Cancellation of state registration. Andriol TK®

May 15, 2018
Active substances:
Trade names:
ICD-10:
II.C50.C50    Malignant neoplasm of breast
IV.E20-E35.E23.0    Hypopituitarism
IV.E20-E35.E29.1    Hypofunction of the testes
XIII.M80-M85.M82 *    Osteoporosis in diseases classified elsewhere
XIV.N40-N51.N46    Male infertility
XIV.N40-N51.N48.4    Impotence of organic origin
XIV.N80-N98.N93    Other abnormal bleeding from the uterus and vagina
XIV.N80-N98.N95.1    Menopause and menopause in women
XIV.N80-N98.N95.3    Conditions associated with artificially induced menopause
Andriol TK, testosterone, hypogonadism, male infertility, belated puberty in boys, breast cancer, menopause, dysfunctional uterine bleeding, menopause

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 LS-002458 from 08/15/2011 issued by NV Organon, the Netherlands):

Andriol TK® (trade name of the medicinal product)

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

capsules, 40 mg (dosage form, dosage)

N.V. Organon, The Netherlands Kloosterstraat 6, 5349 AB, Oss ,the Netherlands (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 "MSD Pharmaceuticals" to cancel the state registration of the medicinal product.