Euroopan unioni - malta - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - besponsa huwa indikat bħala monoterapija għall-kura ta ' adulti b'all rikadut jew refrattarju cd22-pożittivi taċ-ċellula b prekursur li għandhom lewkimja limfoblastika akuta (all). pazjenti adulti bi prekursur taċ-ċelluli b tal-kromożomi posittivi (ph +) li rkadew jew refrattarji ta 'philadelphia kollha kellhom ikunu fallew il-kura b'inqas minn 1 tyrosine kinase inhibitor (tki).

Euroopan unioni - malta - EMA (European Medicines Agency)

pfizer europe ma eeig - glasdegib maleate - lewkimja, mijelojda, akuta - aġenti antineoplastiċi - daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (aml) in adult patients who are not candidates for standard induction chemotherapy.

Euroopan unioni - malta - EMA (European Medicines Agency)

accord healthcare s.l.u. - fingolimod hydrochloride - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti, selettiv immunosuppressanti - indikat bħala terapija li timmodifika l-marda waħda fl attiva ħafna sklerożi multipla li tirkadi u tbatti l-isklerożi multipla għal dawn il-gruppi ta 'pazjenti adulti u pazjenti pedjatriċi ta'bejn l-10 snin u akbar:pazjenti b'ħafna marda attiva minkejja sħiħa u adegwata-kors tal-kura b'mill-inqas waħda li timmodifika l-marda therapyorpatients mal li qed tevolvi malajr severa sklerożi multipla li tirkadi u tbatti l-isklerożi multipla definita minn 2 jew iktar diżabilità attakki reċidivi fis-sena, u b'1 jew aktar gadolinium-tisħiħ tal-leżjonijiet fuq il-moħħ ta' l-mri jew żieda sinifikanti fil-t2 tal-leżjonijiet tat-tagħbija kif meta mqabbel ma 'qabel riċenti ta' l-mri.

Euroopan unioni - malta - 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.

Euroopan unioni - malta - EMA (European Medicines Agency)

janssen-cilag international n.v.    - ponesimod - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Euroopan unioni - malta - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 u 5. 1)orpatients mal li qed tevolvi malajr severa sklerożi multipla li tirkadi u tbatti l-isklerożi multipla definita minn 2 jew iktar diżabilità attakki reċidivi fis-sena, u b'1 jew aktar gadolinium-tisħiħ tal-leżjonijiet fuq il-moħħ ta 'l-mri jew żieda sinifikanti fil-t2 tal-leżjonijiet tat-tagħbija kif meta mqabbel ma ' qabel riċenti ta ' l-mri.

Euroopan unioni - malta - EMA (European Medicines Agency)

mylan ireland limited - abiraterone acetate - neoplasmi prostatiċi - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan 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 indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Euroopan unioni - malta - EMA (European Medicines Agency)

krka, d.d., novo mesto - abiraterone acetate - neoplasmi prostatiċi - terapija endokrinali - abiraterone krka 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) (see section 5. 1)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 indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Euroopan unioni - malta - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (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.

Euroopan unioni - malta - EMA (European Medicines Agency)

teva b.v. - efavirenz - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - efavirenz huwa indikat fit-trattament ta 'kombinazzjoni antivirali ta' adulti, adolexxenti u tfal ta '3 snin u aktar b'infezzjoni ta' hiv-1 tal-bniedem-immunodefiċjenza-virus-1. efavirenz ma ġiex studjat biżżejjed fil-pazjenti f'fażi avvanzata tal-marda tal-hiv, u speċifikament pazjenti b'għadd cd4 < 50 ċellula/mm3, jew wara falliment ta ' inibitur tal-protease (pi) taħt kuri li kien fihom. għalkemm il-reżistenza msallba ta 'efavirenz ma' inibituri tal-protease (pis) ma ġietx dokumentata, fil-preżent hemm biżżejjed informazzjoni fuq l-effikaċja tal-użu sussegwenti tal-pi tal-kura kombinata bbażata fuq wara li jkunu fallew il-kuri li fihom efavirenz.