European Union - English - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - imatinib teva b.v. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment., paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis., adult patients with ph+ cml in blast crisis., adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy., adult patients with relapsed or refractory ph+ all as monotherapy.,  adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements., adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. , the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib teva b.v. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist)., the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatment., the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited. there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.,

Israel - English - Ministry of Health

ben shimon floris ltd, israel - chlorhexidine digluconate - solution - chlorhexidine digluconate 0.2 %w/v - chlorhexidine - antibacterial solution for the disinfection of the mouth:1) as an aid to maintaining oral hygiene. 2) as an aid in the treatment and prevention of gingivitis. 3) inhibition of formation of dental plaque. 4) for use in aphtous ulceration and oral candidal infections (e.g., denture stomatitis and thrush). 5) for use in a post- periodontal surgery or treatment regimen to promote gingival healing.

Israel - English - Ministry of Health

medison pharma ltd - lisdexamfetamine dimesylate - capsules - lisdexamfetamine dimesylate 50 mg - lisdexamfetamine - vyvanse is a central nervous system (cns) stimulant indicated for the treatment of attention deficit hyperactivity disorder (adhd) in patients ages 6 years and above.vyvanse is indicated for the treatment of moderate to severe binge eating disorder (bed) for patient over 18 years.limitation of use:vyvanse is not indicated or recommended for weight loss. use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. the safety and effectiveness of vyvanse for the treatment of obesity have not been established

Israel - English - Ministry of Health

merck serono ltd - cladribine - tablets - cladribine 10 mg - cladribine - mavenclad 10mg tablets is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (ms) as defined by clinical or imaging features

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - dimetindene maleate - gel - dimetindene maleate 0.1 %w/w - dimetindene - urticaria, pruritis, dermatoses, burns, insect bites, allergic dermatitis and eczema.

Israel - English - Ministry of Health

inovamed ltd - emtricitabine; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; emtricitabine 200 mg - tenofovir disoproxil and emtricitabine - tenovamed inovamed is indicated in combination with other anti-retroviral medicinal products for the treatment of hiv-1 infected adults over 18 years of age. tenovamed inovamed is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults at high risk

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - charcoal activated; simethicone - capsules - simethicone 45 mg; charcoal activated 140 mg - medicinal charcoal, combinations - medicinal charcoal, combinations - anti-flatulent, for symptomatic treatment of stomach ache resulting from accumulation of gas, relief of sensation of fullness, meteorism, bloating and flatulence.

Israel - English - Ministry of Health

cts ltd - levonorgestrel - tablets - levonorgestrel 0.75 mg - levonorgestrel - levonorgestrel - emergency contraceptive.

Israel - English - Ministry of Health

teva israel ltd - xylometazoline hydrochloride - nasal spray, solution - xylometazoline hydrochloride 1 mg/ml - xylometazoline - rapid relief of nasal congestion for up to ten hours in adults and adolescents aged 12 years and older.

Israel - English - Ministry of Health

teva israel ltd - xylometazoline hydrochloride - nasal spray, solution - xylometazoline hydrochloride 0.5 mg/ml - xylometazoline - rapid symptomatic relief of nasal decongestion up to 10 hours in children aged 2-12 years.