Unjoni Ewropea - Malti - EMA (European Medicines Agency)

valneva sweden ab - 'tossina b tal-kolera, vibrio cholerae 01 - cholera; immunization - vaċċini - dukoral huwa indikat għall-immunizzazzjoni attiva kontra l-marda kkawżata minn vogrio cholerae serogroup o1 f'adulti u tfal minn sentejn li se jżuru żoni endemiċi / epidemiċi. l-użu ta 'dukoral għandha tiġi stabbilita fuq il-bażi ta' rakkomandazzjonijiet uffiċjali filwaqt li jitqiesu l-varjabilità tal-epidemjoloġija tal-post u r-riskju tat-teħid tal-marda f'żoni ġeografikament differenti u l-kundizzjonijiet waqt il-vjaġġ. dukoral m'għandux jissostitwixxi miżuri ta ' ħarsien standard. fil-każ ta ' dijarea-miżuri ta'rijidrattazzjoni għandhom jiġu istitwiti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - vaċċini - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age.  the use of this vaccine should be in accordance with official recommendations.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

valneva austria gmbh - virus tal-enċefalite Ġappuniż, inattivat (strain attenwat sa14-14-2 imkabbar f'ċelloli vero) - encephalitis, japanese; immunization - vaċċini - ixiaro huwa indikat għal immunizzazzjoni attiva kontra l-enċefalite Ġappuniża f'adulti, adolexxenti, tfal u trabi b'età ta 'xahrejn u aktar. ixiaro għandu jkun ikkunsidrat għall-użu f'individwi f'riskju ta'l-espożizzjoni permezz tal-ivvjaġġar jew fil-kors ta'l-impjieg tagħhom.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vbi vaccines b.v. - antigen tal-wiċċ ta 'l-epatite b - epatite b - vaċċini - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

seqirus netherlands b.v. - a/darwin/6/2021(h3n2)-like strain (a/darwin/11/2021, wild type) / a/wisconsin/67/2022 (h1n1)pdm09-like strain (a/georgia/12/2022 cvr-167) / b/austria/1359417/2021-like strain (b/singapore/wuh4618/2021) / b/phuket/3073/2013-like virus (b/singapore/inftt-16-0610/2016, wild type) - influwenza, bniedem - l-influwenza, mhux attivat, maqsuma virus jew antiġen tal-wiċċ - prophylaxis of influenza in adults and children from 2 years of age. flucelvax tetra għandu jintuża skond ir-rakkomandazzjonijiet uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

seqirus netherlands b.v. - a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227) / a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238) / b/phuket/3073/2013-like strain (b/phuket/3073/2013, bvr-1b) / influenza virus b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26) - influwenza, bniedem - vaċċini - profilassi tal-influwenza fl-anzjani (65 sena u aktar). fluad tetra għandu jintuża skond ir-rakkomandazzjonijiet uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ab science s.a. - masitinib mesilate - aġenti antineoplastiċi - klieb - trattament ta 'tumuri taċ-ċelluli taċ-ċelluli tal-klieb li ma jistgħux jerġgħu jiddaħħlu (grad 2 jew 3) b'riċettur ikkonfermat ta' c-kit tyrosine kinase.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

octapharma ab - simoctocog alfa - hemofilja a - fatturi ta 'koagulazzjoni tad-demm - trattament u profilassi ta 'fsada f'pazjenti b'emofilja a (nuqqas konġenitali ta' fattur viii). nuwiq jistgħu jiġu użati għall-gruppi kollha tal-età.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - virus ta 'l-influwenza li jassorbi mill-ġdid (ħaj attenwat) tar-razza li ġejja: razza a / vietnam / 1203/2004 (h5n1) - influwenza, bniedem - vaċċini - profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment fit-tfal u fl-adolexxenti minn 12-il xahar sa inqas minn 18-il sena. l-influwenza pandemika-vaċċin h5n1 astrazeneca għandu jintuża skont il-gwida uffiċjali.

Unjoni Ewropea - Malti - 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.