Cancellation of state registration. Dahleron (suspension for ingestion for children)

December 07, 2016
Active substances:
Trade names:
ICD-10:
XI.K00-K14.K08.8    Other specified changes in teeth and their supporting apparatus
XIII.M70-M79.M79.1    Myalgia
XIII.M70-M79.M79.2    Neuralgia and neuritis, unspecified
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
XVIII.R50-R69.R52.0    Acute pain
XVIII.R50-R69.R52.2    Another constant pain
Daleron, paracetamol, antipyretic for children, treatment of pain in children, dysmenorrhea, toothache, headache

Russian Ministry of Health in accordance with Article 32 of the Federal Law of 12.04.2010 number 61-FZ "On Circulation of Medicines" decided to cancel state registration and exclusion from the state register of medicines for medical use of the drug (registration certificate P N011471 / 02 from 29.10.2009 issued to Krka, dd, Novo mesto, Slovenia):

Daleron (trade name of the medicinal product)

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

suspension for ingestion for children, 120 mg / 5 ml (dosage form, dosage)

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 the submission by the authorized representative of the JSC "Krka, dd, Novo mesto", Russia, a statement on the abolition of the state registration of the medicinal product.