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Community Register of medicinal products
Community register of medicinal products for human use
|Invented name:||Riluzole Zentiva This product is authorized under a different brandname in the EU in the folowing languages: - Riluzol Zentiva (DA) - Riluzol Zentiva (DE) - Riluzol Zentiva (ES) - Riluzol Zentiva (HU) - Riluzolo Zentiva (IT) - Riluzol Zentiva (PT)|
|Auth. number :||EU/1/12/768|
|ATC:||N - Nervous system|
N07 - Other nervous system drugs
N07X - Other nervous system drugs
N07XX - Other nervous system drugs
N07XX02 - Riluzole
(See WHO ATC Index)
|Indication:||Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).|
Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1). Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.
There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS.
Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor neurone disease.
|Marketing Authorisation Holder:||Aventis Pharma S.A.
20 avenue Raymond Aron, F-92160 Antony CEDEX, France
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|10/05/2012||Centralised - Authorisation||EMEA/H/C/2622||(2012)3141 of 07/05/2012|
|29/10/2012||Centralised - Variation||EMEA/H/C/2622/N/2|