الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

zoetis belgium - inaktivēts infekciozā katarālā drudža vīruss, 8. serotips, celms btv-8 / bel2006 / 02 - imunoloģiskie līdzekļi - liellopi - active immunisation of cattle from three months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.

الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistiskā fibroze - other respiratory system products - 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 un 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 un 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.

الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - imūnsupresanti - reimatoīdais artrīts (ra)kineret ir norādīts ārstēšanai pieaugušajiem pazīmes un simptomi ra kombinācijā ar metotreksātu, ar nepietiekamu atbildes reakciju uz metotreksātu vien. covid-19kineret is indicated for the treatment of coronavirus disease 2019 (covid-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (supar) ≥ 6 ng/ml. periodic fever syndromeskineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above:cryopyrin-associated periodic syndromes (caps)kineret is indicated for the treatment of caps, including:neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca)muckle-wells syndrome (mws)familial cold autoinflammatory syndrome (fcas)familial mediterranean fever (fmf)kineret is indicated for the treatment of familial mediterranean fever (fmf). kineret būtu jādod kopā ar kolhicīnu, ja nepieciešams. joprojām ir diseasekineret ir norādīts pieaugušajiem, pusaudžiem, bērniem un zīdaiņiem vecumā no 8 mēnešus veci un vecāki ar ķermeņa svaru 10 kg vai vairāk, lai ārstētu joprojām ir slimība, tostarp sistēmiskas mazuļu idiopātisko artrītu (sjia) un pieaugušo sākums joprojām ir slimība (aosd), ar aktīvo sistēmisko funkcijas, vidēji augstu slimības aktivitāti, vai pacientiem ar ilgstošu slimības aktivitāti pēc apstrādes ar nesteroīdiem pretiekaisuma līdzekļiem (npl) vai glucocorticoids. kineret var tikt dota monotherapy vai kombinācijā ar citām pretiekaisuma zāles un slimību modificējošiem pretreimatisma zālēm (dmards).

الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

roche registration gmbh - metoksipolietilēnglikolepoetīns, bēta - anemia; kidney failure, chronic - antianēmiski līdzekļi - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

sanofi winthrop industrie - klopidogrela ūdeņraža sulfāts - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - antitrombotiskie līdzekļi - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome:non-st-segment-elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st-segment-elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. profilakse atherothrombotic un trombembolisku notikumu ātriju fibrillationin pieaugušiem pacientiem ar priekškambaru mirdzēšana, kuriem ir vismaz viena riska faktors asinsvadu notikumi, nav piemēroti apstrādei ar vitamīna k antagonisti un, kas ir zems asiņošanas risku, klopidogrelu, ir norādīts kopā ar asa novēršanas atherothrombotic un trombembolisku notikumu, tostarp insulta.

الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

corza medical gmbh - cilvēka fibrinogēns, cilvēka trombīns - hemostāze, ķirurģija - antihemorāģija - tachosil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. tachosil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.

الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

novartis europharm limited - eltrombopags - purpura, trombocitopēnija, idiopātija - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 un 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 un 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - antibakteriālas līdzekļi sistēmiskai lietošanai, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4. 2, 4. 4 un 5. jāņem vērā oficiālās vadlīnijas par piemērotu izmantot antibakteriālas vielas.

الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

novartis europharm ltd - aliskiren, amlodipine - hipertensija - agents, kas iedarbojas uz renīna-angiotenzīna sistēmu - rasilamlo tiek norādīts būtisks hipertensija pieaugušiem pacientiem, kuru asinsspiediens netiek pienācīgi kontrolēts ar aliskiren vai amlodipīnu, ko lieto vienus pašus ārstēšanai.

الاتحاد الأوروبي - اللاتفية - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - antineoplastiski līdzekļi - rixathon is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rixathon is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. rixathon monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. rixathon is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. rixathon in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). hroniskas limfocītu leikēmija (cll)rixathon kombinācijā ar ķīmijterapiju, ir indicēts, lai ārstētu pacientus ar iepriekš neārstētiem un relapsed/ugunsizturīgi hronisku limfocītu leikēmija. ir pieejami visai ierobežoti dati par efektivitāti un drošību pacientiem, kas iepriekš ārstēti ar monoklonālo antivielu tostarp rituksimabs vai pacientiem, ugunsizturīgas, lai iepriekšējā rituksimabs plus ķīmijterapiju. skatīt nodaĝā 5. 1, lai iegūtu papildu informāciju. reimatoīdais arthritisrixathon kombinācijā ar metotreksātu ir indicēts, lai ārstētu pieaugušiem pacientiem ar smagu aktīvu reimatoīdo artrītu, kas ir bijusi neatbilstoša atbildreakcija vai neiecietību pret citiem slimību modificējošiem pretreimatisma zāles (dmard), tostarp viens vai vairāki audzēju nekrozes faktoru (tnf) inhibitoru terapiju. rituksimabs ir pierādīts, lai samazinātu likmi, locītavu bojājumu progresēšanu, mērot ar x-ray un uzlabot fizisko funkciju, ja to lieto kopā ar metotreksātu. granulomatosis with polyangiitis and microscopic polyangiitisrixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). rixathon, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisrixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).