תאריך רישום: January 2, 2019

מסלול הגשה: תכשיר גנרי

יצרן: LEK PHARMACEUTICALS D. D., SLOVENIA

בעל רישום: SANDOZ PHARMACEUTICALS ISRAEL LTD

N05AX12 :ATC Code

תאריך רישום: February 26, 2019

מסלול הגשה: תכשיר גנרי

יצרן: LEK PHARMACEUTICALS D. D., SLOVENIA

בעל רישום: SANDOZ PHARMACEUTICALS ISRAEL LTD

N05AX12 :ATC Code

תאריך רישום: March 1, 2017

מסלול הגשה: תכשיר גנרי

יצרן: UNIPHARM LTD, ISRAEL

בעל רישום: UNIPHARM LTD, ISRAEL

N06AB03 :ATC Code

4.1 Therapeutic indications Adults: Major depressive episodes. Obsessive-compulsive disorder (OCD). Bulimia nervosa: Fluoxetine is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. Children and adolescents aged 8 years and above: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4–6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.

תאריך רישום: March 4, 2018

מסלול הגשה: ביו סימילאר

יצרן: BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

בעל רישום: PFIZER PFE PHARMACEUTICALS ISRAEL LTD

L04AB02 :ATC Code

4.1 Therapeutic indications Rheumatoid arthritis: Ixifi®, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: ฀ adult patients with active disease when the response to disease modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. ฀ adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X ray, has been demonstrated. Ankylosing spondylitis: Ixifi® is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis: Ixifi® is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. * Ixifi® should be administered: ฀ in combination with methotrexate ฀ or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis: Ixifi® is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA) Adult Crohn’s disease: Ixifi® is indicated for treatment: ฀ of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. ฀ treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Ulcerative colitis : Ixifi® is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

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.