Kriptazen

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halofuginone

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 01/03/2019

Authorisation details

Product details
Name
Kriptazen
Agency product number
EMEA/V/C/004868
Active substance
halofuginone
International non-proprietary name (INN) or common name
halofuginone
Species
Calves, newborn
Anatomical therapeutic chemical veterinary (ATCvet) codes
QP51AX08
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Virbac S.A.
Date of issue of marketing authorisation valid throughout the European Union
08/02/2019
Contact address

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

Product information

Kriptazen - EMEA/V/C/004868 -

Contents

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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.

Assessment history

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