The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Oprymea 0.7 mg tablets



KRKA, d.d., Novo mestoEU/1/08/469/16-20

Main Information

Trade NameOprymea 0.7 mg tablets
Active SubstancesPramipexole
Dosage FormTablet
Licence HolderKRKA, d.d., Novo mesto
Licence NumberEU/1/08/469/16-20

Group Information

ATC CodeN04BC Dopamine agonists
N04BC05 pramipexole

Status

License statusAuthorised
Licence Issued12/09/2008
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Generics Information

Interchangeable ListPramipexole 0.7 mg Tablets
Interchangeable List CodeIC0152-184-002
Interchangeable List DocumentPDF of Interchangeable List
« Back