Cancellation of state registration. Cedex®

May 04, 2018
Active substances:
Trade names:
ICD-10:
I.A00-A09.A09    Diarrhea and gastroenteritis of allegedly infectious origin
X.J00-J06.J00    Acute nasopharyngitis (runny nose)
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.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
XIV.N10-N16.N11    Chronic tubulointerstitial nephritis
XIV.N10-N16.N10    Acute tubulointerstitial nephritis
XIV.N30-N39.N30    Cystitis
XIV.N30-N39.N34    Urethritis and urethral syndrome
XIV.N40-N51.N41    Inflammatory diseases of the prostate
Tzedek, ceftibuten, urinary tract infections, infectious and inflammatory diseases of the upper and lower respiratory tract, enteritis, gastroenteritis

Ministry of Health of the Russian Federation at According to Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On circulation of medicinal products", a decision was made to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate No. N013725 / 01 of 23.01.2009 issued LLC "MSD Pharmaceuticals", Russia):

Cedex® (trade name of the medicinal product)

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

capsules, 400 mg (dosage form, dosage)

Merck Sharp and Doe Corp., USA 13900 NW 57th Court, Miami Lakes, FL 33014, USA (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 "MSD Pharmaceuticals" to cancel the state registration of the medicinal product.