Cancellation of state registration. Virollex

May 04, 2017

Active substances:

Acyclovir

Trade names:

Virollex

ICD-10:

I.A50-A64.A60 Anogenital herpetic viral infection [herpes simplex]

I.B00-B09.B00.5 Herpetic eye disease

I.B00-B09.B00 Infections caused by the herpes simplex virus [herpes simplex]

I.B00-B09.B01 Chicken Pox [varicella]

I.B00-B09.B02 Shingles [herpes zoster]

I.B20-B24.B20 Disease caused by the human immunodeficiency virus [HIV], manifested as infectious and parasitic diseases

VII.H15-H22.H19.1 * Keratitis due to herpes simplex virus, and keratoconjunctivitis (B00.5 +)

Virolex, acyclovir, treatment infections caused by Herpes simplex virus types 1 and 2 and Varicella zoster, prevention of infections caused by Herpes simplex and Varicella zoster viruses, complex therapy for severe immunodeficiency, bone marrow transplantation, prevention of cytomegalovirus infection after bone marrow transplantation

Ministry of Health The Russian Federation in in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On circulation of medicinal products", a decision was taken to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate No. N014287 / 03 dated February 28, 2008 issued JSC "Krka, dd, Novo mesto", Slovenia):

Virolex (trade name of the drug)

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

lyophilizate for the preparation of a solution for infusions, 250 mg (dosage form, dosage)

JSC "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 the submission by the authorized representative of the representative office of JSC "Krka, dd, Novo mesto", Russia, a statement on the abolition of the state registration of the medicinal product.