Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp dohme ltd - papillomavirus uman tip 6 l1 proteina, tal-papillomavirus uman tip 11 l1 proteina, tal-papillomavirus uman tip 16 l1 proteina, tal-papillomavirus uman tip 18 l1 proteina - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - vaċċini - silgard huwa vaċċin għall-użu mill-età ta'9 snin għall-prevenzjoni ta': leżjonijiet ġenitali premalinni (ċervikali, tal-vulva u vaġinali), premalignant leżjonijiet anali, 'kanċers ċervikali u kanċer anali każwalment relatat ċerti onkoġeniċi-papillomavirus uman (hpv) tat-tipi;felul ġenitali (kondiloma acuminata) każwalment relatat speċifiċi tipi ta' hpv. ara t-taqsimiet 4. 4 u 5. 1 għal informazzjoni importanti dwar id-dejta li tappoġġja din l-indikazzjoni. l-użu ta ' silgard għandu jkun skond ir-rakkomandazzjonijiet uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

krka, d.d., novo mesto - telmisartan, hydrochlorothiazide - pressjoni għolja - telmisartan u dijuretiċi - kombinazzjoni ta ' dożi fissi ta ' tolucombi (80 mg telmisartan/25 mg idrochlorothiazide) huwa indikat fl-adulti l-pressjoni tad-demm tagħhom mhix ikkontrollata b'mod adegwat dwar tolucombi 80 mg/12. 5 mg (80 mg telmisartan / 12. 5 mg hydrochlorothiazide) jew adulti li qabel kienu stabbilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ferrer internacional s.a. - loxapine - schizophrenia; bipolar disorder - sistema nervuża - adasuve huwa indikat għall-kontroll rapidu ta 'aġitazzjoni ħafifa għal moderata f'pazjenti adulti bi skiżofrenja jew disturb bipolari. il-pazjenti għandhom jirċievu trattament regolari immedjatament wara l-kontroll ta 'sintomi ta' aġitazzjoni akuta.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zoetis belgium sa - live recombinant e2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus e2 gene (cp7_e2alf) - live viral vaccines, immunologicals for suidae - majjali - għal immunizzazzjoni attiva ta 'majjali minn 7 ġimgħat' il quddiem biex tevita l-mortalità u tnaqqas l-infezzjoni u l-mard ikkawżat mill-virus tad-deni klassiku tal-ħnieżer (csfv). onset of immunity: 14 days after vaccinationduration of immunity: at least 6 months after vaccinationfor active immunisation of breeding females to reduce transplacental infection caused by csfv. onset of immunity: 21 days after vaccinationduration of immunity has not been demonstrated.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - granisetron - vomiting; cancer - anti-emetiċi u anti-nawżjanti, , serotonin (5ht3) antagonisti - prevenzjoni ta 'nawżja u remettar f'pazjenti li qed jirċievu kimoterapija moderata jew ħafna emetogenika, bi jew mingħajr cisplatin, sa ħames ijiem konsekuttivi. sancuso tista'tintuża fil-pazjenti li kienu qed jirċievu l-ewwel kors ta ' kimoterapija jew f'pazjenti li qabel kienu rċivew il-kimoterapija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

covis pharma europe b.v. - formoterol fumarate dihydrate, aclidinium bromide - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - brimica genuair huwa indikat bħala l-manutenzjoni bronkodilatur trattament għall-arja ostruzzjoni u l-serħan mis-sintomi fil-pazjenti adulti bil-marda pulmonari ostruttiva kronika (copd).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

norton healthcare ltd. - paclitaxel - sarcoma, kaposi; carcinoma, non-small-cell lung; ovarian neoplasms; breast neoplasms - aġenti antineoplastiċi - paxene huwa indikat għall-kura ta 'pazjenti b':• avvanzati relatat mal-aids sarkoma ta'kaposi (aids-ks) li ma rnexxewx qabel anthracycline liposomali-terapija;• karċinoma metastatika ta'l-sider (mbc) li ma jkunux ħadmu jew ma jkunux-kandidati għall-istandard anthracycline-terapija li jkun fiha;• karċinoma avvanzata ta 'l-ovarji (aoc) jew bi residwu tal-marda (> 1 ċm) wara l-ewwel laparotomija, flimkien ma' cisplatin bħala l-ewwel linja ta 'trattament;• karċinoma metastatika ta' l-ovarju (moc) wara l-falliment ta jkun fihom il-platinu terapija kombinata mingħajr taxanes bħala t-tieni linja ta 'trattament;• non-small cell lung avvanzata (nsclc) li mhumiex kandidati għall-potenzjalment kurattiva-kirurġija u/jew terapija ta' radjazzjoni, flimkien ma ' cisplatin. dejta ta 'effikaċja limitata tappoġġja din l-indikazzjoni (ara sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bayer ag - radium (223ra) dichloride - neoplasmi prostatiċi - radjofarmaċewtiċi terapewtiċi - xofigo huwa indikat għat-trattament ta 'adulti b'kanċer tal-prostata li jiflaħ għall-kastrazzjoni, metastasi sintomatika fl-għadam u l-ebda metastasi viscerali magħrufa.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - aġenti antineoplastiċi - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. hemm biss informazzjoni limitata disponibbli fuq l-effikaċja u s-sigurtà għall-pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż rituximab jew pazjenti refrattarji għal preċedenti rituximab flimkien ma ' kimoterapija. ara t-taqsima 5. 1 għal aktar informazzjoni. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituximab wera li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

akcea therapeutics ireland limited - inotersen sodium - amyloidosis - drogi oħra tas-sistema nervuża - it-trattament tal-fażi 1 jew l-istadju 2 polinewropatija f'pazjenti adulti b'ereditarji transthyretin amilojdożi (hattr).