Cancellation of state registration. Estrofem®

January 31, 2017
Active substances:
Trade names:
ICD-10:
IV.E20-E35.E28    Dysfunction of the ovaries
XIII.M80-M85.M81.0    Postmenopausal osteoporosis
XIII.M80-M85.M81.1    Osteoporosis after removal of ovaries
XIV.N80-N98.N91    Absence of menstruation, meager and rare menstruation
XIV.N80-N98.N95.1    Menopause and menopause in women
XIV.N80-N98.N95.3    Conditions associated with artificially induced menopause
Estrofem, estradiol, amenorrhea, hormone replacement therapy for menopause, menopause, menopause, ovarian dysfunction

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 P N015573 / 01 dated Nov. 29, 2009 issued to Novo Nordisk A / S, Denmark):

Estrofem® (trade name of the medicinal product)

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

film coated tablets, 2 mg (dosage form, dosage)

Novo Nordisk A / S, Denmark Novo Alle DK-2880, Bagsvaerd, Denmark (name and address of the location of the manufacturer of the medicinal product)

on the basis of an application by an authorized legal entity of Novo Nordisk LLC to cancel the state registration of a medicinal product.