Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - apalutamide - neoplasmi prostatiċi - terapija endokrinali - erleada huwa indikat:fl-irġiel adulti għal kura ta ' mhux metastatiku-kastrazzjoni reżistenti għall-kanċer tal-prostata (nmcrpc) li huma f'riskju għoli li jiżviluppaw mard metastatiku. fl-irġiel adulti għal kura tal-kanċer metastatiku tal-ormon tat-sensittivi għall-kanċer tal-prostata (mhspc) flimkien mal-privazzjoni tal-androgen-terapija (adt).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bayer ag - darolutamide - prostatika neoplażmi, il-kastrazzjoni-reżistenti - terapija endokrinali - nubeqa is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease (see section 5. - metastatic hormone sensitive prostate cancer (mhspc) in combination with docetaxel and androgen deprivation therapy (see section 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

instituto grifols s.a. - fostamatinib disodium - tromboċitopenja - sistemiċi oħra hemostatics - tavlesse huwa indikat għall-kura ta immuni kronika tromboċitopenja (itp) f'pazjenti adulti li huma refrattarji għall-kuri oħra.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - aġenti antitrombotiċi - clopidogrel/acetylsalicylic acid mylan huwa indikat għall-prevenzjoni sekondarja ta ' avvenimenti aterotrombotiċi f'pazjenti adulti li diġà qed jieħdu ż-żewġ clopidogrel u acetylsalicylic acid (asa). clopidogrel/acetylsalicylic acid mylan huwa kombinazzjoni b'doża fissa tal-prodott mediċinali għall-kontinwazzjoni tat-terapija:mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux-mewġa-q infart mijokardijaku) li jinkludu pazjenti fi proċess li titpoġġa stent wara koronarju perkutanju interventionst elevazzjoni tas-segment infart mijokardijaku akut fil-medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic acid - hypercholesterolemia; dyslipidemias - aġenti li jimmodifikaw il-lipidi - nilemdo huwa indikat fl-adulti b'iperkolesterolemija primarja (eterozigote familjali u mhux familjali) jew dislipidemija mħallta, bħala żieda mad-dieta:f'kombinazzjoni ma 'statin jew statin oħra li jbaxxu l-lipidi terapiji fil-pazjenti li ma jistgħux jilħqu l-ldl-c-għanijiet mal-doża massima ttollerata ta' statin (ara sezzjonijiet 4. 2, 4. 3, u 4. 4), jew waħdu jew flimkien ma ' oħrajn li jbaxxu l-lipidi terapiji f'pazjenti li huma statin intolleranti għal, jew li għalihom il-statin huwa kontra-indikat.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic acid, ezetimibe - hypercholesterolemia; dyslipidemias - aġenti li jimmodifikaw il-lipidi - nustendi huwa indikat fl-adulti b'iperkolesterolemija primarja (eterozigote familjali u mhux familjali) jew dislipidemija mħallta, bħala żieda mad-dieta:f'kombinazzjoni ma 'statin fil-pazjenti li ma jistgħux jilħqu l-ldl-c-għanijiet mal-doża massima ttollerata ta' statin minbarra l-ezetimibealone f'pazjenti li huma statin jew intolleranti għal imatinib jew li għalihom statin huwa kontra-indikat, u ma jkunux jistgħu jilħqu livell ta ' ldl-c-għanijiet mal-ezetimibe waħdu,fil-pazjenti li diġà qegħdin jiġu kkurati b'kumbinazzjoni ta bempedoic acid u ezetimibe bħala pilloli separati bi jew mingħajr statin.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - antivirali għal użu sistemiku - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

nabriva therapeutics ireland dac - lefamulin acetate - pneumonia, bacterial; community-acquired infections - antibatteriċi għal użu sistemiku, - xenleta is indicated for the treatment of community-acquired pneumonia (cap) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of cap or when these have failed. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.