Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sifrol   
Auth. number : EU/1/97/050
INN : pramipexole
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N04 - Anti-parkinson drugs
Pharmacological subgroup: N04B - Dopaminergic agents
Chemical subgroup: N04BC - Dopamine agonists
Chemical substance: N04BC05 - Pramipexole
(See WHO ATC Index)
Indication: SIFROL is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
SIFROL is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt).
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, 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
15/10/1997 Centralised - Authorisation EMEA/H/C/133 (97)3144 of 14/10/1997
27/07/1998 Centralised - Variation EMEA/H/C/133/I/1 (1998)2201 of 24/07/1998
13/10/1999 Centralised - Variation (1999)3211 of 11/10/1999
19/11/1999 Centralised - Authorisation EMEA/H/C/133/X/2 (1999)3717 of 16/11/1999
02/12/1999 Centralised - Variation EMEA/H/C/133/II/3 (1999)3843 of 29/11/1999
22/08/2000 Centralised - Variation EMEA/H/C/133/I/5 (2000)2403 of 21/08/2000
12/10/2000 Centralised - Variation EMEA/H/C/133/II/4 (2000)2798 of 09/10/2000
20/12/2001 Centralised - Variation EMEA/H/C/133/II/7 (2001)4321 of 17/12/2001
29/04/2002 Centralised - Variation EMEA/H/C/133/II/8 (2002)1587 of 23/04/2002
16/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/I/13
16/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/I/9
16/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/I/12
16/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/I/11
16/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/I/10
13/11/2002 Centralised - Renewal EMEA/H/C/133/R/15 (2002)4443 of 08/11/2002
26/02/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/I/17
26/02/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/I/16
18/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/I/20
06/10/2003 Centralised - Variation EMEA/H/C/133/I/19 (2003)3581 of 02/10/2003
19/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IB/23
19/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IB/22
05/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IB/24
30/07/2004 Centralised - Notification EMEA/H/C/133/N/25
Updated with Decision(2004)4251 of 22/10/2004
26/10/2004 Centralised - Variation EMEA/H/C/133/II/26 (2004)4251 of 22/10/2004
21/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/II/28
21/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/II/27
01/04/2005 Centralised - Variation EMEA/H/C/133/II/29 (2005)1088 of 30/03/2005
16/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IA/32
25/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IB/31
10/04/2006 Centralised - Variation EMEA/H/C/133/II/30 (2006)1575 of 06/04/2006
20/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IA/34
20/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IA/35
12/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IB/36
16/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IA/38
16/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IA/37
09/08/2006 Centralised - Variation EMEA/H/C/133/II/33 (2006)3669 of 07/08/2006
27/09/2007 Centralised - Renewal EMEA/H/C/133/R/39 (2007)4488 of 25/09/2007
25/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/II/41
03/03/2008 Centralised - Variation EMEA/H/C/133/II/40 (2008)844 of 28/02/2008
15/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IB/43
14/05/2008 Centralised - Notification EMEA/H/C/133/N/42
Updated with Decision(2008)4677 of 25/08/2008
07/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IA/46
27/08/2008 Centralised - Variation EMEA/H/C/133/II/45 (2008)4677 of 25/08/2008
04/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IA/50
05/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IA/49
04/02/2009 Centralised - Variation EMEA/H/C/133/II/48 (2009)699 of 30/01/2009
21/04/2009 Centralised - Variation EMEA/H/C/133/II/52 (2009)3063 of 17/04/2009
12/10/2009 Centralised - Variation EMEA/H/C/133/X/51 (2009)7882 of 08/10/2009
08/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/133/IA/55
17/06/2010 Centralised - Variation EMEA/H/C/133/X/54 (2010)4121 of 14/06/2010
05/07/2010 Centralised - Variation EMEA/H/C/133/WS/3/57 (2010)4673 of 01/07/2010
08/07/2010 Centralised - Variation EMEA/H/C/133/II/56 (2010)4704 of 02/07/2010
27/10/2010 Centralised - Variation EMEA/H/C/133/WS/41, 42/G (2010)7548 of 25/10/2010
15/12/2010 Centralised - Variation EMEA/H/C/133/WS/61 (2010)9292 of 13/12/2010
23/03/2011 Centralised - Variation EMEA/H/C/133/WS/101 (2011)1913 of 18/03/2011
24/06/2011 Centralised - Variation EMEA/H/C/133/WS/128 (2011)4465 of 17/06/2011
22/11/2012 Centralised - Variation EMEA/H/C/133/WS/311 (2012)8584 of 19/11/2012
12/12/2012 Centralised - Variation EMEA/H/C/133/WS/326/IB/66 (2012)9543 of 10/12/2012
03/07/2013 Centralised - Notification EMEA/H/C/133/N/67
Updated with Decision(2014)1462 of 28/02/2014
04/03/2014 Centralised - Modification EMEA/H/C/133/PSUSA/2491 (2014)1462 of 28/02/2014
23/10/2014 Centralised - Variation EMEA/H/C/133/WS/648