Cancellation of state registration. Sulfacetamide

June 14, 2017
Active substances:
Trade names:
ICD-10:
I.A50-A64.A54.3    Gonococcal infection of the eye
VII.H00-H06.H01.0    Blepharitis
VII.H10-H13.H10.4    Chronic conjunctivitis
VII.H10-H13.H10.2    Other acute conjunctivitis
VII.H15-H22.H16.0    Corneal ulcer
Sulfacetamide, eye drops, infectious eye diseases, inflammatory eye diseases, conjunctivitis, corneal ulcer, prophylaxis of blenearitis in newborns, blepharitis, gonorrheal diseases of the eyes

The Ministry of Health of the Russian Federation in accordance withArticles 29 and 32 of Federal Law No. 61-FZ of 12.04.2010 "On circulation of medicinal products" decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate LP-001498 dated February 13, 2012, issued Open Joint Stock Company Research and Production Concern "ECKOM", Russia):

Sulfacetamide (trade name of the medicinal product)

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

eye drops, 20% (dosage form, dosage)

Open Joint-Stock Company Research and Production Concern "ESCOM", Russia 355107, Stavropol, Staromarevskoye Shosse, 9G (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 relationship between the expected benefit and the possible risk of drug use.