Genasense

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oblimersen

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

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