Israel - English - Ministry of Health

j-c health care ltd - estradiol as hemihydrate; estradiol as hemihydrate; norethisterone acetate - patches - estradiol as hemihydrate 3.2 mg; norethisterone acetate 11.2 mg; estradiol as hemihydrate 3.2 mg - estradiol, combinations - estradiol, combinations - hormone replacement therapy for the relief of menopausal symptoms.

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - infliximab - solution for injection - infliximab 120 mg/ml - infliximab - rheumatoid arthritis: remsima, 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.crohn’s diseaseremsima 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 colitisremsima 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.ankylosing spondylitisremsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.psoriatic arthritisremsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.remsima 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.psoriasisremsima 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 ciclosporin, methotrexate or psoralen ultra-violet a (puva).

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - medroxyprogesterone acetate - suspension for injection - medroxyprogesterone acetate 104 mg / 0.65 ml - medroxyprogesterone - medroxyprogesterone - * sayana is indicated for long-term female contraception. each subcutaneous injection prevents ovulation and provides contraception for at least 13 weeks (+/- 1 week). however, it should be taken into consideration that the return to fertility (ovulation) may be delayed for up to one year .since loss of bone mineral density may occur in females of all ages who use sayana long-term, a risk/benefit assessment, which also takes into consideration the decrease in bone mineral density that occurs during pregnancy and/or lactation, should be considered.* use in adolescents (12-18 years)in adolescents, use of sayana is only indicated when other contraceptive methods are considered unsuitable or unacceptable, due to unknown long-term effects of bone loss associated with sayana during the critical period of bone accretion.sayana has not been studied in women under the age of 18 years but data is available for intramuscular medroxyprogesterone acetate in this population.

Israel - English - Ministry of Health

sanofi israel ltd - sarilumab - solution for injection - sarilumab 131.6 mg / 1 ml - sarilumab - kevzara in combination with methotrexate (mtx) is indicated for the treatment of moderately to severely active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). kevzara can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate.

Israel - English - Ministry of Health

sanofi israel ltd - sarilumab - solution for injection - sarilumab 175 mg / 1 ml - sarilumab - kevzara in combination with methotrexate (mtx) is indicated for the treatment of moderately to severely active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). kevzara can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate.kevzara is indicated for treatment of adult patients with polymyalgia rheumatica who cannot tolerate corticosteroid taper

Israel - English - Ministry of Health

bayer israel ltd - levonorgestrel - film coated tablets - levonorgestrel 0.03 mg - levonorgestrel - oral contraception.

Israel - English - Ministry of Health

novartis israel ltd - travoprost - ophthalmic solution - travoprost 0.004 %w/v - travoprost - travoprost - for the reduction of elevated intra ocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other iop lowering medications or insufficiently responsive to another iop lowering medication.

Israel - English - Ministry of Health

perrigo israel agencies ltd - ciclopirox - lacque - ciclopirox 8 %w/w - ciclopirox - treatment of fungal infections of the nails.

Israel - English - Ministry of Health

unipharm ltd, israel - simvastatin - film coated tablets - simvastatin 10 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvacor is indicated to: reduce the risk of total mortality by reducing coronary death reduce the risk of non-fatal myocardial infarction reduce the risk for undergoing myocardial revascularization procedures. reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvacor is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvacor therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvacor is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertri

Israel - English - Ministry of Health

unipharm ltd, israel - simvastatin - film coated tablets - simvastatin 40 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvacor is indicated to: reduce the risk of total mortality by reducing coronary death reduce the risk of non-fatal myocardial infarction reduce the risk for undergoing myocardial revascularization procedures. reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvacor is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvacor therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios.homozygous familial hypercholesterolemia: simvacor is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertrig