Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - patiromer sorbitex calcium - iperkalemija - - mediċini għal-kura tal-iperkalimja u ' l-iperphosphatemija - veltassa huwa indikat għall-kura ta 'iperkalimja fl-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - linaclotide - sindromu tal-musrana irritabbli - drogi għal stitikezza - constella hija indikata għat-trattament sintomatiku ta 'sindromu tal-musrana irritabbli moderata għal severa b'stitikazzjoni (ibs-c) f'adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - ethelcalcetide hydrochloride - iperparatirojdiżmu, sekondarja - anti-parathyroid agents, calcium homeostasis - parsabiv huwa indikat għall-kura ta 'iperparatirojdiżmu sekondarju (shpt) f'pazjenti adulti b'mard kroniku tal-kliewi (ckd) fuq terapija ta' emodijalisi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

theramex ireland limited - abaloparatide - osteoporosis, postmenopausal; osteoporosis - homeostasi tal-kalċju - trattament ta 'l-osteoporożi f'nisa wara l-menopawża b'riskju akbar ta' ksur.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - ibandronic acid - wounds and injuries; breast diseases; neoplastic processes; calcium metabolism disorders; water-electrolyte imbalance - drogi għat-trattament ta 'mard tal-għadam - ibandronic acid huwa indikat fl-adulti forprevention ta ' episodji skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl-għadam li jeħtieġu r-radjuterapija jew il-kirurġija) f'pazjenti b'kanċer tas-sider u metastażi fl-għadam. trattament ta ' iperkalċemja kkawżata minn tumuri bi jew mingħajr metastażi. it-trattament ta'l-osteoporożi f'nisa wara l-menopawża f'riskju miżjud ta'ksur (ara sezzjoni 5. tnaqqis fir-riskju ta ' ksur vertebrali ġie muri, l-effikaċja fuq il-ksur fl-għonq tal-femora ma ġietx stabbilita.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi b.v. - sevelamer - renal dialysis; hyperphosphatemia - il-prodotti terapewtiċi l-oħra kollha - renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - irbesartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. din id-doża fissa kombinata hija indikata f'pazjenti adulti li l-pressjoni tad-demm ma tkunx ikkontrollata adegwatament fuq irbesartan jew b ' hydrochlorothiazide waħidhom (ara sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - telmisartan - pressjoni għolja - sistema kardjovaskulari - it-trattament tal-ipertensjoni essenzjali fl-adulti:Żid fuq therapyonduarp huwa indikat fl-adulti li l-pressjoni tad-demm mhijiex ikkontrollata adegwatament bl-amlodipina. is-sostituzzjoni therapyadult pazjenti li kienu qed jirċievu telmisartan u amlodipine minn pilloli separati jistgħu minflok ma jirċievu l-pilloli ta ' onduarp li fihom l-istess dożi tal-komponenti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mallinckrodt deutschland gmbh - gadoversetamide - immaġni tar-reżonanza manjetika - midja ta 'kuntrast - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. optimark hu indikat għall-użu mal-immaġni tar-reżonanza manjetika (mri) tas-sistema nervuża ċentrali (cns) u l-fwied. jipprovdi titjib tal-kuntrast u jiffaċilita l-viżwalizzazzjoni u jgħin fil-karatterizzazzjoni tal-leżjonijiet fokali u strutturi anormali fis-cns u fil-fwied f'pazjenti b'magħrufa jew issuspettata patoloġija.