Pramipexole Accord

pramipexole

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This is a summary of the European public assessment report (EPAR) for Pramipexole Accord. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pramipexole Accord.

What is Pramipexole Accord?

Pramipexole Accord is a medicine that contains the active substance pramipexole. It is available as tablets (0.088, 0.18, 0.35, 0.7 and 1.1 mg).

Pramipexole Accord is a ‘generic medicine’. This means that Pramipexole Accord is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Mirapexin.

What is Pramipexole Accord used for?

Pramipexole Accord is used to treat the symptoms of the following diseases:

  • Parkinson’s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Pramipexole Accord 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;
  • moderate to severe restless-legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night. Pramipexole Accord is used when a specific cause for the disorder cannot be identified.

The medicine can only be obtained with a prescription.

How is Pramipexole Accord used?

For Parkinson’s disease, the starting dose is one 0.088 mg tablet three times a 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 three 1.1 mg tablets. Pramipexole Accord must be given less often in patients who have problems with their kidneys. If treatment is stopped for any reason, the dose should be decreased gradually.

For restless-legs syndrome, Pramipexole Accord should be taken once a day, two to three hours before going to bed. The recommended starting dose is 0.088 mg, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of 0.54 mg. The patient’s response and the need for further treatment should be evaluated after three months.

Pramipexole Accord should be swallowed with water. For more information, see the package leaflet.

How does Pramipexole Accord work?

The active substance in Pramipexole Accord, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine). Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination. 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.

The way pramipexole works in restless-legs syndrome is not fully understood. The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be corrected by pramipexole.

How has Pramipexole Accord been studied?

Because Pramipexole Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Mirapexin. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Pramipexole Accord?

Because Pramipexole Accord 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 has Pramipexole Accord been approved?

The CHMP concluded that, in accordance with EU requirements, Pramipexole Accord has been shown to have comparable quality and to be bioequivalent to Mirapexin. Therefore, the CHMP’s view was that, as for Mirapexin, the benefit outweighs the identified risk. The Committee recommended that Pramipexole Accord be given marketing authorisation.

Other information about Pramipexole Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Pramipexole Accord on 30 September 2011.

For more information about treatment with Pramipexole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Pramipexole Accord : EPAR - Summary for the public BG = bălgarski 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public ES = español 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public CS = čeština 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public DA = dansk 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public DE = Deutsch 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public ET = eesti keel 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public EL = elliniká 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public EN = English 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public FR = français 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public IT = italiano 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public LV = latviešu valoda 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public LT = lietuvių kalba 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public HU = magyar 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public MT = Malti 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public NL = Nederlands 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public PL = polski 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public PT = português 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public RO = română 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public SK = slovenčina 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public SL = slovenščina 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public FI = suomi 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public SV = svenska 2011-10-19 2016-09-27
Pramipexole Accord : EPAR - Summary for the public HR = Hrvatski 2011-10-19 2016-09-27

This EPAR was last updated on 07/12/2017 .

Authorisation details

Product details

Product details for Pramipexole Accord
NamePramipexole Accord
Agency product numberEMEA/H/C/002291
Active substance

pramipexole dihydrochloride monohydrate

International non-proprietary name (INN) or common name

pramipexole

Therapeutic area Restless Legs SyndromeParkinson Disease
Anatomical therapeutic chemical (ATC) code N04BC05
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 Pramipexole Accord
Marketing-authorisation holder

Accord Healthcare Ltd

Revision6
Date of issue of marketing authorisation valid throughout the European Union30/09/2011

Contact address:

Accord Healthcare Ltd
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom

Product information

Product information

24/10/2017  Pramipexole Accord -EMEA/H/C/002291 -IAIN/0012

Name Language First published Last updated
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07
Pramipexole Accord : EPAR - Product Information HR = Hrvatski 2011-10-19 2017-12-07

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
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  
Pramipexole Accord : EPAR - All Authorised presentations HR = Hrvatski 2011-10-19  

Pharmacotherapeutic group

Anti-Parkinson drugs

Therapeutic indication

Pramipexole Accord is indicated in adults 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).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Pramipexole Accord : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2013-02-26 2017-12-07

Initial marketing-authorisation documents

Name Language First published Last updated
Pramipexole Accord : EPAR - Public assessment report HR = Hrvatski 2011-10-19  
CHMP summary of positive opinion for Pramipexole Accord HR = Hrvatski 2011-07-22  

Authorised

This medicine is approved for use in the European Union

More information on Pramipexole Accord