Trovan

Withdrawn

This medicine's authorisation has been withdrawn

trovafloxacin

Overview

The European Commission granted Marketing Authorisations valid throughout the European Union to Pfizer Limited on 3 July 1998 for Trovan (trovafloxacin) and Trovan IV (alatrofloxacin), and to Roerig Farmaceutici Italiana S.p.A. on 8 July 1998 for Turvel (trovafloxacin) and on 3 July 1998 for Turvel IV (alatrofloxacin).

On 23 October 2000, the Marketing Authorisation Holders notified the European Commission of their decision to withdraw voluntarily the Marketing Authorisations for Trovan/ Trovan IV/ Turvel/ Turvel IV.

On 20 March 2001, the European Commission adopted the decisions withdrawing the Marketing Authorisations for the medicinal products for human use Trovan/ Trovan IV/ Turvel/ Turvel IV. Pursuant to this decision, the European Public Assessment Reports for Trovan/ Trovan IV/ Turvel/ Turvel IV have been removed from this website.

For further information:

The Marketing Authorisations of Trovan/Trovan IV/Turvel/Turvel IV were suspended by the European Commission on 10 August 1999, following increasing concerns over 152 documented reports of cases of serious hepatic events, including 9 cases where patients died or required a liver transplant (see Public statement EMEA/18046/99 dated 15 June 1999). Trovan/TrovanIV/Turvel/TurvelIV could no longer be safely maintained in normal clinical usage due to the occurrence of severe, serious and unpredictable hepatic injuries. Taking into consideration this hepatotoxicity, the overall benefit/risk balance of alatrofloxacin/trovafloxacin was considered to be unfavourable in authorised indications and it was not felt possible to restrict these indications adequately to permit safe use.

The suspensions of Marketing Authorisations were renewed by the European Commission on 12 September 2000.

Trovan/Trovan IV have been marketed in eight member states (Austria, Denmark, Finland, Germany, Netherlands, Portugal, Spain and Sweden).Turvel had been marketed in one member state, Spain and Turvel IV had never been marketed within the European Economic Area.

Product information

Product details

• Name of medicine:
  Trovan
• Active substance:
  trovafloxacin
• International non-proprietary name (INN) or common name:
  trovafloxacin
• Therapeutic area (MeSH):
  Bacterial Infections
• Anatomical therapeutic chemical (ATC) code:
  J01MA13

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic 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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000160
• Marketing authorisation holder:
  Pfizer Limited

  Ramsgate Road; Sandwich; Kent; CT13 9NJ; United Kingdom

• Marketing authorisation issued:
  03/07/1998
• Withdrawal of marketing authorisation:
  20/03/2001