Clevor

ropinirole hydrochloride

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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.

How is Clevor used?

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.

How does Clevor work?

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.

What benefits of Clevor have been shown in studies?

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.

What are the risks associated with Clevor?

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.

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

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.

Why is Clevor authorised in the EU?

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

Other information about Clevor

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

Name Language First published Last updated
Clevor : EPAR - Medicine overview BG = bălgarski 2018-05-16  
Clevor : EPAR - Medicine overview ES = español 2018-05-16  
Clevor : EPAR - Medicine overview CS = čeština 2018-05-16  
Clevor : EPAR - Medicine overview DA = dansk 2018-05-16  
Clevor : EPAR - Medicine overview DE = Deutsch 2018-05-16  
Clevor : EPAR - Medicine overview ET = eesti keel 2018-05-16  
Clevor : EPAR - Medicine overview EL = elliniká 2018-05-16  
Clevor : EPAR - Medicine overview EN = English 2018-05-16  
Clevor : EPAR - Medicine overview FR = français 2018-05-16  
Clevor : EPAR - Medicine overview IT = italiano 2018-05-16  
Clevor : EPAR - Medicine overview LV = latviešu valoda 2018-05-16  
Clevor : EPAR - Medicine overview LT = lietuvių kalba 2018-05-16  
Clevor : EPAR - Medicine overview HU = magyar 2018-05-16  
Clevor : EPAR - Medicine overview MT = Malti 2018-05-16  
Clevor : EPAR - Medicine overview NL = Nederlands 2018-05-16  
Clevor : EPAR - Medicine overview PL = polski 2018-05-16  
Clevor : EPAR - Medicine overview PT = português 2018-05-16  
Clevor : EPAR - Medicine overview RO = română 2018-05-16  
Clevor : EPAR - Medicine overview SK = slovenčina 2018-05-16  
Clevor : EPAR - Medicine overview SL = slovenščina 2018-05-16  
Clevor : EPAR - Medicine overview FI = suomi 2018-05-16  
Clevor : EPAR - Medicine overview SV = svenska 2018-05-16  
Clevor : EPAR - Medicine overview HR = Hrvatski 2018-05-16  

This EPAR was last updated on 16/05/2018 .

Authorisation details

Product details

Product details for Clevor
NameClevor
Agency product numberEMEA/V/C/004417
Active substance

ropinirole hydrochloride

International non-proprietary name (INN) or common name

ropinirole

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QN04BC04


Publication details

Publication details for Clevor
Marketing-authorisation holder

Orion Corporation

Revision0
Date of issue of marketing authorisation valid throughout the European Union13/04/2018

Contact address:

Orion Corporation
Orionintie 1 
02200 Espoo 
Finland

Product information

Product information

13/04/2018  Clevor -EMEA/V/C/004417

Name Language First published Last updated
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  
Clevor : EPAR - Product Information HR = Hrvatski 2018-05-16  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  
Clevor : EPAR - All Authorised presentations HR = Hrvatski 2018-05-16  

Pharmacotherapeutic group

Dopaminergic agents, dopamine agonists

Therapeutic indication

Induction of vomiting in dogs.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Clevor : EPAR - Public assessment report HR = Hrvatski 2018-05-16  
CVMP summary of positive opinion for Clevor HR = Hrvatski 2018-02-16  

Authorised

This medicine is approved for use in the European Union