Cancellation of state registration. Oronazole

May 2, 2017

Active substances:

Ketoconazole

Trade names:

Oronazole

ICD-10:

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

I.B35-B49.B35.1 Mycosis of nails

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.B35.6 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

Oronazole, ketoconazole, antifungal drug, treatment of mycosis, treatment of candidiasis, candida septicemia, prevention of fungal infections

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 medicines" decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate P N013691 / 01 from 25.03.2008, issued to Krka, dd, Novo mesto, Slovenia):

Oronazole (trade name of the medicinal product)

Ketoconazole (international non-proprietary or chemical name of the medicinal product)

tablets, 200 mg (dosage form, dosage)

KRKA, dd, Novo mesto, Slovenia Smarjeska cesta 6, 8501 Novo mesto, Slovenia (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 company "Krka, dd, Novo mesto" to cancel the state registration of the medicinal product.