Europäische Union - Maltesisch - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karċinoma, Ċellula squamous - aġenti antineoplastiċi - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

bayer ag - finerenone - renal insufficiency, chronic; diabetes mellitus, type 2 - aġenti li jaġixxu fuq is-sistema renin-angiotensin - kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogi użati fid-dijabete - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 u 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - aġenti antineoplastiċi - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - rikombinanti, l-istomatite stomatite virus (razza indiana) bi tħassir tal-pakkett glycoprotein, sostitwit bl-zaire ebolavirus (razza kikwit 1995) tal-wiċċ glycoprotein - emorraġiku-deni, l-ebola - vaċċini - ervebo is indicated for active immunization of individuals 1 year of age or older to protect against ebola virus disease (evd) caused by zaire ebola virus. l-użu ta ervebo għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - busulfan - trapjant ta 'ċelloli staminali ematopojetiċi - alkyl sulfonates - busulfan fresenius kabi warajh cyclophosphamide (bucy2) huwa indikat bħala kondizzjonament trattament qabel haematopoietic konvenzjonali trapjant ta ' proġenitur taċ-ċelloli (hpct) fil-pazjenti adulti meta l-għaqda hija kkunsidrata l-aħjar għażla disponibbli. busulfan fresenius kabi-ċiklofosfamid (regimen bucy4) jew melfalan (bumel) hu indikat bħala trattament kondizzjonarju konvenzjonali taċ-ċelluli ematopojetiċi tat-trapjant fil-pazjenti pedjatriċi.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - mercaptamine bitartrate - Ċistinosi - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - procysbi huwa indikat għat-trattament ta 'ċistinosi nefropatika ppruvata. cysteamine jnaqqas l-akkumulazzjoni taċ-ċistina f'xi ċelluli (e. lewkoċiti, iċ-ċelloli tal-muskoli u l-fwied) tal-pazjenti nephropathic cystinosis u, meta t-trattament jibda kmieni, huwa dewmien l-iżvilupp tal-falliment renali.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

merck sharp dohme limited - sulfat vorapaxar - infart mijokardijaku - aġenti antitrombotiċi - zontivityis indikat għat-tnaqqis ta 'episodji aterotrombotiċi f'pazjenti adulti bil - storja ta' infart mijokardijaku (mi)l-ko-amministrat ma 'acetylsalicylic acid (asa) u, fejn xieraq, clopidogrel; jew - sintomatika mard arterjali periferali(pad), mogħti flimkien ma' acetylsalicylic acid (asa) jew, fejn xieraq, clopidogrel.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - telmisartan - aġenti li jaġixxu fuq is-sistema renin-anġjotensin, antagonisti ta ' angiotensin ii, sempliċi - qtates - tnaqqis ta 'proteinuria assoċjata ma' mard kroniku tal-kliewi (ckd).

Europäische Union - Maltesisch - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - aġenti antineoplastiċi - imatinib teva b. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. , il-pazjenti pedjatriċi b'ph+ cml fil-fażi kronika wara l-falliment ta ' l-interferon-alpha-terapija, jew fil-fażi aċċelerata jew blast crisis. , pazjenti adulti b'ph+ cml fi blast crisis. , pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew dijanjostikati philadelphia chromosome positive li għandhom lewkimja limfoblastika akuta (ph+ all) integrata b'kimoterapija. , pazjenti adulti b'all rikadut jew refrattarju ph+ all bħala monoterapija. , pazjenti adulti b'mard majelodisplastiku/majeloproliferattiv (mds/mpd) assoċjat ma ' plejtlits-riċettur tal-fattur tat-tkabbir derivat (pdgfr) ġeni mill-ġdid l-arranġamenti. , pazjenti adulti b'avvanzati sindrome ipereżinofiliku (hes) u/jew lewkimja kronika eosinofilika (cel) b'fip1l1-pdgfra arranġament mill-ġdid. , l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. imatinib teva b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). , il-kura awżiljarja ta 'pazjenti adulti li huma f'riskju sinifikanti ta' rikaduta wara r-risezzjoni tat-kit (cd117) pożittivi għall-gist. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja. , il-kura ta'pazjenti adulti li ma jistax jitneħħa dermatofibrosarcoma protuberans (dfsp) u pazjenti adulti bil-rikorrenti u/jew metastatiku dfsp li mhumiex eliġibbli għall-kirurġija. , f'pazjenti adulti u pedjatriċi, l-effikaċja ta 'imatinib hija bbażata fuq globali ematoloġiċi u ċitoġenetiċi-rati ta' rispons u sopravivenza mingħajr progressjoni f'cml, fuq ematoloġiċi u ċitoġenetiċi-rati ta 'rispons f'ph+ all, mds/mpd, fuq il-rati ta' rispons ematoloġiku f'hes/cel u dwar l-objettiv tal-rati ta ' rispons fil-pazjenti adulti li ma jistax jitneħħa u/jew metastiku-gist u dfsp u dwar ir-rikorrenza-sopravivenza mingħajr progressjoni fl-adjuvant gist. l-esperjenza b'imatinib f'pazjenti b'mds/mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna. m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.