Unió Europea - maltès - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - pegunigalsidase alfa - marda ta 'fabry - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase).

Unió Europea - maltès - EMA (European Medicines Agency)

mylan s.a.s - ribavirin - epatite Ċ, kronika - antivirali għal użu sistemiku - ribavirin mylan huwa indikat għall-kura ta ' kronika epatite c u għandhom jintużaw biss bħala parti minn a dożaġġ tal-kombinazzjoni b ' interferon alfa-2b (adulti, tfal (tliet snin fl-età u l-eqdem) u l-adolexxenti). monoterapija b'ribavirin m'għandhiex tintuża. hemm l-ebda sigurtà jew effikaċja ta ' informazzjoni dwar l-użu ta ' ribavirin ma ' forom oħra ta ' interferon (i. mhux alfa-2b). jekk jogħġbok irreferi wkoll għall-interferon alfa-2b sommarju tal-karatteristiċi tal-prodott (spc) għall-informazzjoni dwar kif ikun preskritt dak il-prodott partikulari. naïve patientsadult patientsribavirin mylan huwa indikat, f'kombinazzjoni ma 'interferon alfa-2b, għall-kura ta' pazjenti adulti bil-tipi kollha ta 'epatite Ċ kronika ħlief-ġenotip 1, li ma ġietx ikkurata qabel, mingħajr dikumpensazzjoni tal-fwied, b'livelli għoljin ta' alanine aminotransferase (alt), li huma pożittivi għall-serum ta ' l-epatite c-virus (hcv) rna. it-tfal u l-adolescentsribavirin mylan huwa indikat, f'kors ta 'kombinazzjoni ma' interferon alfa-2b, għall-kura ta 'tfal u adolexxenti minn tliet snin' il fuq, li għandhom it-tipi kollha ta ' epatite Ċ kronika ħlief-ġenotip 1, li ma ġietx ikkurata qabel, mingħajr dikumpensazzjoni tal-fwied, u li huma pożittivi għall-hcv-rna. meta tiddeċiedi li ma li tipposponi it-trattament sakemm il-ħajja adulta, huwa importanti li wieħed jikkunsidra li l-terapija kombinata indotta-inibizzjoni tat-tkabbir. l-riversibbiltà ta ' inibizzjoni tat-tkabbir huwa inċert. id-deċiżjoni li l-kura għandha tittieħed fuq bażi ta'każ b'każ bażi (ara sezzjoni 4. qabel il-kura tal-insuffiċjenza tal-patientsadult patientsribavirin mylan huwa indikat, f'kombinazzjoni ma 'interferon alfa-2b, għall-kura ta' pazjenti adulti b'epatite c kronika li qabel kienu wrew rispons (bin-normalizzazzjoni ta 'alt fi tmiem il-kura) għal monoterapija ta' interferon alfa, iżda li wara rkadew.

Unió Europea - maltès - EMA (European Medicines Agency)

viiv healthcare bv - dolutegravir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Unió Europea - maltès - EMA (European Medicines Agency)

viiv healthcare b.v. - dolutegravir tas-sodju, rilpivirina hydrochloride - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - juluca huwa indikat għall-kura tal-vajrus tal-immunodefiċjenza umana tat-tip 1 (hiv-1) f'adulti li huma viroloġikament-mrażżna (hiv-1 rna.

Unió Europea - maltès - EMA (European Medicines Agency)

viiv healthcare b.v. - dolutegravir tas-sodju, lamivudine - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - dovato huwa indikat għall-kura tal-vajrus tal-immunodefiċjenza umana tat-tip 1 (hiv-1) f'adulti u adolexxenti'il fuq minn 12-il sena li jiżnu mill-inqas 40 kg, bl-ebda magħrufa jew suspettati reżistenza biex l - ' integrase inibitur tal-klassi, jew lamivudine.

