Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Halocur   
Auth. number : EU/2/99/013
Active substance : Halofuginone (as lactate salt)
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP51 - Antiprotozoals
Pharmacological subgroup: QP51A - Agents against protozoal diseases
Chemical subgroup: QP51AX - Other antiprotozoal agents
Chemical substance: QP51AX09 - amprolium
(See WHO ATCvet Index)
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.
Marketing Authorisation Holder: Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
09/11/1999 Centralised - Authorisation EMEA/V/C/40 (1999)3517 of 29/10/1999
02/01/2001 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/40/T/1 (2000)4290 of 28/12/2000
29/10/2002 Centralised - Variation EMEA/V/C/40/I/2 (2002)4294 of 24/10/2002
29/11/2004 Centralised - Renewal EMEA/V/C/40/R/3 (2004)4627 of 25/11/2004
18/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/40/II/4
13/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/40/IB/5
25/11/2009 Centralised - Renewal EMEA/V/C/40/R/6 (2009)9442 of 23/11/2009
22/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/40/IB/8
22/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/40/IB/7
05/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/40/II/9