Cepedex

dexmedetomidine hydrochloride

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

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

What is Cepedex and what is it used for?

Cepedex is a medicine used to sedate (calm down) dogs and cats in the following situations:

  • when carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated and made less sensitive to pain (analgesia). Cepedex is used in non-invasive procedures which do not involve breaking the skin or a body cavity.
  • as premedication before inducing general anaesthesia.

Cepedex can also be used in dogs to provide pain relief and deep sedation when carrying out medical procedures and minor surgery where it is used in combination with butorphanol (a sedative and analgesic).

Cepedex contains the active substance dexmedetomidine and is a ‘generic medicine’. This means that Cepedex is similar to a ‘reference medicine’ already authorised in the EU called Dexdomitor.

For further information, see the package leaflet.

How is Cepedex used?

Cepedex is available as a solution for injection and can only be obtained with a prescription.

In dogs, Cepedex is given by injection into a vein or a muscle. In cats, it is given by injection into a muscle. For dogs the dose depends on their body surface area (calculated using bodyweight) and in cats it is based on bodyweight. It also depends on the use and the way it is given. The duration and depth of sedation and analgesia depend on the dose that is used.

How does Cepedex work?

Cepedex is an alpha2-adrenoceptor agonist. It works by attaching to receptors known as alpha2-adrenergic receptors and preventing the release of the neurotransmitter noradrenaline from nerve cells in the body. A neurotransmitter is a substance that nerve cells use to communicate with neighbouring cells. Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain. Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.

How has Cepedex been studied?

The company provided information on the quality and manufacture of Cepedex. No additional studies were needed as Cepedex is a generic medicine that is given by injection, is similar in composition to, and contains the same active substance as the reference medicine, Dexdomitor.

What are the benefits and risks of Cepedex?

Because Cepedex 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.

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

Safety information has been included in the summary of product characteristics and the package leaflet for Cepedex, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when giving Cepedex. Because Cepedex is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine.

Why is Cepedex approved?

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

Other information about Cepedex

The European Commission granted a marketing authorisation valid throughout the EU for Cepedex on 13 December 2016.

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

Name Language First published Last updated
Cepedex : EPAR - Summary for the public BG = bălgarski 2016-12-22  
Cepedex : EPAR - Summary for the public ES = español 2016-12-22  
Cepedex : EPAR - Summary for the public CS = čeština 2016-12-22  
Cepedex : EPAR - Summary for the public DA = dansk 2016-12-22  
Cepedex : EPAR - Summary for the public DE = Deutsch 2016-12-22  
Cepedex : EPAR - Summary for the public ET = eesti keel 2016-12-22  
Cepedex : EPAR - Summary for the public EL = elliniká 2016-12-22  
Cepedex : EPAR - Summary for the public EN = English 2016-12-22  
Cepedex : EPAR - Summary for the public FR = français 2016-12-22  
Cepedex : EPAR - Summary for the public IT = italiano 2016-12-22  
Cepedex : EPAR - Summary for the public LV = latviešu valoda 2016-12-22  
Cepedex : EPAR - Summary for the public LT = lietuvių kalba 2016-12-22  
Cepedex : EPAR - Summary for the public HU = magyar 2016-12-22  
Cepedex : EPAR - Summary for the public MT = Malti 2016-12-22  
Cepedex : EPAR - Summary for the public NL = Nederlands 2016-12-22  
Cepedex : EPAR - Summary for the public PL = polski 2016-12-22  
Cepedex : EPAR - Summary for the public PT = português 2016-12-22  
Cepedex : EPAR - Summary for the public RO = română 2016-12-22  
Cepedex : EPAR - Summary for the public SK = slovenčina 2016-12-22  
Cepedex : EPAR - Summary for the public SL = slovenščina 2016-12-22  
Cepedex : EPAR - Summary for the public FI = suomi 2016-12-22  
Cepedex : EPAR - Summary for the public SV = svenska 2016-12-22  
Cepedex : EPAR - Summary for the public HR = Hrvatski 2016-12-22  

This EPAR was last updated on 22/12/2016 .

Authorisation details

Product details

Product details for Cepedex
NameCepedex
Agency product numberEMEA/V/C/004376
Active substance

dexmedetomidine hydrochloride

International non-proprietary name (INN) or common name

dexmedetomidine

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codes QN05CM18


Publication details

Publication details for Cepedex
Marketing-authorisation holder

CP-Pharma Handelsgesellschaft mbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union13/12/2016

Contact address:

CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
31303 Burgdorf
Germany

Product information

Product information

13/12/2016  Cepedex -EMEA/V/C/004376

Name Language First published Last updated
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  
Cepedex : EPAR - Product Information HR = Hrvatski 2016-12-22  

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
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Cepedex : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  

Pharmacotherapeutic group

Psycholeptics, hypnotics and sedatives

Therapeutic indication

Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs and cats before induction and maintenance of general anaesthesia.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Cepedex : EPAR - Public assessment report HR = Hrvatski 2016-12-22  
CVMP summary of positive opinion for Cepedex HR = Hrvatski 2016-10-07  

Authorised

This medicine is approved for use in the European Union