Zonisamide Viatris (previously Zonisamide Mylan)

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Overview

Zonisamide Viatris is a medicine used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain). It is used on its own in newly diagnosed adults and as an ‘add-on’ therapy in adults and children aged six years and above already receiving other anti-epilepsy medicines.

Zonisamide Viatris contains the active substance zonisamide and is a ‘generic medicine’. This means that Zonisamide Viatris is similar to a ‘reference medicine’ already authorised in the EU called Zonegran. For more information on generic medicines, see the question-and-answer document here.

The medicine can only be obtained with a prescription and is available as capsules.

The dose and how often the medicine is taken depends on the condition being treated and whether the patient is an adult or a child.

For further information, see the package leaflet or contact your doctor or pharmacist.

The active substance in Zonisamide Viatris, zonisamide, is an anti‑epileptic. Epileptic fits are caused by abnormal electrical activity in the brain.

Zonisamide is thought to work by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels, through which sodium or calcium normally enter nerve cells. When calcium and sodium enter nerve cells, electrical impulses can be transmitted between the nerve cells. By blocking these channels, zonisamide is expected to prevent abnormal electrical activity spreading through the brain, thereby reducing the chances of an epileptic fit.

Zonisamide Viatris also acts on the neurotransmitter gamma‑aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other). This may help to stabilise electrical activity in the brain.

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zonegran, and do not need to be repeated for Zonisamide Viatris.

As for every medicine, the company provided studies on the quality of Zonisamide Viatris. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Zonisamide Viatris 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.

The European Medicines Agency concluded that, in accordance with EU requirements, Zonisamide Viatris has been shown to have comparable quality and to be bioequivalent to Zonegran. Therefore, the Agency’s view was that, as for Zonegran, the benefits outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zonisamide Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Zonegran also apply to Zonisamide Viatris where appropriate.

As for all medicines, data on the use of Zonisamide Viatris are continuously monitored. Suspected side effects reported with Zonisamide Viatris are carefully evaluated and any necessary action taken to protect patients.

The European Commission granted a marketing authorisation valid throughout the European Union for Zonisamide Viatris on 31 March 2016.

The name of the medicine was changed to Zonisamide Viatris on 15 October 2024.

English (EN)
(140.39 KB – PDF)

First published: 06/04/2016Last updated: 27/01/2025

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English (EN)
(101.35 KB – PDF)

First published: 06/04/2016

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Product information

English (EN)
(591.44 KB – PDF)

First published: 06/04/2016Last updated: 17/10/2024

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Latest procedure affecting product information:
IG1772

15/10/2024

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(50.39 KB – PDF)

First published: 06/04/2016Last updated: 17/10/2024

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Product details

Name of medicine: Zonisamide Viatris (previously Zonisamide Mylan)
Active substance: zonisamide
International non-proprietary name (INN) or common name: zonisamide
Therapeutic area (MeSH): Epilepsy
Anatomical therapeutic chemical (ATC) code: N03AX15

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.

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