Cancellation of state registration. Fonzial®

June 01, 2017
Active substances:
Trade names:
ICD-10:
I.B35-B49.B35.4    Mycosis of the trunk
I.B35-B49.B35.3    Mycosis of the feet
I.B35-B49.B35.2    Mycosis brushes
I.B35-B49.B37.3    Candidiasis of the vulva and vagina (N77.1 *)
Fonzial, cyclopyrox, antifungal drug, mycosis of feet, mycosis of brushes, mycosis of the trunk, candidiasis of the vagina

The Ministry of Health of the Russian Federation, in accordance with articles 29 and 32 of the Federal Law No. 61-FZ of 12.04.2010 "On circulation of medicines", decided to abolish state registration and exclude fromthe state register of medicinal products for the medical use of the medicinal product (registration certificate LP-000908 dated 18.10.2011, issued by Pierre Fabre Dermatology, France):

Fonzial® (trade name of the medicinal product)

Cyclopyrox (international non-proprietary, or grouping, or chemical name medicinal product)

nail polish for medical, 8% (dosage form, dosage)

Pierre Fabre Medication Production, France 45, place Abel Gance, 92100 Boulogne, France (name and address of the place of production)

in connection with the non-confirmation of the state registration of the medicinal product for medical use according to the results of the examination of the quality of the medicinal product and the examination of the relationship of the expected benefit to the possible risk of drug use.