🇪🇺 TROVAFLOXACIN in European Union

EMA authorised TROVAFLOXACIN on 3 July 1998

Marketing authorisations

Application: EMEA/H/C/000159
Marketing authorisation holder: Pfizer Limited
Local brand name: Turvel IV
Indication: 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 Ure
Status: withdrawn

Application: EMEA/H/C/000160
Marketing authorisation holder: Pfizer Limited
Local brand name: Trovan
Indication: 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 Uret
Status: withdrawn

Application: EMEA/H/C/000161
Marketing authorisation holder: Pfizer Limited
Local brand name: Trovan IV
Indication: 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 Ure
Status: withdrawn

Application: EMEA/H/C/000158
Marketing authorisation holder: Pfizer Limited
Local brand name: Turvel
Indication: 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 Ure
Status: withdrawn

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is TROVAFLOXACIN approved in European Union?

Yes. EMA authorised it on 3 July 1998; EMA authorised it on 3 July 1998; EMA authorised it on 3 July 1998.

Who is the marketing authorisation holder for TROVAFLOXACIN in European Union?

Pfizer Limited holds the EU marketing authorisation.