Enspryng Eiropas Savienība - latviešu - EMA (European Medicines Agency)

enspryng

roche registration gmbh - satralizumab - neuromyelitis optica - imūnsupresanti - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Kalydeco Eiropas Savienība - latviešu - EMA (European Medicines Agency)

kalydeco

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.

Yervoy Eiropas Savienība - latviešu - EMA (European Medicines Agency)

yervoy

bristol-myers squibb pharma eeig - ipilimumabs - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastiski līdzekļi - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 un 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Adakveo Eiropas Savienība - latviešu - EMA (European Medicines Agency)

adakveo

novartis europharm limited - crizanlizumab - anēmija, sirpjveida šūna - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Olumiant Eiropas Savienība - latviešu - EMA (European Medicines Agency)

olumiant

eli lilly nederland b.v. - baricitinibs - artrīts, reimatoīds - imūnsupresanti - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumiant var lietot monoterapijā vai kombinācijā ar metotreksātu. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Zoledronic acid Actavis Eiropas Savienība - latviešu - EMA (European Medicines Agency)

zoledronic acid actavis

actavis group ptc ehf   - pain skābes monohidrāts - lūzumi, kauls - zāles kaulu slimību ārstēšanai - skeleta saistītiem notikumiem (patoloģisku lūzumu, mugurkaula saspiešanas, starojuma vai operācija kaulu vai audzēju izraisītas hypercalcaemia) pieaugušiem pacientiem ar modernu malignancies iesaistot kaulu profilakses. Ārstēšana pieaugušiem pacientiem ar audzēju izraisītu hypercalcaemia.

Zoledronic Acid Hospira Eiropas Savienība - latviešu - EMA (European Medicines Agency)

zoledronic acid hospira

pfizer europe ma eeig - pain skābes monohidrāts - hiperkalciēmija - zāles kaulu slimību ārstēšanai - 4 mg / 5 ml un 4 mg / 100 ml:novēršanu skeleta saistīti notikumi (patoloģisku lūzumu, mugurkaula kompresiju, starojuma vai operācijas, kaulu, vai audzēja izraisītu hypercalcaemia) pieaugušiem pacientiem ar progresējošu ļaundabīgu audzēju, iesaistot kaulu. Ārstēšana pieaugušiem pacientiem ar audzēju izraisītu hypercalcaemia (tih). 5 mg / 100 ml:Ārstēšana osteoporozes:menopauzes sievietēm;vīriešiem;paaugstināts risks lūzums, tostarp tiem, kas nesen zemu traumas gūžas lūzumu. attieksmi pret osteoporozi, kas saistītas ar ilgtermiņa sistēmisko glikokortikoīdu terapija:menopauzes sievietēm;vīriešiem;paaugstināts risks lūzums. Ārstēšana paget ir slimības, kaulu pieaugušajiem.

Ypozane Eiropas Savienība - latviešu - EMA (European Medicines Agency)

ypozane

virbac s.a. - osaterone acetāts - uroloģiskie līdzekļi - suņi - labdabīgas prostatas hipertrofijas (bph) ārstēšana suņiem vīriešiem.

Dimenhydrinate/Vitamin B6 Sigmapharm 50 mg/25 mg apvalkotās tabletes Latvija - latviešu - Zāļu valsts aģentūra

dimenhydrinate/vitamin b6 sigmapharm 50 mg/25 mg apvalkotās tabletes

sigmapharm arzneimittel gmbh, austria - dimenhydrinatum, pyridoxini hydrochloridum - apvalkotā tablete - 50 mg/25 mg

Vertirosan 92,5 mg/ml pilieni iekšķīgai lietošanai, šķīdums Latvija - latviešu - Zāļu valsts aģentūra

vertirosan 92,5 mg/ml pilieni iekšķīgai lietošanai, šķīdums

umip limited, ireland - dimenhidrināts - pilieni iekšķīgai lietošanai, šķīdums - 92,5 mg/ml