Cancellation of state registration. Spasmonet® forte

February 13, 2018
Active substances:
ICD-10:
IX.I70-I79.I73.1    Obliterating thromboangitis [Berger's disease]
IX.I70-I79.I73.9    Peripheral vascular disease, unspecified
XI.K20-K31.K25    Stomach ulcer
XI.K20-K31.K26    Duodenal ulcer
XI.K20-K31.K29    Gastritis and duodenitis
XI.K20-K31.K31.3    Pylorospasm, not elsewhere classified
XI.K50-K52.K52    Other non-infectious gastroenteritis and colitis
XI.K55-K63.K59.0    Constipation
XI.K55-K63.K62.8    Other specified diseases of anus and rectum
XI.K80-K87.K80    Gallstone disease [cholelithiasis]
XI.K80-K87.K81.1    Chronic cholecystitis
XI.K80-K87.K81.0    Acute cholecystitis
XI.K80-K87.K82.8    Other specified diseases of the gallbladder
XI.K90-K93.K91.5    Postcholecystectomy syndrome
XIV.N10-N16.N11    Chronic tubulointerstitial nephritis
XIV.N10-N16.N10    Acute tubulointerstitial nephritis
XIV.N20-N23.N23    Renal colic, unspecified
XIV.N80-N98.N94.4    Primary dysmenorrhea
XIV.N80-N98.N94.5    Secondary dysmenorrhea
XV.O20-O29.O20.0    Threatening abortion
XV.O60-O75.O60    Premature birth
XV.O60-O75.O62    Violations of labor [of the clan]
XVIII.R10-R19.R10.4    Other and unspecified abdominal pain
XVIII.R50-R69.R51    Headache
XXI.Z40-Z54.Z51.4    Preparatory procedures for subsequent treatment, not elsewhere classified
Spasmonet forte, drotaverin, spasmolytic, pain relief, pain, pain management

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 abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate LSR-003585 / 07 dated 06.11.2007, the Limited Liability Company KRKA-RUS (LLC Krka-Rus), Russia) was issued:

Spasmonet® forte (trade name of the drug)

Drotaverine (international non-proprietary or grouping or chemical name)

tablets, 80 mg (dosage form, dosage)

Limited Liability Company "KRKA-RUS" (LLC "KRKA-RUS"), 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 an application by the authorized legal entity LLC KRKA-RUS to cancel the state registration of the medicinal product.