Norfloxacin-haltige Arzneimittel: Europäische Arzneimittelagentur empfiehlt Anwendungsbeschränkung bei komplizierten Nierenbeckeninfektionen (Pyelonephritis)

Zusammenfassung

European Medicines Agency London, 24 July 2008 Doc. Ref. EMEA/378867/2008 Questions and answers on the review of oral formulations of medicines containing norfloxacin The European Medicines Agency (EMEA) has completed a review of the safety and effectiveness of ‘oral formulations’ of medicines containing norfloxacin for the treatment of complicated pyelonephritis. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of these medicines do not outwei

Kerninformationen

se for other diseases, were unaffected by the CHMP’s review. What is norfloxacin? Norfloxacin is an antibiotic that is used to treat infections of the urinary tract (the structures that carry urine). One type of urinary infection is ‘complicated pyelonephritis’, a type of kidney infection. ‘Complica...

h, such as tablets, capsules and solutions) as well as formulations for injection. They are authorised by regulatory authorities in Member States. Norfloxacin belongs to the ‘fluoroquinolone’ family. It works by blocking an enzyme that bacteria use to make more DNA. By doing this, it stops the bacte...

ed using either injectable antibiotics, or other fluoroquinolones taken by mouth or given by injection. Consequently, the Belgian medicines regulatory agency asked the CHMP to carry out an assessment of the benefit-risk balance of oral formulations of all norfloxacin-containing medicines for complic...

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