessment history
-
List item
Genasense : EPAR - Refusal public assessment report (PDF/486.58 KB)
First published: 31/10/2007
Last updated: 31/10/2007 -
List item
Questions and answers on the recommendation for the refusal of the marketing authorization for Genasense (PDF/40.57 KB)
First published: 31/10/2007
Last updated: 31/10/2007 -