Evropská unie - maltština - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - lopinavir, ritonavir - infezzjonijiet ta 'hiv - antivirals for systemic use, protease inhibitors - kaletra huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' adulti infettati bil-virus tal-immunodefiċjenza umana (hiv-1), adolexxenti u tfal ta '14-il jum jew aktar. l-għażla ta 'kaletra għall-kura ta' impedituri protease tal-hiv-1 f'pazjenti infettati għandha tkun ibbażata fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjenti.

Evropská unie - maltština - EMA (European Medicines Agency)

mylan ireland limited - abiraterone acetate - neoplasmi prostatiċi - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Evropská unie - maltština - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - aġenti antineoplastiċi - rituzena huwa indikat fl-adulti għall-indikazzjonijiet li ġejjin:mhux ta 'hodgkin (nhl)rituzena huwa indikat għall-kura ta' pazjenti mhux trattati qabel ma l-istadju iii-iv limfoma follikulari flimkien mal-kimoterapija. rituzena monoterapija hija indikata għat-trattament ta 'pazjenti b'stadju iii-iv limfoma follikulari li huma kemo reżistenti jew li qegħdin fit-tieni jew aktar episodju ta' rkadar wara kimoterapija. rituzena huwa indikat għall-kura ta 'pazjenti bil-tixrid pożittiv cd20 taċ-ċelluli b kbar mhux ta' hodgkin il-limfoma f'kombinazzjoni ma ' chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) l-kimoterapija. lewkimja limfoċitika kronika (cll)rituzena flimkien ma 'kimoterapija huwa indikat għat-trattament ta' pazjenti li ma kienux trattati qabel u li reġgħet tfaċċat/refrattarja cll. hemm biss informazzjoni limitata disponibbli fuq l-effikaċja u s-sigurtà għall-pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż rituzenaor pazjenti refrattarji għal preċedenti rituzena flimkien ma ' kimoterapija. granulomatosi b'polianġite u mikroskopika polyangiitisrituzena, flimkien ma 'glukokortikosterojdi, huwa indikat għall-induzzjoni ta' remissjoni f'pazjenti adulti b'mard sever, attiv granulomatosi b'polianġite (wegener) (fap) u polianġite mikroskopika (mpa).

Evropská unie - maltština - EMA (European Medicines Agency)

takeda gmbh - pantoprazole - reflux gastroesofagi - inibituri tal-proton pump - trattament fuq medda qasira ta 'żmien ta' sintomi ta 'rifluss (e. ħruq ta 'stonku, riġenerazzjoni tal-aċidu) fl-adulti.

Evropská unie - maltština - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - clopidogrel (as hydrogen sulfate) - stroke; peripheral vascular diseases; myocardial infarction; acute coronary syndrome - aġenti antitrombotiċi - clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta 'avvenimenti aterotrombotiċi f': pazjenti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali. - pazjenti li jbatu mis-sindromu koronarju akut:mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux-mewġa-q infart mijokardijaku), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutanju, flimkien ma ' acetylsalicylic acid (asa). elevazzjoni tas-segment st infart mijokardijaku akut, flimkien ma ' asa f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika.

Evropská unie - maltština - EMA (European Medicines Agency)

biomarin international limited - vosoritide - achondroplasia - drogi għat-trattament ta 'mard tal-għadam - voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Evropská unie - maltština - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - aġenti antitrombotiċi - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Evropská unie - maltština - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedemas, ereditarji - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Evropská unie - maltština - EMA (European Medicines Agency)

takeda gmbh - pantoprazole - reflux gastroesofagi - inibituri tal-proton pump - trattament fuq medda qasira ta 'żmien ta' sintomi ta 'rifluss (e. ħruq ta 'stonku, riġenerazzjoni tal-aċidu) fl-adulti.

Evropská unie - maltština - EMA (European Medicines Agency)

roche registration gmbh - enfuvirtide - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - fuzeon huwa indikat f ' għaqda mal-oħrajn antiretroviral prodotti mediċinali għat-trattament ta ' l-hiv 1-infettata pazjenti li jkunu rċevew trattament ma u falla fuq reġimi li jkun fih il-prodott mediċinali mill-inqas wieħed minn kull waħda minn dawn li ġejjin klassijiet ta ' antiretroviral: inibituri tal-protease, in-nuqqas ta ' nukleosidi transcriptase tat-treġġiegħ lura inibituri u nukleosidi transcriptase tat-treġġiegħ lura inibituri, jew li jkollhom intolleranza għal reġimi ta ' antiretroviral qabel. biex jiġi deċiż programm ta 'kura ġdid għal pazjenti li jkunu fallew kors antiretrovirali, attenzjoni partikulari għandha tingħata lill-istorja tat-trattament tal-pazjent individwali u l-mudelli ta' tibdiliet ġenetiċi assoċjati ma ' prodotti mediċinali differenti. fejn disponibbli, l-ittestjar tar-reżistenza jista ' jkun adattat.