Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; rilpivirine as hydrochloride 25 mg - rilpivirine - odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; rilpivirine as hydrochloride 25 mg - rilpivirine - odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; rilpivirine as hydrochloride 25 mg; emtricitabine 200 mg - rilpivirine - eviplera, a combination of two nucleoside analog hiv 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of hiv-1 infection in adult patients with no antiretroviral treatment history and with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy, and in certain virologically-suppressed (hiv-1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).the following points should be considered when initiating therapy with eviplera in adult patients with no antiretroviral treatment history: • more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)]. • regardless of hiv-1 rna level at the start of therapy, more rilpivirine-treated subjects with cd4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with cd4+ cell count greater than or equal to 200 cells/mm3 [see clinical studies (14)]. • the observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the nnrti class compared to efavirenz [see microbiology (12.4)]• more subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [see microbiology (12.4)].

Israel - English - Ministry of Health

j-c health care ltd - apalutamide - film coated tablets - apalutamide 60 mg - apalutamide - "erleada is indicated in adult men for the treatment of• metastatic hormone‐sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt)• non-metastatic castration-resistant prostate cancer (nm-crpc)."

Israel - English - Ministry of Health

j-c health care ltd - paliperidone as palmitate - extended release suspension for injection - paliperidone as palmitate 200 mg / 1 ml - paliperidone - trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product

Israel - English - Ministry of Health

j-c health care ltd - cobicistate; darunavir as ethanolate - film coated tablets - cobicistate 150 mg; darunavir as ethanolate 800 mg - darunavir - rezolsta is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv 1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (v11i, v32i, l33f, i47v, i50v, i54l, i54m, t74p, l76v, i84v, l89v).שינוי משטר מינון 2/4/2019pregnancy and postpartumtreatment with rezolsta during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2). therefore, therapy with rezolsta should not be initiated during pregnancy, and women who become pregnant during therapy with rezolsta should be switched to an alternative regimen, see section 4.4 and 4.6. darunavir/ritonavir may be considered as an alternative.

Israel - English - Ministry of Health

j-c health care ltd - galantamine as hydrobromide - capsules prolonged release - galantamine as hydrobromide 16 mg - galantamine - reminyl is indicated for the smptomatic treatment of mild to moderately severe dementia of the alzheimer type.

Israel - English - Ministry of Health

j-c health care ltd - haloperidol as decanoate - solution for injection - haloperidol as decanoate 100 mg/ml - haloperidol - maintainance therapy of chronic schizophrenic patients.

Israel - English - Ministry of Health

j-c health care ltd - erdafitinib - film coated tablets - erdafitinib 3 mg - erdafitinib - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc), that has:- susceptible fgfr3 or fgfr2 genetiic alterations, and- progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Israel - English - Ministry of Health

j-c health care ltd - erdafitinib - film coated tablets - erdafitinib 4 mg - erdafitinib - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc), that has:- susceptible fgfr3 or fgfr2 genetiic alterations, and- progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.