Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - pomalidomide - majloma multipla - immunosoppressanti - imnovid f'kombinazzjoni ma'bortezomib u dexamethasone hu indikat fit-trattament ta'pazjenti adulti b'mjeloma multipla li rċievew mill-inqas wieħed minn qabel ta ' trattament inkluż lenalidomide. imnovid fil kombinazzjoni ma dexamethasone hija indikata fit-trattament tal-pazjenti adulti ma relapsed u refrattorji myeloma multipla li jkunu rċevew mill-inqas żewġ reġimi ta ' trattament minn qabel, inklużi kemm lenalidomide u bortezomib, u wrew progressjoni tal-marda fuq l-aħħar terapija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - aġenti antineoplastiċi - zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl), after two or more lines of systemic therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gedeon richter plc. - follitropin alfa - anovulazzjoni - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - in adult women:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift);follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. fi provi kliniċi dawn il-pazjenti ġew definiti bil-livelli endoġeni tas-serum lh < 1. 2 iu / l. in adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - kliewi poliċistiku, autosomal dominanti - id-dijuretiċi, - jinarc huwa indikat biex tnaqqas il-progressjoni tal-iżvilupp tal-Ġlata u insuffiċjenza renali tal-marda tal-kliewi polycystic dominanti autosomal (adpkd) fl-adulti b ' ckd stadju 1 sa 3 fil-bidu tat-trattament bi prova tal-marda malajr jipprogressa b ' mod.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck europe b.v.  - lutropin alfa - ovulation induction; infertility, female - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - luveris fl-assoċjazzjoni mal-preparazzjoni (fsh) follicle-istimulazzjoni-ormoni huwa rakkomandat għall-istimulazzjoni ta ' l-iżvilupp follicular fin-nisa ma severi luteinising-ormoni (lh) u fsh defiċjenza. fi provi kliniċi, dawn il-pazjenti ġew definiti bil-livelli endoġeni tas-serum lh.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - aġenti antineoplastiċi - sprycel huwa indikat għat-trattament ta 'pazjenti pedjatriċi:għadhom kif ġew dijanjostikati-kromosoma ta' filadelfja pożittivi għall-lewkimja tal-mudullun kronika fil-fażi l-kronika (ph+ cml-cp) jew ph+ cml-cp reżistenti jew intolleranti għal terapija ta ' qabel inkluża imatinib. għadhom kif ġew dijanjostikati ph+ lewkimja limfoblastika akuta (all) flimkien mal-kimoterapija. sprycel huwa indikat għat-trattament ta 'pazjenti adulti:għadhom kif ġew dijanjostikati philadelphia-kromożomi-positive (ph+) lewkimja miloġenja kronika (cml) fil-fażi kronika;kronika, aċċelerata jew blast phase cml b'reżistenza jew intolleranza għal terapija ta' qabel inkluża imatinib mesilate;ph+ lewkimja limfoblastika akuta (all) u lymphoid blast cml b'reżistenza jew intolleranza għal terapija ta ' qabel. sprycel huwa indikat għat-trattament ta 'pazjenti pedjatriċi:għadhom kif ġew dijanjostikati ph+ cml fil-fażi l-kronika (ph+ cml-cp) jew ph+ cml-cp reżistenti jew intolleranti għal terapija ta' qabel inkluża imatinib.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

dechra regulatory b.v. - pivalate ta 'desoxycortone - kortikosterojdi għal użu sistemiku - klieb - għall-użu bħala terapija ta ' sostituzzjoni għall-mineralocorticoid defiċjenza fil-klieb b'primarja iperadrenokortiċiżmu (addison tal-marda).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

retrophin europe ltd - aċidu kolesteriku - metaboliżmu, Żbalji inborn - terapija biljari u tal-fwied - aċtu koliku acid, fgk huwa indikat għall-kura ta twieldu l-iżbalji tal-primarja tal-aċidi biljari sinteżi, fit-trabi mill-età ta'xahar għall-kontinwu trattament tul il-ħajja permezz tal-ħajja adulta, u jinkludi l-wara l-enżima waħda, difetti:tal-27-hydroxylase (l-preżentazzjoni kif cerebrotendinous xanthomatosis, ctx) in-nuqqas;2- (jew alfa) methylacyl-coa racemase (amacr) in-nuqqas;l-kolesterol fid-7 alfa-hydroxylase (cyp7a1) defiċjenza.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - sodium żirkonju cyclosilicate - iperkalemija - il-prodotti terapewtiċi l-oħra kollha - lokelma huwa indikat għall-kura ta ' l-iperkalemija f'pazjenti adulti.