Europeiska unionen - svenska - EMA (European Medicines Agency)

nova laboratories ireland limited - hydroxikarbamid - anemi, sickle cell - antineoplastiska medel - förebyggande av vaso-ocklusiv komplikationer av sickle cell sjukdom hos patienter över 2 års ålder.

Europeiska unionen - svenska - EMA (European Medicines Agency)

theravia - hydroxikarbamid - anemi, sickle cell - antineoplastiska medel - siklos är indicerat för förebyggande av återkommande smärtsamma vaso-ocklusiv kriser, inklusive acute chest syndrome hos pediatriska och vuxna patienter som lider av symtomatisk sickle-cell syndrom.

Europeiska unionen - svenska - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - carcinom, non-small cell lung - antineoplastiska medel - gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (ret) fusion-positive advanced non-small cell lung cancer (nsclc) not previously treated with a ret inhibitor.

Europeiska unionen - svenska - EMA (European Medicines Agency)

roche registration gmbh - mykofenolatmofetil - graftförkastning - immunsuppressiva - cellcept är indicerat i kombination med ciklosporin och kortikosteroider för profylax av akut transplantatavstötning hos patienter som får allogena njur-, hjärt- eller levertransplantationer.

Europeiska unionen - svenska - EMA (European Medicines Agency)

merck sharp dohme ltd - boceprevir - hepatit c, kronisk - antivirala medel för systemisk användning - victrelis är indicerat för behandling av kronisk hepatit-c (chc) genotyp-1-infektion, i kombination med peginterferonalfa och ribavirin, hos vuxna patienter med kompenserad leversjukdom som är tidigare obehandlade eller som inte svarat på tidigare behandling.

Europeiska unionen - svenska - EMA (European Medicines Agency)

immedica pharma ab - glycerolfenylbutyrat - urincyklusstörningar, inborn - andra matsmältningsorgan och ämnesomsättning produkter, - ravicti är indicerat för användning som tilläggsbehandling vid kronisk behandling av patienter med urea-cykeln störningar (ucds) inklusive brister i carbamoyl fosfat-syntas-jag (cps), ornitin carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginas jag (arg) och ornitin translokas brist hyperornithinaemia-hyperammonaemia homocitrullinuria syndrom (hhh) som inte kan hanteras av protein begränsning och/eller aminosyra tillskott ensam. ravicti måste användas med protein begränsning och i vissa fall, kosttillskott (e. , essentiella aminosyror, arginin, citrullin, proteinfria kalorietillskott).

Europeiska unionen - svenska - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastiska medel - 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 som monoterapi är indicerat för behandling av vuxna patienter med lokalt avancerad eller metastaserad icke-småcellig lungcancer efter tidigare kemoterapi. 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 som monoterapi är indicerat för behandling av vuxna patienter med lokalt avancerad eller metastaserad icke-småcellig lungcancer efter tidigare kemoterapi. 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - lymfom, b-cell - antineoplastiska medel - polivy i kombination med bendamustine och rituximab är indicerat för behandling av vuxna patienter med återfall/refraktär diffusa stora b-cellslymfom (dlbcl) som inte är kandidater för hematopoietisk stamcellstransplantation. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Europeiska unionen - svenska - EMA (European Medicines Agency)

janssen-cilag international n.v. - telaprevir - hepatit c, kronisk - antivirala medel för systemisk användning - incivo, i kombination med peginterferon alfa och ribavirin, är indicerat för behandling av genotyp-1 kronisk hepatit c hos vuxna patienter med kompenserad leversjukdom (inklusive cirros):vem är behandling naiva, de som tidigare behandlats med interferon alfa (pegylerat eller icke-pegylerat) ensamt eller i kombination med ribavirin, inklusive relapsers, partiella responders null responders.

Europeiska unionen - svenska - EMA (European Medicines Agency)

roche registration gmbh - metoxi-polyetylenglykol-epoetin beta - anemia; kidney failure, chronic - antianemiska preparat - 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.