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: March 28, 1993

מסלול הגשה: מולקולה חדשה

יצרן: RECIPHARM KARLSKOGA AB, SWEDEN

בעל רישום: PADAGIS ISRAEL AGENCIES LTD, ISRAEL

N01BB54 :ATC Code

4.1 Therapeutic indications Topical anesthesia for superficial dermal analgesia in connection with insertion of IV catheters, blood sampling and superficial surgical procedures.

תאריך רישום: July 1, 2018

מסלול הגשה: מולקולה חדשה

יצרן: CELLFORCURE, FRANCE

בעל רישום: NOVARTIS ISRAEL LTD

:ATC Code

4.1 Therapeutic indications Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 25 years of age with CD19+ B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse. • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Limitation of Use: Kymriah is not indicated for treatment of patients with primary or secondary central nervous system lymphoma. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

תאריך רישום: November 1, 2018

מסלול הגשה: מולקולה חדשה

יצרן: ELI LILLY AND COMPANY, USA

בעל רישום: ELI LILLY ISRAEL LTD, ISRAEL

N02CX08 :ATC Code

4.1 Therapeutic indications Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.