Uniunea Europeană - română - EMA (European Medicines Agency)

instituto grifols s.a. - imunoglobulina umană normală - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - seruri imune și imunoglobuline, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Uniunea Europeană - română - EMA (European Medicines Agency)

astrazeneca ab - a/darwin/9/2021 (h3n2) - like strain (a/norway/16606/2021, medi 355293) / a/victoria/2570/2019 (h1n1)pdm09 - like strain (a/victoria/1/2020, medi 340505) / b/austria/1359417/2021 - like strain (b/austria/1359417/2021, medi 355292) / b/phuket/3073/2013 - like strain (b/phuket/3073/2013, medi 306444) - gripa, umană - vaccinurile împotriva gripei, gripa, viu atenuat - prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. utilizarea fluenz tetra trebuie să se bazeze pe recomandările oficiale.

Uniunea Europeană - română - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - medicamente utilizate în diabet - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. în plus față de alte medicamente pentru tratamentul diabetului zaharat de tip 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 și 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Uniunea Europeană - română - EMA (European Medicines Agency)

csl behring gmbh - imunoglobuline umane normale (scig) - sindroame de imunodeficiență - seruri imune și imunoglobuline, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Uniunea Europeană - română - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - guanfacină clorhidrat - tulburare de deficit de atenție cu hiperactivitate - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv trebuie să fie folosit ca o parte dintr-un amplu tratament adhd program, de obicei, inclusiv psihologice, educaționale și sociale măsuri.

Uniunea Europeană - română - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibroză chistică - alte produse ale sistemului respirator - 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 și 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 și 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.

Uniunea Europeană - română - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - imunosupresoare - rheumatoid arthritis (ra)kineret is indicated in adults for the treatment of the signs and symptoms of ra in combination with methotrexate, with an inadequate response to methotrexate alone. 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 ar trebui să fie administrat în asociere cu colchicina, dacă este cazul. Încă e diseasekineret este indicat la adulți, adolescenți, copii și sugari cu vârsta de 8 luni și mai mari, cu o greutate de 10 kg sau mai mult pentru tratamentul de boala lui still, inclusiv sistemic, artrită idiopatică juvenilă (ajis) și adult-debut boala lui still (ordonatorii de credite subdelegați), cu active sistemice caracteristici ale moderat spre ridicat de activitate a bolii, sau la pacienții cu continuarea activității bolii după tratamentul cu medicamente non-steroidiene medicamente anti-inflamatorii (ains) sau glucocorticoizi. kineret poate fi administrat ca monoterapie sau în combinație cu alte medicamente anti-inflamatorii și medicamente antireumatice modificatoare ale bolii (marmb).

Uniunea Europeană - română - EMA (European Medicines Agency)

teva b.v. - lipegfilgrastim - neutropenie - imunostimulante, , factorilor de stimulare a coloniilor - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Uniunea Europeană - română - EMA (European Medicines Agency)

novartis europharm limited - sacubitril, valsartan - insuficienta cardiaca - agenți care acționează asupra sistemului renină-angiotensină - paediatric heart failureneparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5. adult heart failureneparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.

Uniunea Europeană - română - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - astm - medicamente pentru afecțiuni obstructive ale căilor respiratorii, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.