Cancellation of state registration. Acestin®

September 29, 2017
Active substances:
Trade names:
ICD-10:
IV.E70-E90.E84    Cystic fibrosis
X.J00-J06.J01    Acute Sinusitis
X.J00-J06.J05    Acute obstructive laryngitis [croup] and epiglottitis
X.J10-J18.J15    Bacterial pneumonia, not elsewhere classified
X.J20-J22.J20    Acute bronchitis
X.J30-J39.J32    Chronic Sinusitis
X.J30-J39.J37    Chronic laryngitis and laryngotracheitis
X.J40-J47.J42    Chronic bronchitis, unspecified
X.J40-J47.J45    Asthma
X.J40-J47.J47    Bronchoectasia
Acetin, acetylcysteine, mucolytic drug, cough with sputum, bronchitis, tracheitis, pneumonia

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 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 LSR-005200 / 09 of June 29, 2009 issued by STADA Artsnaymittel AG, Germany):

Acestin® (trade name of the medicinal product)

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

tablets effervescent, 200 mg, 600 mg (dosage form, dosage)

STADA Arzneimittel AG, Germany Stadastrasse 2-18 D-61118 Bad Vilbel, Germany (name and address of the location of the manufacturer of the medicinal product)

on the basis of an application by the authorized legal entity of Nizhpharm JSC to cancel the state registration of the medicinal product.