Rasagiline Mylan
Authorised
This medicine is authorised for use in the European Union
rasagiline
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Rasagiline Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Rasagiline Mylan.
For practical information about using Rasagiline Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Rasagiline Mylan is a medicine used to treat adults with Parkinson’s disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Rasagiline Mylan 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 Mylan is a ‘generic medicine’. This means that Rasagiline Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Azilect.
Rasagiline Mylan contains the active substance rasagiline.
Rasagiline Mylan is available as tablets (1 mg). The standard dose is one tablet once a day.
The medicine can only be obtained with a prescription.
The active substance in Rasagiline Mylan, 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 Mylan reduces the symptoms of Parkinson’s disease, such as stiffness and slowness of movement.
Because Rasagiline Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Azilect. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Because Rasagiline Mylan 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 Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rasagiline Mylan has been shown to have comparable quality and to be bioequivalent to Azilect. Therefore, the CHMP’s view was that, as for Azilect, the benefit outweighs the identified risk. The Committee recommended that Rasagiline Mylan be approved for use in the EU.
A risk management plan has been developed to ensure that Rasagiline Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasagiline Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
The European Commission granted a marketing authorisation valid throughout the European Union for Rasagiline Mylan on 4 April 2016.
For more information about treatment with Rasagiline Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: N/0012
22/02/2023
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 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 Mylan 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 Mylan
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