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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/284074/2016

EMEA/V/C/004199

EPAR summary for the public

Sevohale¹

sevoflurane

This is a summary of the European public assessment report (EPAR) for Sevohale. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Sevohale.

For practical information about using Sevohale, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Sevohale and what is it used for?

Sevohale is a general anaesthetic medicine that is used to produce and maintain general anaesthesia (loss of consciousness) in dogs. It contains the active substance sevoflurane.

Sevohale is a 'generic medicine'. This means that Sevohale is similar to a 'reference medicine' already authorised in the EU called SevoFlo.

For further information, see the package leaflet.

How is Sevohale used?

Sevohale is available as a liquid that becomes a vapour when it is heated and can only be obtained with a prescription. It is given using specialised anaesthetic equipment that supplies Sevohale vapour as a carefully controlled mixture including oxygen. The dog breathes in this gas mixture, which causes it to become unconscious. For further information, see the package leaflet.

How does Sevohale work?

When a dog breathes Sevohale vapour, the active substance sevoflurane passes from its lungs into the blood, which carries it to the brain. In the brain it stimulates receptors for GABA, a substance involved in reducing electrical activity in the brain. It also blocks receptors for glutamate, which is a substance which increases electrical activity in the brain. The combination of these effects reduces the activity of the brain and so causes unconsciousness.

¹ Previously known as Sevocalm

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How has Sevohale been studied?

No additional studies were needed as Sevohale is a generic medicine that is given by inhalation and contains the same active substance as the reference medicine, SevoFlo.

What are the benefits and risks of Sevohale?

Because Sevohale is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Safety information has been included in the summary of product characteristics and the package leaflet for Sevohale, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. The precautions are the same as for the reference medicine since Sevohale is a generic medicine.

Why is Sevohale approved?

The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Sevohale has been shown to be comparable to SevoFlo. Therefore, the CVMP's view was that, as for SevoFlo, the benefits outweigh the identified risks. The Committee recommended that Sevohale be approved for use in the EU.

Other information about Sevohale:

The European Commission granted a marketing authorisation valid throughout the EU for Sevocalm on 21/06/2016. The name of the medicine was changed to Sevohale on 29 July 2016.

The full EPAR for Sevohale can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with Sevohale, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

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

This summary was last updated in August 2016.

Sevohale

EMA/284074/2016