Europese Unie - Maltees - EMA (European Medicines Agency)

accord healthcare s.l.u. - ċitrat ta 'sildenafil - pressjoni għolja, pulmonari - uroloġiċi - adultstreatment ta ' pazjenti adulti bi pressjoni għolja arterjali tal-pulmun ikklassifikata bħala klassi funzjonali who ii u iii, biex itejbu l-kapaċità għall-eżerċizzju. l-effikaċja intweriet fl-ipertensjoni primarja pulmonari u pressjoni għolja pulmonari assoċjata ma 'mard tat-tessut konnettiv. pedjatriċi populationtreatment tal-pazjenti pedjatriċi li kellhom minn sena 1 sa 17-il sena bi pressjoni arterjali pulmonari għolja. effikaċja skont it-titjib tal-kapaċità ta ' l-eżerċizzju jew haemodynamics pulmonari intwera fl-ipertensjoni pulmonari primarji u ipertensjoni pulmonari assoċjati ma ' mard tal-qalb konġenitali.

Europese Unie - Maltees - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Europese Unie - Maltees - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - għall-pazjenti adulti b'dijabete tat-tip 2 mellitus, januvia huwa indikat biex itejbu l-kontroll gliċemiku:bħala monoterapija:f'pazjenti li mhumiex ikkontrollati biżżejjed bid-dieta u l-eżerċizzju waħidhom u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza;bħala terapija dupliċi orali flimkien mal:metformin meta d-dieta u l-eżerċizzju flimkien ma 'metformin waħdu ma jipprovdux kontroll gliċemiku adegwat;sulphonylurea meta d-dieta u l-eżerċizzju flimkien ma' doża massima tollerata ta ' sulphonylurea waħedhom ma jipprovdux kontroll gliċemiku adegwat u meta metformin ma jkunx adegwat minħabba kontraindikazzjonijiet jew intolleranza;a peroxisome-proliferator-activated-riċettur gamma (ppary) agonist (i. thiazolidinedione) meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma ' l-agonist ppary waħdu ma jipprovdux kontroll gliċemiku adegwat;ppary agonist (i. thiazolidinedione) meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma 'l-agonist ppary waħdu ma jipprovdux kontroll gliċemiku adegwat;bħala terapija trippla orali f'kombinazzjoni ma': sulphonylurea u metformin meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat;ppary agonista u metformin meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat. januvia huwa wkoll indikat bħala żieda mal-insulina (bil-metformina jew mingħajrha) meta d-dieta u l-eżerċizzju flimkien ma doża stabbli ta ' l-insulina ma jipprovdux kontroll gliċemiku adegwat.

Europese Unie - Maltees - EMA (European Medicines Agency)

viatris limited - ċitrat ta 'sildenafil - pressjoni għolja, pulmonari - uroloġiċi - adultstreatment ta ' pazjenti adulti bi pressjoni għolja arterjali tal-pulmun ikklassifikata bħala klassi funzjonali who ii u iii, biex itejbu l-kapaċità għall-eżerċizzju. l-effikaċja intweriet fl-ipertensjoni primarja pulmonari u pressjoni għolja pulmonari assoċjata ma 'mard tat-tessut konnettiv. pedjatriċi populationtreatment tal-pazjenti pedjatriċi li kellhom minn sena 1 sa 17-il sena bi pressjoni arterjali pulmonari għolja. l-effikaċja f'termini ta 'titjib tal-kapaċità ta' eżerċizzju jew ta 'emodinamiċità pulmonari intweriet fl-ipertensjoni primarja pulmonari u pressjoni għolja pulmonari assoċjata ma' mard tal-qalb konġenitali (ara sezzjoni 5.

Europese Unie - Maltees - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiċi għal użu sistemiku - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 u 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 u 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 u 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 u 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 u 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 u 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 u 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1): il - każ tal-asperġillożi invażiva f'pazjenti b'mard li hu refrattarju għal amphotericin b jew itraconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali; l - fusarjożi f'pazjenti b'mard li hu refrattarju għal amphotericin b jew f'pazjenti intolleranti għal amphotericin b;- kromoblastomikożi u miċetoma f'pazjenti b'mard li hu refrattarju għal itraconazole jew f'pazjenti intolleranti għal itraconazole;- kokkidajojdomikożi f'pazjenti b'mard li hu refrattarju għal amphotericin b, itraconazole jew fluconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali;- kandidijażi orofarinġali: bħala l-kura preferita f'pazjenti li għandhom mard sever jew li huma immunokompromessi, li r-rispons għal terapija topika hija mistennija li tkun fqir. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Europese Unie - Maltees - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - għall-pazjenti adulti b'dijabete tat-tip 2 mellitus, ristaben huwa indikat biex itejbu l-kontroll gliċemiku:bħala monoterapija:f'pazjenti li mhumiex ikkontrollati biżżejjed bid-dieta u l-eżerċizzju waħidhom u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza;bħala terapija dupliċi orali flimkien mal:metformin meta d-dieta u l-eżerċizzju flimkien ma 'metformin waħdu ma jipprovdux kontroll gliċemiku adegwat;sulphonylurea meta d-dieta u l-eżerċizzju flimkien ma' doża massima tollerata ta ' sulphonylurea waħedhom ma jipprovdux kontroll gliċemiku adegwat u meta metformin ma jkunx adegwat minħabba kontraindikazzjonijiet jew intolleranza;a peroxisome proliferator-activated-riċettur gamma (ppary) agonist (i. thiazolidinedione) meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma 'l-agonist ppary waħdu ma jipprovdux kontroll gliċemiku adegwat;bħala terapija trippla orali f'kombinazzjoni ma': sulphonylurea u metformin meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat;ppary agonista u metformin meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat. ristaben huwa wkoll indikat bħala żieda mal-insulina (bil-metformina jew mingħajrha) meta d-dieta u l-eżerċizzju flimkien ma doża stabbli ta ' l-insulina ma jipprovdux kontroll gliċemiku adegwat.

