Cancellation of state registration. Ambrohexal

August 30, 2017
Active substances:
Trade names:
ICD-10:
X.J10-J18.J15    Bacterial pneumonia, not elsewhere classified
X.J20-J22.J20    Acute bronchitis
X.J40-J47.J42    Chronic bronchitis, unspecified
X.J40-J47.J44    Other chronic obstructive pulmonary disease
X.J40-J47.J45    Asthma
X.J40-J47.J47    Bronchoectasia
X.J80-J84.J80    Syndrome of respiratory distress in an adult
XVIII.R00-R09.R05    Cough
Ambroghexal, ambroxol, cough, cough treatment, improvement of sputum discharge, bronchial asthma, bronchitis

The Ministry of Health of the Russian Federation in accordance with Article 32 of the Federal Law of 12.04.2010 No. 61-FZ "On the circulation of medicinal products" decided to abolish state registration and exclusion from the state register of medicinal products for medical use of the medicinal product (registration certificate P N012596 / 02 from 14.03.2008 issued by Sandoz dd, Slovenia):

Ambrohexal (trade name of the drug)

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

solution for ingestion and inhalation, 7.5 mg / ml (dosage form, dosage)

Salutas Pharma GmbH, Germany Otto-von-Guericke-Allee 1, 39179 Barleben, Germany (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing an application by an authorized legal entity of ZAO Sandoz to cancel the state registration of the medicinal product.