Europese Unie - Letlands - EMA (European Medicines Agency)

gilead sciences international ltd  - emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate - hiv infekcijas - pretvīrusu līdzekļi sistēmiskai lietošanai - eviplera ir norādīts, par attieksmi pret pieaugušajiem, kas inficēti ar cilvēka imūndeficīta vīrusa tips 1 (hiv-1) bez zināmas mutācijas, kas saistīts ar rezistenci pret ārpus tpr apgrieztās transkriptāzes inhibitors (nnrti) klases, tenofovir vai emtricitabine, un ar vīrusu slodze ≤ 100000 hiv 1 rns kopijas/ml. tāpat kā attiecībā uz citām pretretrovīrusu zālēm, eviplera lietošanai vajadzētu būt orientētai uz genotipisko pretestību un / vai vēsturiskiem rezistences datiem..

Europese Unie - Letlands - EMA (European Medicines Agency)

akebia europe limited - dzelzs citratu koordinācijas komplekss - hyperphosphatemia; renal dialysis - zāles hiperkaliēmijas un hiperfosfātēmijas ārstēšanai - feksērs ir indicēts hiperfosfatēmijas kontrolei pieaugušiem pacientiem ar hronisku nieru slimību (ckd).

Europese Unie - Letlands - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin - cukura diabēts, 2. tips - cukura diabēts - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Europese Unie - Letlands - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastiski līdzekļi - glivec 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-pdgfra rearrangement. spēkā glivec par rezultātiem, kaulu smadzeņu transplantācija nav noteikta. glivec is indicated for: , 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. pacienti, kuriem ir ar zemu vai ļoti zemu atkārtošanās risku, nevajadzētu saņemt palīgvielu apstrāde;, ārstēšanai pieaugušiem pacientiem ar unresectable dermatofibrosarcoma protuberans (dfsp) un pieaugušiem pacientiem ar recidivējošu un / vai metastātisku dfsp, kas nav tiesīgi operācijas. , pieaugušo un bērnu pacientiem, efektivitāti glivec ir balstīta uz vispārējo hematoloģisko, un cytogenetic atbildes likmes un attīstība-bezmaksas izdzīvošanu cml, hematoloģisko, un cytogenetic atsaucības līmenis ph+ visi, mds / mpd, hematoloģisko atbilde likmes hes / cel un uz objektīviem atbilde likmes pieaugušiem pacientiem ar unresectable un / vai metastātisku bŪtĪba un dfsp un par atkārtošanos-bezmaksas izdzīvošanu palīgvielu bŪtĪba. pieredze ar glivec pacientiem ar mds / mpd, kas saistīti ar pdgfr gēnu re-kārtība ir ļoti ierobežota (skatīt 5. iedaļu. izņemot tikko diagnosticēta cml hroniskā fāzē, nav kontrolētos pētījumos, kas liecina par klīnisko ieguvumu vai palielina izdzīvošanas šo slimību.

Europese Unie - Letlands - EMA (European Medicines Agency)

takeda pharma a/s - metformīns hidrohlorīds, pioglitazone hidrohlorīds - cukura diabēts, 2. tips - cukura diabēts - glubrava ir norādīts, kā otrās rindas apstrāde tips 2 diabetes mellitus pieaugušiem pacientiem, īpaši liekais svars pacientiem, kuri nespēj sasniegt pietiekamu glycaemic kontroles pie to maksimāli pieļaujamo devu mutisku metformīns vienatnē. pēc tam, kad sākta terapija ar pioglitazone, pacientiem būtu jāpārskata pēc trīs līdz seši mēneši, lai novērtētu atbilstību ārstēšanas e. samazinājums hba1c). pacientiem, kas nespēj izrādīt pienācīgu atbildi, pioglitazone būtu jāpārtrauc. Ņemot vērā potenciālos riskus, ar ilgstošu terapiju, prescribers jāapstiprina turpmāk kārtējās atsauksmes, ka labā pioglitazone ir vēsture.

Europese Unie - Letlands - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin, linagliptin - cukura diabēts, 2. tips - cukura diabēts - glyxambi, fiksētas devas kombinācija empagliflozin un linagliptin, ir norādīts pieaugušajiem vecumā no 18 gadiem un vecāki ar 2. tipa cukura diabētu:lai uzlabotu glycaemic kontroles, ja metformīns un/vai sulfonilurīnvielas pamata, (su), un viens no monocomponents no glyxambi nenodrošina pietiekamu glycaemic kontroli;kad jau tiek ārstēti ar bezmaksas kombinācija empagliflozin un linagliptin.

Europese Unie - Letlands - EMA (European Medicines Agency)

ecuphar - meloxicam - pretiekaisuma un antirheumatic produkti - dogs; cats - mutvārdu apturēšana:suņiem pret iekaisumu un sāpes, gan akūtu, gan hronisku balsta un kustību aparāta slimības. Šķīdums injekcijām:suņiem pret iekaisumu un sāpes, gan akūtu, gan hronisku balsta un kustību aparāta slimības. pēcoperācijas sāpju un iekaisuma samazināšana pēc ortopēdisko un mīksto audu operācijas. kaķiem:samazināt pēcoperācijas sāpes pēc ovariohysterectomy un neliels mīksto audu ķirurģija.

Europese Unie - Letlands - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metformīns hidrohlorīds - cukura diabēts, 2. tips - 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 un 5. 1 pieejamo datu par dažādām kombinācijām).

Europese Unie - Letlands - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinibs - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. skatīt nodaļas 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Europese Unie - Letlands - 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. izņemot tikko diagnosticēta cml hroniskā fāzē, nav kontrolētos pētījumos, kas liecina par klīnisko ieguvumu vai palielina izdzīvošanas šo slimību. .