Quofenix Unjoni Ewropea - Malti - EMA (European Medicines Agency)

quofenix

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - infezzjonijiet akkwistati mill-komunità - antibatteriċi għal użu sistemiku, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 u 5. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Sogroya Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sogroya

novo nordisk a/s - somapacitan - tkabbir - ormoni u analogi pitwitarji u ipotalamiċi - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).

Ngenla Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ngenla

pfizer europe ma eeig - somatrogon - growth and development - pitwitarja u l-assi ipotalamika-ormoni u analogi - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.

Mounjaro Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mounjaro

eli lilly nederland b.v. - tirzepatide - diabetes mellitus, tip 2 - drogi użati fid-dijabete - mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications- in addition to other medicinal products for the treatment of diabetes. for study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4. 4, 4. 5 u 5.

Dapagliflozin Viatris Unjoni Ewropea - Malti - EMA (European Medicines Agency)

dapagliflozin viatris

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogi użati fid-dijabete - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 u 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Aflunov Unjoni Ewropea - Malti - EMA (European Medicines Agency)

aflunov

seqirus s.r.l.  - antiġeni tal-wiċċ tal-virus tal-influwenza (emagglutinin u neuraminidase) ta 'razza: razza a / dundjan / turkija / 1/05 (h5n1) (nibrg-23) - influenza, human; immunization; disease outbreaks - vaċċini - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus ta 'l-influwenza a. din l-indikazzjoni hija bbażata fuq dejta ta 'immunoġeniċità minn individwi b'saħħithom mill-età ta' 18-il sena'l quddiem wara l-amministrazzjoni ta ' żewġ dożi tal-vaċċin li fih a/turkey/turkey/1/05 (h5n1) like strain. aflunov għandu jintuża skond ir-rakkomandazzjonijiet uffiċjali.

Entyvio Unjoni Ewropea - Malti - EMA (European Medicines Agency)

entyvio

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - immunosuppressanti selettivi - kolite colitisentyvio huwa indikat għall-kura ta ' pazjenti adulti b'attiva minn moderata sa gravi kolite bl-ulċeri li kellhom rispons inadegwat b', tilfu r-rispons għal, jew li kienu intolleranti jew terapija konvenzjonali jew fattur tan-nekrożi tat-tumur alfa (tnfa) antagonist. crohn diseaseentyvio huwa indikat għall-kura ta 'pazjenti adulti b'attiva minn moderata sa gravi marda ta' crohn li kellhom rispons inadegwat b', tilfu r-rispons għal, jew li kienu intolleranti jew terapija konvenzjonali jew fattur tan-nekrożi tat-tumur alfa (tnfa) antagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Evoltra Unjoni Ewropea - Malti - EMA (European Medicines Agency)

evoltra

sanofi b.v. - clofarabine - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - trattament ta ' akuta lymphoblastic lewċemja (kollha) fil-pazjenti pedjatriċi li jkunu relapsed jew huma refrattorju wara li jirċievu mill-inqas żewġ reġimi minn qabel u fejn hemm l-ebda oħra trattament għażla antiċipat li jirriżultaw fi tweġiba dejjiema. is-sigurtà u l-effikaċja ġew ivvalutati fi studji ta 'pazjenti ta' ≤ 21 sena fid-dijanjożi inizjali.

Foclivia Unjoni Ewropea - Malti - EMA (European Medicines Agency)

foclivia

seqirus s.r.l.  - antiġeni tal-wiċċ tal-virus ta 'l-influwenza, inattivati: a / vjet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini ta 'l-influwenza - profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment. il-vaċċin kontra l-influwenza pandemika għandu jintuża skond il-gwida uffiċjali.

Humira Unjoni Ewropea - Malti - EMA (European Medicines Agency)

humira

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - immunosoppressanti - jekk jogħġbok irreferi għad-dokument ta 'informazzjoni dwar il-prodott.