Nimvastid - rivastigmine
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). By orodispersible it is meant 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, please 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 type 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 initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's disease or dementia associated with Parkinson's disease. Therapy should only be initiated if a caregiver ("caregiver") is available to regularly monitor the patient's intake of the medicine. Treatment should be continued as long as the medicine has a beneficial effect, but the dose can be reduced or treatment stopped if the patient experiences side effects.
Nimvastid should be administered twice a day, with breakfast and dinner. The capsules must be swallowed whole. Nimvastid orodispersible tablets should be placed on the tongue, where they rapidly disintegrate in 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 increments of 1.5 mg at intervals of not less than two weeks to a regular dose of 3-6 mg twice daily. For maximum benefit, use the highest tolerated dose, but do not exceed 6 mg twice daily.
How does Nimvastid work?
The active substance in Nimvastid, rivastigmine, is an anti-dementia medicine. In patients with Alzheimer's-type dementia or dementia due to Parkinson's disease, some nerve cells die in the brain resulting in lower levels of the neurotransmitter acetylcholine (the chemical that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that destroy acetylcholine, namely acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Nimvastid promotes an increase in acetylcholine levels in the brain, which helps reduce the symptoms of Alzheimer's-type dementia and Parkinson's disease dementia.
How has Nimvastid been studied?
Since Nimvastid is a generic medicine, studies have been limited to evidence designed to show that the medicine 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, the benefits and risks of the medicine are assumed to be 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 view that, as with Exelon, the benefits outweigh the identified risks. The committee recommended that Nimvastid be given marketing authorization.
Other information about Nimvastid
On 11 May 2009, the European Commission granted the company KRKA, d.d., Novo Mesto a "marketing authorization" for Nimvastid, valid throughout the European Union.
For the full version of Nimvastid's EPAR click here.
Last update of this summary: 05-2009
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