Európai Unió - máltai - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - limfoma, b-cell - aġenti antineoplastiċi - polivy flimkien ma bendamustine u rituximab huwa indikat għall-kura ta ' pazjenti adulti b'reġgħet tfaċċat/refrattarja b kbira mxerrda-cell lymphoma (dlbcl) li mhumiex kandidati għall-trapjant ta'ċelloli staminali ematopojetiċi. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Európai Unió - máltai - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - majloma multipla - aġenti antineoplastiċi - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Európai Unió - máltai - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkulożi, b'resistema multidrug - antimikobatterjali - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Európai Unió - máltai - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - atrofija muskolari, spinali - mediċini oħra għal disturbi fis-sistema muskoloskeletali - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

Európai Unió - máltai - 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.

Európai Unió - máltai - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - limfoma, follicular - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

Európai Unió - máltai - EMA (European Medicines Agency)

teva b.v. - fentanyl - pain; cancer - analġeżiċi - effentora huwa indikat għall-kura ta 'uġigħ qawwi (btp) f'adulti b'kanċer li diġà qed jirċievu terapija ta' manteniment ta 'opjojdi għal uġigħ kroniku tal-kanċer. btp huwa aggravament transitorju ta 'uġigħ li jseħħ fuq sfond ta' uġigħ persistenti li altrimenti jkun ikkontrollat. pazjenti li kienu qed jirċievu l-manutenzjoni terapija b'opioid huma dawk li qed jieħdu ta 'lanqas 60 mg ta' morfina orali kuljum, mill-inqas 25 mikrogramma ta 'fentanyl transdermali kull siegħa, mill-inqas 30 mg ta' oxycodone kuljum, mill-inqas 8 mg ta 'hydromorphone orali kuljum jew doża analġeżika ekwivalenti ta' opioid ieħor għal ġimgħa jew aktar.

Európai Unió - máltai - EMA (European Medicines Agency)

orexigen therapeutics ireland limited - bupropion hydrochloride, naltrexone hydrochloride - obesity; overweight - preparazzjonijiet ta 'kontra l-ossessjoni, esklużi prodotti tad-dieta - mysimba huwa indikat bħala żieda mad-mnaqqsa dieta ta 'kaloriji u żieda fl-attività fiżika, għall-ġestjoni tal-piż f'pazjenti adulti (≥18-il sena) b'inizjali tal-massa tal-Ġisem (bmi) ta' ≥ 30 kg/m2 (obeżi), jew≥ 27 kg/m2 sa < 30 kg/m2 (piż żejjed) fil-preżenza ta'wieħed jew aktar mill-piż relatata mal-ko-morbożitajiet (e. , dijabete tat-tip 2, dislipidemija, jew kontrollata l-pressjoni għolja)it-trattament b'mysimba għandu jitwaqqaf wara 16-il ġimgħa jekk il-pazjenti ma jkunux tilfu tal-inqas 5% tal-inizjali tagħhom piż tal-ġisem.

Európai Unió - máltai - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazole - schizophrenia; bipolar disorder - psikolettiċi - abilify huwa indikat għat-trattament tal-iskiżofrenja fl-adulti u fl-adolexxenti ta '15-il sena jew ikbar. abilify huwa indikat għat-trattament ta 'episodji manijaċi serji f'disturb bipolari i u għall-prevenzjoni ta' episodju manijaku ġdid f'adulti li esperjenzaw episodji predominantament manijaċi u li l-episodji manijaċi rrispondew għat-trattament b'aripiprazole. abilify huwa indikat għat-trattament sa 12-il ġimgħa ta 'episodji manijaċi serji f'disturb bipolari i fl-adolexxenti ta' minn 13-il sena u anzjani.

Európai Unió - máltai - EMA (European Medicines Agency)

bayer ag - riociguat - pressjoni għolja, pulmonari - antihypertensives għall-ipertensjoni arterjali pulmonari - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. l-effikaċja ġiet murija fil-pah popolazzjoni inklużi l-etjoloġiji ta idjopatika jew li tintiret-pah jew pah assoċċjata ma'mard tal-connective tissue. paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.