Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - sklerosi multipla - immunosuppressanti selettivi - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 u 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - verteporfin - myopia, degenerative; macular degeneration - oftalmoloġiċi - visudyne huwa indikat għat-trattament ta 'adulti bl-exudative (imxarrba) relatata mal-età deġenerazzjoni makulari (amd) - biċċa l-kbira' subfoveal choroidal neovascularisation klassika (cnv) jew;adulti b'neovaskularizzazzjoni korojdali subfoveali sekondarja għal mijopija patoloġika.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gedeon richter plc. - relugolix, norethisterone acetate, estradiol hemihydrate - leiomyoma - ormoni u analogi pitwitarji u ipotalamiċi - ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunosoppressanti - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 u 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - entecavir - epatite b, kronika - antivirali għal użu sistemiku - baraclude huwa indikat għat-trattament ta kronika tal-virus epatite b (hbv) fl-adulti bil:mard tal-fwied ikkumpensat u evidenza ta 'replikazzjoni virali attiva, persistenti elevati fis-serum alanine aminotransferase (alt) livelli u evidenza istoloġika ta' infjammazzjoni attiva u/jew fibrożi;mard tal-fwied dekompensat. kemm għall-kkumpensati u mard tal-fwied dikumpensat, din l-indikazzjoni hija bbażata fuq tagħrif minn provi kliniċi f'pazjenti li huma nucleoside naïve b'hbeag pożittiv u hbeag negattiv li jaqbadhom infezzjoni hbv. fir-rigward ta 'pazjenti b'epatite b refrattarja għal lamivudine.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viiv healthcare b.v. - maraviroc - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only ccr5-tropic hiv-1 detectable,.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - daclatasvir dihydrochloride - epatite Ċ, kronika - antivirali għal użu sistemiku - daklinza huwa indikat flimkien ma 'prodotti mediċinali oħra għall-kura ta' infezzjoni kronika tal-virus tal-epatite Ċ (hcv) fl-adulti (ara sezzjonijiet 4. 2, 4. 4 u 5. għall-ġenotip hcv-attività speċifika, ara sezzjonijiet 4. 4 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):għat-trattament ta ' l-hiv-1 infezzjoni fil-kura antiretrovirali (art)-l-esperjenza f'pazjenti adulti, inklużi dawk li ġew ħafna ttrattati minn qabel. għat-trattament ta 'l-hiv-1 infezzjoni fil-pazjenti pedjatriċi mill-eta' ta 3 snin u mill-inqas 15-il kg piż tal-ġisem. id-deċiżjoni li jinbeda it-trattament b'darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir, għandha tingħata konsiderazzjoni kbira lill-istorja tat-trattament tal-pazjent individwali u l-mudelli ta 'tibdiliet ġenetiċi assocjati ma' mediċini differenti. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 u 5. darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir huwa indikat, flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' pazjenti bil-vajrus tal-immunodefiċjenza umana (hiv-1) .  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. id-deċiżjoni li jinbeda it-trattament b'darunavir f'dawn l-arti-pazjenti b'esperjenza, ġenotipika l-ittestjar għandu jiggwida l-użu ta ' darunavir (ara sezzjonijiet 4. 2, 4. 3, 4. 4 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - emtricitabine, tenofovir disoproxil maleate - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - treatment of hiv-1 infection:emtricitabine/tenofovir disoproxil mylan is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults (see section 5. emtricitabine/tenofovir disoproxil mylan is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, (see sections 4. 2, 4. 4 u 5. pre-exposure prophylaxis (prep):emtricitabine/tenofovir disoproxil mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk (see sections 4. 2, 4. 4 u 5.