European Union - Maltese - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - antibatteriċi għal użu sistemiku, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4. 2, 4. 4 u 5. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

European Union - Maltese - EMA (European Medicines Agency)

glaxo group ltd. - fondaparinux sodium - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - aġenti antitrombotiċi - 5 mg / 0. 3 ml u 2. 5 mg / 0. 5 ml, soluzzjoni għall-injezzjoni:, il-prevenzjoni ta ' każi trombo-emboliċi venużi (vte) f'pazjenti għaddejjin minn kirurġija ortopedika maġġuri tar-riġlejn bħal fratturi fil-ġenb, kirurġija maġġuri fl-irkoppa jew tal-ġenbejn operazzjoni tas-sostituzzjoni. , il-prevenzjoni ta 'każi trombo-emboliċi venużi (vte) f'pazjenti għaddejjin minn kirurġija addominali li huma meqjusa f'riskju għoli ta 'kumplikazzjonijiet ta' trombo-emboliżmu, bħal pazjenti li jgħaddu minn kirurġija għall-kanċer (ara sezzjoni 5. , il-prevenzjoni ta 'każi trombo-emboliċi venużi (vte) f' pazjenti mediċi li huma meqjusa f'riskju għoli ta 'vte u li huma immobili minħabba mard akut bħal insuffiċienza kardijaka u/jew mard respiratorju akut, u/jew mard akut infettiv jew ta' infjammazzjoni. , , 2. 5 mg / 0. 5 ml, soluzzjoni għall-injezzjoni:, it-trattament ta 'anġina mhux stabbli jew mhux tas-segment st' infart mijokardijaku b'elevazzjoni (ua/nstemi) fil-pazjenti li għalihom urġenti (< 120 minuta) invasif (pci) mhuwiex indikat (ara sezzjonijiet 4. 4 u 5. , it-trattament tal-elevazzjoni tas-segment st 'infart mijokardijaku (stemi) f'pazjenti li huma ttrattati b'trombolitiċi jew li fil-bidu qegħdin jirċievu l-ebda forma oħra ta' riperfużjoni-terapija. , , 5 mg/0. 4 ml, 7. 5 mg / 0. 6 ml u 10 mg / 0. 8 ml soluzzjoni għall-injezzjoni:, it-trattament ta 'trombożi f' vina fonda (dvt) u t-trattament ta ' emboliżmu pulmonari (pe), ħlief fil-ħruġ emodinamikament instabbli, jew pazjenti li għandhom bżonn tromboliżi jew embolektomija.

European Union - Maltese - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - aġenti antineoplastiċi oħra - removab huwa indikat għat-trattament intraperitoneali ta 'axxiti malinni f'pazjenti b'karċinomi pożittivi għal epcam fejn it-terapija standard mhijiex disponibbli jew m'għadhiex possibbli.

European Union - Maltese - EMA (European Medicines Agency)

ceva santé animale - torasemide - għolja limitu dijuretiċi, għas-sulfonamidi, sempliċi - klieb - għat-trattament ta ' sinjali kliniċi relatati mal-insuffiċjenza tal-qalb konġestiva fil-klieb, inkluż edima pulmonari.

European Union - Maltese - 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.

European Union - Maltese - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - sera immuni u immunoglobulini, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

European Union - Maltese - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - regdanvimab - covid-19 virus infection - sera immuni u immunoglobulini, - regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (covid-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19.

European Union - Maltese - EMA (European Medicines Agency)

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - sera immuni u immunoglobulini, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. ara t-taqsimiet 4. 4 u 5.

European Union - Maltese - EMA (European Medicines Agency)

stada arzneimittel ag - budesonide, micronised - glomerulonephritis, iga - antidiarrheals, intestinali anti-infjammatorji / antiinfective aġenti - kinpeygo is indicated for the treatment of primary immunoglobulin a (iga) nephropathy (igan) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (upcr) ≥1. 5 g/gram.

European Union - Maltese - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - majloma multipla - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.