Rasagiline Mylan

rasagiline

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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.

What is Rasagiline Mylan and what is it used for?

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.

How is Rasagiline Mylan used?

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.

How does Rasagiline Mylan work?

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.

How has Rasagiline Mylan been studied?

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.

What are the benefits and risks of Rasagiline Mylan?

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.

Why is Rasagiline Mylan approved?

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.

What measures are being taken to ensure the safe and effective use of Rasagiline Mylan?

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.

Other information about Rasagiline Mylan

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.

Name Language First published Last updated
Rasagiline Mylan : EPAR - Summary for the public BG = bălgarski 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public ES = español 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public CS = čeština 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public DA = dansk 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public DE = Deutsch 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public ET = eesti keel 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public EL = elliniká 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public EN = English 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public FR = français 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public IT = italiano 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public LV = latviešu valoda 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public LT = lietuvių kalba 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public HU = magyar 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public MT = Malti 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public NL = Nederlands 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public PL = polski 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public PT = português 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public RO = română 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public SK = slovenčina 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public SL = slovenščina 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public FI = suomi 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public SV = svenska 2016-04-29  
Rasagiline Mylan : EPAR - Summary for the public HR = Hrvatski 2016-04-29  

This EPAR was last updated on 22/06/2016 .

Authorisation details

Product details

Product details for Rasagiline Mylan
NameRasagiline Mylan
Agency product numberEMEA/H/C/004064
Active substance

rasagiline tartrate

International non-proprietary name (INN) or common name

rasagiline

Therapeutic area Parkinson Disease
Anatomical therapeutic chemical (ATC) code N04BD02
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Rasagiline Mylan
Marketing-authorisation holder

Mylan S.A.S.

Revision1
Date of issue of marketing authorisation valid throughout the European Union04/04/2016

Contact address:

Mylan S.A.S.
117 Allée des Parcs 
69800 Saint Priest 
France
 

Product information

Product information

18/05/2016  Rasagiline Mylan -EMEA/H/C/004064 -IAIN/0001/G

Name Language First published Last updated
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - Product Information HR = Hrvatski 2016-04-29 2016-06-22

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22
Rasagiline Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-29 2016-06-22

Pharmacotherapeutic group

Anti-Parkinson drugs

Therapeutic 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Rasagiline Mylan : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-06-22  

Initial marketing-authorisation documents

Name Language First published Last updated
Rasagiline Mylan : EPAR - Public assessment report HR = Hrvatski 2016-04-29  
CHMP summary of opinion for Rasagiline Mylan HR = Hrvatski 2016-01-29  

Authorised

This medicine is approved for use in the European Union

More information on Rasagiline Mylan

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