Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Azilect   
Auth. number : EU/1/04/304
INN : rasagiline
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N04 - Anti-parkinson drugs
Pharmacological subgroup: N04B - Dopaminergic agents
Chemical subgroup: N04BD - Monoamine oxidase type B inhibitors
Chemical substance: N04BD02 - Rasagiline
(See WHO ATC Index)
Indication: AZILECT is indicated for the treatment of idiopathic Parkinson´s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Marketing Authorisation Holder: Teva Pharma GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

  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
24/02/2005 Centralised - Authorisation EMEA/H/C/574 (2005)460 of 21/02/2005
26/04/2005 Centralised - Variation EMEA/H/C/574/IA/2
Updated with Decision(2006)221 of 25/01/2006
20/05/2005 Centralised - Variation EMEA/H/C/574/IA/3
14/06/2005 Centralised - Variation EMEA/H/C/574/II/1 (2005)1801 of 10/06/2005
16/06/2005 Centralised - Variation EMEA/H/C/574/IA/4
10/08/2005 Centralised - Variation EMEA/H/C/574/IA/5
30/01/2006 Centralised - Variation (2006)221 of 25/01/2006
07/04/2006 Centralised - Variation EMEA/H/C/574/IA/13
07/04/2006 Centralised - Variation EMEA/H/C/574/IA/10
07/04/2006 Centralised - Variation EMEA/H/C/574/IA/11
07/04/2006 Centralised - Variation EMEA/H/C/574/IA/12
21/04/2006 Centralised - Variation EMEA/H/C/574/IA/14
03/05/2006 Centralised - Variation EMEA/H/C/574/IB/9
03/05/2006 Centralised - Variation EMEA/H/C/574/IB/7
03/05/2006 Centralised - Variation EMEA/H/C/574/IB/6
03/05/2006 Centralised - Variation EMEA/H/C/574/IB/8
20/02/2007 Centralised - Variation EMEA/H/C/574/IA/17
16/03/2007 Centralised - Variation EMEA/H/C/574/IB/16
16/03/2007 Centralised - Variation EMEA/H/C/574/IB/19
Updated with Decision(2007)5057 of 09/10/2007
16/03/2007 Centralised - Variation EMEA/H/C/574/IB/18
04/04/2007 Centralised - Variation EMEA/H/C/574/II/15 (2007)1599 of 02/04/2007
29/06/2007 Centralised - Variation EMEA/H/C/574/IA/21
29/06/2007 Centralised - Variation EMEA/H/C/574/IA/20
11/10/2007 Centralised - Variation (2007)5057 of 09/10/2007
15/01/2008 Centralised - Variation EMEA/H/C/574/IA/25
31/01/2008 Centralised - Variation EMEA/H/C/574/IB/22
01/02/2008 Centralised - Variation EMEA/H/C/574/IB/24
07/02/2008 Centralised - Variation EMEA/H/C/574/IB/23
21/10/2008 Centralised - Variation EMEA/H/C/574/IB/26
22/10/2008 Centralised - Variation EMEA/H/C/574/IB/28, 29
23/10/2008 Centralised - Variation EMEA/H/C/574/IB/30
13/02/2009 Centralised - Variation EMEA/H/C/574/IA/35
13/02/2009 Centralised - Variation EMEA/H/C/574/IA/34
13/02/2009 Centralised - Variation EMEA/H/C/574/IA/33
17/02/2009 Centralised - Variation EMEA/H/C/574/IA/31
Updated with Decision(2009)7417 of 21/09/2009
09/03/2009 Centralised - Variation EMEA/H/C/574/IB/32
20/05/2009 Centralised - Variation EMEA/H/C/574/IB/38
18/08/2009 Centralised - Variation EMEA/H/C/574/IA/40
08/09/2009 Centralised - Variation EMEA/H/C/574/IB/41
23/09/2009 Centralised - Renewal EMEA/H/C/574/R/36 (2009)7417 of 21/09/2009
25/11/2009 Centralised - Variation EMEA/H/C/574/II/39 (2009)9452 of 23/11/2009
18/01/2010 Centralised - Variation EMEA/H/C/574/IA/46
18/01/2010 Centralised - Variation EMEA/H/C/574/IA/45
18/01/2010 Centralised - Variation EMEA/H/C/574/IA/43
09/02/2010 Centralised - Variation EMEA/H/C/574/IB/42
31/03/2010 Centralised - Variation EMEA/H/C/574/IB/44
29/10/2010 Centralised - Variation EMEA/H/C/574/II/47 (2010) 7527 of 25/10/2010
30/08/2011 Centralised - Variation EMEA/H/C/574/IA/48
Updated with Decision(2012)2173 of 26/03/2012
11/10/2011 Centralised - Variation EMEA/H/C/574/N/49
Updated with Decision(2012)2173 of 26/03/2012
05/01/2012 Centralised - Variation EMEA/H/C/574/N/51
Updated with Decision(2012)2173 of 26/03/2012
28/03/2012 Centralised - Variation (2012)2173 of 26/03/2012
08/08/2013 Centralised - Variation EMEA/H/C/574/N/57
Updated with Decision(2013)8154 of 15/11/2013
14/08/2013 Centralised - Variation EMEA/H/C/574/N/58
Updated with Decision(2013)8154 of 15/11/2013
19/11/2013 Centralised - Modification EMEA/H/C/574/PSUV/60 (2013)8154 of 15/11/2013