Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Mirapexin   
Auth. number : EU/1/97/051
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: MIRAPEXIN 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).
MIRAPEXIN 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
24/02/1998 Centralised - Authorisation EMEA/H/C/134 (1998)408 of 23/02/1998
18/09/1998 Centralised - Notification EMEA/H/C/134/N/1 (1998)2646 of 16/09/1998
06/10/1999 Centralised - Variation (1999)3164 of 01/10/1999
27/10/1999 Centralised - Authorisation EMEA/H/C/134/X/2 (1999)3477 of 26/10/1999
01/12/1999 Centralised - Variation EMEA/H/C/134/II/3 (1998)3936 of 29/11/1999
03/08/2000 Centralised - Variation EMEA/H/C/134/I/5 (2000)2334 of 27/07/2000
25/10/2000 Centralised - Variation EMEA/H/C/134/II/4 (2000)2854 of 20/10/2000
03/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/I/6
16/11/2001 Centralised - Variation EMEA/H/C/134/I/8, 9 (2001)3524 of 12/11/2001
28/11/2001 Centralised - Variation EMEA/H/C/134/II/7 (2001)3528 of 12/11/2001
22/04/2002 Centralised - Variation EMEA/H/C/134/II/10 (2002)1543 of 18/04/2002
09/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/I/11, 15
13/11/2002 Centralised - Renewal EMEA/H/C/134/R/17 (2002)4442 of 08/11/2002
04/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/I/19
04/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/I/18
05/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/I/21
18/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/I/22
22/10/2003 Centralised - Variation EMEA/H/C/134/IA/23
Updated with Decision(2004)2920 of 22/07/2004
19/01/2004 Centralised - Variation EMEA/H/C/134/IA/25
Updated with Decision(2004)2920 of 22/07/2004
29/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/26
18/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IB/28
18/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IB/27
11/06/2004 Centralised - Variation EMEA/H/C/134/IA/24
Updated with Decision(2004)2920 of 22/07/2004
05/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IB/30
26/07/2004 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/134/T/29 (2004)2920 of 22/07/2004
01/11/2004 Centralised - Variation EMEA/H/C/134/II/32 (2004)4304 of 28/10/2004
27/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/II/34
23/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/II/33
31/03/2005 Centralised - Variation EMEA/H/C/134/II/35 (2005)1065 of 29/03/2005
16/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/37
19/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/39
27/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IB/38
10/04/2006 Centralised - Variation EMEA/H/C/134/II/36 (2006)1578 of 06/04/2006
19/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/41
19/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/43
19/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/42
12/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IB/44
16/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/46
16/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/45
08/08/2006 Centralised - Variation EMEA/H/C/134/II/40 (2006)3640 of 04/08/2006
20/09/2007 Centralised - Renewal EMEA/H/C/134/R/47 (2007)4377 of 17/09/2007
26/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/II/49
04/03/2008 Centralised - Variation EMEA/H/C/134/II/48 (2008)883 of 29/02/2008
31/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/52
15/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IB/51
14/05/2008 Centralised - Notification EMEA/H/C/134/N/50
Updated with Decision(2008)4978 of 03/09/2008
07/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/54
14/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IB/55
04/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/58
05/09/2008 Centralised - Variation EMEA/H/C/134/II/53 (2008)4978 of 03/09/2008
05/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/57
28/01/2009 Centralised - Variation EMEA/H/C/134/II/56 (2009)554 of 26/01/2009
21/04/2009 Centralised - Variation EMEA/H/C/134/II/60 (2009)3065 of 17/04/2009
12/10/2009 Centralised - Variation EMEA/H/C/134/X/59 (2009)7883 of 08/10/2009
01/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/134/IA/63
15/06/2010 Centralised - Variation EMEA/H/C/134/X/62 (2010)3890 of 10/06/2010
21/06/2010 Centralised - Variation EMEA/H/C/134/WS/3/65 (2010)4209 of 17/06/2010
05/07/2010 Centralised - Variation EMEA/H/C/134/II/64 (2010)4668 of 01/07/2010
27/10/2010 Centralised - Variation EMEA/H/C/134/WS/41, 42/G (2010)7546 of 25/10/2010
15/12/2010 Centralised - Notification EMEA/H/C/134/N/65
Updated with Decision(2011)1926 of 18/03/2011
23/12/2010 Centralised - Variation EMEA/H/C/134/WS/61 (2010)9624 of 20/12/2010
23/03/2011 Centralised - Variation EMEA/H/C/134/WS/101 (2011)1926 of 18/03/2011
24/06/2011 Centralised - Variation EMEA/H/C/134/WS/128 (2011)4475 of 17/06/2011
23/11/2012 Centralised - Variation EMEA/H/C/134/WS/311 (2012)8597 of 19/11/2012
05/12/2012 Centralised - Variation EMEA/H/C/134/WS/326/75 (2012)9097 of 30/11/2012
03/07/2013 Centralised - Notification EMEA/H/C/134/N/76
Updated with Decision(2014)1465 of 28/02/2014
04/03/2014 Centralised - Modification EMEA/H/C/134/PSUSA/2491 (2014)1465 of 28/02/2014
23/10/2014 Centralised - Variation EMEA/H/C/134/WS/468