Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

zaklady farmafarmaceutyczne polpharma s.aceutyczne polpharma s.a. - dimetil fumarate - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - dimethyl fumarate polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

teva gmbh - dimetil fumarate - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - dimethyl fumarate teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

accord healthcare s.l.u. - dimetil fumarate - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - aġenti antineoplastiċi - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosoppressanti - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

bayer ag  - interferon beta-1b - sklerosi multipla - immunostimulanti, - betaferon huwa indikat għall-kura ofpatients b'każ demjelinizzanti wieħed biss bi proċess infjammatorju attiv, jekk ikun sever biżżejjed li jkun jeħtieġ il-kura b'kortikosterojdi ġol-vina, jekk dijanjosi alternattivi kienu esklużi, u jekk kien stabbilit li huma f'riskju għoli li jiżviluppaw sklerożi multipla klinikament definita;pazjenti bi sklerożi multipla li tirkadi u tbatti l-isklerożi multipla u żewġ jew aktar attakki reċidivi fi żmien l-aħħar sentejn;il-pazjenti bi sklerożi multipla progressiva sekondarja bil-marda attiva, evidenzjata mill-irkadar.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

eisai gmbh - eribulin - breast neoplasms; liposarcoma - aġenti antineoplastiċi - monoterapija b'halaven hija indikata għat-trattament ta 'pazjenti b'kanċer tas-sider lokalment avvanzat jew metastatiku li għamel progress wara mill-inqas korsijiet kemoterapewtiċi għal mard avvanzat (ara sezzjoni 5. terapija ta 'qabel kellha tinkludi anthracycline u taxane sakemm il-pazjenti ma kinux adattati għal dawn it-trattamenti. halaven huwa indikat għall-kura ta ' pazjenti adulti li ma jistax jitneħħa pazjenti b'liposarkoma li kienu rċevew qabel terapija li jkun fiha anthracycline (sakemm ma jkunux addattati) għall-marda avvanzata jew metastatika (ara sezzjoni 5.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

jenson pharmaceutical services limited - dextromethorphan, quinidine - manifestazzjonijiet ta 'mard newboliku - drogi oħra tas-sistema nervuża - nuedexta huwa indikat għat-trattament sintomatiku ta 'l-effett ta' pseudobulbar (pba) fl-adulti. l-effikaċja ġiet studjata biss f'pazjenti bi sklerożi laterali amjotrofika sottostanti jew sklerosi multipla.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

les laboratoires servier - irinotecan anhydrous free-base - neoplażmi pankreatiċi - aġenti antineoplastiċi - trattament ta ' adenocarcinoma metastatic ta-pancreas, flimkien ma ' 5 fluorouracil (artikolu 5) u leucovorin (lv), fil-pazjenti adulti li wettqu wara gemcitabine bbażati fuq terapija.