Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rilutek   
Auth. number : EU/1/96/010
Active substance : 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: RILUTEK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Clinical trials have demonstrated that RILUTEK extends survival for patients with ALS (see section 5.1). Survival was defined as patients who were alive, not intubated for mechanical ventilation andtracheotomy-free.
There is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. RILUTEK has not been shown to be effective in the late stages of ALS.
Safety and efficacy of RILUTEK has only been studied in ALS. Therefore, RILUTEK 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 is 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
12/06/1996 Centralised - Authorisation EMEA/H/C/109 (96)1441 of 10/06/1996
10/10/1997 Centralised - Variation EMEA/H/C/109/II/3 (97)2987 of 08/10/1997
16/06/1998 Centralised - Variation EMEA/H/C/109/II/4 (1998)1605 of 15/06/1998
24/01/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/I/6, 7, 8
09/02/2000 Centralised - Variation EMEA/H/C/109/II/5 (2000)152 of 31/01/2000
27/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/I/11
08/01/2001 Centralised - Variation EMEA/H/C/109/I/9, 10 (2000)4301 of 29/12/2000
11/07/2001 Centralised - Renewal EMEA/H/C/109/R/12 (2001)1997 of 11/07/2001
27/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/I/16
27/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/I/15
07/03/2002 Centralised - Variation EMEA/H/C/109/I/13 (2002)981 of 05/03/2002
27/03/2002 Centralised - Variation EMEA/H/C/109/I/14 (2002)1289 of 22/03/2002
30/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/I/18
21/11/2002 Centralised - Variation EMEA/H/C/109/II/17 (2002)4577 of 20/11/2002
30/06/2003 Centralised - Variation EMEA/H/C/109/II/20 (2003)2125 of 26/06/2003
15/06/2004 Centralised - Variation EMEA/H/C/109/IA/21
Updated with Decision(2004)5381 of 17/12/2004
29/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/IA/23
21/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/II/22
13/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/IA/24
22/12/2004 Centralised - Variation (2004)5381 of 17/12/2004
13/12/2005 Centralised - Variation EMEA/H/C/109/IA/26
Updated with Decision(2006)3525 of 28/07/2006
28/12/2005 Centralised - Variation EMEA/H/C/109/II/25 (2005)6013 of 23/12/2005
16/03/2006 Centralised - Notification EMEA/H/C/109/N/28
Updated with Decision(2006)3525 of 28/07/2006
02/08/2006 Centralised - Renewal EMEA/H/C/109/R/27 (2006)3525 of 28/07/2006
26/01/2007 Centralised - Notification EMEA/H/C/109/N/29
Updated with Decision(2008)1683 of 22/04/2008
03/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/IA/31
24/04/2008 Centralised - Variation EMEA/H/C/109/II/30 (2008)1683 of 22/04/2008
29/05/2008 Centralised - Variation EMEA/H/C/109/IA/32
Updated with Decision(2009)85 of 09/01/2009
13/01/2009 Centralised - Variation (2009)85 of 09/01/2009
29/05/2009 Centralised - Variation EMEA/H/C/109/II/33 (2009)4239 of 27/05/2009
20/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/IA/34
04/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/II/35
08/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/IB/36/G
06/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/IB/37
20/12/2010 Centralised - Notification EMEA/H/C/109/N/38
Updated with Decision(2014)10245 of 19/12/2014
10/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/109/IA/39/G
30/10/2012 Centralised - Notification EMEA/H/C/109/N/42
Updated with Decision(2014)10245 of 19/12/2014
18/12/2013 Centralised - Variation EMEA/H/C/109/IB/46
Updated with Decision(2014)10245 of 19/12/2014
27/03/2014 Centralised - Notification EMEA/H/C/109/N/47
Updated with Decision(2014)10245 of 19/12/2014
11/11/2014 Centralised - Notification EMEA/H/C/109/N/52
Updated with Decision(2014)10245 of 19/12/2014
23/12/2014 Centralised - Yearly update (2014)10245 of 19/12/2014