מלטה - אנגלית - Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - cytarabine - solution for infusion or injection - cytarabine 100 mg/ml - antineoplastic agents

מלטה - אנגלית - Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - cytarabine - solution for infusion or injection - cytarabine 100 mg/ml - antineoplastic agents

מלטה - אנגלית - Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - cytarabine - solution for infusion or injection - cytarabine 100 mg/ml - antineoplastic agents

מלטה - אנגלית - Medicines Authority

accord healthcare limited - etoposide - concentrate for solution for infusion - etoposide 20 mg/ml - antineoplastic agents

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

ucb pharma sa  - certolizumab pegol - arthritis, rheumatoid - immunosuppressants - rheumatoid arthritiscimzia, in combination with methotrexate (mtx), is indicated for:the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmards) including mtx, has been inadequate. cimzia can be given as monotherapy in case of intolerance to mtx or when continued treatment with mtx is inappropriatethe treatment of severe, active and progressive ra in adults not previously treated with mtx or other dmards.cimzia has been shown to reduce the rate of progression of joint damage as measured by x ray and to improve physical function, when given in combination with mtx.axial spondyloarthritis cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:ankylosing spondylitis (as)adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids).axial spondyloarthritis without radiogra

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamide - prostatic neoplasms - endocrine therapy - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5.1).the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - cobicistat 150mg;  ;  ;  ; elvitegravir 150mg;  ;  ; emtricitabine 200mg;  ;  ;  ;  ; tenofovir disoproxil fumarate 300mg;  ;  ;   - film coated tablet - active: cobicistat 150mg       elvitegravir 150mg     emtricitabine 200mg         tenofovir disoproxil fumarate 300mg       excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry green sodium laurilsulfate - stribild is indicated as a single tablet regimen for the treatment of hiv infection in treatment-naive adults. stribild is also indicated in certain virologically suppressed (hiv1 rna stribild is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - cobicistat 150mg;  ;  ;   - film coated tablet - 150 mg - active: cobicistat 150mg       excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry orange 85f93642 - tybost is indicated as a pharmacokinetic enhancer of appropriate hiv-1 protease inhibitors in adults

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - prezcobix, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus- 1 (hiv-1) infection in:,- antiretroviral treatment-naive patients,- antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma hiv-1 rna <100,000 copies/ml,- antiretroviral treatment-experienced but hiv protease inhibitor-naive patients for whom hiv-1 genotype testing is unavailable (see section 4.2 dose and method of administration)

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - paclitaxel, quantity: 300 mg - injection, concentrated - excipient ingredients: peg-35 castor oil; ethanol absolute - - primary treatment of ovarian cancer in combination with a platinum agent. - treatment of metastatic carcinoma of the ovary after failure of standard therapy. - treatment of metastatic carcinoma of the breast after failure of standard therapy. - adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin and cyclophosphamide. - treatment of metastatic cancer of the breast, in combination with trastuzumab (herceptin), in patients who have tumours that over-express her-2 and who have not received previous chemotherapy for their metastatic disease. - in combination with gemcitabine (gemzar), is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. - for the treatment of non-small cell lung cancer (nsclc).