Kanāda - angļu - Health Canada

xediton pharmaceuticals inc - naproxen; esomeprazole (esomeprazole magnesium trihydrate) - tablet (immediate and delayed-release) - 500mg; 20mg - naproxen 500mg; esomeprazole (esomeprazole magnesium trihydrate) 20mg - other nonsteroidal antiimflammatory agents

Lielbritānija - angļu - MHRA (Medicines & Healthcare Products Regulatory Agency)

kent pharma (uk) ltd - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

Izraēla - angļu - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 80 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c rema

Izraēla - angļu - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 10 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c rema

Izraēla - angļu - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 20 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c rema

Eiropas Savienība - angļu - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; psoriasis; arthritis, psoriatic; spondylitis, ankylosing; uveitis; colitis, ulcerative; crohn disease - immunosuppressants - rheumatoid arthritiskromeya in combination with methotrexate, is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.adalimumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritiskromeya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). adalimumab has not been studied in patients aged less than 2 years.enthesitis-related arthritiskromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).axial spondyloarthritisankylosing spondylitis (as)kromeya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.axial spondyloarthritis without radiographic evidence of askromeya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.psoriatic arthritiskromeya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.psoriasiskromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.paediatric plaque psoriasiskromeya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.crohn’s diseasekromeya 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.paediatric crohn's diseasekromeya is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.ulcerative colitiskromeya 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.uveitiskromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate.paediatric uveitiskromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Malta - angļu - Medicines Authority

1 a pharma gmbh - celecoxib - hard capsule - celecoxib 100 milligram(s) - antiinflammatory and antirheumatic products

Malta - angļu - Medicines Authority

1 a pharma gmbh - celecoxib - hard capsule - celecoxib 200 milligram(s) - antiinflammatory and antirheumatic products

Īrija - angļu - HPRA (Health Products Regulatory Authority)

pharmexon consulting s.r.o - gentamicin sulfate - solution for injection/infusion - 40 milligram(s)/millilitre - other aminoglycosides; gentamicin

Malta - angļu - Medicines Authority

abanta pharma gmbh reichsstraße 78, 58840 plettenberg , germany - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals