Cancellation of state registration. Rocefin®

January 9, 2017

Active substances:

Ceftriaxone

Trade names:

Rocefin®

ICD-10:

I.A30-A49.A39 Meningococcal infection

I.A30-A49.A40 Streptococcal septicemia

I.A30-A49.A41 Other septicemia

I.A50-A64.A54 Gonococcal infection

I.A65-A69.A69.2 Lyme disease

VI.G00-G09.G00 Bacterial meningitis, not elsewhere classified

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.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

XI.K65-K67.K65.0 Acute peritonitis

XI.K80-K87.K81.1 Chronic cholecystitis

XI.K80-K87.K81.0 Acute cholecystitis

XI.K80-K87.K83.0 Cholangitis

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

XIII.M00-M03.M00 Pyogenic arthritis

XIII.M86-M90.M86 Osteomyelitis

XIV.N10-N16.N10 Acute tubulointerstitial nephritis

XIV.N10-N16.N11 Chronic tubulointerstitial nephritis

XIV.N30-N39.N30 Cystitis

XIV.N30-N39.N34 Urethritis and urethral syndrome

XIV.N40-N51.N41 Inflammatory diseases of the prostate

XIV.N70-N77.N70 Salpingitis and oophoritis

XIV.N70-N77.N71.0 Acute inflammatory disease of the uterus

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

XIX.T79.T79.3 Post-traumatic wound infection, not elsewhere classified

XXI.Z20-Z29.Z29.2 Another type of preventive chemotherapy

Rocefin, ceftriaxone, cephalosporins of the third generation, sepsis, meningitis, peritonitis, infections of the kidneys and urinary tract, pneumonia, sinusitis, tonsillitis, prevention of infections in the postoperative period

Ministry of Health of the Russian Federation in accordance with Article 32 of the Federal Law of 12.04.2010 No.61-FZ "On Circulation of Medicines" decided to cancel state registration and exclusion from the state register of medicines for medical use of the drug (registration certificate P N013244 / 03 dated 26.08.2010 issued by F. Hoffmann-La Roche Ltd., Switzerland) :

Rocefin® (trade name of the medicinal product)

Ceftriaxone (international non-proprietary or chemical name of the medicinal product)

Powder for solution for infusion, 2 g (dosage form, dosage)

F. Hoffmann-La Roche Ltd, Switzerland Grenzacherstrasse 124. 4070 Basel, Switzerland (name and address of the location of the manufacturer of the medicinal product)

based on the submission of the Delegation of F. Hoffmann-La Roche Ltd. (Switzerland), Russian statement on the abolition of state registration of the drug.