Union européenne - maltais - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - iperkolesterolemija - aġenti li jimmodifikaw il-lipidi - lojuxta huwa indikat bħala frozen dieta low‑fat u lipid‑lowering prodotti mediċinali oħra jew mingħajru baxxa density-lipoprotein (ldl) aferesi fil-pazjenti adulti ma hypercholesterolaemia homozygous familjari (hofh). Ġenetiċi-konferma tal-hofh għandu jinkiseb kull meta jkun possibbli. - forom l-oħra tal-primarja hyperlipoproteinaemia u l-kawżi sekondarji ta ' l-iperkolesterolimja (e. sindromu nefrotiku, ipotirojdiżmu) għandhom jiġu esklużi.

Union européenne - maltais - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic acid, ezetimibe - hypercholesterolemia; dyslipidemias - aġenti li jimmodifikaw il-lipidi - nustendi huwa indikat fl-adulti b'iperkolesterolemija primarja (eterozigote familjali u mhux familjali) jew dislipidemija mħallta, bħala żieda mad-dieta:f'kombinazzjoni ma 'statin fil-pazjenti li ma jistgħux jilħqu l-ldl-c-għanijiet mal-doża massima ttollerata ta' statin minbarra l-ezetimibealone f'pazjenti li huma statin jew intolleranti għal imatinib jew li għalihom statin huwa kontra-indikat, u ma jkunux jistgħu jilħqu livell ta ' ldl-c-għanijiet mal-ezetimibe waħdu,fil-pazjenti li diġà qegħdin jiġu kkurati b'kumbinazzjoni ta bempedoic acid u ezetimibe bħala pilloli separati bi jew mingħajr statin.

Union européenne - maltais - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - thiotepa - hematopoietic stem cell transplantation; neoplasms - aġenti antineoplastiċi - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Union européenne - maltais - EMA (European Medicines Agency)

tad pharma gmbh - clopidogrel (as hydrochloride) - peripheral vascular diseases; stroke; myocardial infarction - aġenti antitrombotiċi - clopidogrel is indicated in adults for the prevention of atherothrombotic events in: , patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

Union européenne - maltais - EMA (European Medicines Agency)

plusultra pharma gmbh - sirolimus - angiofibroma; tuberous sclerosis - hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.

Union européenne - maltais - EMA (European Medicines Agency)

teva b.v. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - drogi għat-trattament ta 'mard tal-għadam - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. it-trattament tal-marda ta'paget ta ' l-għadam fl-adulti.

Union européenne - maltais - EMA (European Medicines Agency)

merck sharp dohme ltd. - laropiprant, l-aċidu nikotiniku - dyslipidemias - aġenti li jimmodifikaw il-lipidi - tredaptive huwa indikat għall-kura tal-dyslipidaemia, b'mod partikolari fil-pazjenti bl-dyslipidaemia magħquda imħallat (kkaratterizzati minn livelli elevati ta ' kolesterol baxxa-density-lipoprotein (ldl) u trigliċeridi u baxx għolja-density-lipoprotein (hdl kolesterol)) u fil-pazjenti bl-hypercholesterolaemia primarji (heterozygous familjari u mhux familjari). tredaptive għandu jintuża fil-pazjenti flimkien ma '3-hydroxy-3-methyl-glutaryl-ko-enzima-a (hmg-coa)-l-inibituri reductase (statins), meta l-kolesterol fid-effett ta 'tnaqqis ta' impedituri hmg-coa-reductase ' monoterapija b'inibitur hija inadegwata. huwa jista ' jintuża bħala monoterapija biss fil-pazjenti li fihom l-inibituri hmg-coa-inibituri reductase jkunu kkunsidrati bħala mhux xierqa jew mhux ittollerati. id-dieta u trattamenti oħra mhux farmakoloġiċi (e. l-eżerċizzju, tnaqqis fil-piż) għandhom jitkomplew matul it-terapija bi tredaptive.

Union européenne - maltais - EMA (European Medicines Agency)

merck sharp dohme ltd - laropiprant, l-aċidu nikotiniku - dyslipidemias - aġenti li jimmodifikaw il-lipidi - trevaclyn huwa indikat għall-kura tal-dyslipidaemia, b'mod partikolari fil-pazjenti bl-dyslipidaemia magħquda imħallat (kkaratterizzati minn livelli elevati ta ' kolesterol baxxa-density-lipoprotein (ldl) u trigliċeridi u baxx għolja-density-lipoprotein (hdl) kolesterol) u fil-pazjenti bl-hypercholesterolaemia primarji (heterozygous familjari u mhux familjari). trevaclyn għandu jintuża fil-pazjenti flimkien ma '3-hydroxy-3-methyl-glutaryl-ko-enzima-a (hmg-coa)-l-inibituri reductase (statins), meta l-kolesterol fid-effett ta 'tnaqqis ta' impedituri hmg-coa-reductase-inibitur tal-monoterapija hija inadegwata. huwa jista ' jintuża bħala monoterapija biss fil-pazjenti li fihom l-inibituri hmg-coa-inibituri reductase jkunu kkunsidrati bħala mhux xierqa jew mhux ittollerati. id-dieta u trattamenti oħra mhux farmakoloġiċi (e. l-eżerċizzju, tnaqqis fil-piż) għandhom jitkomplew matul it-terapija bi trevaclyn.

Union européenne - maltais - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - colesevelam (as hydrochloride) - iperkolesterolemija - aġenti li jimmodifikaw il-lipidi - cholestagel ko amministrati bil-3-hydroxy-3-methyl-glutaryl-coenzyme-a (hmg-coa)-inibitur reductase (statin) huwa indikat bħala terapija adjunctive biex tad-dieta li jipprovdu xi addittiv tnaqqis fil-livelli baxxa-density-lipoprotein-kolesterol (ldl-c) f ' pazjenti adulti bl-hypercholesterolaemia primarji li mhumiex ikkontrollati b'mod adegwat bl-statin waħdu. cholestagel waħdu jintuża bħala terapija aġġuntiva mad-dieta għat-tnaqqis ta ' total-kolesterol u ldl-c f'pazjenti adulti b'iperkolesterolemija primarja, li statin huwa meqjus bħala mhux xierqa jew mhux ittollerati sewwa. cholestagel jista ' jintuża wkoll f'kombinazzjoni ma ezetimibe, bi jew mingħajr statin, f'pazjenti adulti b'iperkolesterolemija primarja, inklużi pazjenti b'familial iperkolesterolemija (ara sezzjoni 5.

Union européenne - maltais - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic acid - hypercholesterolemia; dyslipidemias - aġenti li jimmodifikaw il-lipidi - nilemdo huwa indikat fl-adulti b'iperkolesterolemija primarja (eterozigote familjali u mhux familjali) jew dislipidemija mħallta, bħala żieda mad-dieta:f'kombinazzjoni ma 'statin jew statin oħra li jbaxxu l-lipidi terapiji fil-pazjenti li ma jistgħux jilħqu l-ldl-c-għanijiet mal-doża massima ttollerata ta' statin (ara sezzjonijiet 4. 2, 4. 3, u 4. 4), jew waħdu jew flimkien ma ' oħrajn li jbaxxu l-lipidi terapiji f'pazjenti li huma statin intolleranti għal, jew li għalihom il-statin huwa kontra-indikat.