Basic Information
N04BC05
pramipexole
Anti-Parkinson drugs
Therapeutic 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).
Overview Summary
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).
Active Substances (2)
pramipexole dihydrochloride monohydrate
pramipexole dihydrochloride monohydrate
Documents (8)
Committee for medicinal products for human use, summary of positive opinion for Pramipexole Teva
October 22, 2008
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Pramipexole Teva : EPAR - Summary for the public
March 9, 2009
OVERVIEW_DOCUMENT
Pramipexole Teva : EPAR - Public assessment report
March 9, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Committee for medicinal products for human use, summary of positive opinion for Pramipexole Teva
October 22, 2008
CHANGES_SINCE_INITIAL_AUTHORISATION
Pramipexole Teva : EPAR - All Authorised presentations
March 9, 2009
AUTHORISED_PRESENTATIONS
Pramipexole Teva : EPAR - Public assessment report
March 9, 2009
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Pramipexole Teva : EPAR - Product Information
August 27, 2009
DRUG_PRODUCT_INFORMATION
Pramipexole Teva : EPAR - Procedural steps taken and scientific information after authorisation
August 27, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (8)
Question
Other information about Pramipexole Teva
Answer
The European Commission granted a marketing authorisation valid throughout the EU for Pramipexole Teva to Teva Pharma B.V. on 18 December 2008.
Question
How is Pramipexole Teva used?
Answer
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.
Question
How does Pramipexole Teva work?
Answer
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.
Question
How has Pramipexole Teva been studied?
Answer
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).
Question
What are the benefit and risk of Pramipexole Teva?
Answer
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.
Question
Why has Pramipexole Teva been approved?
Answer
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.
Question
What is Pramipexole Teva?
Answer
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.
Question
What is Pramipexole Teva used for?
Answer
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.