Euroopan unioni - suomi - EMA (European Medicines Agency)

biogen idec ltd - daklitsumabia - multippeliskleroosi - immunosuppressantit - zinbryta on tarkoitettu aikuispotilaille multippeliskleroottisten relapsoivien muotojen (rms) hoitoon..

Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - prekursorisolujen lymfoblastinen leukemia-lymfooma - antineoplastiset aineet - besponsa on merkitty monoterapiana aikuisten hoidossa, joilla on uusiutunut tai tulenkestoinen cd22-positiivinen b-solu-esiaste akuutti lymfaattinen leukemia (all). aikuispotilailla, joilla on philadelphia-kromosomin positiivinen (ph +) uusiutunut tai tulenkestävä b-soluprekursori all, pitäisi olla epäonnistunut hoito vähintään 1 tyrosiinikinaasi-inhibiittorilla (tki).

Suomi - suomi - Fimea (Suomen lääkevirasto)

atnahs pharma netherlands b.v. - ketorolac trometamol - injektioneste, liuos - 30 mg/ml - ketorolaakki

Suomi - suomi - Fimea (Suomen lääkevirasto)

eli lilly finland oy ab - isophane insulin human - injektioneste, suspensio, esitäytetty kynä - 100 iu/ml - ihmisinsuliini

Suomi - suomi - Fimea (Suomen lääkevirasto)

csl behring gmbh - albumin, human - infuusioneste, liuos - 200 g/l - albumiini

Euroopan unioni - suomi - EMA (European Medicines Agency)

roche registration gmbh - ocrelizumab - multippeliskleroosi - immunosuppressantit - hoidetaan aikuispotilaita, joilla on relapsoiva multippeliskleroosi (rms), ja kliinisten tai kuvantamisominaisuuksien määrittelemä aktiivinen sairaus. aikuisille potilaille, joilla on varhainen ensisijainen progressiivinen multippeliskleroosi (ppm) osalta taudin kesto ja taso vammaisuuden, ja kuvantamisen ominaisuuksia ominaista inflammatorinen aktiivisuus.

Euroopan unioni - suomi - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastiset aineet - 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 monoterapiana on tarkoitettu aikuisille potilaille, joilla on paikallisesti pitkälle edennyt tai metastaattinen ei-pienisoluinen keuhkosyöpä aikaisemman kemoterapian jälkeen. 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 monoterapiana on tarkoitettu aikuisille potilaille, joilla on paikallisesti pitkälle edennyt tai metastaattinen ei-pienisoluinen keuhkosyöpä aikaisemman kemoterapian jälkeen. 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemofilia a - hemostaatit - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra voidaan käyttää kaikissa ikäryhmissä.

Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer europe ma eeig - gemtutsumab-ozogamisiini - leukemia, myeloidi, akuutti - antineoplastiset aineet - mylotarg on tarkoitettu yhdistelmähoito daunorubicin (dnr) ja sytarabiinin (arac) hoitoon potilaille, ikä 15 vuotta ja yli kanssa aiemmin hoitamatonta, de novo-cd33-positiivisia akuutti myelooinen leukemia (aml), paitsi akuutti promyelosyyttinen leukemia (apl).

Euroopan unioni - suomi - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - mogamulizumab - sezary syndrome; mycosis fungoides - antineoplastiset aineet - poteligeo on tarkoitettu aikuisille potilaille, joilla on t-solulymfooman (mf) tai sézary oireyhtymä (ss), jotka ovat saaneet vähintään yksi aikaisempi systeeminen hoito.