Pramipexole Teva
Authorised
This medicine is authorised for use in the European Union
pramipexole
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Pramipexole Teva is a medicine containing the active substance pramipexole base. It is available as white, round tablets (0.088, 0.18, 0.35 and 0.7 mg).
Pramipexole Teva is a ‘generic medicine’. This means that Pramipexole Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Sifrol.
Pramipexole Teva is used to treat the symptoms of Parkinson’s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Pramipexole Teva 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.
The medicine can only be obtained with a prescription.
Pramipexole Teva tablets should be swallowed with water, with or without food. The starting dose is 0.088 mg three times per day. The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated. The maximum daily dose is 1.1 mg three times per day. Pramipexole Teva must be given less frequently in patients who have problems with their kidneys. If treatment is stopped for any reason, the dose should be decreased gradually.
For more information, see the package leaflet.
The active substance in Pramipexole Teva, pramipexole, is a dopamine agonist, which imitates the action of dopamine. Dopamine is a messenger substance in the parts of the brain that control movement and coordination. In patients with Parkinson’s disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’s disease, such as shaking, stiffness and slowness of movement.
Because Pramipexole Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (i.e. that the two medicines produce the same levels of the active substance in the body).
Because Pramipexole Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pramipexole Teva has been shown to have comparable quality and to be bioequivalent to Sifrol. Therefore, the CHMP’s view was that, as for Sifrol, the benefit outweighs the identified risk. The Committee recommended that Pramipexole Teva be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the EU for Pramipexole Teva to Teva Pharma B.V. on 18 December 2008.
Product information
Latest procedure affecting product information:IB/0057
29/08/2024
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).
Product details
- Name of medicine
- Pramipexole Teva
- 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
Pharmacotherapeutic group
Anti-Parkinson drugsTherapeutic indication
Pramipexole Teva 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).
Pramipexole Teva 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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