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Rivastigmine 3M Health Care Ltd (rivastigmine) - N06DA03

Updated on site: 10-Oct-2017

Medication nameRivastigmine 3M Health Care Ltd
ATC CodeN06DA03
Substancerivastigmine
Manufacturer3M Health Care Limited
EMA/58565/2014
EMEA/H/C/003824
EPAR summary for the public

Rivastigmine 3M Health Care Ltd

rivastigmine

This is a summary of the European public assessment report (EPAR) for Rivastigmine 3M Health Care

Rivastigmine 3M Health Care Ltd is a me icine that contains the active substance rivastigmine.

Rivastigmine 3M Health Care Ltd is a ‘generic medicine’. This means that Rivastigmine 3M Health Care Ltd is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Exelon. For more information on generic medicines, see the question-and-answer document here.

How is Rivastigmine 3M Health Care Ltd used?

Rivastigmine 3M Health Care Ltd can only be obtained with a prescription and is available as transdermal patches, which release either 4.6 or 9.5 mg rivastigmine across the skin over 24 hours.

Treatment with Rivastigmine 3M Health Care Ltd should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’s dementia. Treatment should only be started if a caregiver is available who will regularly give and monitor the use of Rivastigmine 3M Health Care Ltd 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.

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

Treatment should be started with the 4.6-mg-per-24-hours patch, with the dose increased to the higher strength 9.5 mg/24-h patch after at least four weeks if the lower dose is well tolerated. Treatment should be continued for as long as the patient benefits from it. The patches are applied to clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours. They should not be placed on irritated or red skin, on the thigh or abdomen (tummy), or in places where they will be rubbed by tight clothing. The patches can be worn during bathing and hot weather. The patches should not be cut into pieces. Patients can be switched from rivastigmine capsules or oral solution to the patches. See the summary of product characteristics (also part of the EPAR) for detailed information.

How does Rivastigmine 3M Health Care Ltd work?

How has Rivastigmine 3M Health Care Ltd been studied?authorised

In patients with Alzheimer’s dementia, certain nerve cells die in the brain, resulting in low levels of the

neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with ach other).

The active substance in Rivastigmine 3M Health Care Ltd, rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these

enzymes, Rivastigmine 3M Health Care Ltd allows levels of acetylcholine o be increased in the brain, helping to reduce the symptoms of Alzheimer’s dementia.

Because Rivastigmine 3M HealthproductCare Ltd 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 is Rivastigmine 3M Health Care Ltd approved?

and to be bioequivalent to Exelon. Therefore, the CHMP’s view was that, as for Exelon, the benefit outweighs the ident f ed risk. The Committee recommended that Rivastigmine 3M Health Care Ltd be approved for use in the EU.

The Agency’sMedicinalCommittee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Riv stigmine 3M Health Care Ltd has been shown to have comparable quality

What measures are being taken to ensure the safe and effective use of Rivastigmine 3M Health Care Ltd?

A risk management plan has been developed to ensure that Rivastigmine 3M Health Care Ltd is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rivastigmine 3M Health Care Ltd, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Rivastigmine 3M Health Care Ltd

The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 3M Health Care Ltd on 3 April 2014.

The full EPAR and risk management plan summary for Rivastigmine 3M Health Care Ltd can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Rivastigmine 3M Health Care Ltd, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

This summary was last updated in 04-2014.

 

 

 

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