Cancellation of state registration. Atoris® Combi

April 13, 2018
Active substances:
Trade names:
ICD-10:
IX.I10-I15.I10    Essential [primary] hypertension
Amlodipine + Atorvastatin, Atoris Combi, arterial hypertension, hypolipidemic drug, antihypertensive drug

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 medicinal products" decided to abolish state registration and exclude from the state register of medicinal products for medical useof the medicinal product (registration certificate LP-003954 dated 09.11.2016 issued by Krka dd, Novo Mesto, Slovenia):

Atoris® Combi (trade name of the medicinal product)

Amlodipine + Atorvastatin (international non-proprietary or grouping or chemical name)

tablets, film-coated, 5 mg + 10 mg, 5 mg + 20 mg, 10 mg + 10 mg, 10 mg + 20 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 filing an application by the authorized legal entity LLC KRKA-RUS to cancel the state registration of the medicinal product.