Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - baloxavir marboxil - film coated tablets - baloxavir marboxil 40 mg - baloxavir marboxil - xofluza is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are: • otherwise healthy, or • at high risk of developing influenza-related complications. xofluza is indicated for post-exposure prophylaxis of influenza in persons 12 years of age and older following contact with an individual who has influenza.limitations of use: influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use xofluza

Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - rituximab - mabthera is indicated for the following indications: * non-hodgkin’s lymphoma (nhl)mabthera is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma.mabthera is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy mabthera is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. mabthera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. * chronic lymphocytic leukaemia (cll)mabthera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including mabthera or patients refractory to previous mabthera plus chemotherapy.* rheumatoid arthritismabthera is indicated, in combination with methotrexate, to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to one or more tnf antagonist therapies.* granulomatosis with polyangiitis and microscopic polyangiitismabthera, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener’s granulomatosis (wg) and microscopic polyangiitis (mpa). *pemphigus vulgarismabthera is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).

Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - bevacizumab - concentrate for solution for infusion - bevacizumab 25 mg/ml - bevacizumab - bevacizumab - - avastin in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.- avastin in addition to platinum - based chemotherapy is indicated for first - line treatment of patients with unresectable advanced metastatic or recurrent non- small cell lung cancer other than predominantly squamous cell histology. - avastin in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and /or metastatic renal cell cancer. - avastin in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.- avastin as asingle agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.- avastin, in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of advanced (figo stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are at high risk for recurrence (residual disease after debulking).- avastin, in combination with carboplatin and gemcitabine, is indicated for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents.- avastin ( bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents - avastin ( bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for treatment of patients with persistent, recurrent, or metastatic carcinoma of the cervix.- bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. - bevacizumab, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.

Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - pertuzumab - concentrate for solution for infusion - pertuzumab 420 mg / 14 ml - pertuzumab - pertuzumab - early breast cancer perjeta is indicated for use in combination with trastuzumab and chemotherapy for: • the neoadjuvant treatment of patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. • the adjuvant treatment of patients with her2-positive early breast cancer (node positive) at high risk of recurrence .metastatic breast cancerperjeta is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with her2-positive metastatic breast cancer who have not received prior anti-her2 therapy or chemotherapy for metastatic disease.

Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - ocrelizumab - concentrate for solution for infusion - ocrelizumab 30 mg/ml - ocrelizumab - ocrevus is indicated for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis.

Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - atezolizumab - concentrate for solution for infusion - atezolizumab 60 mg / 1 ml - urothelial carcinoma• tecentriq (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours have a pd-l1 expression ≥ 5%.• tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.- non-small cell lung cancer •tecentriq, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have high pd-l1 expression (pd-l1 stained ≥ 50% of tumor cells [tc ≥ 50%] or pd-l1 stained tumor-infiltrating immune cells [ic] covering ≥ 10% of the tumor area [ic ≥ 10%]), as determined by an approved test, with no egfr or alk genomic tumor aberrations.•tecentriq, in combination with paclitaxel protein-bound and carboplatin,

Singapore - engleză - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - clinical chemistry - roche diagnostics combur 5 test hc test strips are for graduated determinations of glucose, leukocytes, nitrite, protein and blood in urine. suitable for self‑testing.

Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - obinutuzumab - concentrate for solution for infusion - obinutuzumab 1000 mg / 40 ml - obinutuzumab - chronic lymphocytic leukaemia (cll)gazyva, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll).follicular lymphoma (fl )gazyva, in combination with bendamustine followed by gazyva monotherapy, is indicated for the treatment of patients with follicular lymphoma (fl) who did not respond or who progressed during or up to 6 months after treatment with a rituximab-containing regimen.gazyva in combination with chemotherapy, followed by gazyva maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.

Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - trastuzumab emtansine - powder for concentrate for solution for infusion - trastuzumab emtansine 20 mg/ml - trastuzumab - "early breast cancer (ebc):kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab -based treatment."metastatic breast cancer (mbc)kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:• received prior therapy for metastatic disease, or• developed disease recurrence during or within six months of completing adjuvant therapy."

Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - polatuzumab vedotin - powder for concentrate for solution for infusion - polatuzumab vedotin 140 mg/vial - polivy in combination with bendamustine and rituximab is indicated for the treatment of previously treated adult patients with diffuse large b-cell lymphoma who are not candidates for hematopoietic stem cell transplant.polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).