Cancellation of state registration. Fluconazole Zentiva

November 20, 2017

Active substances:

Fluconazole

Trade names:

Fluconazole Zentiva

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.B35.1 Mycosis of nails

I.B35-B49.B35.0 Mycosis of the beard and head

I.B35-B49.B35.6 Epidermophytosis inguinal

I.B35-B49.B36.0 Multicolored lichen

I.B35-B49.B37.0 Candidiasis stomatitis

I.B35-B49.B37.1 Pulmonary Candidiasis

I.B35-B49.B37.2 Candidiasis of skin and nails

I.B35-B49.B37.3 Candidiasis of the vulva and vagina (N77.1 *)

I.B35-B49.B37.4 Candidiasis of other urogenital localizations

I.B35-B49.B37.6 Candidiasis endocarditis (I39.8 *)

I.B35-B49.B37.7 Candida septicemia

I.B35-B49.B37.8 Candidiasis of other localizations

I.B35-B49.B38 Coccidioidomycosis

I.B35-B49.B39 Histoplasmosis

I.B35-B49.B41 Paracoccidioidomycosis

I.B35-B49.B42 Sporotrichosis

I.B35-B49.B45 Cryptococcosis

Fluconazole, antifungal drug, mycosis, candidiasis, treatment of mycosis, treatment of candidiasis, treatment of thrush

The Ministry of Health of the Russian Federation in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On circulation of medicinal products" decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate P N013252 / 03 from 30.07.2007 issued by Zentiva, Czech Republic):

Fluconazole Zentiva (trade name of the drug)

Fluconazole (international non-patented or batch or chemical name)

solution for infusions, 2 mg / ml (dosage form, dosage)

Zentiva, Czech Republic U kabelovny 130, 102 37 Prague 10, Dolni Mecholupy, Czech Republic (name and address of the location of the manufacturer of the medicinal product)

on the basis of an application by the authorized legal entity of the Sanofi-aventis Group JSC to cancel the state registration of the medicinal product.