Israel - English - Ministry of Health

novartis israel ltd - octreotide - solution for injection / infusion - octreotide 0.5 mg/ml - octreotide - octreotide - prevention of complications following pancreatic surgery. symptomatic control and reduction of gh and igf-1plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. sandostatin treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery or in the interim period until radiotherapy becomes fully effective. relief of symptoms associated with functional gastroenteropancreatic endocrine tumours: carcinoid tumours with features of the carcinoid syndrome. vipomas . glucagonomas . gastrinomas / zollinger-ellison syndrome usually in conjunction with proton pump inhibitors or h2- antagonist therapy . insulinomas for pre-operative control of hypoglycaemia and for maintenance therapy . grfomas. sandostatin is not an antitumour therapy and is not curative in these patients.emergency management of bleeding gastro-oesophageal varices secondary to cirrhosis in combination with specific therapy such as endoscopic sclerotherapy.

Israel - English - Ministry of Health

novartis israel ltd - octreotide - powder and solvent for suspension for injection - octreotide 30 mg - octreotide - octreotide - treatment of acromegaly in: patients already adequately controlled on standard doses of sandostatin s.c. patients in whom surgery or radiotherapy are inappropriate or ineffective, or who are in the latency period before radiotherapy becomes fully effective.endocrine gastro-entero- pancreatic (gep) tumors, carcinoid tumors.

Israel - English - Ministry of Health

novartis israel ltd - octreotide - powder and solvent for suspension for injection - octreotide 20 mg - octreotide - octreotide - treatment of acromegaly in: patients already adequately controlled on standard doses of sandostatin s.c. patients in whom surgery or radiotherapy are inappropriate or ineffective, or who are in the latency period before radiotherapy becomes fully effective. endocrine gastro-entero- pancreatic (gep) tumors, carcinoid tumors.

Israel - English - Ministry of Health

novartis israel ltd - octreotide - powder and solvent for suspension for injection - octreotide 10 mg - octreotide - octreotide - treatment of acromegaly in: patients already adequately controlled on standard doses of sandostatin s.c. patients in whom surgery or radiotherapy are inappropriate or ineffective, or who are in the latency period before radiotherapy becomes fully effective. endocrine gastro-entero- pancreatic (gep) tumors, carcinoid tumors.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 400 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 600 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

European Union - English - EMA (European Medicines Agency)

orexigen therapeutics ireland limited - bupropion hydrochloride, naltrexone hydrochloride - obesity; overweight - antiobesity preparations, excl. diet products - mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial body mass index (bmi) of≥ 30 kg/m2 (obese), or≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)treatment with mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 651.6 mg (equivalent: raltegravir, qty 600 mg) - tablet, film coated - excipient ingredients: hypromellose; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; carnauba wax; titanium dioxide; lactose monohydrate; triacetin; iron oxide yellow; iron oxide black - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 434.4 mg (equivalent: raltegravir, qty 400 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; calcium hydrogen phosphate; hypromellose; poloxamer; sodium stearylfumarate; magnesium stearate; butylated hydroxytoluene; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 108.6 mg (equivalent: raltegravir, qty 100 mg) - tablet, chewable - excipient ingredients: hyprolose; sucralose; saccharin sodium; sodium citrate dihydrate; mannitol; sodium stearylfumarate; magnesium stearate; iron oxide yellow; crospovidone; iron oxide red; purified water; strong ammonia solution; ethylcellulose; oleic acid; medium chain triglycerides; sorbitol; ammonium glycyrrhizinate; fructose; flavour; hypromellose; macrogol 400 - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.