Clevor

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Authorised

This medicine is authorised for use in the European Union

ropinirole
MedicineVeterinaryAuthorised
  • Application under evaluation
  • CVMP opinion
  • European Commission decision

Overview

An overview of Clevor and why it is authorised in the EU

Clevor is a veterinary medicine used to induce vomiting in dogs. It contains the active substance ropinirole.

For more information, see the package leaflet.

Clevor is an eye drop solution, given into the eye at a dose of 1–8 drops according to the dog’s bodyweight. If a dose of more than one drop is needed it should be divided between both eyes and when 6 or more drops are to be given the dose should be divided into 2 separate treatments given 1–2 minutes apart. If the dog does not vomit within 15 minutes of treatment, treatment may be repeated. The medicine should only be given by a veterinarian or under his/her close supervision and can only be obtained with a prescription.

For more information about using Clevor, see the package leaflet or contact your veterinarian or pharmacist.

Ropinirole is a dopamine agonist, which means that it imitates the action of dopamine. Dopamine is a messenger substance in the part of the brain which controls vomiting. By stimulating this part of the brain ropinirole triggers vomiting.

In a field trial involving 132 healthy dogs which compared Clevor with placebo (dummy treatment), 95% of the dogs vomited within 30 minutes. A second dose was given after 20 minutes to 13% of the dogs as they had not vomited. Three dogs did not vomit at all despite a second dose. In the group of 32 dogs which received placebo eye drops only one dog vomited.

The most common side effects with Clevor (which may affect more than 1 in 10 animals) are short-lived, mild hyperaemia (redness) of the eye, discharge from the eye, protrusion of the third eyelid, blepharospasm (closure of the eyelids due to muscle contraction), short-lived mild lack of energy and increased heart rate.

Clevor must not be used in dogs:

  • with central nervous system depression (low levels of consciousness), seizures (fits) or other problems with the nervous system which could lead to inhalation pneumonia (lung damage due to content from the stomach entering the lungs).
  • which are hypoxic (have lower than normal oxygen levels in the blood), dyspnoeic (have difficulty breathing) or lack pharyngeal (swallowing) reflexes.
  • which have swallowed sharp foreign objects, corrosive agents, volatile substances or organic solvents.

For the full list of side effects and restrictions of Clevor, see the package leaflet.

People who are hypersensitive (allergic) to ropinirole should avoid contact with Clevor.

Pregnant or breast-feeding women should not handle this medicine.

In case of skin or eye contact the affected area should be rinsed immediately with water. If symptoms occur, medical advice should be sought and the package leaflet or label shown to the doctor.

The European Medicines Agency decided that Clevor’s benefits are greater than its risks and it can be authorised for use in the EU.

Clevor received a marketing authorisation valid throughout the EU on 13 April 2018.

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Product information

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Latest procedure affecting product information: IAIN/0001
30/01/2019

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Product details

Name of medicine
Clevor
Active substance
ropinirole hydrochloride
International non-proprietary name (INN) or common name
ropinirole
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) code
QN04BC04

Pharmacotherapeutic group

  • Dopaminergic agents
  • Dopamine agonists

Therapeutic indication

Induction of vomiting in dogs.

Authorisation details

EMA product number
EMEA/V/C/004417
Marketing authorisation holder
Orion Corporation

Orionintie 1
02 200 Espoo
Finland

Marketing authorisation issued
13/04/2018
Revision
1

Assessment history

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