Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - infezzjonijiet ta 'virus sintetiku respiratorju - vaċċini - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older. l-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - emoglobinurja, paroxysmal - immunosuppressanti selettivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - andexanet alfa - relatati mal-mediċina l-effetti sekondarji u l-reazzjonijiet avversi - il-prodotti terapewtiċi l-oħra kollha - għall-pazjenti adulti kkurati b'dirett fattur xa (fxa) inibitur tal - (apixaban jew rivaroxaban) meta t-treġġigħ lura ta 'l-antikoagulazzjoni hu meħtieġ minħabba l-periklu għall-ħajja jew mhux ikkontrollat ta' fsada.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - oħra antianemic preparazzjonijiet - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5. reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amicus therapeutics europe limited - cipaglucosidase alfa - mard tal-Ħażna tal-glukoġen tat-tip ii - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zoetis belgium sa - dibotermin alfa - proteini morfogenetiċi għall-għadam - klieb - aġent osteoindużiv għall-użu fit-trattament ta 'ksur tal-għadam fit-tul bħala addizzjoni għal kura kirurġika standard bl-użu ta' tnaqqis fil-fratturi miftuħ fil-klieb.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - darbepoetin alfa - anemia; cancer; kidney failure, chronic - oħra antianemic preparazzjonijiet - kura ta 'anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (crf) f'adulti u pazjenti pedjatriċi. kura ta ' anemija sintomatika f'pazjenti adulti bil-kanċer tumuri malinni mhux majelojdi li qed jirċievu l-kimoterapija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen technology (ireland) uc - bevacizumab - carcinoma, renal cell; peritoneal neoplasms; ovarian neoplasms; breast neoplasms; carcinoma, non-small-cell lung; fallopian tube neoplasms - aġenti antineoplastiċi - mvasi flimkien ma ' bbażati fuq il-fluoropyrimidine chemotherapy huwa indikat għall-kura tal-pazjenti adulti b ' karċinoma metastatic ta-colon jew rectum. mvasi f'kombinazzjoni ma 'paclitaxel, huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. mvasi, barra minn hekk 'kimoterapija bbażata fuq platinum, huwa ndikat għall-kura preferita ta' pazjenti adulti li ma jistax jitneħħa, avvanzat, li mmetastatizza jew rikorrenti taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi. mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. mvasi, f'kombinazzjoni ma 'carboplatin u paclitaxel huwa ndikat għall-quddiem il-linja ta 'trattament ta' pazjenti adulti b'avvanzati (il-federazzjoni internazzjonali tal-mard tal-ġilda u l-ostetriċja (medjevali) istadji iiib, iii u iv) ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan, jew primarja peritoneali-kanċer. mvasi, f'kombinazzjoni ma 'carboplatin u gemcitabine jew f'kombinazzjoni ma' carboplatin u paclitaxel, huwa indikat għall-kura ta 'pazjenti adulti bil-ewwel rikorrenza tal-sensittiva għall-platinum ta' l-epitilju ta 'l-ovarji, l-tubu fallopjan jew primarja peritoneali-kanċer li ma rċevew terapija minn qabel ma' bevacizumab, jew l-oħra ' impedituri vegf jew vegf-riċetturi fil-mira l-aġenti. mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. mvasi, flimkien ma 'paclitaxel u cisplatin jew, alternattivament, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu l-platinum-terapija, huwa indikat għall-kura ta' pazjenti adulti b'persistenti, rikorrenti, jew karċinoma metastatika taċ-ċerviċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - bevacizumab - colorectal neoplasms; breast neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - zirabev flimkien ma 'kimoterapija bbażata fuq fluoropyrimidine huwa indikat għall-kura ta' pazjenti adulti b'karċinoma metastatika tal-kolon jew tar-rektum. zirabev f'kombinazzjoni ma 'paclitaxel, huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider. għal aktar informazzjoni kif tal-bniedem tar-riċettur tal-fattur tat-tkabbir epidermali 2 (her2) status. zirabev, barra minn hekk 'kimoterapija bbażata fuq platinum, huwa ndikat għall-kura preferita ta' pazjenti adulti li ma jistax jitneħħa, avvanzat, li mmetastatizza jew rikorrenti taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi. zirabev flimkien ma 'interferon alfa-2a huwa indikat għall-ewwel linja tal-kura ta' pazjenti adulti b'avvanzat u/jew metastatiku taċ-ċelluli renali kanċer. zirabev, flimkien ma 'paclitaxel u cisplatin jew, alternattivament, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu l-platinum-terapija, huwa indikat għall-kura ta' pazjenti adulti b'persistenti, rikorrenti, jew karċinoma metastatika taċ-ċerviċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - tezepelumab - ażma - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.