European Union - Maltese - EMA (European Medicines Agency)

n.v. organon - desloratadine - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - anti-istaminiċi għall-użu sistemiku, - neoclarityn huwa indikat għas-serħan mis-sintomi assoċjati ma': allerġiċi rhinitisurticaria.

European Union - Maltese - EMA (European Medicines Agency)

krka, d.d., novo mesto - rivastigmine - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - trattament sintomatiku ta 'dimenzja ta' alzheimer ħafifa għal moderatament gravi. kura sintomatika ta 'minn ħafifa għal moderatament gravi dimenzja f'pazjenti bil-marda idjopatika ta' parkinson.

European Union - Maltese - 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.

European Union - Maltese - EMA (European Medicines Agency)

merck sharp & dohme b.v. - rotavirus serotip g1, serotip g2, serotip g3, serotip g4, serotip p1 - immunization; rotavirus infections - vaccines, viral vaccines - rotateq huwa indikat għall-immunizzazzjoni attiva tat-trabi mill-età ta 'sitt ġimgħat sa 32 ġimgħa għall-prevenzjoni ta' gastroenterite minħabba infezzjoni ta 'rotavirus. rotateq għandu jintuża fuq il-bażi ta ' rakkomandazzjonijiet uffiċjali.

European Union - Maltese - EMA (European Medicines Agency)

n.v. organon - follitropin beta - infertility; hypogonadism - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - fil-mara:puregon huwa indikat għall-kura ta 'nisa infertilità fis-sitwazzjonijiet kliniċi li ġejjin:meta ma jkunx hemm ovulazzjoni (inkluż l-sindromu tal-ovarji poliċistiċi, pcos) fin-nisa li ġew jirrispondux għall-kura bi clomifene citrate;iperstimulazzjoni kkontrollata ta' l-ovarji sabiex tistimula l-iżvilupp tal-follikuli multipli fi programmi ta ' riproduzzjoni medikament assistiti (e. fil-fertilizzazzjoni in vitro / - trasferiment tal-embriju (ivf/et), il-gameti intrafallopian trasferiment (gift) u intracytoplasmic-injezzjoni ta ' l-isperma (icsi)). fir-raġel:defiċjenza ta ' spermatoġenesi minħabba ipogonadiżmu ipogonadotrofiku.

European Union - Maltese - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - pemetrexed - carcinoma, non-small-cell lung; mesothelioma - aġenti antineoplastiċi - plewrali malinna mesotheliomapemetrexed fresenius kabi flimkien ma ' cisplatin huwa indikat għat-trattament tal-kimoterapija naïve pazjenti b'mesoteljoma plewrali malinna u li ma jistax jitneħħa. taċ-ċelluli mhux żgħar tal-pulmun cancerpemetrexed fresenius kabi flimkien ma 'cisplatin huwa indikat għat-trattament tal-ewwel linja ta' pazjenti b'lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi. pemetrexed fresenius kabi huwa indikat bħala monoterapija għall-kura ta 'manteniment ta lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta' ċelluli skwamużi fir-pazjenti li l-marda tagħhom ma jkunx hemm progress immedjatament wara ibbażat fuq il-platinu ' kimoterapija. pemetrexed fresenius kabi huwa indikat bħala monoterapija għall-tieni linja ta 'trattament ta' pazjenti b'lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi.

European Union - Maltese - 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.

European Union - Maltese - EMA (European Medicines Agency)

krka - olanzapine - schizophrenia; bipolar disorder - psikolettiċi - olanzapine huwa indikat għall-kura ta 'l-iskiżofrenja. olanzapine hija effettiva biex iżżomm it-titjib kliniku waqt terapija kontinwa f'pazjenti li wrew rispons inizjali għat-trattament. olanzapine hu indikat għall-kura moderata għal severa ta ' episodju ta'manija. f'pazjenti li l-episodju ta'manija għandu rrispondew għat-trattament b'olanzapine, olanzapine hija indikata għall-prevenzjoni ta'rikorrenza f'pazjenti b'diżordni bipolari.

European Union - Maltese - 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.

European Union - Maltese - EMA (European Medicines Agency)

merck sharp dohme ltd - boceprevir - epatite Ċ, kronika - antivirali għal użu sistemiku - victrelis huwa indikat għall-kura ta ' l-infezzjoni tal-ġenotip-1 kronika epatite-c (chc), flimkien mal-peginterferon alfa u ribavirin, fil-pazjenti adulti b ' mard tal-fwied kompensat li huma mhux ittrattat minn qabel jew li jkunu fallew terapija qabel.