Halagon

halofuginone lactate

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

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

What is Halagon and what is it used for?

Halagon is a medicine used to treat newborn calves to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum. This is a parasite belonging to the ‘protozoa’ family that invades the digestive system, causing diarrhoea. The infection is known as cryptosporidiosis.

The medicine contains the active substance halofuginone.

Halagon is a ‘generic medicine’. This means that Halagon is similar to a ‘reference medicine’ already authorised in the EU called Halocur.

How is Halagon used?

Halagon can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth). It is given to newborn calves once a day for one week. For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of diarrhoea. Halagon should be given after feeding.

For further information, see the package leaflet.

How does Halagon work?

The active substance in Halagon, halofuginone, prevents the growth of Cryptosporidium parvum. It also limits the spread of the disease by preventing the formation of oocysts, which are a stage in the lifecycle of the parasite that are passed in the faeces. The exact way halofuginone works is unknown.

How has Halagon been studied?

The company provided data on the quality and manufacture of Halagon. No additional studies were needed as Halagon is a water based oral solution containing the same active substance and other ingredients as the reference medicine, in the same concentrations.

What are the benefits and risks of Halagon?

Because Halagon is a generic 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 Halagon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when using Halagon. Because Halagon is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.

The withdrawal period for meat from newborn calves treated with Halagon is 13 days.

Why is Halagon approved?

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

Other information about Halagon

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

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

Name Language First published Last updated
Halagon : EPAR - Summary for the public BG = bălgarski 2016-12-22  
Halagon : EPAR - Summary for the public ES = español 2016-12-22  
Halagon : EPAR - Summary for the public CS = čeština 2016-12-22  
Halagon : EPAR - Summary for the public DA = dansk 2016-12-22  
Halagon : EPAR - Summary for the public DE = Deutsch 2016-12-22  
Halagon : EPAR - Summary for the public ET = eesti keel 2016-12-22  
Halagon : EPAR - Summary for the public EL = elliniká 2016-12-22  
Halagon : EPAR - Summary for the public EN = English 2016-12-22  
Halagon : EPAR - Summary for the public FR = français 2016-12-22  
Halagon : EPAR - Summary for the public IT = italiano 2016-12-22  
Halagon : EPAR - Summary for the public LV = latviešu valoda 2016-12-22  
Halagon : EPAR - Summary for the public LT = lietuvių kalba 2016-12-22  
Halagon : EPAR - Summary for the public HU = magyar 2016-12-22  
Halagon : EPAR - Summary for the public MT = Malti 2016-12-22  
Halagon : EPAR - Summary for the public NL = Nederlands 2016-12-22  
Halagon : EPAR - Summary for the public PL = polski 2016-12-22  
Halagon : EPAR - Summary for the public PT = português 2016-12-22  
Halagon : EPAR - Summary for the public RO = română 2016-12-22  
Halagon : EPAR - Summary for the public SK = slovenčina 2016-12-22  
Halagon : EPAR - Summary for the public SL = slovenščina 2016-12-22  
Halagon : EPAR - Summary for the public FI = suomi 2016-12-22  
Halagon : EPAR - Summary for the public SV = svenska 2016-12-22  
Halagon : 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 Halagon
NameHalagon
Agency product numberEMEA/V/C/004201
Active substance

halofuginone lactate

International non-proprietary name (INN) or common name

halofuginone

Species Calves, newborn
Anatomical therapeutic chemical veterinary (ATCvet) codes QP51AX08


Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Halagon
Marketing-authorisation holder

Emdoka BVBA

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

Contact address:

Emdoka BVBA
John Lijsenstraat 16
2321 Hoogstraten
Belgium

Product information

Product information

13/12/2016  Halagon -EMEA/V/C/004201

Name Language First published Last updated
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : EPAR - Product Information HR = Hrvatski 2016-12-22  
Halagon : 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
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  
Halagon : EPAR - All Authorised presentations HR = Hrvatski 2016-12-22  

Pharmacotherapeutic group

Antiparasitic products, insecticides and repellents, other antiprotozoal agents

Therapeutic indication

In newborn calves: • Prevention of diarrhoea due to diagnosed Cryptosporidium parvum infection, in farms with history of cryptosporidiosis. Administration should start in the first 24 to 48 hours of age. • Reduction of diarrhoea due to diagnosed Cryptosporidium parvum infection. Administration should start within 24 hours after the onset of diarrhoea. In both cases, the reduction of oocysts excretion has been demonstrated.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Halagon : EPAR - Public assessment report HR = Hrvatski 2016-12-22 2017-01-20
CVMP summary of positive opinion for Halagon HR = Hrvatski 2016-10-07  

Authorised

This medicine is approved for use in the European Union