Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited  - brolucizumab - märkä makuladegeneraatio - silmätautien - beovu on tarkoitettu aikuisten hoitoon neovaskulaarisen (kostean) ikään liittyvä silmänpohjan rappeuma (amd).

Euroopan unioni - suomi - EMA (European Medicines Agency)

eli lilly nederland b.v. - ramucirumab - mahalaukun kasvaimet - antineoplastiset aineet - mahalaukun cancercyramza yhdessä paklitakselin kanssa on tarkoitettu aikuispotilaille, joilla on edennyt mahasyöpä tai maha-ruokatorven risteyksessä adenokarsinooma kanssa taudin etenemisen jälkeen ennen platina-ja fluoropyrimidiini kemoterapiaa. cyramza-monoterapia on tarkoitettu aikuisille pitkälle edenneen mahasyövän tai maha-ruokatorven risteyksessä adenokarsinooma kanssa taudin etenemisen jälkeen ennen platinaa tai fluoropyrimidiini kemoterapiaa, joiden hoito yhdessä paklitakselin kanssa ei ole tarkoituksenmukaista. paksu-ja peräsuolen cancercyramza, yhdessä folfiri (irinotekaani, foliinihappo, ja 5‑fluorourasiilia), on tarkoitettu aikuisille potilaille, joilla on metastaattinen kolorektaalisyöpä (mcrc) kanssa taudin etenemiseen tai sen jälkeen ennen hoito bevasitsumabin kanssa, oksaliplatiini-ja fluoropyrimidiini. ei-pienisoluisen keuhkosyövän cancercyramza doketakselin kanssa on tarkoitettu aikuispotilaille, joilla on paikallisesti edennyt tai metastasoitunut ei-pienisoluinen keuhkosyöpä kanssa taudin etenemisen jälkeen platinapohjaisen kemoterapian. hepatosellulaarinen carcinomacyramza monoterapia on tarkoitettu aikuisille potilaille, joilla on levinneen tai leikkaushoitoon maksasolusyövän, jotka ovat seerumin alfa-fetoprotein (afp) ≥ 400 ng/ml ja jotka on aiemmin käsitelty sorafenibi.

Euroopan unioni - suomi - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - idarucizumab - verenvuoto - kaikki muut terapeuttiset tuotteet - praxbind on erityinen kääntyminen agentti dabigatraani ja on tarkoitettu aikuisille potilaille, joita hoidettiin pradaxa (dabigatraanieteksilaatti), kun nopea kääntyminen sen antikoagulantti vaikutuksia on tarpeen:hätä leikkaus/kiireellisiä menettelyjä;elämää uhkaava tai hallitsematon verenvuoto.

Euroopan unioni - suomi - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektiiviset immunosuppressantit - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Suomi - suomi - Fimea (Suomen lääkevirasto)

amgen europe b.v. - bevacizumabum - infuusiokonsentraatti, liuosta varten - 25 mg/ml - bevasitsumabi

Euroopan unioni - suomi - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevasitsumabi - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - antineoplastiset aineet - bevacizumabia yhdessä fluoripyrimidiinipohjaisen kemoterapian kanssa on tarkoitettu hoidettaessa aikuispotilaita, joilla on metastasoitunut koolonin tai peräsuolen karsinooma. bevasitsumabi yhdessä paklitakselin kanssa on tarkoitettu ensilinjan hoito aikuisilla potilailla, joilla on metastasoitunut rintasyöpä. lisätietoja ihmisen epidermaalisen kasvutekijäreseptorin 2 (her2) tilasta on kohdassa 5. bevasitsumabia yhdistelmänä kapesitabiinin kanssa on tarkoitettu ensilinjan hoito aikuisilla potilailla, joilla on metastasoitunut rintasyöpä ja joilla hoito yhdessä muiden kemoterapia vaihtoehtoja, mukaan lukien taksaanit tai antrasykliinit, ei pidetä tarkoituksenmukaisena. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. lisätietoja her2-tilasta on kohdassa 5. bevacizumab, 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. bevasitsumabi yhdessä erlotinibin on tarkoitettu käytettäväksi ensilinjan hoitoon aikuisille potilaille, joilla on leikattavissa oleva edennyttä, metastasoitunutta tai uusiutunutta ei-levyepiteelikarsinooma ei-pienisoluinen keuhkosyöpä, joilla on epidermaalisen kasvutekijän reseptorin (egfr) aktivointi mutaatioita. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, 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 iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, 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. bevasitsumabi yhdessä paklitakselin ja sisplatiinin tai vaihtoehtoisesti paklitakselin ja topotekaanin potilaille, jotka eivät voi saada platinum-hoito on tarkoitettu aikuisille potilaille, joilla on jatkuva, toistuva, tai metastasoitunut syöpä kohdunkaula.

