Kriptazen
halofuginone
Table of contents
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.
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
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Virbac S.A.
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
08/02/2019
|
| Contact address |
1ère Avenue 2065 M - L.I.D. |
Product information
07/10/2021 Kriptazen - EMEA/V/C/004868 - IAIN/0005
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.