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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/277035/2016

EMEA/H/C/003717

EPAR summary for the public

Ebilfumin

oseltamivir

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

For practical information about using Ebilfumin, patients should read the package leaflet or contact their doctor or pharmacist.

What is Ebilfumin and what is it used for?

Ebilfumin is an antiviral medicine that contains the active substance oseltamivir. It is used to treat or prevent influenza (flu):

•    in the treatment of flu, it can be used in adults and children (including full-term newborns) who have the symptoms of flu, when the flu virus is known to be circulating in the community;

•    in the prevention of flu, it can be used in adults and children over 1 year of age who have been in contact with someone who has flu. This is generally done on a case-by-case basis. Ebilfumin can also be used as preventative treatment in exceptional cases, for instance when the seasonal flu vaccine may not provide sufficient protection and when there is a pandemic (a global epidemic of flu).

During a flu pandemic, Ebilfumin can also be used to treat or prevent flu in babies below one year of age. Doctors should make decisions on whether to use Ebilfumin in babies of this age based on the severity of the disease caused by the flu virus and the baby's state of health, to ensure that the baby is likely to benefit from the medicine.

Ebilfumin does not replace flu vaccination, and its use should be based on official recommendations.

Ebilfumin is a 'generic medicine'. This means that Ebilfumin is similar to a 'reference medicine' already authorised in the European Union (EU) called Tamiflu. For more information on generic medicines, see the question-and-answer document here.

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

How is Ebilfumin used?

Ebilfumin is available as capsules (30, 45 and 75 mg) and can only be obtained with a prescription.

In the treatment of flu, Ebilfumin must be started within two days of the onset of symptoms. It is given as one dose twice a day for five days.

In the prevention of flu, Ebilfumin must be started within two days of contact with someone who has flu. It is given as one dose once a day for 10 days after contact with an infected person. When Ebilfumin is used during a flu epidemic, this dose can be given for up to six weeks.

The dose of Ebilfumin is 75 mg in patients aged 13 years and over, and in children aged between one and 12 years who weigh more than 40 kg. For children who weigh less than 40 kg, the dose is adjusted according to their weight using the lower-dose capsules (30 or 45 mg).

In the treatment of flu in full-term babies up to 1 year of age, this medicine should be given a liquid form to be taken by mouth (oral suspension) in a dose of 3 mg per kg body weight twice a day. The dose to use in premature babies has not been determined. Other patients who cannot swallow capsules may also receive the appropriate dose of the oral suspension. The oral suspension should be prepared by the pharmacist using commercially available oseltamivir powder for oral suspension.

If the powder for oral suspension is not available, the pharmacist can make up a solution using the contents of Ebilfumin capsules, or the contents of the capsules can be mixed into sweetened food at home. The solution made up by a pharmacist is preferable to a home preparation as a pharmacist can measure the dose more accurately.

Doses may need to be lower in patients who have kidney problems. See the summary of product characteristics for full details.

How does Ebilfumin work?

The active substance in Ebilfumin, oseltamivir, acts specifically on the flu virus, blocking some of the enzymes on its surface known as neuramidases. When the neuramidases are blocked, the virus cannot spread. Oseltamivir works on the neuramidases of both influenza-A (the most common type) and influenza-B viruses.

How has Ebilfumin been studied?

Because Ebilfumin is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Tamiflu. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Ebilfumin?

Because Ebilfumin 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 Ebilfumin approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ebilfumin has been shown to have comparable quality and to be bioequivalent

Ebilfumin

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to Tamiflu. Therefore, the CHMP's view was that, as for Tamiflu, the benefit outweighs the identified risks. The Committee recommended that Ebilfumin be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Ebilfumin?

A risk management plan has been developed to ensure that Ebilfumin 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 Ebilfumin, 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 Ebilfumin

The European Commission granted a marketing authorisation valid throughout the European Union for Ebilfumin on 22 May 2014.

The full EPAR and risk management plan summary for Ebilfumin 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 Ebilfumin, 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 04-2016.

Ebilfumin

EMA/277035/2016