Rasagiline Viatris (previously Rasagiline Mylan)
Authorised
This medicine is authorised for use in the European Union
rasagiline
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Rasagiline Viatris is a medicine used to treat adults with Parkinson’s disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Rasagiline Viatris can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson’s disease) in patients who are having fluctuations in the control of their condition. Fluctuations happen when the effects of the medication wear off and symptoms re-emerge before the next dose is due. They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on’ and able to move, and being ‘off’ and having difficulty moving about.
Rasagiline Viatris contains the active substance rasagiline and is a ‘generic medicine’. This means that Rasagiline Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Rasagiline Viatris is Azilect. For more information on generic medicines, see the question-and-answer document here.
Rasagiline Viatris is available as tablets. The standard dose is one tablet once a day.
The medicine can only be obtained with a prescription.
For more information about using Rasagiline Viatris, see the package leaflet or contact your doctor or pharmacist.
The active substance in Rasagiline Viatris, rasagiline, is a ‘monoamine oxidase B inhibitor’. It blocks the enzyme monoamine oxidase type B, which breaks down a substance called dopamine in the brain. Dopamine is important for controlling 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. By increasing levels of dopamine in the parts of the brain that control movement and coordination, Rasagiline Viatris reduces the symptoms of Parkinson’s disease, such as stiffness and slowness of movement.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Azilect, and do not need to be repeated for Rasagiline Viatris.
As for every medicine, the company provided studies on the quality of Rasagiline Viatris. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Because Rasagiline Viatris is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Rasagiline Viatris has been shown to have comparable quality and to be bioequivalent to Azilect. Therefore, the Agency’s view was that, as for Azilect, the benefit outweighs the identified risk and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rasagiline Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Azilect also apply to Rasagiline Viatris where appropriate.
As for all medicines, data on the use of Rasagiline Viatris are continuously monitored. Suspected side effects reported with Rasagiline Viatris are carefully evaluated and any necessary action taken to protect patients.
Rasagiline Mylan received a marketing authorisation valid throughout the EU on 4 April 2016.
The name of the medicine was changed to Rasagiline Viatris on 29 July 2024.
Product information
Latest procedure affecting product information:
T-0000179065
29/07/2024
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
- Rasagiline Viatris (previously Rasagiline Mylan)
- Active substance
- rasagiline tartrate
- International non-proprietary name (INN) or common name
- rasagiline
- Therapeutic area (MeSH)
- Parkinson Disease
- Anatomical therapeutic chemical (ATC) code
- N04BD02
Pharmacotherapeutic group
Anti-Parkinson drugsTherapeutic indication
Rasagiline Viatris is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
News on Rasagiline Viatris (previously Rasagiline Mylan)
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