Suomi - suomi - Fimea (Suomen lääkevirasto)

bluefish pharmaceuticals ab bluefish pharmaceuticals ab - omeprazolum - enterotabletti - 20 mg - omepratsoli

Euroopan unioni - suomi - EMA (European Medicines Agency)

teva b.v. - zoledronihappoa - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - lääkkeet luusairauksien hoitoon - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. hoitoon pagetin tauti luu aikuisilla.

Suomi - suomi - Fimea (Suomen lääkevirasto)

mylan ireland limited mylan ireland limited - pantoprazolum natricum sesquihydricum - injektiokuiva-aine, liuosta varten - 40 mg - pantopratsoli

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - eturauhasen kasvaimet, kastraatio-resistentin - antineoplastiset aineet - treatment of adult patients with prostate cancer.

Suomi - suomi - Fimea (Suomen lääkevirasto)

intas pharmaceuticals limited - bendamustinum hydrochloridum - kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos - 2.5 mg/ml - bendamustiini

Euroopan unioni - suomi - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Euroopan unioni - suomi - EMA (European Medicines Agency)

teva b.v. - imatinibi - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva on tarkoitettu hoitoon ofadult ja lapsipotilailla, joilla on vasta diagnosoitu philadelphia-kromosomi (bcr‑abl) positiivinen (ph+) kroonisen myelooisen leukemian (kml), joille luuytimensiirto ei pidetä ensimmäinen rivi hoito. aikuis-ja lapsipotilailla, joilla on ph+ kml: n kroonisen vaiheen epäonnistumisen jälkeen interferoni‑alfa-hoidon, tai akseleraatiovaiheeseen tai blastikriisivaiheeseen. aikuis-ja lapsipotilailla, joilla on vasta diagnosoitu philadelphia-kromosomipositiivinen akuutti lymfaattinen leukemia (ph+ all) integroitu kemoterapiaa. aikuispotilaille, joilla on uusiutunut tai vaikeahoitoinen ph+ all, kuin yksinään. aikuispotilailla, myelodysplastisen oireyhtymän ja myeloproliferatiivisten sairauksien (mds/mpd), johon liittyy platelet-derived growth factor-reseptorin (pdgfr) geeni uudelleen järjestelyt. aikuispotilaille, joilla on pitkälle edennyt hypereosinofiilinen oireyhtymä (hes) ja/tai krooninen eosinofiilinen leukemia (cel), jossa todettiin fip1l1-pdgfra-uudelleenjärjestely. vaikutukset imatinibi on luuytimensiirron lopputulokseen ei ole selvitetty. imatinib teva is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. potilaat, joilla on alhainen tai hyvin alhainen riski toistumisen pitäisi saada adjuvanttihoitona. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. paitsi äskettäin diagnosoitu kroonisen vaiheen kml, ei ole kontrolloituja tutkimuksia, jotka osoittaisivat kliinistä tehoa tai eloonjäämisetua näissä sairauksia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

astrazeneca ab - olaparib - munasarjojen kasvaimet - antineoplastiset aineet - munasarjojen cancerlynparza on tarkoitettu monoterapiana:huolto aikuisille potilaille, joilla on pitkälle edennyt (figo vaiheet iii ja iv) brca1/2-mutaation (ituradan ja/tai somaattisten) korkea-asteen epiteelin munasarjojen, munanjohtimien tai ensisijainen vatsakalvon syöpä, jotka ovat vaste (täydellinen tai osittainen) jälkeen ensilinjan platinapohjaisen kemoterapian. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 ja 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. potilaita on aikaisemmin hoidettu antrasykliineillä ja taxane in (neo)adjuvantti-tai metastasoitunut asetus, ellei potilaat eivät sovellu näihin hoitoihin (ks. kohta 5. potilaat, joilla on hormoni-reseptori (hr)-positiivinen rintasyöpä pitäisi myös olla edennyt tai sen jälkeen ennen hormonaalisen hoidon, tai katsotaan sopimattomaksi hormonaalisen hoidon. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Suomi - suomi - Fimea (Suomen lääkevirasto)

alliance pharma (ireland) ltd - terlipressin - injektiokuiva-aine ja liuotin, liuosta varten - 1 mg - terlipressiini

Euroopan unioni - suomi - EMA (European Medicines Agency)

krka, d.d., novo mesto - abirateroniasetaatti - prostatiset kasvaimet - endokriinihoito - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5. 1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.