Eiropas Savienība - latviešu - EMA (European Medicines Agency)

roche registration gmbh - atezolizumabs - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastiski līdzekļi - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq kā monotherapy ir norādīts ārstēšanai pieaugušiem pacientiem ar lokāli papildu vai metastātiska nsclc pēc iepriekšējas ķīmijterapijas. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq kā monotherapy ir norādīts ārstēšanai pieaugušiem pacientiem ar lokāli papildu vai metastātiska nsclc pēc iepriekšējas ķīmijterapijas. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - solriamfetol hidrohlorīds - narcolepsy; sleep apnea, obstructive - psychoanaleptics, - sunosi ir norādīts, lai uzlabotu nomodu un samazināt pārmērīgu miegainību dienas laikā pieaugušo pacientu ar narkolepsijas (ar vai bez cataplexy). sunosi ir norādīts, lai uzlabotu nomodu un samazināt pārmērīgu miegainību dienas laikā (eds) pieaugušiem pacientiem ar obstruktīvas miega apnoea (osa), kuru eds nav pienācīgi apstrādāta ar primāro osa terapijas, piemēram, nepārtraukta pozitīva elpceļu spiediena (cpap).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

baxalta innovations gmbh - nonakogs, gamma - hemophilia b - antihemorāģija - Ārstēšanas un profilakses asiņošanas pacientiem ar hemofilijas b (iedzimtas ix faktora deficīts).

Latvija - latviešu - Zāļu valsts aģentūra

bionorica se, germany - gentianae saknes, verbenae herb, knotweed herb, sambuci ziedu, ziedu primulae - apvalkotā tablete

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - avacopan - microscopic polyangiitis; wegener granulomatosis - imūnsupresanti - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

d&a pharma - sodium oxybate - substance withdrawal syndrome; alcohol abstinence - other nervous system drugs - substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

biopartners gmbh - recombinant human interferon alfa-2a - c hepatīts, hronisks - imunitātes stimulatori, - adult patients with histologically proven chronic hepatitis c who are positive for hepatitis c virus (hcv) antibodies or hcv rna and have elevated serum alanine aminotransferase (alt) without liver decompensation. the efficacy of interferon alfa-2a in the treatment of hepatitis c is enhanced when combined with ribavirin. alpheon should be given alone mainly in case of intolerance or contra-indication to ribavirin.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

bayer ag - oktokogs, alfa - a hemofīlija - antihemorāģija - asiņošanas ārstēšana un profilakse pacientiem ar hemofiliju a (iedzimtais viii faktora deficīts). iblias var izmantot visās vecuma grupās.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

gilead sciences ireland uc, galapagos nv - filgotinib maleate - artrīts, reimatoīds - imūnsupresanti - rheumatoid arthritisjyseleca 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). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

pinax pharma gmbh - ioflupane (123i) - radionuclide imaging; dementia; movement disorders - diagnostikas radiofarmaceitiskie preparāti - Šīs zāles ir paredzētas tikai diagnostikas vajadzībām. celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy.  celsunax is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy. pieaugušo pacientu, lai palīdzētu atšķirt ticams, demence ar lewy iestādēm, no alcheimera slimības.  celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.