{"topic_id":"eu_ema_qj_antiinfectives_pet","category":"eu-2026-approvals","context":"---\ntopic_id: eu_ema_qj_antiinfectives_pet\ncategory: eu-2026-approvals\ntitle: \"EU EMA Veterinary Antiinfectives: Fluoroquinolone and Doxycycline Antibiotics for Dogs and Cats\"\nlang: en\nsource: \"ema-medicines-report.xlsx\"\ndate_parsed: \"2026-07-21\"\ntokens_estimated: 280\nverification:\n  method: substring_match\n  claims: 5\n  passed: 5\n  date: \"2026-07-21\"\n---\n\n## Overview\n\nThe 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.\n\n## QJ Antiinfective Pet Medicines in EMA Database\n\n### Veraflox (pradofloxacin) — EMEA/V/C/000099\n\n- **ATCvet code**: QJ01MA (fluoroquinolones)\n- **INN**: Pradofloxacin (INN: pradofloxacin)\n- **Active substance**: pradofloxacin\n- **Species**: Dogs\n- **Status**: Refused\n- **Pharmacotherapeutic group**: Antibacterials for systemic use\n- **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\n- **Marketing authorisation holder**: Bayer HealthCare AG\n\n### Dicural (difloxacin) — EMEA/V/C/000031\n\n- **ATCvet code**: QJ01MA94\n- **INN**: Difloxacin (INN: difloxacin)\n- **Active substance**: difloxacin\n- **Species**: Turkeys;Dogs;Cattle;Chicken\n- **Status**: Withdrawn\n- **Pharmacotherapeutic group**: Antibacterials for systemic use; Antiinfectives for systemic use\n- **Therapeutic indication**: Chickens: for the treatment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)\n- **Marketing authorisation holder**: Pfizer Limited\n\n### Ibaflin (ibafloxacin) — EMEA/V/C/000052\n\n- **ATCvet code**: QJ01MA96\n- **INN**: Ibafloxacin (INN: ibafloxacin)\n- **Active substance**: ibafloxacin\n- **Species**: Dogs;Cats\n- **Status**: Withdrawn\n- **Pharmacotherapeutic group**: Antibacterials for systemic use\n- **Therapeutic indication**: Dogs: Ibaflin is indicated for the treatment of the following conditions in dogs: dermal infections (pyoderma — superficial and deep), and soft tissue infections. Cats: indicated for the treatment of urinary tract infections.\n- **Marketing authorisation holder**: Intervet International BV\n\n### Doxirobe (doxycycline) — EMEA/V/C/000044\n\n- **ATCvet code**: QJ01AA02 (tetracyclines)\n- **INN**: Doxycycline (INN: doxycycline)\n- **Active substance**: doxycycline\n- **Species**: Dogs\n- **Status**: Withdrawn\n- **Pharmacotherapeutic group**: Antibacterials for systemic use\n- **Therapeutic indication**: Treatment of periodontal disease in dogs. Periodontal pocket probing depths ≥ 4 mm are evidence of disease that may indicate the use of Doxirobe.\n- **Marketing authorisation holder**: Pfizer Limited\n\n### Tulatrixx (tulathromycin) — EMEA/V/C/005364\n\n- **ATCvet code**: QJ01FA94 (macrolides)\n- **INN**: Tulathromycin (INN: tulathromycin)\n- **Active substance**: tulathromycin\n- **Species**: Cattle;Pigs;Sheep\n- **Status**: Application withdrawn\n- **Pharmacotherapeutic group**: Antibacterials for systemic use\n- **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*.\n- **Marketing authorisation holder**: Emdoka BVBA\n\n## Key Facts\n\n1. **QJ01MA = pradofloxacin** — third-generation fluoroquinolone specifically developed for dogs (dermal/soft tissue infections); MA applicant Bayer HealthCare AG; EMA decision: Refused (EMEA/V/C/000099).\n2. **QJ01MA94 = difloxacin** — fluoroquinolone with multi-species authorisation (dogs, turkeys, cattle, chicken); Pfizer MA holder; status Withdrawn.\n3. **QJ01MA96 = ibafloxacin** — fluoroquinolone for dogs and cats; Indicated for canine pyoderma/dermatitis and feline urinary tract infection; Intervet International BV MA holder; status Withdrawn.\n4. **QJ01AA02 = doxycycline** — tetracycline antibiotic specifically for canine periodontal disease (pocket depth ≥4 mm indication); Pfizer; status Withdrawn.\n5. All QJ pet antiinfectives in the EMA database carry **Withdrawn** or **Refused** status — none are currently authorised under these EMA MA numbers.\n\nSource: 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`.\n","sources":[],"tokens_estimated":280,"generated_at":null,"tip":"Use /api/v1/topics to discover more topics. /api/v1/nutrient for precise single-point queries. /api/v1/cross_compare for 2-3 standard comparisons."}