Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - aġenti antineoplastiċi oħra - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - immunosoppressanti - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen biologics b.v.  - infliximab - spondylitis, ankylosing; arthritis, rheumatoid; psoriasis; crohn disease; arthritis, psoriatic; colitis, ulcerative - immunosoppressanti - rewmatika arthritisremicade, flimkien ma ' methotrexate, huwa indikat għat-tnaqqis tas-sinjali u s-sintomi kif ukoll it-titjib fil-funzjoni fiżika:pazjenti adulti bil-marda attiva meta r-rispons għall li jimmodifikaw il-marda mediċini anti-rewmatiċi (dmards), inkluż methotrexate, ma kienx adegwat;pazjenti adulti bi ħsara severa, attiva u progressiva tal-mard li ma kinux ittrattati qabel b'methotrexate jew dmards oħra. f'dawn il-popolazzjonijiet ta 'pazjenti, it-tnaqqis fir-rata ta' avvanz tal-ħsara fil-ġogi, hekk kif imkejla permezz ta ' x-ray, intweriet. adulti crohn diseaseremicade huwa indikat għall -: - trattament tal-mod moderat għal sever tal-marda ta'crohn attiva, f'pazjenti adulti li ma kellhomx rispons minkejja sħiħ u adegwat matul it-terapija b'xi corticosteroid u / jew immunosoppressanti; jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn;il-kura ta fistulizzanti, marda ta'crohn attiva, f'pazjenti adulti li ma kellhomx rispons minkejja sħiħa u adegwata-kors ta ' terapija bi trattament konvenzjonali (li jinkludu l-antibijotiċi, drenaġġ u terapija immunosoppressiva). pedjatriċi crohn diseaseremicade huwa indikat għall-kura ta 'marda ta'crohn attiva, fit-tfal u fl-adolexxenti ta' età minn sitt sa 17-il sena, li ma kellhomx rispons għat-terapija konvenzjonali inklużi kortikosterojd, immunomodulatur u primarja-nutrizzjoni-terapija; jew li ma jifilħux jew għandhom kontra-indikazzjonijiet għal dawn it-terapiji. remicade ġie studjat biss f'kombinazzjoni ma ' terapija konvenzjonali immunosoppressiva. kolite colitisremicade huwa indikat għall-kura ta attiva minn moderata sa gravi kolite bl-ulċeri fil-pazjenti adulti li kellhom rispons mhux adekwat għat-terapija konvenzjonali, inkluż kortikosterojdi u 6-mercaptopurine (6-mp) jew azathioprine (aza), jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. pedjatriċi kolite colitisremicade huwa indikat għall-kura ta severament attiva kolite bl-ulċeri, f'pazjenti pedjatriċi li għandhom minn sitta sa 17-il sena, li kellhom rispons mhux adekwat għat-terapija konvenzjonali, inkluż kortikosterojdi u 6-mp jew aza, jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. ankylosing spondylitisremicade huwa indikat għall-kura ta ' ankylosing spondylitis attiva, f'pazjenti adulti li ma kellhomx rispons xieraq għat-terapija konvenzjonali. psorjatika arthritisremicade huwa indikat għall-kura tas-sustanza attiva u progressiva artrite psorjatika f'pazjenti adulti meta r-rispons għall-preċedenti dmard it-terapija kienet inadegwata. remicade għandu jingħata flimkien ma ' methotrexate;jew waħdu f'pazjenti li juru intolleranza għal methotrexate jew li għalihom methotrexate huwa kontra-indikat. remicade intwera li jtejjeb il-funzjoni fiżika f'pazjenti b'artrite psorjatika, u li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi periferali kif imkejjel permezz ta' x-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda. psoriasisremicade huwa indikat għall-kura moderata għal severa ta ' psorjasi tal-plakka f'pazjenti adulti li naqsu milli jirrispondu għal, jew li għandhom kontraindikazzjoni għal, jew li ma jittollerawx terapija sistemika oħra inkluż cyclosporine, methotrexate jew psoralen ultraviolet-a (puva).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

co.don gmbh - sferojdi ta 'kondutturi autologi umani assoċjati ma' matriċi - mard tal-qarquċa - mediċini oħra għal disturbi fis-sistema muskoloskeletali - tiswija ta ' difetti ta ' qarquċa sintomatiċi articular tal-condyle femoral u l-galletta ta ' l-irkoppa (internazzjonali tas-soċjetà tal-tiswija tal-qarquċa [icrs] grad iii jew iv) ma difett daqsijiet sa 10 cm2 fl-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - vaċċini - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. l-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - vaċċini - jcovden is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. l-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - orlistat - obeżità - preparazzjonijiet ta 'kontra l-ossessjoni, esklużi prodotti tad-dieta - alli huwa ndikat għal telf tal-piż f'adulti b'piż żejjed (indiċi tal-massa tal-ġisem, bmi ≥ 28 kg/m2) u li għandhom jittieħdu flimkien ma'b'kaloriji kemmxejn baxxi, inqas xaħam.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - idursulfase - mucopolysaccharidosis ii - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - elaprase huwa indikat għall-kura fit-tul ta ' pazjenti bl-kaċċatur syndrome (mucopolysaccharidosis ii, mps ii). in-nisa eterozigoti ma ġewx studjati fil-provi kliniċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

valneva austria gmbh - virus tal-enċefalite Ġappuniż, inattivat (strain attenwat sa14-14-2 imkabbar f'ċelloli vero) - encephalitis, japanese; immunization - vaċċini - ixiaro huwa indikat għal immunizzazzjoni attiva kontra l-enċefalite Ġappuniża f'adulti, adolexxenti, tfal u trabi b'età ta 'xahrejn u aktar. ixiaro għandu jkun ikkunsidrat għall-użu f'individwi f'riskju ta'l-espożizzjoni permezz tal-ivvjaġġar jew fil-kors ta'l-impjieg tagħhom.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - idarucizumab - emorraġija - il-prodotti terapewtiċi l-oħra kollha - praxbind huwa speċifiku treġġigħ lura aġent għal dabigatran u huwa indikat f'pazjenti adulti kkurati bi pradaxa (dabigatran etexilate) meta l-treġġigħ lura malajr tiegħu kontra l-koagulazzjoni effetti huwa meħtieġ:għall-emerġenza kirurġija/urġenti proċeduri;fil-periklu għall-ħajja jew mhux ikkontrollat ta ' fsada.