Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pramipexole Accord   
Auth. number : EU/1/11/728
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: Pramipexole Accord 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: Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

  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
04/10/2011 Centralised - Authorisation EMEA/H/C/2291 (2011)7149 of 30/09/2011
17/02/2012 Centralised - Variation EMEA/H/C/2291/IB/1
Updated with Decision(2012)6697 of 24/09/2012
24/09/2012 Centralised - Variation (2012)6697 of 24/09/2012
06/11/2012 Centralised - Variation EMEA/H/C/2291/IB/3
Updated with Decision(2014)78 of 08/01/2014
20/12/2012 Centralised - Variation EMEA/H/C/2291/IA/4
Updated with Decision(2014)78 of 08/01/2014
17/01/2013 Centralised - Variation EMEA/H/C/2291/IB/5/G
Updated with Decision(2014)78 of 08/01/2014
10/01/2014 Centralised - Yearly update (2014)78 of 08/01/2014
04/06/2014 Centralised - Variation EMEA/H/C/2291/IB/8