Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Dicural   
Auth. number : EU/2/97/003
INN : Difloxacin
ATC: Anatomical main group: QJ - Antiinfectives for systemic use
Therapeutic subgroup: QJ01 - Antibacterials for systemic use
Pharmacological subgroup: QJ01M - Quinolone and quinoxaline antibacterials
Chemical subgroup: QJ01MA - Fluoroquinolones
Chemical substance: QJ01MA94 - Difloxacin
(See WHO ATCvet Index)
Indication: Treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum (chickens and turkeys), treatment of infections caused by Pasteurella multocida (turkeys)
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

  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
20/01/1998 Centralised - Authorisation EMEA/V/C/31 (1998)72 of 16/01/1998
18/11/1998 Centralised - Variation EMEA/V/C/31/I/2 (1998)3501 of 12/11/1998
19/11/1999 Centralised - Variation EMEA/V/C/31/I/5 (1999)3718 of 16/11/1999
23/11/1999 Centralised - Authorisation EMEA/V/C/31/X (1999)3788 of 16/11/1999
20/03/2000 Centralised - Variation EMEA/V/C/31/N/4 (2000)718 of 16/03/2000
25/10/2000 Centralised - Variation EMEA/V/C/31/II/6 (2000)2856 of 24/10/2000
08/12/2000 Centralised - Variation EMEA/V/C/31/N/5 (2000)3477 of 07/12/2000
03/09/2001 Centralised - Variation EMEA/V/C/31/I/7
22/10/2001 Centralised - Variation EMEA/V/C/31/I/8 (2001)2872 of 19/10/2001
08/02/2002 Centralised - Variation EMEA/V/C/31/I/9 (2002)491 of 06/02/2002
24/07/2003 Centralised - Renewal EMEA/V/C/31/R/14 (2003)2740 of 22/07/2003
24/04/2004 Centralised - Variation EMEA/V/C/31/N/15
01/10/2004 Centralised - Variation EMEA/V/C/31/IA/16
06/07/2006 Centralised - Variation EMEA/V/C/31/N/17
Updated with Decision(2008)237 of 15/01/2008
17/01/2008 Centralised - Renewal EMEA/V/C/31/R/18 (2008)237 of 15/01/2008
25/01/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/31/T/19 (2011)384 of 21/01/2011
14/07/2011 Centralised - Variation EMEA/V/C/31/IA/21
Updated with Decision(2012)1280 of 21/02/2012
24/02/2012 Centralised - Variation (2012)1280 of 21/02/2012