Europese Unie - Maltees - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterokolite, pseudomembranuża - sera immuni u immunoglobulini, - zinplava huwa indikat għall-prevenzjoni ta 'rikorrenza ta' infezzjoni clostridium difficile (cdi) f'persuni adulti f'riskju għoli għal rikorrenza ta 'cdi.

Europese Unie - Maltees - EMA (European Medicines Agency)

upjohn eesv - sildenafil - pressjoni għolja, pulmonari - uroloġiċi - trattament tal-pazjenti adulti bl-ipertensjoni arterjali pulmonari klassifikati bħala klassi funzjonali tal-organizzazzjoni dinjija tas-saħħa (who) ii u iii, biex itejbu l-kapaċità ta ' l-eżerċizzju. l-effikaċja intweriet fl-ipertensjoni primarja pulmonari u pressjoni għolja pulmonari assoċjata ma 'mard tat-tessut konnettiv. pedjatriċi populationtreatment tal-pazjenti pedjatriċi li għandhom minn sena sa 17-il sena bi pressjoni arterjali pulmonari għolja. effikaċja skont it-titjib tal-kapaċità ta ' l-eżerċizzju jew haemodynamics pulmonari intwera fl-ipertensjoni pulmonari primarji u ipertensjoni pulmonari assoċjati ma ' mard tal-qalb konġenitali. revatio soluzzjoni għall-injezzjoni hija għall-kura ta ' pazjenti adulti bi pressjoni għolja arterjali pulmonari li bħalissa huma preskritti orali revatio u li huma temporanjament inkapaċi li jieħdu terapija orali, iżda huma inkella klinikament u emodinamikament stabbli. revatio (mill-ħalq) huwa indikat għat-trattament ta ' pazjenti adulti bi pressjoni għolja arterjali tal-pulmun ikklassifikata bħala klassi funzjonali who ii u iii, biex itejbu l-kapaċità għall-eżerċizzju. l-effikaċja intweriet fl-ipertensjoni primarja pulmonari u pressjoni għolja pulmonari assoċjata ma 'mard tat-tessut konnettiv.

Europese Unie - Maltees - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - għall-pazjenti adulti b'dijabete tat-tip 2 mellitus, xelevia huwa indikat biex itejbu l-kontroll gliċemiku:bħala monoterapija:f'pazjenti li mhumiex ikkontrollati biżżejjed bid-dieta u l-eżerċizzju waħidhom u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza;bħala terapija dupliċi orali flimkien mal:metformin meta d-dieta u l-eżerċizzju flimkien ma 'metformin waħdu ma jipprovdux kontroll gliċemiku adegwat;sulphonylurea meta d-dieta u l-eżerċizzju flimkien ma' doża massima tollerata ta ' sulphonylurea waħedhom ma jipprovdux kontroll gliċemiku adegwat u meta metformin ma jkunx adegwat minħabba kontraindikazzjonijiet jew intolleranza;a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. thiazolidinedione) meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma 'l-agonist ppary waħdu ma jipprovdux kontroll gliċemiku adegwat;bħala terapija trippla orali f'kombinazzjoni ma': sulphonylurea u metformin meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat;ppary agonista u metformin meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat. xelevia huwa wkoll indikat bħala żieda mal-insulina (bil-metformina jew mingħajrha) meta d-dieta u l-eżerċizzju flimkien ma doża stabbli ta ' l-insulina ma jipprovdux kontroll gliċemiku adegwat.

Europese Unie - Maltees - EMA (European Medicines Agency)

novartis europharm limited  - pazopanib - karċinoma, Ċellula renali - aġenti antineoplastiċi - tal-kliewi-karċinoma taċ-ċellola (rcc)votrient huwa indikat fl-adulti għall-ewwel linja ta ' trattament ta avvanzat tal-kliewi-karċinoma taċ-ċellola (rcc) u għall-pazjenti li rċevew terapija minn qabel b'ċitokini għal marda avvanzata. sarkoma tat-tessuti rotob (sts)votrient huwa indikat għall-kura ta 'pazjenti adulti b'selettiv sottotipi ta' sarkoma tat-tessuti rotob (sts) u li jkunu ħadu l-kimoterapija qabel, għal mard metastatiku jew li għamlu progress fi żmien 12-il xahar ta'wara (neo)terapija miżjuda. l-effikaċja u s-sigurtà għandhom biss ġewx stabbiliti f'ċerti sts istoloġika tat-tumur sottotipi.