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
News
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23/05/2014
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21/02/2014
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 201424/01/2014