תאריך רישום: February 7, 2008

מסלול הגשה: מולקולה חדשה

יצרן: JANSSEN CILAG S.P.A, ITALY

בעל רישום: J-C HEALTH CARE LTD

J05AG04 :ATC Code

4.1 Therapeutic indications INTELENCE, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, including those with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. Treatment history and, when available, resistance testing, should guide the use of INTELENCE. In patients who have experienced virological failure on an NNRTI- and nucleoside or nucleotide reverse transcriptase inhibitor (N[t]RTI)-containing regimen, INTELENCE is not recommended for use in combination with N(t)RTIs only.

תאריך רישום: June 27, 2017

מסלול הגשה: מולקולה חדשה

יצרן: MILLMOUNT HEALTHCARE LIMITED, IRELAND

בעל רישום: MEDISON PHARMA LTD

L01XC16 :ATC Code

4.1 Therapeutic indications Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2).

תאריך רישום: December 27, 2016

מסלול הגשה: מולקולה חדשה

יצרן: EMCURE PHARMA UK LIMITED , UK

בעל רישום: RAZ PHARMACEUTICS LTD, ISRAEL

L01AD01 :ATC Code

4.1 Therapeutic indications Carmustine Raz 100mg is indicated as palliative therapy as a single agent or in established combination therapy with other approved agents in the following: • Brain tumors - glioblastoma, medulloblastoma, astrocytoma and metastatic brain tumors. • Multiple myeloma - in combination with glucocorticoid such as prednisone. • Hodgkin’s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. • Non-Hodgkin’s lymphomas - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.

תאריך רישום: April 15, 2008

מסלול הגשה: מולקולה חדשה

יצרן: BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

בעל רישום: MERCK SERONO LTD

L01XC06 :ATC Code

4.1. Therapeutic indications Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, RAS wild-type metastatic colorectal cancer • in combination with irinotecan-based chemotherapy, • in first-line in combination with FOLFOX, • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. For details, see section 5.1. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck • in combination with radiation therapy for locally advanced disease, • in combination with platinum-based chemotherapy for recurrent and/or metastatic disease, • as a single agent after failure of platinum-based chemotherapy for recurrent and/or metastatic disease.

תאריך רישום: June 25, 2018

מסלול הגשה: מולקולה חדשה

יצרן: KITE PHARMA EU B.V., THE NETHERLANDS

בעל רישום: GILEAD SCIENCES ISRAEL LTD

:ATC Code

4.1 Therapeutic indications Yescarta is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. Limitation of Use: Yescarta is not indicated for the treatment of patients with primary or secondary central nervous system lymphoma. Yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

תאריך רישום: June 4, 2017

מסלול הגשה: מולקולה חדשה

יצרן: BIOGEN NETHERLANDS B.V, THE NETHERLANDS

בעל רישום: MEDISON PHARMA LTD

:ATC Code

4.1 Therapeutic indications Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy except type 0 and type IV.