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; red-brown: 4.5 mg and red-brown and orange: 6 mg) and 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 authorized in the European Union (EU) called Exelon. For more information on generic medicines, see the questions and answers by clicking here.
What is Nimvastid used for?
Nimvastid is used to treat patients with mild to moderately severe Alzheimer's dementia, a progressive brain disease that gradually affects memory, intellectual ability and behavior.
It can also be used for the treatment of 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 started and supervised by a doctor experienced in the diagnosis and treatment of Alzheimer's disease or dementia associated with Parkinson's disease. Therapy should only be started if a caregiver ("caregiver", the one who habitually assists the patient) is available who regularly controls the patient's intake of the medicine. Treatment should be maintained until the medicine has a beneficial effect, but the dose can be reduced or treatment stopped if the patient experiences side effects.
Nimvastid should be given twice a day, for breakfast and dinner. The capsules must be swallowed whole. Nimvastid orodispersible tablets should be placed on the tongue, where they quickly disintegrate in the saliva before being swallowed.
The starting dose of Nimvastid is 1.5 mg twice a day. If this dose is well tolerated, it may be increased, in 1.5 mg increments at intervals of not less than two weeks, to a regular dose of 3-6 mg twice a day. To get the maximum benefit it is good to use the highest tolerated dose, without exceeding 6 mg twice a day.
How does Nimvastid work?
The active substance in Nimvastid, rivastigmine, is an antidementia medicine. In patients with dementia of the Alzheimer type or dementia due to Parkinson's disease some nerve cells die in the brain resulting in lowering the levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that destroy acetylcholine, ie acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Nimvastid promotes an increase in acetylcholine levels in the brain, which helps 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 show that the drug is bioequivalent to the reference medicine (ie that the two medicines produce the same levels of the active substance in the body).
What are the risks and benefits associated with Nimvastid?
Because Nimvastid is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same.
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 is of the opinion that, as with Exelon, the benefits outweigh the identified risks. The committee recommended the granting of a marketing authorization for Nimvastid.
More information on Nimvastid
On 11 May 2009, the European Commission issued a marketing authorization for Nimvastid, valid throughout the European Union, to the company KRKA, dd, Novo Mesto.
The full EPAR for Nimvastid can be found here.
Last update of this summary: 05-2009
