Uniunea Europeană - malteză - EMA (European Medicines Agency)

mylan pharmaceuticals limited - efavirenz, emtricitabine, tenofovir disoproxil maleate - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - efavirenz / emtricitabine / tenofovir disoproxil mylan huwa kombinazzjoni ta 'doża fissa ta' efavirenz, emtricitabine u tenofovir disoproxil. dan huwa indikat għat-trattament ta ' l-infezzjoni tal-virus ta ' immunodefiċjenza umani-1 (hiv-1) fl-adulti età ta ' 18-il sena u aktar ma virologic it-trażżin għall-hiv-1 rna livelli ta ' < 50 kopji/ml fuq tagħhom terapija kurrenti antiretroviral ta ' l-għaqda għal aktar minn tliet xhur. pazjenti għandu ma esperjenzaw nuqqas viroloġika fuq xi terapija antiretroviral minn qabel u għandhom ikunu magħrufa li ma jkunu harboured ir-razez tal-virus bl-mutazzjonijiet li jikkonferixxu reżistenza sinifikanti lil xi tat-tliet komponenti li jinsabu fil-efavirenz / emtricitabine/tenofovir disoproxil mylan qabel il-bidu ta ' l-ewwel skoperta ta ' trattament ta ' antiretroviral. id-dimostrazzjoni tal-benefiċċju ta 'efavirenz/emtricitabine/tenofovir disoproxil huwa bbażat primarjament fuq dejta minn 48 ġimgħa minn studju kliniku li fih il-pazjenti b'soppressjoni viroloġika stabbli fuq terapija antiretrovirali ta' kombinazzjoni bidlu għal efavirenz/emtricitabine/tenofovir disoproxil (ara sezzjoni 5. bħalissa m'hemm l-ebda dejta disponibbli minn studji kliniċi b'efavirenz / emtricitabine / tenofovir disoproxil f'pazjenti li qatt ma ħadu kura jew f'pazjenti ttrattati bil-kbir. ebda dejta ma hija disponibbli biex tappoġġja l-kumbinazzjoni ta ' efavirenz/emtricitabine/tenofovir disoproxil u aġenti antiretrovirali oħra.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

chanelle pharmaceuticals manufacturing limited - sevoflurane - anestetiċi ġenerali, - dogs; cats - għall-induzzjoni u l-manutenzjoni ta 'l-anestesija.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanoma - aġenti antineoplastiċi - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 u 5. kura awżiljarja tal-melanomadabrafenib flimkien ma trametinib huwa indikat għall-kura awżiljarja ta ' pazjenti adulti b'fażi iii melanoma bil-braf v600, wara li jitlesta r-risezzjoni. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

biomarin international limited - pegvaliase - phenylketonurias - prodotti oħra alimentari u metaboliżmu - palynziq huwa indikat għall-kura ta 'pazjenti b'phenylketonuria (pku) fl-età ta'16-il sena u ikbar li jkunu adegwati ta' phenylalanine fid-demm tal-kontroll (fenilalanina fid-demm livelli akbar minn 600 mikromol/l) minkejja qabel l-immaniġġjar bl-għażliet ta ' trattament disponibbli.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - neoplażmi tas-sider - aġenti antineoplastiċi - piqray huwa indikat, flimkien ma 'fulvestrant għall-kura ta' nisa wara l-menopawża, u l-irġiel, bl-ormon tat-riċettur (hr)-pożittivi, tal-bniedem tar-riċettur tal-fattur tat-tkabbir epidermali 2 (her2)-negattivi, lokalment avvanzat jew dak metastatiku-kanċer tas-sider bil-pik3ca mutazzjoni wara l-progressjoni tal-marda wara l-terapija endokrinali bħala monoterapija (ara sezzjoni 5.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - rifjut ta 'graft - immunosoppressanti - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):għat-trattament ta ' l-hiv-1 infezzjoni fil-kura antiretrovirali (art)-l-esperjenza f'pazjenti adulti, inklużi dawk li ġew ħafna ttrattati minn qabel. għat-trattament ta 'l-hiv-1 infezzjoni fil-pazjenti pedjatriċi mill-eta' ta 3 snin u mill-inqas 15-il kg piż tal-ġisem. id-deċiżjoni li jinbeda it-trattament b'darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir, għandha tingħata konsiderazzjoni kbira lill-istorja tat-trattament tal-pazjent individwali u l-mudelli ta 'tibdiliet ġenetiċi assocjati ma' mediċini differenti. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 u 5. darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir huwa indikat, flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' pazjenti bil-vajrus tal-immunodefiċjenza umana (hiv-1) .  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. id-deċiżjoni li jinbeda it-trattament b'darunavir f'dawn l-arti-pazjenti b'esperjenza, ġenotipika l-ittestjar għandu jiggwida l-użu ta ' darunavir (ara sezzjonijiet 4. 2, 4. 3, 4. 4 u 5.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

cipla (eu) limited - olanzapine - schizophrenia; bipolar disorder - psikolettiċi - adultsolanzapine huwa indikat għall-kura ta ' skizofrenja. 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.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

resilience biomanufacturing ireland limited - influwenza avjana (kollu virion, mhux attivati) li jkun fih anti $ enu ta: a/vjetnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini - profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment. il-vaċċin kontra l-influwenza pandemika għandu jintuża skond il-gwida uffiċjali.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

gilead sciences international limited - cidofovir - cytomegalovirus retinite - antivirali għal użu sistemiku - vistide huwa indikat għall-kura ta 'retinite b'cytomegalovirus f'pazjenti b'sindromu ta' immunodefiċjenza miksuba (aids) u mingħajr disfunzjoni tal-kliewi. vistide għandu jintuża biss meta aġenti oħra huma kkunsidrati bħala mhux adattati.