Jyseleca Unjoni Ewropea - Malti - EMA (European Medicines Agency)

jyseleca

gilead sciences ireland uc, galapagos nv - filgotinib maleate - artrite, rewmatika - immunosoppressanti - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

IDflu Unjoni Ewropea - Malti - EMA (European Medicines Agency)

idflu

sanofi pasteur s.a. - virus tal-influwenza (inattivat, maqsuma) tar-razez li ġejjin:/california/7/2009 (h1n1)pdm09 - like strain (a/california/7/2009, nymc x-179a)a/hong kong/4801/2014 (h3n2) like strain (a/hong kong/4801/2014, nymc x-263b)b/brisbane/60/2008 - like strain (b/brisbane/60/2008, tat-tip selvaġġ) - influenza, human; immunization - vaċċini - profilassi ta 'l-influwenza f'individwi ta' 60 sena jew aktar, speċjalment f'dawk li għandhom riskju akbar ta 'kumplikazzjonijiet assoċjati. l-użu ta ' idflu għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.

Intanza Unjoni Ewropea - Malti - EMA (European Medicines Agency)

intanza

sanofi pasteur europe - virus tal-influwenza (inattivat, maqsuma) tar-razez li ġejjin:/california/7/2009 (h1n1)pdm09 - like strain (a/california/7/2009, nymc x-179a)a/hong kong/4801/2014 (h3n2) like strain (a/hong kong/4801/2014, nymc x-263b)b/brisbane/60/2008 - like strain (b/brisbane/60/2008, tat-tip selvaġġ) - influenza, human; immunization - vaċċini - profilassi ta 'l-influwenza f'individwi ta' 60 sena jew aktar, speċjalment f'dawk li għandhom riskju akbar ta 'kumplikazzjonijiet assoċjati. l-użu ta ' intanza għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.

Aldurazyme Unjoni Ewropea - Malti - EMA (European Medicines Agency)

aldurazyme

sanofi b.v. - laronidase - mucopolysaccharidosis i - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - aldurazyme hu indikat għal enżimi fuq żmien twil terapija tas-sostituzzjoni f'pazjenti b'dijanjosi kkonfermata ta ' mucopolysaccharidosis i (mps i; alfa-l-iduronidase defiċjenza) biex jikkura l-nonneurological manifestazzjonijiet tal-marda.

Aprovel Unjoni Ewropea - Malti - EMA (European Medicines Agency)

aprovel

sanofi winthrop industrie - irbesartan - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. it-trattament tal-mard renali f'pazjenti bi pressjoni għolja u dijabete tat-tip 2 mellitus bħala parti ta'kontra l-pressjoni għolja mediċinali-prodott reġimen.

Aubagio Unjoni Ewropea - Malti - EMA (European Medicines Agency)

aubagio

sanofi winthrop industrie - teriflunomide - sklerosi multipla - immunosuppressanti selettivi - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Cerdelga Unjoni Ewropea - Malti - EMA (European Medicines Agency)

cerdelga

sanofi b.v. - eliglustat - mard gaucher - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - cerdelga huwa indikat għall-fit-tul it-trattament tal-pazjenti adulti ma gaucher il-marda tat-tip 1 (gd1), li huma metabolisers fqir cyp2d6 (pms), metabolisers intermedjarji (ims) jew metabolisers estensiva (ems).

Cerezyme Unjoni Ewropea - Malti - EMA (European Medicines Agency)

cerezyme

sanofi b.v. - imiglucerase - mard gaucher - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - cerezyme (imiglucerase) huwa indikat għall-użu bħala longterm enżima terapija ta ' sostituzzjoni fil-pazjenti bl-djanjosi konfermat ta ' non-neuronopathic (tip 1) jew neuronopathic kronika (tip 3) mard gaucher li jesebixxu klinikament sinifikanti nonneurological manifestazzjonijiet tal-marda. il-manifestazzjonijiet mhux newroloġiċi tal-marda gaucher jinkludu wieħed jew aktar mill-kondizzjonijiet li ġejjin:anemija wara l-esklużjoni ta 'kawżi oħra, bħal iron deficiencythrombocytopeniabone-marda wara l-esklużjoni ta' kawżi oħra bħal vitamina d deficiencyhepatomegaly jew splenomegalija.

CoAprovel Unjoni Ewropea - Malti - EMA (European Medicines Agency)

coaprovel

sanofi winthrop industrie - irbesartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. din il-kombinazzjoni tad-doża fissa hija indikata f'pazjenti adulti li l-pressjoni tad-demm tagħhom mhix ikkontrollata b'mod adegwat fuq irbesartan jew hydrochlorothiazide waħdu.

DuoPlavin Unjoni Ewropea - Malti - EMA (European Medicines Agency)

duoplavin

sanofi winthrop industrie - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - aġenti antitrombotiċi - duoplavin huwa indikat għall-prevenzjoni sekondarja ta 'avvenimenti aterotrombotiċi f'pazjenti adulti li diġà qegħdin jieħdu clopidogrel u acetylsalicylic acid (asa). duoplavin is a fixed-dose combination medicinal product for continuation of therapy in:non st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention (pci);st segment elevation acute myocardial infarction (stemi) in patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.