האיחוד האירופי - מלטית - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - lamivudine - epatite b, kronika - antivirali għal użu sistemiku - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. il-bidu tal-kura b'lamivudine għandhom jiġu kkunsidrati biss meta l-użu ta ' sustanza antivirali alternattiva bl-ogħla ġenetiċi barriera ma tkunx disponibbli jew ikun xieraq;, mard tal-fwied dekompensat flimkien mal-tieni aġent mingħajr kross-reżistenza għal lamivudine.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

theramex ireland limited - teriparatide - l-osteoporożi - homeostasi tal-kalċju - livogiva is indicated in adults. trattament ta 'l-osteoporożi f'nisa wara l-menopawża u fl-irġiel b'riskju akbar ta' ksur. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. trattament ta 'osteoporożi assoċjat ma sostnut sistemika terapija bi glukokortikojdi f'nisa u l-irġiel f'riskju akbar ta' ksur.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

nova laboratories ireland limited - 6-mercaptopurine monohydrate - lewkimja, limfoma - aġenti antineoplastiċi - xaluprine huwa indikat għall-kura ta 'lewkimja limfoblastika akuta (all) f'adulti, adolexxenti u tfal.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed ditromethamine - carcinoma, non-small-cell lung; mesothelioma - l-aċidu foliku l-analogi tagħhom, antimetaboliti - plewrali malinna mesotheliomapemetrexed hospira uk limited flimkien ma ' cisplatin huwa indikat għat-trattament tal-kimoterapija naïve pazjenti b'mesoteljoma plewrali malinna u li ma jistax jitneħħa. taċ-ċelluli mhux żgħar tal-pulmun cancerpemetrexed hospira uk limited flimkien ma 'cisplatin huwa indikat għall-kura tal-ewwel linja ta' pazjenti b'lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija taċ-ċellola skwamuża (ara l-smpc taqsima 5. pemetrexed hospira uk limited huwa indikat bħala monoterapija għall-kura ta 'manteniment ta lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta' ċelluli skwamużi fir-pazjenti li l-marda tagħhom ma jkunx hemm progress immedjatament wara ibbażat fuq il-platinu ' kimoterapija (ara l-smpc taqsima 5. pemetrexed hospira uk limited huwa indikat bħala monoterapija għall-tieni linja ta 'trattament ta' pazjenti b'lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija taċ-ċellola skwamuża (ara l-smpc taqsima 5.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

mylan ireland limited - l-arsenic trioxide - lewkimja, promyelocytic, akuta - aġenti antineoplastiċi - l-arsenic trioxide mylan huwa indikat għall-induzzjoni tar-remissjoni u l-konsolidazzjoni f'pazjenti adulti bi:- li għadhom kif ġew dijanjostikati baxx intermedju-riskju tal-lewkimja promijeloċitika akuta (apl) (ċelluli bojod tad-demm, ≤ 10 x 103/µl) fil-kombinazzjoni ma'l trans retinoic acid (atra)- li reġgħet tfaċċat/refrattarja-lewkimja promijeloċitika akuta (apl) (t-trattament preċedenti kellha tinkludi xi retinojdi u l-kemoterapija)ikkaratterizzata mill-preżenza ta ' l-t(15;17) traslokazzjoni u/jew il-preżenza tal-lewkimja promijeloċitika/retinoic acid receptor-alpha (pml/rar-alfa) tal-ġene. ir-rata ta ' rispons ta oħra akuti lewkimja miloġenja-sottotipi għall-arsenic trioxide ma beenexamined.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - orkambi b'rita huma ndikati għall-kura ta 'fibrożi ċistika (cf) fl-pazjenti ta' bejn 6 snin u ikbar li omozigoti għall-f508del mutazzjoni fil-cftr ġene. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolactone - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 u 5.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - immunosoppressanti - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psorjatika arthritiscosentyx, waħdu jew f'taħlita ma 'methotrexate (mtx), huwa indikat għall-kura ta' artrite psorjatika attiva f'pazjenti adulti meta r-rispons għall-preċedenti li timmodifika l-marda anti rewmatiċi tad-droga (dmard) it-terapija kienet inadegwata. assjali aksjali (axspa)ankylosing spondylitis (as, radjografiku assjali aksjali)cosentyx huwa indikat għat-trattament ta ' ankylosing spondylitis attiva fl-adulti li ma kellhomx rispons xieraq għat-terapija konvenzjonali. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

novartis europharm limited - telbivudine - epatite b, kronika - inibituri nucleoside u nucleotide reverse transcriptase - sebivo huwa indikat għall-it-trattament ta ' kronika epatite b fil-pazjenti adulti b ' mard tal-fwied kompensat u evidenza ta ' replikazzjoni virali, b'persistenza elevati tas-serum aminotransferażi ta ' l alanina (alt) livelli u istoloġiċi evidenza ta ' infjammazzjoni attiva u/jew fibrosis. il-bidu ta 'sebivo it-trattament għandu jiġi kkunsidrat biss meta l-użu ta' sustanza antivirali alternattiva bl-ogħla ġenetiċi barriera għall-reżistenza mhix disponibbli jew ikun xieraq.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 u 5. 1)orpatients mal li qed tevolvi malajr severa sklerożi multipla li tirkadi u tbatti l-isklerożi multipla definita minn 2 jew iktar diżabilità attakki reċidivi fis-sena, u b'1 jew aktar gadolinium-tisħiħ tal-leżjonijiet fuq il-moħħ ta 'l-mri jew żieda sinifikanti fil-t2 tal-leżjonijiet tat-tagħbija kif meta mqabbel ma ' qabel riċenti ta ' l-mri.