Cancellation of state registration. Azithromycin Zentiva

December 19, 2017

Active substances:

Azithromycin

Trade names:

Azithromycin Zentiva

ICD-10:

I.A30-A49.A46 Erys

I.A30-A49.A48.1 Legionnaires' disease

I.A50-A64.A56.0 Chlamydial infections of the lower parts of the genito-urinary tract

I.A50-A64.A56.1 Chlamydial infections of the pelvic organs and other urogenital organs

I.A50-A64.A56.4 Chlamydial pharyngitis

I.A65-A69.A69.2 Lyme disease

VIII.H65-H75.H66 Purulent and unspecified otitis media

X.J00-J06.J01 Acute Sinusitis

X.J00-J06.J02 Acute pharyngitis

X.J00-J06.J03 Acute tonsillitis

X.J00-J06.J04 Acute laryngitis and tracheitis

X.J10-J18.J15 Bacterial pneumonia, not elsewhere classified

X.J10-J18.J16.0 Pneumonia caused by chlamydia

X.J10-J18.J15.7 Pneumonia caused by Mycoplasma pneumoniae

X.J20-J22.J20 Acute bronchitis

X.J30-J39.J31 Chronic rhinitis, nasopharyngitis and pharyngitis

X.J30-J39.J32 Chronic Sinusitis

X.J30-J39.J35.0 Chronic tonsillitis

X.J30-J39.J37 Chronic laryngitis and laryngotracheitis

X.J40-J47.J42 Chronic bronchitis, unspecified

XII.L00-L08.L01 Impetigo

XII.L00-L08.L02 Abscess of skin, boil and carbuncle

XII.L00-L08.L03 Phlegmon

XII.L00-L08.L08.0 Pyoderma

XII.L20-L30.L30.3 Infectious dermatitis

XII.L60-L75.L70 Acne

XIV.N30-N39.N34 Urethritis and urethral syndrome

XIV.N70-N77.N72 Inflammatory disease of the cervix

Azithromycin Zentiva, azithromycin, broad-spectrum antibiotic, treatment of chlamydial infections, treatment of infectious and inflammatory skin diseases, acne, pyoderma, pneumonia, cystitis, tonsillitis, erysipelas, lyme disease

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 LP-003379 dated 22.12.2015 issued by Zentiva, Czech Republic):

Azithromycin Zentiva (trade name of the drug)

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

powder for suspension for oral administration, 200 mg / 5 ml (dosage form, dosage)

Zentiva, Czech Republic U kabelovny 130, 102 37 Prague 10, Dolni Mecholupy, Czech Republic (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 the Sanofi-aventis Group JSC to cancel the state registration of the medicinal product.