Cancellation of state registration. Siergan®

November 22, 2016
Active substances:
Trade names:
ICD-10:
VII.H15-H22.H19.1 *    Keratitis due to herpes simplex virus, and keratoconjunctivitis (B00.5 +)
Zirgan, ganciclovir, eye gel, herpes simplex virus, keratitis, keratoconjunctivitis

The Ministry of Health of the Russian Federation in accordance with articles 29 and 32 of the Federal Law of 12.04.2010 No. 61-FZ "On the circulation of medicines" decided to abolish state registration and exclude from the state register of medicinal products for medical usemedicinal product (registration certificate LTT-000988 dated 18.10.2011, issued by Laboratory Tea, France):

ZIRGAN® (trade name of the medicinal product)

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

gel eye, 0.15% (dosage form, dosage)

Farmila-Thea Pharmaceuticals, Italy Via E. Fermi, 50 - 20019 Settimo Milanese (MI), Italy (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.