Europäische Union - Maltesisch - 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.

Europäische Union - Maltesisch - 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.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - sera immuni u immunoglobulini, - xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe covid-19.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus eritematoso, sistemiku - immunosoppressanti - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunosoppressanti - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan pharmaceuticals limited - emtricitabine, tenofovir disoproxil maleate - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - treatment of hiv-1 infection:emtricitabine/tenofovir disoproxil mylan is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults (see section 5. emtricitabine/tenofovir disoproxil mylan is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, (see sections 4. 2, 4. 4 u 5. pre-exposure prophylaxis (prep):emtricitabine/tenofovir disoproxil mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk (see sections 4. 2, 4. 4 u 5.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

zentiva k.s. - emtricitabine, tenofovir disoproxil phosphate - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - it-trattament ta 'l-hiv-1 infectionemtricitabine/tenofovir disoproxil zentiva hu indikat għal terapija antiretrovirali kombinata għall-kura ta' l-hiv-1 adulti infettati. emtricitabine/tenofovir disoproxil zentiva huwa wkoll indikat għall-kura ta ' l-hiv-1 infettati fl-adolexxenti, b'reżistenza għal nrti li dehret jew tossiċitajiet li teskludi l-użu tal-ewwel linja aġenti. espożizzjoni minn qabel profilassi (j)ta ' emtricitabine/tenofovir disoproxil zentiva hu indikat flimkien mal-prattiċi ta'sess aktar għall-espożizzjoni minn qabel l-profilassi biex jitnaqqas ir-riskju ta sesswalment miksuba bl-hiv-1-infezzjoni fl-adulti u fl-adoloxxenti f'riskju għoli.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

zentiva k.s. - tenofovir disoproxil phosphate - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - bl‑hiv-1 infectiontenofovir disoproxil zentiva hu indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' l-hiv‑1 adulti infettati. fl-adulti, id-dimostrazzjoni tal-benefiċċju ta 'tenofovir disoproxil fl-hiv‑1 li l-infezzjoni hija bbażata fuq ir-riżultati ta' studju wieħed f'pazjenti bi trattament naïve, inklużi pazjenti bi piż virali għoli (> 100, 000 kopja/ml) u studji li fihom tenofovir disoproxil ġie miżjud mal-stabbli terapija ta 'sfond (l-aktar tritherapy) fil antiretrovirali qabel l‑kkurati pazjenti li qed jesperjenzaw il-bidu ta' falliment viroloġiku (< kull 10, 000 kopji/ml, bil-maġġoranza tal-pazjenti jkollhom < 5, 000 kopji/ml). tenofovir disoproxil zentiva huwa wkoll indikat għall-kura ta ' l-hiv‑1 infettati fl-adolexxenti, b'nrti (nucleotide reverse transcriptase inhibitor) ir-reżistenza jew tossiċitajiet li teskludi l-użu tal-ewwel linja ta'l-aġenti, l-età bejn 12 u < 18-il sena. l-għażla ta ' tenofovir disoproxil zentiva għall-kura antiretrovirali f'pazjenti esperjenzati bl-hiv‑1 infezzjoni għandha tkun ibbażata fuq testijiet tar-reżistenza virali u/jew l-istorja tat-trattament tal-pazjenti. l-epatite b infectiontenofovir disoproxil zentiva hu indikat għall-kura ta 'epatite b kronika f'adulti b': mard tal-fwied kumpensat, b'evidenza ta 'replikazzjoni virali attiva, persistenti elevati fis-serum alanine aminotransferase (alt) livelli u evidenza istoloġika ta' infjammazzjoni attiva u/jew fibrożi (ara sezzjoni 5. 1);l-evidenza ta ' lamivudine reżistenti tal-virus epatite b (ara sezzjonijiet 4. 8 u 5. 1);mard tal-fwied dekompensat (ara sezzjonijiet 4. 4, 4. 8 u 5. tenofovir disoproxil zentiva hu indikat għall-kura ta ' epatite b kronika f'adolexxenti minn 12 sa < 18-il sena:mard tal-fwied ikkumpensat u evidenza ta immuni-marda attiva, i. replikazzjoni virali attiva, persistenti elevati fis-serum livelli ta 'alt u evidenza istoloġika ta' infjammazzjoni attiva u/jew fibrożi (ara sezzjonijiet 4. 4, 4. 8 u 5.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - sindromu adh inappropriate - id-dijuretiċi, - trattament ta 'pazjenti adulti b'iponatrija sekondarja għal sindromu ta' sekrezzjoni mhux xierqa ta 'l-ormon antidijuretiku (siadh).