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: 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: July 28, 1977

מסלול הגשה: מולקולה חדשה

יצרן: RAFA LABORATORIES LTD., ISRAEL

בעל רישום: RAFA LABORATORIES LTD

N02CX02 :ATC Code

4.1 Therapeutic indications Prophylaxis of migraine and recurrent vascular headache, but not acute attacks. Treatment of menopausal flushing.

תאריך רישום: July 19, 1998

מסלול הגשה: מולקולה חדשה

יצרן: N.V. ORGANON, THE NETHERLANDS

בעל רישום: ORGANON PHARMA ISRAEL LTD., ISRAEL

G03DC05 :ATC Code

4.1 Therapeutic indications • Complaints resulting from the natural or artificial menopause. Treatment of oestrogen deficiency symptoms in postmenopausal women, more than one year after menopause. Women above 60 years of age should only start with Livial treatment when they are intolerant of, or contraindicated for, other medicinal products approved for the treatment of oestrogen deficiency symptoms. • Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. (See also section 5.1.) For all women the decision to prescribe Livial should be based on an assessment of the individual patient’s overall risks and, particularly in the over 60s, should include consideration of the risk of stroke (see sections 4.4 and 4.8).