欧州連合 - マルタ語 - EMA (European Medicines Agency)

teva pharma b.v. - leflunomide - artrite, rewmatika - immunosoppressanti - leflunomide huwa indikat għall-kura ta 'pazjenti adulti b'artrite rewmatika attiva bħala' mediċina antirewmatika li timmodifika l-mard '(dmard). riċenti jew fl-istess waqt it-trattament b'tossiku għall-fwied jew haematotoxic dmards (e. methotrexate) jista 'jirriżulta f'riskju akbar ta' reazzjonijiet avversi serji; għalhekk, il-bidu tat-trattament ta 'leflunomide għandu jiġi kkunsidrat bir-reqqa fir-rigward ta' dawn l-aspetti ta 'benefiċċju / riskju. barra minn hekk, il-qlib minn leflunomide għal dmard ieħor, mingħajr wara l-proċedura tat-tneħħija jistgħu wkoll iżidu r-riskju ta ' reazzjonijiet avversi serji anke għal żmien twil wara l-qlib tal -.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

baxalta innovations gmbh - l-immunoglobulina normali umana - sindromi ta 'defiċjenza immunoloġika - sera immuni u immunoglobulini, - terapija tas-sostituzzjoni fl-adulti, it-tfal u l-adolexxenti (0-18-il sena) bil -: sindromi ta 'immunodefiċjenza primarja b'indeboliment fil-produzzjoni ta' antikorpi. ipogammaglobulinemija u rikorrenti ta ' infezzjonijiet batteriċi fil-pazjenti b'lewċemija linfoċitika kronika (cll), fejn l-antibijotiċi profilatiċi fallew jew li huma kontra‑indikat. ipogammaglobulinemija u rikorrenti ta ' infezzjonijiet batteriċi fil-mjeloma multipla (mm) tal-pazjenti. ipogammaglobulinemija f'pazjenti qabel u wara t‑ trapjant ta ' ċelluli stem ħematopejetiċi alloġeniċi (hsct).

欧州連合 - マルタ語 - EMA (European Medicines Agency)

pfizer europe ma eeig  - crisaborole - dermatite, atopika - preparazzjonijiet oħra dermatoloġiċi - staquis huwa indikat għall-kura ta ħfief għal moderati-dermatite atopika fl-adulti u f'pazjenti pedjatriċi minn 2-il sena ma ' ≤ 40% - superfiċje tal-ġisem (bsa) milquta.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

teva b.v. - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosoppressanti - leflunomide huwa indikat għall-kura ta ' pazjenti adulti bil:artrite rewmatika attiva bħala 'mard tal-anti-rewmatiċi li jimmodifikaw il-mediċina' (dmard);artrite psorjatika attiva. riċenti jew fl-istess waqt it-trattament b'tossiku għall-fwied jew haematotoxic dmards (e. methotrexate) jista 'jirriżulta f'riskju akbar ta' reazzjonijiet avversi serji; għalhekk, il-bidu tat-trattament ta 'leflunomide għandu jiġi kkunsidrat bir-reqqa fir-rigward ta' dawn l-aspetti ta 'benefiċċju / riskju. barra minn hekk, il-qlib minn leflunomide għal dmard ieħor, mingħajr wara l-proċedura tat-tneħħija jistgħu wkoll iżidu r-riskju ta ' reazzjonijiet avversi serji anke għal żmien twil wara l-qlib tal -.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

h. lundbeck a/s - nalmefene hydrochloride dihydrate - disturbi relatati ma 'l-alkoħol - drogi użati fid-dipendenza fuq l-alkoħol - selincro huwa indikat għat-tnaqqis tal-konsum ta 'alkoħol f'pazjenti adulti b'dipendenza alkoħolika li għandhom livell għoli ta' riskju ta 'xorb (ara sezzjoni 5. 1), mingħajr sintomi ta 'rtirar fiżiku u li ma jeħtiġux ditossifikazzjoni immedjata. selincro għandhom jiġu biss preskritti flimkien mal-kontinwu appoġġ psikosoċjali ffukat fuq it-trattament aderenza u t-tnaqqis tal-konsum tal-alkoħol. selincro għandu jinbeda biss f'pazjenti li jkomplu jkollhom għoli tax-xorb il-livell ta'riskju ġimagħtejn wara l-valutazzjoni inizjali.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

teva b.v. - topotecan - ovarian neoplasms; uterine cervical neoplasms; small cell lung carcinoma - aġenti antineoplastiċi - topotecan monotherapy is indicated for the treatment of: , patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;, patients with relapsed small cell lung cancer [sclc] for whom re-treatment with the first-line regimen is not considered appropriate. , topotecan flimkien ma ' cisplatin huwa indikat għall-pazjenti b'karċinoma taċ-ċerviċi rikorrenti wara radjuterapija u għall-pazjenti bil-marda fl-istadju ivb. pazjenti li qabel kellhom esponiment għal-cisplatin jinħtieġu intervall sostnut mingħajr trattament biex jiġġustifika trattament bil-kombinazzjoni.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

teva b.v. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - drogi għat-trattament ta 'mard tal-għadam - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. it-trattament tal-marda ta'paget ta ' l-għadam fl-adulti.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

allergan pharmaceuticals international ltd - trab tal-frixa - insuffiċjenza pankreatika exocrine - diġestivi, inkl. enżimi - trattament ta 'sostituzzjoni ta' enzimi pankreatiċi f'insuffiċjenza pankreatika exocrine minħabba fibrożi ċistika jew kundizzjonijiet oħra (e. pankreatite kronika, pankreatectomija ta 'wara jew kanċer tal-frixa). enzepi huwa indikat fit-trabi, tfal, l-adoloxxenti u l-adulti.

欧州連合 - マルタ語 - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplażmi fl-ovarji - aġenti antineoplastiċi - ta 'l-ovarji cancerlynparza huwa indikat bħala monoterapija għall -: l-manteniment tat-trattament ta' pazjenti adulti b'avvanzat (medjevali stadji iii u iv) brca1/2 mutat (linja ġerminali u/jew somatiċi) ta 'grad għoli ta' l-epitilju ta 'l-ovarji, tubu fallopjan jew primarja peritoneali-kanċer li huma fir-rispons (sħiħa jew parzjali) wara t-tlestija ta' l-ewwel linja bbażata fuq il-platinu ' kimoterapija. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 u 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. il-pazjenti għandu jkollhom qabel kienu kkurati bil-anthracycline u taxane fil - (neo)adjuvant jew metastatiku-istabbiliment sakemm il-pazjenti li ma kienux tajbin għal dawn it-trattamenti (ara sezzjoni 5. pazjenti bl-ormon tat-riċettur (hr)-kanċer tas-sider posittiv għandu wkoll għamlu progress fuq jew wara qabel l-terapija endokrinali, jew jiġu kkunsidrati bħala mhux adattati għal terapija endokrinali. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.