Tanzania - English - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - levonegestrel , ethinylestradiol - tablets - 150 + 30 mcg

Zimbabwe - English - Medicines Control Authority

population services international, south africa - ethinyl estradiol; ferrous fumarate; levonorgestrel - tablet, coated; oral - 30 mcg; 75 mg; 150 mcg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

access business group llc. - extracto de tÉ verde (camelia sinensis) - extracto de tÉ verde (camelia sinensis)....156,92 mg

Israel - English - Ministry of Health

organon pharma israel ltd., israel - ezetimibe - tablets - ezetimibe 10 mg - ezetimibe - ezetimibe - primary hypercholesterolemia: ezetrol administered with an hmg-coa reductase inhibitor (statin) or alone are indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. homozygous familial hypercholesterolemia (hofh): ezetrol administered with a statin are indicated for use in patients with hofh.patients may also receive adjunctive treatments (e.g. ldl apheresis).homozygous sitosterolemia (phytosterolemia): ezetrol are indicated for use in patients with homozygous familial sitosterolemia.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - canakinumab - cryopyrin-associated periodic syndromes; arthritis, juvenile rheumatoid; arthritis, gouty - interleukin inhibitors, - periodic fever syndromesilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:cryopyrin-associated periodic syndromesilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) including:muckle-wells syndrome (mws),neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca),severe forms of familial cold autoinflammatory syndrome (fcas) / familial cold urticaria (fcu) presenting with signs and symptoms beyond cold-induced urticarial skin rash.tumour necrosis factor receptor associated periodic syndrome (traps)ilaris is indicated for the treatment of tumour necrosis factor (tnf) receptor associated periodic syndrome (traps).hyperimmunoglobulin d syndrome (hids)/mevalonate kinase deficiency (mkd)ilaris is indicated for the treatment of hyperimmunoglobulin d syndrome (hids)/mevalonate kinase deficiency (mkd).familial mediterranean fever (fmf)ilaris is indicated for the treatment of familial mediterranean fever (fmf). ilaris should be given in combination with colchicine, if appropriate.ilaris is also indicated for the treatment of:still’s diseaseilaris is indicated for the treatment of active still’s disease including adult-onset still’s disease (aosd) and systemic juvenile idiopathic arthritis (sjia) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (nsaids) and systemic corticosteroids. ilaris can be given as monotherapy or in combination with methotrexate.gouty arthritisilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (nsaids) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.

European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - immunosuppressants - rheumatoid arthritis (ra)kineret is indicated in adults for the treatment of the signs and symptoms of ra in combination with methotrexate, with an inadequate response to methotrexate alone.covid-19kineret is indicated for the treatment of coronavirus disease 2019 (covid-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (supar) ≥ 6 ng/ml.periodic fever syndromeskineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above:cryopyrin-associated periodic syndromes (caps)kineret is indicated for the treatment of caps, including:neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca)muckle-wells syndrome (mws)familial cold autoinflammatory syndrome (fcas)familial mediterranean fever (fmf)kineret is indicated for the treatment of familial mediterranean fever (fmf). kineret should be given in combination with colchicine, if appropriate.still’s diseasekineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of still’s disease, including systemic juvenile idiopathic arthritis (sjia) and adult-onset still’s disease (aosd), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (nsaids) or glucocorticoids.kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (dmards).

European Union - English - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - hypercholesterolemia - lipid modifying agents - lojuxta is indicated as an adjunct to a low‑fat diet and other lipid‑lowering medicinal products with or without low-density-lipoprotein (ldl) apheresis in adult patients with homozygous familial hypercholesterolaemia (hofh). genetic confirmation of hofh should be obtained whenever possible. other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.,

European Union - English - EMA (European Medicines Agency)

sanofi winthrop industrie - alirocumab - dyslipidemias - lipid modifying agents - primary hypercholesterolaemia and mixed dyslipidaemiapraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.established atherosclerotic cardiovascular disease praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.for study results with respect to effects on ldl-c, cardiovascular events and populations studied see section 5.1.

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - evolocumab - dyslipidemias; hypercholesterolemia - lipid modifying agents - hypercholesterolaemia and mixed dyslipidaemiarepatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.homozygous familial hypercholesterolaemiarepatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.established atherosclerotic cardiovascular diseaserepatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.for study results with respect to effects on ldl-c, cardiovascular events and populations studied see section 5.1.

European Union - English - EMA (European Medicines Agency)

pfizer limited - celecoxib - adenomatous polyposis coli - antineoplastic agents - onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (fap), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).the effect of onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)