Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - afatinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - giotrif bħala monoterapija hija indikata għat-trattament ofepidermal growth factor receptor (egfr) tki pazjenti adulti naΐve għal kura bil-lokalment avvanzat jew dak metastatiku li mhux ta 'ċelluli żgħar kanċer tal-pulmun (nsclc) ma' l-attivazzjoni tal-egfr-mutazzjoni tal - (s);lokalment avvanzat jew metastatiku nsclc tal-kanser skwamuż tar-istoloġija tal-progress fuq jew wara ibbażat fuq il-platinu ' kimoterapija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - kliewi poliċistiku, autosomal dominanti - id-dijuretiċi, - jinarc huwa indikat biex tnaqqas il-progressjoni tal-iżvilupp tal-Ġlata u insuffiċjenza renali tal-marda tal-kliewi polycystic dominanti autosomal (adpkd) fl-adulti b ' ckd stadju 1 sa 3 fil-bidu tat-trattament bi prova tal-marda malajr jipprogressa b ' mod.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

theravance biopharma ireland umited - telavancin - pneumonia, bacterial; cross infection - antibatteriċi għal użu sistemiku, - vibativ huwa indikat għat-trattament ta ' l-adulti bl-pnewmonja nosokomjali inklużi ventilaturi assoċjati pnewmonja, magħrufa jew issuspettat li jkun ikkawżat mill-awrei-reżistenti staphylococcus aureus (mrsa). vibativ għandu jintuża biss f'sitwazzjonijiet fejn huwa magħruf jew hemm suspett li l-alternattivi oħra mhumiex adattati. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - voriconazole - aspergillosis; candidiasis; mycoses - antimikotiċi għall-użu sistemiku-derivattivi tat-triazole - voriconazole huwa aġent broad-spectrum, aġent antifungali triazole u hija indikata fl-adulti u t-tfal li għandhom sentejn u aktar kif ġej:trattament ta 'asperġillożi invażiva;it-trattament ta'candidaemia f'pazjenti mhux newtropeniċi;il-kura ta' fluconazole-'infezzjonijiet invażivi serji candida reżistenti (inkluż c. krusei);il-kura ta'infezzjonijiet fungali serji kkawżati minn scedosporium spp. u fusarium spp. voriconazole għandu jingħata primarjament lil pazjenti b'progressiva, possibbilment ta'theddida għall-ħajja infezzjonijiet.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - evolocumab - dyslipidemias; hypercholesterolemia - aġenti li jimmodifikaw il-lipidi - iperkolesterolemija u mħallta dyslipidaemiarepatha 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 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. omozigota familjali hypercholesterolaemiarepatha hija indikata fl-adulti u adolexxenti minn 12-il sena u aktar bl-omozigota familjali flimkien ma'oħrajn li jbaxxu l-lipidi terapiji. stabbiliti aterosklerotiċi kardjovaskulari diseaserepatha huwa indikat fl-adulti bil-stabbilit aterosklerotiċi mard tal-qalb (infart mijokardijaku, puplesija, jew mard arterjali periferali) biex inaqqsu r-riskju kardjovaskulari minn tnaqqis ta 'ldl-c livelli, bħala kura aġġuntiva għall-korrezzjoni tal-fatturi ta' riskju oħra:fil-kombinazzjoni ma'l-doża massima ttollerata ta 'statin ma' jew mingħajr l-oħra li jbaxxu l-lipidi terapiji 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. għall-riżultati tal-istudju fir-rigward tal-effetti fuq l-ldl-c, episodji kardjovaskulari u l-popolazzjonijiet studjati ara sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

leo pharma a/s - tacrolimus - dermatite, atopika - preparazzjonijiet oħra dermatoloġiċi - flare treatmentadults and adolescents (16 years of age and above)treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. children (two years of age and above)treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. maintenance treatmentmaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i. li jseħħu erba'darbiet jew aktar kull sena) li kellhom rispons inizjali għall-massimu ta 'sitt ġimgħat it-trattament ta' darbtejn kuljum ta ' tacrolimus ingwent (leżjonijiet approvat, kważi approvati jew xi ftit affettwati).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunosoppressanti - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - avacopan - microscopic polyangiitis; wegener granulomatosis - immunosoppressanti - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolactone - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 u 5.