Evropska unija - malteščina - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - tromboċitopenja - sustanzi kontra l-emorraġija - doptelet huwa indikat għall-kura ta ' tromboċitopenja qawwija f'pazjenti adulti b'mard kroniku tal-fwied li huma skedati li jgħaddu minn proċedura invażiva. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. kortikosterojdi, immunoglobulini).

Evropska unija - malteščina - 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.

Evropska unija - malteščina - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - aġenti antineoplastiċi - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Evropska unija - malteščina - EMA (European Medicines Agency)

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - aġenti antineoplastiċi - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

Evropska unija - malteščina - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - lopinavir, ritonavir - infezzjonijiet ta 'hiv - antivirals for systemic use, protease inhibitors - kaletra huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' adulti infettati bil-virus tal-immunodefiċjenza umana (hiv-1), adolexxenti u tfal ta '14-il jum jew aktar. l-għażla ta 'kaletra għall-kura ta' impedituri protease tal-hiv-1 f'pazjenti infettati għandha tkun ibbażata fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjenti.

Evropska unija - malteščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - lopinavir, ritonavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - lopinavir / ritonavir huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' adulti infettati bil-virus tal-immunodefiċjenza umana (hiv-1), adolexxenti u tfal 'il fuq minn sentejn. l-għażla ta 'lopinavir/ritonavir għall-kura ta' impedituri protease tal-hiv-1 f'pazjenti infettati għandha tkun ibbażata fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjenti.

Evropska unija - malteščina - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - ritonavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - ritonavir huwa indikat flimkien ma 'aġenti antiretrovirali oħra għall-kura ta' pazjenti infettati bl-hiv-1 (adulti u tfal ta 'sentejn u akbar).

Evropska unija - malteščina - EMA (European Medicines Agency)

mylan s.a.s - ritonavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - ritonavir huwa indikat flimkien ma 'aġenti antiretrovirali oħra għat-trattament ta' pazjenti infettati bl-hiv 1 (adulti u tfal ta '2 snin u aktar).

Evropska unija - malteščina - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - aġenti antineoplastiċi - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.