Cancellation of state registration. Naklofen

August 30, 2017
Active substances:
Trade names:
ICD-10:
VI.G40-G47.G43    Migraine
VIII.H90-H95.H92.0    Otalgia
XI.K00-K14.K08.8    Other specified changes in teeth and their supporting apparatus
XI.K55-K63.K62.8    Other specified diseases of anus and rectum
XI.K80-K87.K80    Gallstone disease [cholelithiasis]
XIII.M00-M03.M02.3    Reiter's disease
XIII.M05-M14.M05    Seropositive rheumatoid arthritis
XIII.M05-M14.M05.3    Rheumatoid arthritis with involvement of other organs and systems
XIII.M05-M14.M07 *    Psoriatic and enteropathic arthropathies
XIII.M05-M14.M08    Juvenile [juvenile] arthritis
XIII.M05-M14.M10    Gout
XIII.M15-M19.M15    Polyarthrosis
XIII.M40-M43.M42    Osteocondritis of the spine
XIII.M45-M49.M45    Ankylosing spondylitis
XIII.M50-M54.M54.1    Radiculopathy
XIII.M50-M54.M54.3    Sciatica
XIII.M50-M54.M54.4    Lumbago with sciatica
XIII.M60-M63.M60    Myositis
XIII.M65-M68.M65    Synovitis and tenosynovitis
XIII.M70-M79.M70    Diseases of soft tissues associated with exercise, overload and pressure
XIII.M70-M79.M71    Other bursopathies
XIII.M70-M79.M79.1    Myalgia
XIII.M70-M79.M79.2    Neuralgia and neuritis, unspecified
XIV.N20-N23.N23    Renal colic, unspecified
XIV.N70-N77.N70    Salpingitis and oophoritis
XIV.N80-N98.N94.4    Primary dysmenorrhea
XIV.N80-N98.N94.5    Secondary dysmenorrhea
XVIII.R00-R09.R07    Sore throat and chest
XVIII.R50-R69.R50    Fever of unknown origin
XVIII.R50-R69.R51    Headache
XVIII.R50-R69.R52.0    Acute pain
XVIII.R50-R69.R52.2    Another constant pain
XIX.T08-T14.T14.3    Dislocation, stretching and overstrain of the capsular-ligamentous apparatus of the joint of the unspecified area of ​​the body
Naklofen, diclofenac, pain syndrome, pain treatment, arthritis, inflammatory and degenerative diseases of the musculoskeletal system, headache, migraine, toothache, muscle pain, fever

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 use of the medicinal product (registration certificate P N013166 / 03 dated 14.03.2008 issued to JSC "Krka, dd, Novo mesto", Slovenia):

Naklofen (trade name of the medicinal product)

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

tablets, coated with enteric film coating, 50 mg (dosage form, dosage)

JSC "Krka, dd, Novo mesto", Slovenia Smarjeska cesta 6, 8501 Novo mesto, Slovenia Limited Liability Company "KRKA-RUS" (LLC "KRKA-RUS"), Russia 143500, Moscow region, Istra district, Istra, ul. Moscow, d, 50 (name and address of the location of the manufacturer of the medicinal product)

on the basis of an application by the authorized legal entity of the JSC "Krka, dd, Novo mesto" to cancel the state registration of the medicinal product.