Unió Europea - maltès - EMA (European Medicines Agency)

ge healthcare as - flutemetamol (18f) - radionuclide imaging; alzheimer disease - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. vizamyl hija prodott radjufarmaċewtiku il-prodott mediċinali indikati għat-positron emission tomography (pet) tal-immaġini tal-β amyloid neuritic-plakka densità fl-imħuħ tal-pazjenti adulti b'indeboliment konjittiv li jkunu qed jiġu evalwati għall-marda ta'alzheimer (ad) u kawżi oħra ta ' indeboliment konjittiv. vizamyl għandu jintuża flimkien ma 'evalwazzjoni klinika. negattiv scan jindika skarsa jew l-ebda plakek, li mhuwiex konsistenti mal-dijanjosi tal ad.

Unió Europea - maltès - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - aġenti antineoplastiċi - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. l-kimoterapija qabel, għandu jinkludi mill-inqas anthracycline u taxane sakemm il-pazjenti mhumiex tajbin għal dawn it-trattamenti. l-ormon tat pożittiv għar-riċetturi tal-pazjenti għandhom ukoll ikunu fallew it-terapija ormonali, sakemm il-pazjenti mhumiex tajbin għal dawn it-trattamenti.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. flimkien ma 'docetaxel għall-kura ta' dawk il-pazjenti li ma rċevewx il-kimoterapija għal mard metastatiku. f'kumbinazzjoni ma 'inibitur aromatase għall-kura ta' pazjenti bl-ormon tat-pożittiv għar-riċettur mbc, li ma ġietx ikkurata qabel ma ' trastuzumab. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). wara l-kirurġija, kemoterapija (miżjuda fil-bidu jew adjuvant) u r-radjuterapija (jekk applikabbli). wara kimoterapija awżiljarja ma 'doxorubicin u cyclophosphamide, f'kombinazzjoni ma' paclitaxel jew docetaxel. flimkien mal-kimoterapija awżiljarja li jikkonsisti ta ' docetaxel u carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. 'assay preċiż u validat il-metodi għandhom jiġu użati.

Unió Europea - maltès - EMA (European Medicines Agency)

linde healthcare ab - nitric oxide - hypertension, pulmonary; respiratory insufficiency - prodotti oħra tas-sistema respiratorja - inomax, flimkien mal-'ventilazzjoni-appoġġ u l-oħra xierqa sustanzi attivi, huwa indikat għall-kura ta 'trabi tat-twelid ≥34-il-ġimgħa ġestazzjoni b'indeboliment respiratorju ipoksiku assoċjat ma' jew ekokardjografiku evidenza ta 'pressjoni għolja pulmonari, sabiex ittejjeb l-ammont ta' ossiġenu u tnaqqas il-ħtieġa għal ossiġenazzjoni ta 'membrana ekstrakorporali;bħala parti mill-kura ta' waqt u wara l-operazzjoni pressjoni pulmonari għolja fl-adulti u trabi tat-twelid, trabi u tfal żgħar, tfal u l-adoloxxenti, l-etajiet 0-17-il sena, flimkien mal-kirurġija tal-qalb, sabiex selettiv tnaqqis ta ' pressjoni arterjali pulmonari u jtejbu l-ventrikolu tal-lemin tal-funzjoni u l-ossiġenazzjoni.

Unió Europea - maltès - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - aġenti antineoplastiċi - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Unió Europea - maltès - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosoppressanti - leflunomide huwa indikat għall-kura ta ' pazjenti adulti bil:artrite rewmatika attiva bħala 'mard tal-anti-rewmatiċi li jimmodifikaw il-mediċina' (dmard);artrite psorjatika attiva. riċenti jew fl-istess waqt it-trattament b'tossiku għall-fwied jew haematotoxic dmards (e. methotrexate) jista 'jirriżulta f'riskju akbar ta' reazzjonijiet avversi serji; għalhekk, il-bidu tat-trattament ta 'leflunomide għandu jiġi kkunsidrat bir-reqqa fir-rigward ta' dawn l-aspetti ta 'benefiċċju / riskju. barra minn hekk, il-qlib minn leflunomide għal dmard ieħor, mingħajr wara l-proċedura tat-tneħħija jistgħu wkoll iżidu r-riskju ta ' reazzjonijiet avversi serji anke għal żmien twil wara l-qlib tal -.