Cancellation of state registration. Parlodel®

April 04, 2017
Active substances:
Trade names:
ICD-10:
II.C73-C75.C75.1    Malignant neoplasm of pituitary gland
II.D10-D36.D35.2    Benign neoplasm of pituitary gland
IV.E20-E35.E22.0    Acromegaly and pituitary gigantism
IV.E20-E35.E22.1    Hyperprolactinemia
IV.E20-E35.E28.2    Polycystic ovary syndrome
IV.E20-E35.E28.3    Primary ovarian failure
VI.G20-G26.G20    Parkinson's disease
VI.G20-G26.G21    Secondary Parkinsonism
XIV.N40-N51.N46    Male infertility
XIV.N60-N64.N61    Inflammatory diseases of the breast
XIV.N80-N98.N91    Absence of menstruation, meager and rare menstruation
XIV.N80-N98.N97    Female infertility
Bromocriptine, Parlodel, pituitary neoplasm, acromegaly, infertility, Parkinson's disease, parkinsonism, polycystic ovary

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 N015275 / 01 from 11.08.2008 issued by Meda AB, Sweden):

Parlodel® (trade name of the medicinal product)

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

tablets, 2.5 mg (dosage form, dosage)

Novartis Pharma SpA, Italy Via Provinciale Schito 131,1-80058 Torre Annunziata, Italy (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 Meda Pharma to cancel the state registration of the medicinal product.