Unjoni Ewropea - Malti - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - antiepilletiċi oħra - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

cangene europe limited - immunoglobulina tal-epatite b umana - immunization, passive; hepatitis b - immunoglobulini speċifiċi - immunoprophylaxis ta 'l-epatite b fil - każ ta' espożizzjoni aċċidentali mhux pazjenti immunizzati (inklużi l-persuni li t-tilqima isincomplete jew status mhux magħruf). - fil-pazjenti fuq emodijalisi, sakemm it-tilqima għandha ssir effettiva. - fil-twelid tal-virus epatite b trasportatur ta'l-omm. - f'pazjenti li ma jurux rispons immuni (l-ebda li jistgħu jitkejlu l-epatite b ' antikorpi) wara t-tilqim u li għalihom kontinwu il-prevenzjoni hija meħtieġa minħabba l-kontinwu riskju li jiġu infettati bl-epatite b. konsiderazzjoni għandha tingħata wkoll għall-oħra, il-gwida uffiċjali fuq l-użu xieraq tal-bniedem ta 'l-epatite b' immunoglobulina għall-użu għal ġol-muskoli.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (bħala fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - aġenti antineoplastiċi - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. poliċitemija vera (pv)jakavi huwa indikat għall-kura ta ' pazjenti adulti b'poliċitemija vera li huma reżistenti jew intolleranti għal hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - etanercept - arthritis, rheumatoid; arthritis, juvenile rheumatoid; arthritis, psoriatic; spondylarthropathies; spondylitis, ankylosing; psoriasis - immunosoppressanti - rheumatoid arthritisnepexto in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. nepexto jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat.  nepexto is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. nepexto, waħdu jew f'taħlita ma 'methotrexate, intwera li jnaqqas ir-rata ta' progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta ' x-ray, u li jtejjeb il-funzjoni fiżika. idjopatika ġuvenili arthritistreatment tal-poliartrite (rewmatika fattur pożittiv jew negattiv) u estiż oligoarthritis fit-tfal u fl-adolexxenti mill-età ta ' 2 snin li kellhom rispons mhux adegwat għal, jew li intwera li ma jittollerawx, methotrexate. it-trattament tal-artrite psorjatika fl-adolexxenti mill-età ta ' 12-il sena li kellhom rispons mhux adegwat għal, jew li intwera li ma jittollerawx, methotrexate. it-trattament tal-artrite assoċjata ma'entesite fl-adolexxenti mill-età ta ' 12-il sena li kellhom rispons mhux adegwat għal, jew li kienu intolleranti għal, terapija konvenzjonali. etanercept ma ġiex studjat fi tfal li għandhom inqas minn 2 snin. psorjatika arthritistreatment tas-sustanza attiva u progressiva artrite psorjatika fl-adulti meta r-rispons għall-preċedenti li jimmodifikaw il-marda anti-rewmatiċi terapija bil-mediċina kienet inadegwata. etanercept 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. axial spondyloarthritisankylosing spondylitis treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. mhux radjografika assjali aksjali-trattament ta 'adulti li jbatu minn mhux radjografika assjali aksjali bil-għan sinjali ta' infjammazzjoni kif indikat b'żiediet fil-proteina c-reattiva (crp) u/jew l-immaġni tar-reżonanza manjetika (mri) l-evidenza, li kellhom rispons inadegwat għall-mediċini anti-infjammatorji mhux sterojdi (nsaids). plakka psoriasistreatment tal-adulti b'indeboliment moderat jew sever tal-psorjasi tal-plakka li naqsu milli jirrispondu għal, jew li għandhom kontraindikazzjoni għal, jew li ma jittollerawx terapija sistemika oħra, li jinkludu ciclosporin, methotrexate jew psoralen u l-ultravjola-dawl (puva). pedjatrika tal-plakka psoriasistreatment tal-kroniku sever tal-psorjasi tal-plakka fit-tfal u fl-adolexxenti mill-età ta ' 6 snin, li huma kkontrollati b'mod inadegwat minn, jew li huma intolleranti għal, terapiji jew fototerapiji sistemiċi oħrajn.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - glycopyrronium bromide, indacaterol (acetate), mometasone furoate - ażma - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - maintenance treatment of asthma in adults whose disease is not adequately controlled.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudine, raltegravir potassju - infezzjonijiet ta 'hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis huwa indikat f ' għaqda ma ' oħrajn anti‑retroviral prodotti mediċinali għat-trattament ta ' l-infezzjoni tal-virus ta ' immunodefiċjenza umani (hiv‑1) fl-adulti, adolixxenti u tfal mill-età ta ' 6 snin u mill-anqas 30 kg mingħajr preżent użin jew imgħoddi evidenza ta ' reżistenza virali għal aġenti antivirali tal-insti (integrase il-faxxa trasferiment inhibitor) u nrti (inibitur ta ' rivers transcriptase nukleosidi) klassijiet (ara sezzjonijiet 4. 2, 4. 4 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer limited - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - aġenti antineoplastiċi - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. experience with sutent as first-line treatment is limited (see section 5.

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)

novartis europharm limited - indacaterol, glycopyrronium bromide, mometasone - ażma - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - enerzair breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.