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)

pharmathen s.a. - ibandronihappo - hypercalcemia; fractures, bone; neoplasm metastasis; breast neoplasms - lääkkeet luusairauksien hoitoon - concentrate for solution for infusion prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. kasvainten aiheuttaman hyperkalsemian hoitoon tai ilman etäpesäkkeitä. film-coated tablets prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Suomi - suomi - Fimea (Suomen lääkevirasto)

hexal a/s - tamsulosini hydrochloridum,dutasteridum - kapseli, kova - 0.5 mg / 0.4 mg - tamsulosiini ja dutasteridi

Suomi - suomi - Fimea (Suomen lääkevirasto)

bayer ag -

Euroopan unioni - suomi - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - kapesitabiini - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - kapesitabiini - kapesitabiini on tarkoitettu iii-vaihe-leikkauksen (dukes 'stage-c) paksusuolisyövän leikkauksen jälkeiseen adjuvanttikäsittelyyn. kapesitabiini on tarkoitettu käytettäväksi metastasoituneen kolorektaalisyövän hoitoon. kapesitabiinin kanssa on tarkoitettu ensilinjan hoito on edennyt mahasyöpä yhdessä platina-pohjainen hoito. kapesitabiinin yhdistelmähoidossa dosetakselin kanssa on tarkoitettu niiden potilaiden hoitoon, joilla on paikallisesti edennyt tai metastasoitunut rintasyöpä, kun sytotoksinen solunsalpaajahoito. aiempaan hoitoon olisi pitänyt sisältyä antrasykliini. kapesitabiini on tarkoitettu myös monoterapiana potilaille, joilla on paikallisesti edennyt tai metastasoitunut rintasyöpä, sen jälkeen kun vika taksaaneja ja antrasykliiniä sisältävä solunsalpaajahoito on tai joille edelleen antrasykliini-hoitoa ei ole tarkoitettu.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international nv - doripeneemi - pneumonia, ventilator-associated; pneumonia, bacterial; urinary tract infections; bacterial infections; cross infection - systeemiset bakteerilääkkeet, - doribax on tarkoitettu hoitoon seuraavien infektioiden hoitoon aikuisilla:sairaalainfektioiden keuhkokuume (mukaan lukien ventilator-associated pneumonia);komplisoituneet intra-abdominaaliset infektiot komplisoituneet virtsatietulehdukset. on otettava huomioon viralliset ohjeet antibioottien tarkoituksenmukaisesta käytöstä.