Calquence Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

calquence

astrazeneca ab - acalabrutinib - lewkimja, linfokitika, kronika, b-Ċellula - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll). calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.

Actelsar HCT Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

actelsar hct

actavis group hf - telmisartan, hydrochlorothiazide - essential hypertension - agents acting on the renin-angiotensin system, angiotensin ii antagonists and diuretics - trattament ta 'ipertensjoni essenzjali. actelsar hct kombinazzjoni b'doża fissa (40 mg telmisartan / 12. 5 mg ta ' hydrochlorothiazide) hi indikata f'adulti li l-pressjoni tad-demm ma tkunx ikkontrollata sew b'telmisartan waħdu. actelsar hct kombinazzjoni b'doża fissa (80 mg telmisartan / 12. 5 mg ta ' hydrochlorothiazide) hi indikata f'adulti li l-pressjoni tad-demm ma tkunx ikkontrollata sew b'telmisartan waħdu. actelsar hct kombinazzjoni b'doża fissa (80 mg telmisartan / 25 mg hydrochlorothiazide) hi indikata f'adulti li l-pressjoni tad-demm ma tkunx ikkontrollata adegwatament fuq actelsar hct 80 mg / 12. 5 mg (80 mg telmisartan / 12. 5 mg hydrochlorothiazide) jew adulti li qabel kienu stabbilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.

Bridion Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

bridion

merck sharp & dohme b.v. - sugammadex - imblokk neuromuskolari - il-prodotti terapewtiċi l-oħra kollha - it-treġġigħ lura ta 'imblokk newromuskolari kkawżat minn rocuronium jew vecuronium. għall-popolazzjoni pedjatrika: sugammadex hu rakkomandat biss għat-treġġigħ lura ta 'rutina ta' imblokk ikkaġunat minn rocuronium indotta mill-imblokk fit-tfal u l-adoloxxenti.

CoAprovel Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

coaprovel

sanofi winthrop industrie - irbesartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. din il-kombinazzjoni tad-doża fissa hija indikata f'pazjenti adulti li l-pressjoni tad-demm tagħhom mhix ikkontrollata b'mod adegwat fuq irbesartan jew hydrochlorothiazide waħdu.

Eucreas Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

eucreas

novartis europharm limited - vildagliptin, metformin hydrochloride - diabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Icandra (previously Vildagliptin / metformin hydrochloride Novartis) Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

icandra (previously vildagliptin / metformin hydrochloride novartis)

novartis europharm limited - vildagliptin, metformin hydrochloride - diabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 u 5. 1 għad-data disponibbli dwar kombinazzjonijiet differenti).

Imatinib Accord Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

imatinib accord

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. .

Imatinib Actavis Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

imatinib actavis

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. , l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. imatinib actavis is indicated for: , 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. l-esperjenza b'imatinib f'pazjenti b'mds/mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna. m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Convenia Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

convenia

zoetis belgium sa - cefovecin (as sodium salt) - antibacterials għal użu sistemiku - dogs; cats - dogsfor il-kura tal-ġilda u tat-tessuti rotob inkluż pyoderma, feriti u axxessi assoċjati ma ' staphylococcus pseudintermedius, β-haemolytic streptococci, escherichia coli u / jew pasteurella multocida. għat-trattament ta 'infezzjonijiet fl-apparat urinarju assoċjati ma' escherichia coli u / jew proteus spp. bħala trattament aġġuntiv għal terapija perjodontali mekkanika jew kirurġika fit-trattament ta 'infezzjonijiet severi tal-gingiva u tessuti perjodontali assoċjati ma' porphyromonas spp. u prevotella spp. catsfor il-kura tal-ġilda u tat-tessuti rotob axxessi u feriti assoċjati ma ' pasteurella multocida, usobacterium spp. , bacteroides spp. , prevotella oralis, streptokokki β-emolitika u / jew staphylococcus pseudintermedius. għat-trattament ta 'infezzjonijiet fl-apparat urinarju assoċjati ma' escherichia coli.

Karvezide Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

karvezide

sanofi winthrop industrie - irbesartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. din il-kombinazzjoni ta 'doża fissa hija indikata f'pazjenti adulti li l-pressjoni tad-demm tagħhom mhix ikkontrollata b'mod adegwat fuq irbesartan jew hydrochlorothiazide waħdu.