תאריך רישום: June 28, 2017

מסלול הגשה: תכשיר גנרי

יצרן: PLIVA CROATIA LTD, CROATIA

בעל רישום: TEVA ISRAEL LTD

J01FA10 :ATC Code

תאריך רישום: December 2, 2017

מסלול הגשה: תכשיר ותיק

יצרן: MEDOCHEMIE LTD , (AMPOULE INJECTABLE FACILITY), CYPRUS

בעל רישום: A.L. MEDI-MARKET LTD.

J01GB06 :ATC Code

4.1 Therapeutic indications Amikacin-Medo is indicated in the short-term treatment of Gram-negative organisms, including pseudomonas and some Gram-positive organisms. Sensitive Gram-negative organisms include; Pseudomonas aeruginosa, Escherichia coli., indole- positive and indole-negative Proteus spp., Klebsiella, Enterobacter and Serratia spp., Minea- Herralae, Citrobacter freundii, Salmonella, Shigella, Acinetobacter and Providencia spp. The principal Gram-positive organism sensitive to amikacin is Staphylococcus aureus, including some methicillin-resistant strains. Amikacin-Medo has some activity against other Gram-positive organisms including certain strains of Streptococcus pyogenes, Enterococci and Diplococcus pneumoniae. Many strains of these Gram-negative organisms resistant to gentamicin and tobramycin show sensitivity to amikacin in vitro. Although amikacin is not the drug of choice for infections due to staphylococci, at times it may be indicated for the treatment of known or suspected staphylococcal disease. These situations include: the initiation of therapy for severe infections when the organisms suspected are either Gram-negative or staphylococci, patients allergic to other antibiotics, and mixed staphylococcal/Gram-negative infections. Therapy with amikacin may be instituted prior to obtaining the results of sensitivity testing. Surgical procedures should be performed where indicated. Consideration should be given to official guidance on the appropriate use of antibacterial Agents.

תאריך רישום: February 3, 2018

מסלול הגשה: תכשיר ותיק

יצרן: HAUPT PHARMA LIVRON, FRANCE

בעל רישום: PHARMALOGIC LTD

J01GB03 :ATC Code

4.1 Therapeutic indications Gentamicin is indicated in bacteremia, urinary tract infections, endocarditis, chest infections and other serious systemic infections due to confirmed or expected bacteria that are susceptible to gentamicin, in adults and children, including neonates. Bacteriological studies to determine the causative organism(s) and antimicrobial susceptibility are recommended when feasible. Monitoring of peak and trough serum concentrations of gentamicin are usually recommended. Consideration should be given to official local guidance on the appropriate use of antibacterial agents.

תאריך רישום: September 2, 2017

מסלול הגשה: תכשיר גנרי

יצרן: LABORATOIRES STEROP, BELGIUM

בעל רישום: RAZ PHARMACEUTICS LTD, ISRAEL

R03CA02 :ATC Code

4.1 Therapeutic indications Prevention and treatment of hypotension from spinal or epidural anesthesia and during general anesthesia, with or without a reduction in the heart rate, administered for a surgical or obstetric procedure.

תאריך רישום: July 30, 2018

מסלול הגשה: מולקולה חדשה

יצרן: CATALENT CTS (EDINBURGH) LIMITED, UK

בעל רישום: NOVARTIS ISRAEL LTD

:ATC Code

4.1 Therapeutic indications Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to LUX API DEC23 V5 Based on EU SmPC JUL23 inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

תאריך רישום: May 29, 2019

מסלול הגשה: צורת מינון חדשה

יצרן: DR. FALK PHARMA GMBH, GERMANY

בעל רישום: RAFA LABORATORIES LTD

A07EA06 :ATC Code

4.1 Therapeutic indications Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults.