US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| TROVAN PRESERVATIVE FREE | EQ 200MG BASE/VIAL; EQ 300MG BASE/VIAL | injectable · injection | PFIZER | Discontinued | 18 Dec 1997 |
EMA European Union — centrally authorised medicines
Turvel IV Pfizer Limited · Withdrawn · authorised 3 Jul 1998 · ATC J01MA13
Therapeutic indication (EMA)
Trovafloxacin is a synthetic broad spectrum quinolone antibacterial agent indicated for the treatment of the following infections in adults: Pneumonia: Community Acquired Pneumonia and Nosocomial Pneumonia (mild, moderate, and severe). Note: Efficacy in patients with very severe nosocomial pneumonia and in particular infections due to less susceptible pathogens e.g. P. aeruginosa, has not been established. See also section 4.2. Acute Exacerbations of Chronic Bronchitis Acute Sinusitis Complicated Intra-abdominal Infections and Acute Pelvic Infections Salpingitis Uncomplicated Gonococcal Urethritis and Cervicitis Chlamydial Cervicitis Complicated Skin and Soft Tissue Infections Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Trovan IV Pfizer Limited · Withdrawn · authorised 3 Jul 1998 · ATC J01MA13
Therapeutic indication (EMA)
Trovafloxacin is a synthetic broad spectrum quinolone antibacterial agent indicated for the treatment of the following infections in adults: Pneumonia: Community Acquired Pneumonia and Nosocomial Pneumonia (mild, moderate, and severe). Note: Efficacy in patients with very severe nosocomial pneumonia and in particular infections due to less susceptible pathogens e.g. P. aeruginosa, has not been established. See also section 4.2. Acute Exacerbations of Chronic Bronchitis Acute Sinusitis Complicated Intra-abdominal Infections and Acute Pelvic Infections Salpingitis Uncomplicated Gonococcal Urethritis and Cervicitis Chlamydial Cervicitis Complicated Skin and Soft Tissue Infections Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.