Pharmaceuticals - Community Register

  

Community list of not active veterinary medicinal products


WITHDRAWN  

Product information

Invented name: Ibaflin
Auth. number : EU/2/00/022
INN : Ibafloxacin
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: QJ01MA - Fluoroquinolones
(See WHO ATCvet Index)
Indication: Ibaflin is indicated for the treatment of the following conditions in dogs:
Dermal infections (pyoderma – superficial and deep, wounds, abscesses) caused by susceptible strains of Staphylococci, E. coli, and Proteus mirabilis.
Acute, uncomplicated urinary tract infections, caused by susceptible strains of Staphylococci, Proteus spp., Enterobacter spp., E. coli and Klebsiella spp.
Respiratory tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp.
Marketing Authorisation Holder: Intervet International B.V.
Wim de Körverstraat 35, NL-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
15/06/2000 Centralised - Authorisation EMEA/V/C/52 (2000)1462 of 13/06/2000
04/12/2000 Centralised - Notification EMEA/V/C/52/N/1 (2000)3393 of 29/11/2000
22/12/2000 Centralised - Variation EMEA/V/C/52/I/1 (2000)3952 of 20/12/2000
10/12/2001 Centralised - Variation (no change in Commission Decision) EMEA/V/C/52/I/5
10/12/2001 Centralised - Variation (no change in Commission Decision) EMEA/V/C/52/I/6
08/02/2002 Centralised - Variation EMEA/V/C/52/I/4 (2002)492 of 06/02/2002
24/03/2003 Centralised - Variation EMEA/V/C/52/X/3 (2003)956 of 20/03/2003
24/04/2003 Centralised - Variation EMEA/V/C/52/I/9 (2003)1427 of 23/04/2003
05/01/2004 Centralised - Variation EMEA/V/C/52/IB/11
Updated with Decision(2005)276 of 31/01/2005
27/02/2004 Centralised - Variation EMEA/V/C/52/X/7, 8 (2004)624 of 23/02/2004
14/04/2004 Centralised - Notification EMEA/V/C/52/N/12 (2004)1434 of 07/04/2004
02/12/2004 Centralised - Variation EMEA/V/C/52/IA/13
Updated with Decision(2005)2740 of 08/07/2005
02/02/2005 Centralised - Variation (2005)276 of 31/01/2005
11/02/2005 Centralised - Variation EMEA/V/C/52/IB/14
Updated with Decision(2005)2740 of 08/07/2005
12/07/2005 Centralised - Renewal EMEA/V/C/52/R/15 (2005)2740 of 08/07/2005
23/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/52/IA/16
08/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/52/IA/18
08/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/52/IA/17
28/05/2010 Centralised - Renewal EMEA/V/C/52/R/19 (2010)3487 of 26/05/2010
25/06/2013 Centralised - Withdrawal (2013)4024 of 21/06/2013