Nerventra

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laquinimod

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

Overview

On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis. The company that applied for authorisation is Teva Pharma GmbH. The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.

This EPAR was last updated on 01/09/2014

Application details

Product details
Name
Nerventra
Active substance
laquinimod
International non-proprietary name (INN) or common name
laquinimod
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
N07
Application details
Marketing-authorisation applicant
Teva Pharma GmbH
Date of opinion
22/05/2014
Date of refusal of marketing authorisation
19/08/2014

Assessment history

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