Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

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
INN : Riluzole
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N07 - Other nervous system drugs
Pharmacological subgroup: N07X - Other nervous system drugs
Chemical subgroup: N07XX - Other nervous system drugs
Chemical substance: 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-92165 Antony CEDEX, France

  EPAR and active package presentations

Package presentations

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.

 

European Commission proceduresGoto top of the page

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
03/07/2013 Centralised - Variation EMEA/H/C/2622/IB/4/G
12/09/2013 Centralised - Variation EMEA/H/C/2622/IAin/7/G
18/12/2013 Centralised - Variation EMEA/H/C/2622/IB/9
27/03/2014 Centralised - Variation EMEA/H/C/2622/N/47