Eurican Herpes 205

Canine herpesvirus (F205 strain) antigens

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This is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use. 

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Eurican Herpes 205?

Eurican Herpes 205 is a powder and solvent that is made into an emulsion for injection. Eurican Herpes 205 contains the active substance canine herpes virus (F205 strain) antigens in a dose of 0.3 to 1.75 μg.

What is Eurican Herpes 205 used for?

Eurican Herpes 205 is used to immunise pregnant bitches to prevent mortality, clinical signs and lesions in puppies caused by canine herpes virus infections acquired in the first few days of life.

Eurican Herpes 205 is given as two 1 ml subcutaneous (under the skin) doses. The first injection is given either when the bitch is on heat or 7 –10 days after the date of mating. The second injection is given 1 to 2 weeks before the expected date of whelping. The bitch should be revaccinated in the same way during each pregnancy.

How does Eurican Herpes 205 work?

Eurican Herpes 205 contains small amounts of canine herpes virus antigens. When injected, this small exposure helps the dog’s immune system to synthesize antibodies against the canine herpes virus and to neutralize it. Once vaccinated, bitches will, through colostrum, give those antibodies to puppies. When exposed to canine herpes virus later in life, the puppies will either not become infected or have a much less serious infection. Eurican Herpes 205 is intended to protect the puppies from this infection during the first few days of life.

How has the effectiveness of Eurican Herpes 205 been studied?

Eurican Herpes 205 has been studied in three laboratory studies and two field trials. In one field trial the serological response (antibody production) was measured. In the other, a study was made of the effect of vaccination on the ability of bitches to breed in an infected kennel. The first laboratory study tested the dose needed to provide protection. The second study was carried out to show the protection of puppies from vaccinated bitches from canine herpe svirus. Here Eurican Herpes 205 was compared with no vaccination (controls). The last one has demonstrating that induction of antibodies is equivalent when bitches are vaccinated the day of heat or 7-10 days after mating.

What benefit has Eurican Herpes 205 shown during the studies?

Eurican Herpes 205 showed good protection from canine herpes virus. In the study to show the protection of puppies (from vaccinated bitches) from canine herpes virus, over 80% of the pups from the vaccinated bitches survived.

What are the side effects of Eurican Herpes 205?

The injection of Eurican Herpes 205 may cause temporary oedema (fluid under the skin) at the injection site in up to 10% of animals. This side effect usually disappears within one week. Rarely, hypersensitivity (allergic) reactions may occur, which require treatment.

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

Eurican Herpes 205 contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger. If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected. The Package Leaflet should be taken to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

Why has Eurican Herpes 205 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Eurican Herpes 205 are greater than any risks to immunise healthy bitches against canine herpes virus. They recommended that Eurican Herpes 205 should be given a marketing authorisation. The benefitrisk balance may be found in module 6 of this EPAR.

Other information about Eurican Herpes 205

The European Commission granted a marketing authorisation valid throughout the European Union, for Eurican Herpes 205 to Merial on 26 March 2001. Information on the prescription status of this product may be found on the labelling.

Name Language First published Last updated
Eurican Herpes 205 : EPAR - Summary for the public BG = bălgarski 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public ES = español 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public CS = čeština 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public DA = dansk 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public DE = Deutsch 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public ET = eesti keel 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public EL = elliniká 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public EN = English 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public FR = français 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public IT = italiano 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public LV = latviešu valoda 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public LT = lietuvių kalba 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public HU = magyar 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public MT = Malti 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public NL = Nederlands 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public PL = polski 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public PT = português 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public RO = română 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public SK = slovenčina 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public SL = slovenščina 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public FI = suomi 2007-05-02  
Eurican Herpes 205 : EPAR - Summary for the public SV = svenska 2007-05-02  

This EPAR was last updated on 17/06/2016 .

Authorisation details

Product details

Product details for Eurican Herpes 205
NameEurican Herpes 205
Agency product numberEMEA/V/C/000059
Active substance

Canine herpesvirus (F205 strain) antigens

International non-proprietary name (INN) or common name

Canine herpes vaccine (inactivated subunit)

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI07AA





Publication details

Publication details for Eurican Herpes 205
Marketing-authorisation holder

Merial

Revision8
Date of issue of marketing authorisation valid throughout the European Union26/03/2001

Contact address:

Merial
29, avenue Tony Garnier
69007 Lyon
FRANCE

Product information

Product information

10/09/2015  Eurican Herpes 205 -EMEA/V/C/000059 -II/0017

Name Language First published Last updated
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17
Eurican Herpes 205 : EPAR - Product Information SV = svenska 2006-05-31 2016-06-17

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
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  
Eurican Herpes 205 : EPAR - All Authorised presentations SV = svenska 2006-05-31  

Pharmacotherapeutic group

Immunologicals For canidae

Therapeutic indication

Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Eurican Herpes 205 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2008-04-04 2016-06-17

Initial marketing-authorisation documents

Name Language First published Last updated
Eurican Herpes 205 : EPAR - Scientific Discussion SV = svenska 2008-10-03  
Eurican Herpes 205 : EPAR - Procedural steps taken before authorisation SV = svenska 2006-05-31