Oprymea
pramipexole
Table of contents
Overview
Oprymea is a medicine used to treat the symptoms of the following diseases:
- Parkinson’s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Oprymea can be used either on its own or in combination with levodopa (another medicine for Parkinson’s disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
- moderate to severe restless-legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night. Oprymea is used when a specific cause for the disorder cannot be identified.
Oprymea contains the active substance pramipexole.
Oprymea is a ‘generic medicine’. This means that Oprymea contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Sifrol (also known as Mirapexin).
Authorisation details
| Product details | |
|---|---|
| Name |
Oprymea
|
| Agency product number |
EMEA/H/C/000941
|
| Active substance |
pramipexole dihydrochloride monohydrate
|
| International non-proprietary name (INN) or common name |
pramipexole
|
| Therapeutic area (MeSH) |
Parkinson Disease
|
| Anatomical therapeutic chemical (ATC) code |
N04BC05
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Krka, d.d., Novo mesto
|
| Revision |
22
|
| Date of issue of marketing authorisation valid throughout the European Union |
12/09/2008
|
| Contact address |
Šmarješka cesta 6 |
Product information
10/01/2023 Oprymea - EMEA/H/C/000941 - N/0040
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Anti-Parkinson drugs
Therapeutic 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).
Oprymea 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) (see section 4.2).