Европейский союз - мальтийский - EMA (European Medicines Agency)

accord healthcare s.l.u. - dabigatran etexilate mesilate - venous thromboembolism; arthroplasty, replacement - aġenti antitrombotiċi - prevention of venous thromboembolic events.

Европейский союз - мальтийский - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult 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. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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 dfsp. 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. .

Европейский союз - мальтийский - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Европейский союз - мальтийский - EMA (European Medicines Agency)

novartis europharm limited - ranibizumab - wet macular degeneration; macular edema; diabetes complications; myopia, degenerative; choroidal neovascularization - oftalmoloġiċi - lucentis huwa indikat fl-adulti għall -: - trattament ta 'amd (umda) relatat mal-età deġenerazzjoni makulari (amd) - trattament ta' indeboliment tal-vista minħabba ġrieħi ta 'neovaskularizzazzjoni korojdali (cnv)il-kura ta' indeboliment tal-vista minħabba ta 'edima makulari dijabetika (dme)il-kura ta' indeboliment tal-vista minħabba l-edima makulari sekondarja għal okklużjoni tal-vina tar-retina (il-fergħa rvo jew ċentrali rvo).

Европейский союз - мальтийский - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Европейский союз - мальтийский - 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.

Европейский союз - мальтийский - EMA (European Medicines Agency)

zoetis belgium sa - meloxicam - oxicams - klieb - tnaqqis ta 'infjammazzjoni u uġigħ kemm f'mard muskoluskeletriku akut kif ukoll kroniku fil-klieb.

Европейский союз - мальтийский - EMA (European Medicines Agency)

pfizer limited - difloxacin - antibatteriċi għal użu sistemiku, antiinfectives għall-użu sistemiku - turkeys; dogs; cattle; chicken - tiġieġ:għat-trattament ta 'infezzjonijiet kroniċi respiratorji kkawżati minn strejns sensittivi ta' eschericia coli u mycoplasma gallisepticum. dundjani: għall-kura ta 'infezzjonijiet respiratorji kroniċi kkawżati minn razez sensittivi ta' escherichia coli u mycoplasma gallisepticum. ukoll għat-trattament ta 'infezzjonijiet ikkawżati minn pasteurella multocida. klieb: għat-trattament ta 'infezzjonijiet akuti mhux ikkomplikati ta' l-apparat urinarju kkawżati minn escherichia coli jew staphylococcus spp. u pyoderma superfiċjali kkawżata minn staphylococcus intermedius. baqar:għat-trattament tal-marda respiratorja bovina (shipping fever, pnewmonja fl-għoġliet) kkawżata minn doża waħda jew infezzjonijiet imħalta ma ' pasteurella haemolytica, pasteurella multocida, u / jew mycoplasma spp.

Европейский союз - мальтийский - EMA (European Medicines Agency)

pfizer limited  - metaflumizone, amitraz - ektoparasitaċidali għall-użu topiku, inklużi. insettiċidi - klieb - għat-trattament u l-prevenzjoni ta 'infestazzjonijiet bil-briegħed (ctenocephalides canis u c. felis) u qurdien (ixodes ricinus, ixodes hexagonus, rhipicephalus sanguineus, dermacentor reticulatus u dermacentor variabilis), u għall-kura ta ' demodikosi (ikkawżata minn demodex spp. ) u qamel (trichodectes canis) fil-klieb. il-prodott mediċinali veterinarju jista 'jintuża bħala parti minn strateġija ta' trattament għal dermatite tal-allerġija tal-briegħed (fad).

Европейский союз - мальтийский - EMA (European Medicines Agency)

chanelle pharmaceuticals manufacturing limited - sevoflurane - anestetiċi ġenerali, - dogs; cats - għall-induzzjoni u l-manutenzjoni ta 'l-anestesija.