Euroopan unioni - suomi - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevasitsumabi - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastiset aineet - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. lisätietoja ihmisen epidermaalisen kasvutekijäreseptorin 2 (her2) tilasta on kohdassa 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. lisätietoja her2-tilasta on kohdassa 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - bevasitsumabi - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastiset aineet - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. lisätietoja ihmisen epidermaalisen kasvutekijäreseptorin 2 (her2) tilasta on kohdassa 5. vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. lisätietoja her2-tilasta on kohdassa 5. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemofilia b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Euroopan unioni - suomi - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tosilitsumabin - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosuppressantit - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Euroopan unioni - suomi - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiset aineet - imatinib teva b. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. , lapsipotilailla, joilla on ph+ kml: n kroonisen vaiheen epäonnistumisen jälkeen interferoni-alfa-hoidon, tai akseleraatiovaiheeseen tai blastikriisivaiheeseen. aikuiset potilaat, joiden ph+ kml on blastikriisivaiheessa. , aikuis-ja lapsipotilailla, joilla on vasta diagnosoitu philadelphia-kromosomipositiivinen akuutti lymfaattinen leukemia (ph+ all) integroitu kemoterapiaa. aikuiset potilaat, joilla on uusiutunut tai vaikeahoitoinen ph+ all, kuin yksinään. aikuiset potilaat, joilla on myelodysplastisen oireyhtymän ja myeloproliferatiivisten sairauksien (mds/mpd), johon liittyy platelet-derived growth factor-reseptorin (pdgfr) geeni uudelleen järjestelyt. aikuiset potilaat, 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 b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). , adjuvanttia hoitoon aikuisille potilaille, jotka ovat merkittävä riski uusiutumisen jälkeen resektio kit (cd117)-positiivinen ydin. potilaat, joilla on alhainen tai hyvin alhainen riski toistumisen pitäisi saada adjuvanttihoitona. hoito aikuispotilailla, joilla on ei-leikattavissa oleva dermatofibrosarcoma protuberans (dfsp) ja aikuispotilaille, joilla on uusiutunut ja/tai metastasoitunut dfsp, jotka eivät ole oikeutettuja leikkaus. , aikuis-ja lapsipotilailla, tehokkuutta imatinib perustuu hematologisten ja sytogeneettisten vasteiden määrään ja progression-free survival, kml -, hematologinen ja sytogeneettinen vaste ph+ all, mds/mpd, hematologinen vaste hes/cel ja objektiivinen hoitovaste aikuispotilailla, joilla on ei-leikattavissa oleva ja/tai metastaattinen gist ja dfsp ja recurrence-free survival, adjuvanttia ydin. kokemusta imatinib potilailla, joilla on mds/mpd, jotka liittyvät pdgfr-geenin uudelleenjärjestäytymisen yhteydessä järjestelyt on hyvin rajallinen. ei ole kontrolloituja tutkimuksia, jotka osoittaisivat kliinistä tehoa tai eloonjäämisetua näissä sairauksia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroksabaani - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitromboottiset aineet - laskimotromboembolian (vte) ehkäisy aikuisilla potilailla, jotka saavat elektiivisen lonkan tai polven korvaavan leikkauksen. hoito syvä laskimotukos (dvt) ja keuhkoembolian (pe), ja toistuvien dvt ja pe aikuisilla. (see section 4. 4 for haemodynamically unstable pe patients. hoito syvä laskimotukos (dvt) ja keuhkoembolian (pe), ja toistuvien dvt ja pe aikuisilla. (see section 4. 4 hemodynaamisesti epävakaa pe potilaat). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. hoito syvä laskimotukos (dvt) ja keuhkoembolian (pe), ja toistuvien dvt ja pe aikuisilla. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 ja 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. hoito syvä laskimotukos (dvt) ja keuhkoembolian (pe), ja toistuvien dvt ja pe aikuisilla. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Euroopan unioni - suomi - EMA (European Medicines Agency)

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - muut ruuansulatuselimistön sairauksien ja aineenvaihduntasairauksien lääkkeet, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.

Euroopan unioni - suomi - EMA (European Medicines Agency)

recordati rare diseases - betaiinia - homokystinuria - muut ruuansulatuselimistön sairauksien ja aineenvaihduntasairauksien lääkkeet, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl). cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

Euroopan unioni - suomi - EMA (European Medicines Agency)

medac - imatinibi - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - proteiinikinaasin estäjät - imatinib medac on tarkoitettu hoitoon:lapsipotilailla, joilla on vasta diagnosoitu philadelphia-kromosomi (bcr-abl) positiivinen (ph+) kroonisen myelooisen leukemian (kml), joille luuytimensiirto ei pidetä ensimmäinen rivi hoito;lapsipotilailla, joilla on ph+kml: n kroonisen vaiheen epäonnistumisen jälkeen interferoni-alfa-hoidon, tai akseleraatiovaiheessa;aikuis-ja lapsipotilailla, joiden ph+kml on blastikriisivaiheessa;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;aikuisille potilaille, joilla on leikattavissa oleva dermatofibrosarcoma protuberans (dfsp) ja aikuispotilaille, joilla on uusiutunut ja/tai metastasoitunut dfsp, jotka eivät ole oikeutettuja leikkaus. vaikutukset imatinibi on luuytimensiirron lopputulokseen ei ole selvitetty. aikuis-ja lapsipotilaat, tehokkuutta imatinib perustuu hematologisten ja sytogeneettisten vasteiden määrään ja progression-free survival, kml -, hematologinen ja sytogeneettinen vaste ph+all, mds/mpd, hematologinen vaste hes/cel ja objektiivinen hoitovaste aikuispotilailla, joilla on ei-leikattavissa oleva ja/tai metastasoitunut dfsp. kokemusta imatinib potilailla, joilla on mds/mpd, jotka liittyvät pdgfr-geenin uudelleenjärjestäytymisen yhteydessä järjestelyt on hyvin rajallinen. 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)

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.