Euroopan unioni - suomi - EMA (European Medicines Agency)

roche registration gmbh - bevasitsumabi - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; carcinoma, renal cell - antineoplastiset aineet - bevacizumabia yhdessä fluoripyrimidiinipohjaisen kemoterapian kanssa on tarkoitettu hoidettaessa aikuispotilaita, joilla on metastasoitunut koolonin tai peräsuolen karsinooma. bevasitsumabi yhdessä paklitakselin kanssa on tarkoitettu ensilinjan hoito aikuisilla potilailla, joilla on metastasoitunut rintasyöpä. lisätietoja, kuten ihmisen epidermaalisen kasvutekijän reseptoria 2 (her2) tila. bevasitsumabia yhdistelmänä kapesitabiinin kanssa on tarkoitettu ensilinjan hoito aikuisilla potilailla, joilla on metastasoitunut rintasyöpä ja joilla hoito yhdessä muiden kemoterapia vaihtoehtoja, mukaan lukien taksaanit tai antrasykliinit, ei pidetä tarkoituksenmukaisena. potilaat, jotka ovat saaneet taksaania ja antrasykliinipitoisia hoito-ohjelmia adjuvanttisessa ympäristössä viimeisten 12 kuukauden aikana, olisi jätettävä avastinin ja capecitabiinin. lisätietoja siitä, her2-status. bevasitsumabi, lisäksi platina-pohjaista solunsalpaajahoitoa, on tarkoitettu käytettäväksi ensilinjan hoitoon aikuisille potilaille, joilla on leikattavissa oleva edennyttä, metastasoitunutta tai uusiutunutta ei-pienisoluista keuhkosyöpää muu kuin levyepiteelikarsinooma hallitsevana tyyppinä. bevasitsumabi yhdessä erlotinibin on tarkoitettu käytettäväksi ensilinjan hoitoon aikuisille potilaille, joilla on leikattavissa oleva edennyttä, metastasoitunutta tai uusiutunutta ei-levyepiteelikarsinooma ei-pienisoluinen keuhkosyöpä, joilla on epidermaalisen kasvutekijän reseptorin (egfr) aktivointi mutaatioita. bevasitsumabi yhdessä interferoni alfa-2a on tarkoitettu käytettäväksi ensilinjan hoitoon aikuisilla potilailla, joilla on edennyt ja/tai metastasoitunut munuaissyöpä. bevasitsumabi yhdessä karboplatiini-ja paklitakseli on tarkoitettu etulinjan hoito aikuisilla potilailla, joilla on pitkälle edennyt (international federation of naistentautien ja synnytysopin (figo) vaiheiden iii b, iii c ja iv) epiteliaalinen munasarjasyöpä, munanjohtimen, tai ensisijainen vatsakalvon syöpä. bevasitsumabi yhdessä karboplatiinin ja gemsitabiinin kanssa, on tarkoitettu aikuisille potilaille, joilla on ensimmäisen toistumisen platinum-herkkä epiteelin munasarjojen, munanjohtimien tai ensisijainen vatsakalvon syöpä, jotka eivät ole aiemmin saaneet hoitoa bevasitsumabilla tai muulla vegf-estäjien tai vegf-reseptorin kohdennettuja aineet. bevasitsumabi yhdistettynä paklitakseliin, topotekaaniin tai pegyloituun liposomaaliseen doksorubisiiniin on tarkoitettu aikuisille potilaille, joilla on platinum-resistant uusiutunut epiteliaalinen munasarjasyöpä, munanjohtimen, tai ensisijainen vatsakalvon syöpä, joka ei ole saanut enemmän kuin kaksi ennen solunsalpaajahoitoa, ja jotka eivät ole aiemmin saaneet hoitoa bevasitsumabilla tai muulla vegf-estäjien tai vegf-reseptorin kohdennettuja aineet. bevasitsumabi yhdessä paklitakselin ja sisplatiinin tai vaihtoehtoisesti paklitakselin ja topotekaanin potilaille, jotka eivät voi saada platinum-hoito on tarkoitettu aikuisille potilaille, joilla on jatkuva, toistuva, tai metastasoitunut syöpä kohdunkaula.

Euroopan unioni - suomi - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio 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. 1 of the smpc. aybintio 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 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. lisätietoja her2-tilasta on kohdassa 5. 1 of the smpc. aybintio, 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. aybintio, 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. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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. 1 of the smpc). aybintio, 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. aybintio, in combination with 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. 1 of the smpc). aybintio, 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. 1 of the smpc).

Euroopan unioni - suomi - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi 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. onbevzi 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 onbevzi in combination with capecitabine. lisätietoja her2-tilasta on kohdassa 5. onbevzi, 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. onbevzi, 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. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, 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. onbevzi, 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. onbevzi, in combination with 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. onbevzi, 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mabxience research sl - bevasitsumabi - colorectal neoplasms; breast neoplasms; ovarian neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastiset aineet - alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. alymsys 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 alymsys in combination with capecitabine. alymsys, 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. alymsys, 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. alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. alymsys, 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. alymsys, 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. alymsys, in combination with 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. alymsys, 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.