Unjoni Ewropea - Malti - EMA (European Medicines Agency)

leadiant gmbh - chenodeoxycholic acid - xanthomatosis, cerebrotendinous; metabolism, inborn errors - terapija biljari u tal-fwied - aċidu chenodeoxycholic huwa indikat għall-kura ta ' l-iżbalji inborn ta ' l-aċidu bili primarja sintesi minħabba n-nuqqas hydroxylase sterol 27 (li jippreżentaw bħala cerebrotendinous xanthomatosis (ctx)) fl-trabi, tfal u adolexxenti ta ' età żmien xahar għal 18-il sena u adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

recordati rare diseases - ibuprofen - ductus arteriosus, privattiva - terapija kardijaka - trattament ta 'ductus arteriosus ta' brevett emodinamikament sinifikanti fit-trabi tat-twelid li twieldu qabel iż-żmien inqas minn 34 ġimgħa ta 'età tal-ġestazzjoni.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pinnacle biologics b.v.  - porfimer tas-sodju - barrett l-esofagu - aġenti antineoplastiċi - it-terapija fotodinamika (pdt) permezz ta 'photobarr huwa indikat għall -: asportazzjoni ta' displasja qawwija (hgd) f'pazjenti li għandhom esofagu ta ' barrett (bo).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

csl behring gmbh - immunoglobulina normali umana (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - sera immuni u immunoglobulini, - terapija tas-sostituzzjoni fl-adulti, u t-tfal u l-adolexxenti (0-18-il sena) bil -: l-immunodefiċjenza primarja (pid) sindromi b'indeboliment fil-produzzjoni ta 'antikorpi;ipogammaglobulinemija u rikorrenti ta' infezzjonijiet batteriċi f'pazjenti b'lewkimja limfoċitika kronika, li fihom, l-anti-bijotiċi profilattiċi għandhom falla;ipogammaglobulinemija u rikorrenti ta 'infezzjonijiet batteriċi fil-plateau ta'introduzzjoni gradwali multipli pazjenti b'mjeloma multipla li jkunu fallew li jirrispondu għall-immunizzazzjoni pnewmokokkali;ipogammaglobulinemija fil-pazjenti wara trapjant taċ-ċelluli-trapjant taċ-ċelloli staminali (hsct);aids konġenitali bil-rikorrenti ta' infezzjonijiet batteriċi. immunomodulazzjoni fl-adulti, u t-tfal u l-adolexxenti (0-18-il sena) bil -: purpura tromboċitopenika idjopatika (itp), f'pazjenti b'riskju għoli ta'fsada jew qabel kirurġija sabiex jikkoreġu l-għadd tal-plejtlets;sindrome ta ' guillain barré;il-marda ta'kawasaki;infjammazzjoni kronika demajelinanti polinewropatija (cidp). hemm biss esperjenza limitata hija disponibbli dwar l-użu ta ' immunoglobulini ġol-vina fi tfal b'cidp.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ge healthcare as  - regadenoson - immaġini tal-fwieħa mijokardjali - terapija kardijaka - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. rapiscan huwa selettiv koronarju vażodilataturi għall-użu bħala farmakoloġiċi-istress aġent għall-radjunuklidu infart-perfużjoni imaging (mpi) f'pazjenti adulti f'pożizzjoni li jgħaddu minn eżerċizzju adegwat l-istress.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamide - neoplasmi prostatiċi - terapija endokrinali - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

lupin europe gmbh - mexiletine hydrochloride - myotonic disturbi - terapija kardijaka - namuscla huwa indikat għall-kura sintomatika ta myotonia f'pazjenti adulti b'nuqqas distrofiċi myotonic disturbi.

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)

accord healthcare s.l.u. - abiraterone acetate - neoplasmi prostatiċi - terapija endokrinali - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

albireo - odevixibat - cholestasis, intrahepatic - terapija biljari u tal-fwied - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4. 4 u 5.