Oprymea

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pramipexole

Authorised
This medicine is authorised for use in the European Union.

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).

This EPAR was last updated on 24/08/2020

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
GenericGeneric

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
20
Date of issue of marketing authorisation valid throughout the European Union
12/09/2008
Contact address
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

31/07/2020 Oprymea - EMEA/H/C/000941 - IB/0035

Contents

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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).

Assessment history

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