Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Oprymea   
Auth. number : EU/1/08/469
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: Oprymea is indicated 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: Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija

  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
16/09/2008 Centralised - Authorisation EMEA/H/C/941 (2008)5170 of 12/09/2008
02/03/2009 Centralised - Variation EMEA/H/C/941/II/2 (2009)1442 of 26/02/2009
20/05/2009 Centralised - Variation EMEA/H/C/941/II/3 (2009)4046 of 15/05/2009
08/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/941/II/1
17/08/2009 Centralised - Variation EMEA/H/C/941/II/4 (2009)6476 of 13/08/2009
26/08/2010 Centralised - Variation EMEA/H/C/941/IB/6/G
Updated with Decision(2011)2250 of 28/03/2011
05/10/2010 Centralised - Variation EMEA/H/C/941/IB/7
Updated with Decision(2011)2250 of 28/03/2011
08/10/2010 Centralised - Variation (refusal) EMEA/H/C/941/IA/8/G
10/12/2010 Centralised - Variation EMEA/H/C/941/IA/10/G
Updated with Decision(2011)2250 of 28/03/2011
28/01/2011 Centralised - Variation EMEA/H/C/941/IB/11
Updated with Decision(2011)2250 of 28/03/2011
30/03/2011 Centralised - Variation (2011)2250 of 28/03/2011
01/02/2013 Centralised - Variation EMEA/H/C/941/IB/13/G
Updated with Decision(2013)2104 of 09/04/2013
11/04/2013 Centralised - Renewal EMEA/H/C/941/R/12 (2013)2104 of 09/04/2013
13/11/2013 Centralised - Variation EMEA/H/C/941/X/14 (2013)7940 of 11/11/2013
15/05/2014 Centralised - Variation EMEA/H/C/941/IB/16
28/07/2014 Centralised - Notification EMEA/H/C/941/N/18