Kriptazen

Authorised

This medicine is authorised for use in the European Union

halofuginone

Overview

Kriptazen 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, producing an infection called cryptosporidiosis that results in diarrhoea.

Kriptazen contains the active substance halofuginone and is a ‘generic medicine’. This means that Kriptazen contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Halocur.

How is Kriptazen used?

Kriptazen 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 the diarrhoea. Kriptazen should be given after feeding.

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

How does Kriptazen work?

The active substance in Kriptazen, halofuginone lactate, 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 where it is infectious and which are passed in the faeces. The exact way halofuginone works is unknown.

How has Kriptazen been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Halocur, and do not need to be repeated for Kriptazen. As for every medicine, the company provided studies on the quality and manufacture of Kriptazen. No additional studies were needed as Kriptazen is a water based oral solution containing the same active substance and other ingredients as the reference medicine.

What are the benefits and risks of Kriptazen?

Because Kriptazen 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 Kriptazen, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. The precautions are the same as for the reference medicine since Kriptazen is a generic 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 Kriptazen is 13 days.

Why is Kriptazen authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Kriptazen has been shown to be comparable to Halocur. Therefore, the Agency’s view was that, as for Halocur, the benefit of Kriptazen outweighs the identified risk and it can be authorised for use in the EU.

Other information about Kriptazen

Kriptazen received a marketing authorisation valid throughout the EU on 8 February 2019.

Kriptazen : EPAR - Medicine overview

Reference Number: EMA/878973/2018

Product information

Kriptazen : EPAR - Product Information

Kriptazen : EPAR - All authorised presentations

Product details

• Name of medicine:
  Kriptazen
• Active substance:
  halofuginone
• International non-proprietary name (INN) or common name:
  halofuginone
• Species:
  Calves, newborn
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QP51AX08

Pharmacotherapeutic group

Antiprotozoals

Therapeutic indication

In new born calves:

- Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, 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.

Administration should start within 24 hours after the onset of diarrhoea.

In both cases, the reduction of oocysts excretion has been demonstrated.

Authorisation details

• EMA product number:
  EMEA/V/C/004868
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Virbac S.A.

  1ère Avenue 2065 M - L.I.D.; 06516 Carros Cedex; France

• Opinion adopted:
  07/12/2018
• Marketing authorisation issued:
  08/02/2019
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Kriptazen : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Kriptazen : EPAR - Public assessment report

AdoptedReference Number: EMA/867848/2018

CVMP summary of positive opinion for Kriptazen

AdoptedReference Number: EMA/CVMP/788664/2018