Cancellation of state registration. Ibuprofen Sandoz®

June 7, 2017
Active substances:
ICD-10:
XI.K00-K14.K08.8    Other specified changes in teeth and their supporting apparatus
XIII.M05-M14.M05    Seropositive rheumatoid arthritis
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.M45-M49.M46    Other inflammatory spondylopathies
XIII.M50-M54.M54.1    Radiculopathy
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.N70-N77.N70    Salpingitis and oophoritis
XIV.N80-N98.N94.4    Primary dysmenorrhea
XIV.N80-N98.N94.5    Secondary dysmenorrhea
XVIII.R50-R69.R50    Fever of unknown origin
XVIII.R50-R69.R51    Headache
Ibuprofen Sandoz, ibuprofen, anti-inflammatory drug, toothache, headache, pain treatment, fever, algodismenorea, muscle pain

The Ministry of Health of the Russian Federation, in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On 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 LP-002043 dated 04/10/2013 issued by Sandoz dd, Slovenia):

Ibuprofen Sandoz® (trade name of the drug)

Ibuprofen (international nonproprietary, or grouping, or chemical name medicinal product)

film-coated tablets, 200 mg, 400 mg (dosage form, dosage)

Sandoz Ilach Sanayi ve Tidjaret AS, Turkey Gebze Plastikciler Organize Sanayi Bolgesi Ataturk Bulvari 9, Cad No: 1 41400 Gebze-Kocaeli, Turkey; Salutas Pharma GmbH, Germany Otto-von-Guericke Allee 1, 39179 Barleben, Germany (name and address of the location of the manufacturer of the medicinal product)

on the basis of the filing of an application by the authorized legal entity ZAO Sandoz, Russia to cancel the state registration of the medicinal product.