Azilect

rasagiline

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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).

What is Azilect?

Azilect is a medicine that contains the active substance rasagiline. It is available as white, round tablets (1 mg).

What is Azilect used for?

Azilect is used to treat of Parkinson’s disease. Parkinson’s disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Azilect 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’ towards the end of the period between levodopa doses. Fluctuations are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on’ and able to move, and being ‘off’ and immobile.

Azilect can only be obtained with a prescription.

How is Azilect used?

The standard dose of Azilect is one tablet once a day, taken with or without food.

How does Azilect work?

The active substance in Azilect, rasagiline, is a ‘monoamine-oxidase-B inhibitor’. It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain. Neurotransmitters are chemicals that allow nerve cells to communicate with one another. 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, Azilect improves the signs and symptoms of Parkinson’s disease, such as stiffness and slowness of movement.

How has Azilect been studied?

Azilect has been studied in three main studies involving a total of 1,563 patients with Parkinson’s disease. In the first study, two different doses of Azilect taken alone were compared with placebo (a dummy treatment) in 404 patients with early-stage disease. The main measure of effectiveness was the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson’s Disease Rating Scale, UPDRS). The other two studies involved a total of 1,159 patients with later stage disease, where Azilect was added to the patients’ existing treatment including levodopa. It was compared with placebo or entacapone (another medicine for Parkinson’s disease). The studies lasted 26 and 18 weeks, respectively. The main measure of effectiveness was the time spent in the ‘off’ state during the day, as recorded in patient diaries.

What benefit has Azilect shown during the studies?

Azilect was more effective than placebo in all of the studies. In the study where Azilect was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points over the 26-week study from a starting value of 24.69. This was compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54. A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.

When used as an add-on to levodopa, 1 mg Azilect reduced the time in the ‘off’ state more than placebo did. In both studies, patients adding Azilect spent an average of around one hour less in the ‘off’ state than those adding placebo. A similar decrease in time spent in the ‘off’ state was seen in patients taking entacapone.

What is the risk associated with Azilect?

The most common side effect with Azilect (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Azilect, see the package leaflet.

Azilect should not be used in people who may be hypersensitive (allergic) to rasagiline or any of the other ingredients. Azilect must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations without prescription such as St John’s wort. It must also not be used with pethidine (a painkiller). There should be at least 14 days between stopping treatment with Azilect and starting treatment with another monoamine-oxidase inhibitor or with pethidine. Azilect must not be used in patients who have severe problems with their liver. It is not recommended for patients with moderate liver problems. Patients with mild liver problems should use Azilect with caution and should stop treatment if their liver problems get worse.

Why has Azilect been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Azilect’s benefits are greater than its risks for the treatment of idiopathic Parkinson’s disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end-of-dose fluctuations. The Committee recommended that Azilect be given marketing authorisation.

Other information about Azilect

The European Commission granted a marketing authorisation valid throughout the European Union for Azilect to Teva Pharma GmbH on 21 February 2005. The marketing authorisation was renewed on 21 February 2010.

Name Language First published Last updated
Azilect : EPAR - Summary for the public BG = bălgarski 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public ES = español 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public CS = čeština 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public DA = dansk 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public DE = Deutsch 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public ET = eesti keel 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public EL = elliniká 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public EN = English 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public FR = français 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public IT = italiano 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public LV = latviešu valoda 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public LT = lietuvių kalba 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public HU = magyar 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public MT = Malti 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public NL = Nederlands 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public PL = polski 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public PT = português 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public RO = română 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public SK = slovenčina 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public SL = slovenščina 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public FI = suomi 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public SV = svenska 2009-09-24 2016-05-03
Azilect : EPAR - Summary for the public HR = Hrvatski 2009-09-24 2016-05-03

This EPAR was last updated on 03/05/2016 .

Authorisation details

Product details

Product details for Azilect
NameAzilect
Agency product numberEMEA/H/C/000574
Active substance

rasagiline

International non-proprietary name (INN) or common name

rasagiline

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

Publication details

Publication details for Azilect
Marketing-authorisation holder

Teva Pharma GmbH

Revision16
Date of issue of marketing authorisation valid throughout the European Union21/02/2005

Contact address:

Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Product information

Product information

22/02/2016  Azilect -EMEA/H/C/000574 -T/0071

Name Language First published Last updated
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03
Azilect : EPAR - Product Information HR = Hrvatski 2009-12-21 2016-05-03

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
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  
Azilect : EPAR - All Authorised presentations HR = Hrvatski 2006-08-11  

Pharmacotherapeutic group

Anti-Parkinson drugs

Therapeutic indication

Azilect 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

Initial marketing-authorisation documents

Name Language First published Last updated
Azilect : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-08-11  
Azilect : EPAR - Scientific Discussion HR = Hrvatski 2006-08-11  

Authorised

This medicine is approved for use in the European Union