Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pramipexole Teva   
Auth. number : EU/1/08/490
Active substance : 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: Pramipexole Teva 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).
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
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
23/12/2008 Centralised - Authorisation EMEA/H/C/940 (2008)8866 of 18/12/2008
02/03/2009 Corrigendum EMEA/H/C/940 (2009)1457 cor of 26/02/2009
18/05/2009 Centralised - Variation EMEA/H/C/940/IA/2
Updated with Decision(2009)6583 of 20/08/2009
26/05/2009 Centralised - Variation EMEA/H/C/940/II/1 (2009)4111 of 20/05/2009
24/08/2009 Centralised - Variation EMEA/H/C/940/II/3 (2009)6583 of 20/08/2009
14/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/940/IA/4
14/09/2010 Centralised - Variation EMEA/H/C/940/IA/7
Updated with Decision(2011)3531 of 16/05/2011
21/10/2010 Centralised - Variation EMEA/H/C/940/IB/5
Updated with Decision(2011)3531 of 16/05/2011
21/10/2010 Centralised - Variation EMEA/H/C/940/IB/6
Updated with Decision(2011)3531 of 16/05/2011
10/12/2010 Centralised - Notification EMEA/H/C/940/N/9
Updated with Decision(2011)3531 of 16/05/2011
22/12/2010 Centralised - Variation EMEA/H/C/940/IA/8/G
Updated with Decision(2011)3531 of 16/05/2011
28/01/2011 Centralised - Variation EMEA/H/C/940/IB/10/G
Updated with Decision(2011)3531 of 16/05/2011
18/05/2011 Centralised - Variation (2011)3531 of 16/05/2011
04/03/2013 Centralised - Variation EMEA/H/C/940/IB/26/G
Updated with Decision(2013)5614 of 26/08/2013
29/08/2013 Centralised - Renewal EMEA/H/C/940/R/27 (2013)5614 of 26/08/2013
02/06/2014 Centralised - Variation EMEA/H/C/940/IB/28
Updated with Decision(2015)463 of 27/01/2015
30/01/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/940/T/32 (2015)463 of 27/01/2015
22/12/2015 Centralised - Variation EMEA/H/C/940/IAIN/35/G
17/08/2016 Centralised - Variation EMEA/H/C/940/IB/37
20/09/2016 Centralised - Variation EMEA/H/C/940/IAIN/38/G