Nimvastid

rivastigmine

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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 their 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 Nimvastid?

Nimvastid is a medicine that contains the active substance rivastigmine. It is available as capsules (yellow: 1.5 mg, orange: 3 mg, brownish red: 4.5 mg, and brownish red and orange: 6 mg) and as white orodispersible tablets (1.5 mg, 3 mg, 4.5 mg, and 6 mg). Orodispersible means that the tablets dissolve in the mouth.

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

What is Nimvastid used for?

Nimvastid is used for the treatment of patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.

It is also used to treat mild to moderately severe dementia in patients with Parkinson’s disease.

The medicine can only be obtained with a prescription.

How is Nimvastid used?

Treatment with Nimvastid should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’s disease or dementia in patients with Parkinson’s disease. Treatment should only be started if a caregiver is available who will regularly monitor the use of Nimvastid by the patient. Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects.

Nimvastid should be given twice a day, with morning and evening meals. The capsules should be swallowed whole. Nimvastid orodispersible tablets should be placed on the tongue, where they disintegrate quickly in the saliva before being swallowed.

The starting dose for Nimvastid is 1.5 mg twice a day. In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day. The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day. 

How does Nimvastid work?

The active substance in Nimvastid, rivastigmine, is an antidementia medicine. In patients with Alzheimer’s dementia or dementia due to Parkinson’s disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Nimvastid allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s dementia and dementia due to Parkinson’s disease.

How has Nimvastid been studied?

Because Nimvastid is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (this means that the two medicines produce the same levels of the active substance in the body).

What are the benefit and risk of Nimvastid?

Because Nimvastid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Nimvastid been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Nimvastid has been shown to have comparable quality and to be bioequivalent to Exelon. Therefore, the CHMP’s view was that, as for Exelon, the benefit outweighs the identified risk. The Committee recommended that Nimvastid be given marketing authorisation.

Other information about Nimvastid

The European Commission granted a marketing authorisation valid throughout the European Union for Nimvastid to KRKA,d.d., Novo mesto on 11 May 2009.

Name Language First published Last updated
Nimvastid : EPAR - Summary for the public BG = bălgarski 04/06/2009  
Nimvastid : EPAR - Summary for the public ES = español 04/06/2009  
Nimvastid : EPAR - Summary for the public CS = čeština 04/06/2009  
Nimvastid : EPAR - Summary for the public DA = dansk 04/06/2009  
Nimvastid : EPAR - Summary for the public DE = Deutsch 04/06/2009  
Nimvastid : EPAR - Summary for the public ET = eesti keel 04/06/2009  
Nimvastid : EPAR - Summary for the public EL = elliniká 04/06/2009  
Nimvastid : EPAR - Summary for the public EN = English 04/06/2009  
Nimvastid : EPAR - Summary for the public FR = français 04/06/2009  
Nimvastid : EPAR - Summary for the public IT = italiano 04/06/2009  
Nimvastid : EPAR - Summary for the public LV = latviešu valoda 04/06/2009  
Nimvastid : EPAR - Summary for the public LT = lietuvių kalba 04/06/2009  
Nimvastid : EPAR - Summary for the public HU = magyar 04/06/2009  
Nimvastid : EPAR - Summary for the public MT = Malti 04/06/2009  
Nimvastid : EPAR - Summary for the public NL = Nederlands 04/06/2009  
Nimvastid : EPAR - Summary for the public PL = polski 04/06/2009  
Nimvastid : EPAR - Summary for the public PT = português 04/06/2009  
Nimvastid : EPAR - Summary for the public RO = română 04/06/2009  
Nimvastid : EPAR - Summary for the public SK = slovenčina 04/06/2009  
Nimvastid : EPAR - Summary for the public SL = slovenščina 04/06/2009  
Nimvastid : EPAR - Summary for the public FI = suomi 04/06/2009  
Nimvastid : EPAR - Summary for the public SV = svenska 04/06/2009  

This EPAR was last updated on 20/01/2016 .

Authorisation details

Product details

Product details for Nimvastid
NameNimvastid
Agency product numberEMEA/H/C/001029
Active substance

rivastigmine

International non-proprietary name (INN) or common name

rivastigmine

Therapeutic area DementiaParkinson DiseaseAlzheimer Disease
Anatomical therapeutic chemical (ATC) code N06DA03
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 Nimvastid
Marketing-authorisation holder

Krka, d.d., Novo mesto

Revision7
Date of issue of marketing authorisation valid throughout the European Union11/05/2009

Contact address:

Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

Product information

18/12/2015  Nimvastid -EMEA/H/C/001029 -IB/0014

Name Language First published Last updated
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016
Nimvastid : EPAR - Product Information SV = svenska 04/06/2009 20/01/2016

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
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009
Nimvastid : EPAR - All Authorised presentations SV = svenska 04/06/2009 16/07/2009

Pharmacotherapeutic group

Psychoanaleptics

Therapeutic indication

Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nimvastid : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 16/07/2010 20/01/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Nimvastid : EPAR - Public assessment report SV = svenska 04/06/2009  
Committee for medicinal products for human use, summary of positive opinion for Nimvastid SV = svenska 19/03/2009  

Authorised

This medicine is approved for use in the European Union

More information on Nimvastid