Cancellation of state registration. Letizen®

February 08, 2018
Active substances:
Trade names:
ICD-10:
X.J30-J39.J30.1    Allergic rhinitis caused by pollen of plants
X.J30-J39.J30.3    Other allergic rhinitis
XII.L20-L30.L23    Allergic contact dermatitis
XII.L50-L54.L50    Hives
Lethisen, cetirizine, antihistamine, allergic rhinitis, hay fever, hives, allergic dermatitis, Quincke's edema

The Ministry of Health of the Russian Federation in accordance with Article 32 of the Federal Law of 12.04.2010 No. 61-FZ "On the circulation of medicines" decided to cancelstate registration and exclusion from the state register of medicinal products for the medical use of the medicinal product (registration certificate P N013437 / 01 dated 29.09.2011, issued by Krka, dd, Novo mesto, Slovenia):

Lethisen (trade name of the medicinal product)

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

tablets, film-coated, 10 mg (dosage form, dosage)

KRKA, dd, Novo mesto, Slovenia Smarjeska cesta 6, 8501 Novo mesto, Slovenia KRKA-RUS, LLC, Russia 143500, Moscow Region, Istra, ul. Moscow, 50 (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing by the authorized legal entity of the representative office of the company "KRKA-RUS", Russia, a statement on the cancellation of the state registration of the medicinal product.