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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/563874/2016

EMEA/V/C/004239

EPAR summary for the public

Eravac

rabbit haemorrhagic disease vaccine, inactivated

This is a summary of the European public assessment report (EPAR) for Eravac. 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 Eravac.

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

What is Eravac and what is it used for?

Eravac is a veterinary vaccine used in rabbits intended for meat production to reduce death due to the rabbit haemorrhagic disease (RHD), a usually fatal disease caused by a new variant of RHD virus, called RHD type 2 virus, resulting in blood clot formation. RHD type 2 virus differs from the classic form of RHD virus since the course of disease is more prolonged, deaths occur later and over a longer period and there are more deaths in young rabbits than in adults.

Eravac contains inactivated rabbit haemorrhagic disease type 2 virus, strain (V-1037), as the active substance.

How is Eravac used?

Eravac is available as an emulsion for injection and can only be obtained with a prescription. The vaccine is given to rabbits from 30 days of age as a single injection under the skin of the side of the chest. Protection starts one week after vaccination.

For further information, see the package leaflet.

How does Eravac work?

Eravac is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Eravac contains rabbit haemorrhagic disease type 2 virus (RHDV2),

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strain V-1037 which has been inactivated so it cannot cause the disease. When it is given to rabbits the immune system recognises the virus as 'foreign' and makes antibodies against it. In the future if rabbits are exposed to rabbit haemorrhagic disease type 2 virus, the immune system will be able to produce antibodies more quickly. This will help protect them against the disease.

Eravac contains an adjuvant (mineral oil) to enhance the immune response.

What benefits of Eravac have been shown in studies?

The effectiveness of the vaccine was compared with that of a placebo (dummy) vaccine in two laboratory studies involving 232 fattening rabbits intended for meat production. After vaccination the rabbits were artificially infected with rabbit haemorrhagic disease type 2 virus. Both studies showed the vaccine to be effective in reducing death. In one study all Eravac vaccinated rabbits survived compared with a 37% survival rate in the group that received the placebo vaccine. In the second study survival of Eravac vaccinated rabbits was 93% compared with 50% for rabbits given placebo.

What are the risks associated with Eravac?

The most common side effect with Eravac (which may affect more than 1 in 10 rabbits) is a short-lived increase in body temperature to slightly above 40 °C which may occur between two or three days following vaccination. This slight temperature increase resolves spontaneously without treatment within 5 days.

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

Eravac is an emulsion containing mineral oil. Accidental injection may cause severe pain and selling, particularly if injected into a joint or finger - this could result in the loss of the finger if prompt medical attention is not given. If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected. The package leaflet should be shown to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.

The withdrawal period for meat from rabbits treated with Eravac for is 'zero' days, which means there is no mandatory waiting time.

Why is Eravac approved?

The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Eravac's benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Eravac?

The European Commission granted a marketing authorisation valid throughout the EU for Eravac on 22 September 2016.

The full EPAR for Eravac 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 Eravac, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This summary was last updated in July 2016.

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Eravac

EMA/563874/2016