Dear Healthcare Professional Letter on restricted use of Nolicin 400 mg film tablet (Norphloxacin)
Krka - farma d.o.o., in cooperation with the Agency for Medicinal Products and Medical Devices, sent a Dear Healthcare Professional Letter to physicians concerning restriction of indications for use of the Nolicin 400 mg film tablet (norphloxacin) in line with the recommendations of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency of July 2008.
Physicians are hereby once more reminded of the well-known restriction of use of the medicinal products containing norphloxacin as active substance, based on a repeated assessment of the safety and efficacy of oral use of these medicinal products in indication of treatment of an acute and chronic pyelonephritis (kidney infection), because the benefit does not outweigh the risk in this type of infection. The recommendations have no effect on oral use for other types of infections.
The Agency for Medicinal Products and Medical Devices of the Republic of Croatia approved the said changes in the Summary of Product Characteristics and the Patient Information Leaflet for the medicinal products containing norphloxacin as active substance. The Agency will continuously monitor the safe use of this class of medicinal products.
The text of the letter can be found below:
"A Dear Healthcare Professional Letter on restricted use of Nolicin 400 mg film tablet ”
The text of the information about the new recommendations regarding limitation of the oral use of norphloxacin can be found at the link below: