Prevomax

Prevomax is a veterinary medicine used in dogs and cats to treat vomiting, in combination with other supportive measures, or to prevent vomiting (except travel sickness).

In cats Prevomax is also used to reduce nausea (signs of feeling sick).

In dogs Prevomax can also be used both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine. Prevomax is also used to prevent and treat nausea caused by chemotherapy in dogs.

Prevomax contains the active substance maropitant.

Prevomax is a ‘generic medicine’. This means that Prevomax contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Cerenia.

The medicine can only be obtained with a prescription and is available as a solution for injection. Prevomax is injected once daily under the skin or into a vein (1 mg/per kg bodyweight) for up to five days. To prevent vomiting Prevomax should be given more than one hour in advance of the event that might cause vomiting.

For further information, see the package leaflet.

The active substance in Prevomax, maropitant, stops a chemical in the body (substance P) from attaching to certain targets called neurokinin-1 (NK1) receptors, which are found on the surface of cells in the part of the brain that controls nausea and vomiting. When substance P attaches to these receptors it triggers nausea and vomiting. By blocking the receptors, maropitant can prevent nausea and vomiting.

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

As for every medicine, the company provided studies on the quality of Prevomax. There was no need for ‘bioequivalence’ studies to investigate whether Prevomax is absorbed similarly to the reference medicine, Cerenia solution for injection, to produce the same level of the active substance in the blood. This is because when given by injection into a vein, the active substance in Prevomax is delivered straight into the bloodstream. When given by injection under the skin, the active substance in Prevomax is expected to be absorbed in the same way as the reference medicine.

Because Prevomax 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.

Safety information has been included in the summary of product characteristics and the package leaflet for Prevomax, 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 Prevomax is a generic medicine.

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Prevomax has been shown to have comparable quality and to be bioequivalent to Cerenia, solution for injection. Therefore, the CVMP’s view was that, as for Cerenia, the benefits outweigh the identified risks. The Committee recommended that Prevomax be approved for use in the EU.

The European Commission granted a marketing authorisation valid throughout the EU for Prevomax on 19 June 2017.

For more information about treatment with Prevomax, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.