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EU EMA Veterinary Antiinfectives: Fluoroquinolone and Doxycycline Antibiotics for Dogs and Cats

eu_ema_qj_antiinfectives_pet

eu-2026-approvals 280 tok en 2026-07-21

Overview

The ATCvet QJ category covers antiinfectives for systemic use. Within the EMA Union Product Database (medicines-output-medicines-report, dataset generated 20/07/2026), the QJ-classified pet medicines include fluoroquinolone antibiotics and other antibacterials targeting dogs and cats. The J01 subgroup corresponds to antibacterials for systemic use.

QJ Antiinfective Pet Medicines in EMA Database

Veraflox (pradofloxacin) โ€” EMEA/V/C/000099

  • ATCvet code: QJ01MA (fluoroquinolones)
  • INN: Pradofloxacin (INN: pradofloxacin)
  • Active substance: pradofloxacin
  • Species: Dogs
  • Status: Refused
  • Pharmacotherapeutic group: Antibacterials for systemic use
  • Therapeutic indication: Dogs: Infections of the skin and soft tissues, i.e. superficial and deep pyoderma and wound infections caused by Gram-positive and Gram-negative organisms susceptible to pradofloxacin
  • Marketing authorisation holder: Bayer HealthCare AG

Dicural (difloxacin) โ€” EMEA/V/C/000031

  • ATCvet code: QJ01MA94
  • INN: Difloxacin (INN: difloxacin)
  • Active substance: difloxacin
  • Species: Turkeys;Dogs;Cattle;Chicken
  • Status: Withdrawn
  • Pharmacotherapeutic group: Antibacterials for systemic use; Antiinfectives for systemic use
  • Therapeutic indication: Chickens: for the treatment of chronic respiratory infections caused by sensitive strains of *Escherichia coli* and *Mycoplasma* spp. (the database entry reflects the primary target species; diclofenac has been widely used in poultry, cattle, and dogs)
  • Marketing authorisation holder: Pfizer Limited

Ibaflin (ibafloxacin) โ€” EMEA/V/C/000052

  • ATCvet code: QJ01MA96
  • INN: Ibafloxacin (INN: ibafloxacin)
  • Active substance: ibafloxacin
  • Species: Dogs;Cats
  • Status: Withdrawn
  • Pharmacotherapeutic group: Antibacterials for systemic use
  • Therapeutic indication: Dogs: Ibaflin is indicated for the treatment of the following conditions in dogs: dermal infections (pyoderma โ€” superficial and deep), and soft tissue infections. Cats: indicated for the treatment of urinary tract infections.
  • Marketing authorisation holder: Intervet International BV

Doxirobe (doxycycline) โ€” EMEA/V/C/000044

  • ATCvet code: QJ01AA02 (tetracyclines)
  • INN: Doxycycline (INN: doxycycline)
  • Active substance: doxycycline
  • Species: Dogs
  • Status: Withdrawn
  • Pharmacotherapeutic group: Antibacterials for systemic use
  • Therapeutic indication: Treatment of periodontal disease in dogs. Periodontal pocket probing depths โ‰ฅ 4 mm are evidence of disease that may indicate the use of Doxirobe.
  • Marketing authorisation holder: Pfizer Limited

Tulatrixx (tulathromycin) โ€” EMEA/V/C/005364

  • ATCvet code: QJ01FA94 (macrolides)
  • INN: Tulathromycin (INN: tulathromycin)
  • Active substance: tulathromycin
  • Species: Cattle;Pigs;Sheep
  • Status: Application withdrawn
  • Pharmacotherapeutic group: Antibacterials for systemic use
  • Therapeutic indication: Cattle: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with *Mannheimia haemolytica*, *Pasteurella multocida*, *Histophilus somni*, and *Mycoplasma bovis*. Pigs: Treatment of respiratory disease associated with *Actinobacillus pleuropneumoniae*, *Pasteurella multocida*, *Mycoplasma hyopneumoniae*, and *Glaesserella parasuis*.
  • Marketing authorisation holder: Emdoka BVBA

Key Facts

  1. QJ01MA = pradofloxacin โ€” third-generation fluoroquinolone specifically developed for dogs (dermal/soft tissue infections); MA applicant Bayer HealthCare AG; EMA decision: Refused (EMEA/V/C/000099).
  2. QJ01MA94 = difloxacin โ€” fluoroquinolone with multi-species authorisation (dogs, turkeys, cattle, chicken); Pfizer MA holder; status Withdrawn.
  3. QJ01MA96 = ibafloxacin โ€” fluoroquinolone for dogs and cats; Indicated for canine pyoderma/dermatitis and feline urinary tract infection; Intervet International BV MA holder; status Withdrawn.
  4. QJ01AA02 = doxycycline โ€” tetracycline antibiotic specifically for canine periodontal disease (pocket depth โ‰ฅ4 mm indication); Pfizer; status Withdrawn.
  5. All QJ pet antiinfectives in the EMA database carry Withdrawn or Refused status โ€” none are currently authorised under these EMA MA numbers.

Source: EMA medicines-output-medicines-report_en.xlsx, dataset generated 20/07/2026 - 18:00, accessed via https://www.ema.europa.eu/en/medicines/download-medicine-data.

Sources

  • ema-medicines-report.xlsx