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)

amivas ireland ltd - artesunāts - malārija - antiprostozie līdzekļi - artesunate amivas is indicated for the initial treatment of severe malaria in adults and children. jāņem vērā oficiālās vadlīnijas par pareizi lietot pretmalārijas aģentu.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

norton healthcare ltd. - paclitaxel - sarcoma, kaposi; carcinoma, non-small-cell lung; ovarian neoplasms; breast neoplasms - antineoplastiski līdzekļi - paxene ir indicēts, lai ārstētu pacientus ar:• uzlabotas ar aids saistītu kapoši sarkoma (aids-ks), kas ir izdevies, pirms liposomal anthracycline terapija;• metastātisks vēzis krūts (mbc), kas nav izdevies, vai nav kandidātu standarta anthracycline-satur terapija;• uzlabotas vēzis olnīcu (aoc) vai ar atlikušo slimības (> 1 cm) pēc sākotnējās laparotomija, kopā ar cisplatin kā pirmās līnijas ārstēšanu;• metastātisks vēzis olnīcu (km) pēc neveiksmes ar platīnu saturošu kombinēto terapiju, bez taxanes kā otrās līnijas apstrāde;• nav maza šūnu plaušu vēzis (nsclc), kas nav kandidātu uz potenciāli dziednieciska operācijas un/vai staru terapiju, kopā ar cisplatin. ierobežoti dati par efektivitāti apstiprina šo indikāciju (skatīt 5. apakšpunktu).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

navidea biopharmaceuticals europe ltd. - tilmanocept - radionuklīdu attēlveidošana - audzēju konstatēšana, diagnostikas radiofarmaceitiskiem preparātiem - Šīs zāles ir paredzētas tikai diagnostikas vajadzībām. radioaktīvi lymphoseek ir norādīts attēlveidošanas un intraoperative atklāšanas sentinel limfmezgli drenāžas primārā audzēja pieaugušo pacientiem ar krūts vēža, melanoma, vai lokalizētu plakanšūnu karcinomu no mutes dobuma. Ārējās attēlveidošanas un intraoperative novērtēšana var tikt veikta, izmantojot gamma noteikšanas ierīce.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp dohme ltd - cilvēka papilomas vīrusa 6. tipa l1 proteīnu, cilvēka papilomas vīrusa 11. tipa l1 proteīnu, cilvēka papilomas vīrusa 16. tipa l1 proteīnu, cilvēka papilomas vīrusa tipu 18 l1 proteīnu - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - vakcīnas - silgard ir vakcīnas lietošanas vecumā no 9 gadiem, lai novērstu:premalignant dzimumorgānu bojājumi (dzemdes kakla, vulvas un maksts), premalignant anālais bojājumi, dzemdes kakla vēža un anālā vēža kauzāli saistīti ar noteiktu onkoģenētisko cilvēka papilomas vīrusa (hpv) tipi;dzimumorgānu kārpas (condyloma acuminata) kauzāli saistīti ar konkrētiem hpv tipiem. skatīt nodaļas 4. 4 un 5. 1, lai iegūtu svarīgu informāciju par datiem, kas apstiprina šo indikāciju. lietot silgard, jābūt saskaņā ar oficiālo ieteikumi.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

abbvie ltd - nātrija dasabuvīrs - c hepatīts, hronisks - pretvīrusu līdzekļi sistēmiskai lietošanai - exviera ir minēta kopā ar citām zālēm, ārstēšanai hronisku c hepatītu (chc) pieaugušajiem. hepatīta c vīrusa (hcv) genotipa specifiska aktivitāte.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

taw pharma (ireland) limited - klopidogrela hidrohlorīds - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombotiskie līdzekļi - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 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 medically treated patients eligible for thrombolytic therapy. , , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic 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.  , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. , , for further information please refer to section 5. , , ,.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinibs - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - krūts audzējs - antineoplastiski līdzekļi - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5. in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist. advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

fondazione telethon ets - autologās cd34 + bagātina cd34 + šūnu transduced ar antiretrovīrusu vektors, kas kodē cilvēka adenozīna deaminase (ada) cdna sērijai no cilvēka hematopoētisko cilmes/cilmes (cd34 +) šūnu saturošo šūnu frakciju - smags kombinētais imūndeficīts - imunitātes stimulatori, - strimvelis tiek norādīts ārstēšanai pacientiem ar nopietns kombinētās imūndeficīta sakarā ar adenozīna deaminase trūkumu (ada-scid), kuriem nav piemērota cilvēka leikocītu antigēnu (hla)-saskaņoto saistīto cilmes šūnu donors ir pieejams (skatīt 4. sadaļa. 2 un 4. sadaļa.