Cancellation of state registration. Ethaf

November 27, 2017
Active substances:
ICD-10:
IV.E20-E35.E20    Hypoparathyroidism
IV.E20-E35.E20.1    Pseudohypoparathyroidism
IV.E50-E64.E55.0    Rickets active
IV.E70-E90.E72.0    Disruption of amino acid transport
XIII.M80-M85.M81.0    Postmenopausal osteoporosis
XIII.M80-M85.M81.1    Osteoporosis after removal of ovaries
XIII.M80-M85.M82.8 *    Osteoporosis in other diseases classified elsewhere
XIII.M80-M85.M81.8    Other osteoporosis
XIII.M80-M85.M81.4    Medicinal osteoporosis
XIII.M80-M85.M81.2    Osteoporosis caused by immobility
XIII.M80-M85.M83    Osteomalacia in adults
Etagol, alfacalcidol, hypoparathyroidism, osteoporosis, osteomalacia, osteoporosis treatment, rickets, rickets treatment, osteodystrophy

The Ministry of Health of the Russian Federation, in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "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 N012029 / 01 from 05.04.2011 issued by LEO Pharmaceutical Products Ltd. A / S (LEO Pharma A / S), Denmark, registration certificate P N012029 / 03 dated 28.10.2011 issued by LEO Pharmaceutical Products, Denmark, registration certificate П N012029 / 02 of 28.10.2011. issued by LEO Pharmaceutical Products Ltd. A / S (LEO Pharma A / S), Denmark):

Ethyl®, Ethal, Ethaph (trade name of the medicinal product)

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

capsules, 0.25 μg, intravenous solution, 2 μg / ml, drops for oral administration (dosage form, dosage)

LEO Pharmaceutical Products Co., Ltd. A / S (LEO Pharma A / S), Denmark Industriparken 55, DK-2750 Ballerup, Denmark (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 "LEO Pharmaceutical Products" to cancel the state registration of the medicinal product.