Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - trastutsumabi - stomach neoplasms; breast neoplasms - antineoplastiset aineet - rintojen cancermetastatic rintojen cancerogivri on tarkoitettu aikuisille potilaille, joilla on her2-positiivinen metastasoitunut rintasyöpä (mbc):monoterapiana sellaisille potilaille, jotka ovat saaneet ainakin kaksi solunsalpaajahoitoa metastasoituneeseen tautiinsa. ennen kemoterapia on oltava mukana vähintään antrasykliini-ja taxane ellei potilaat eivät sovellu näitä hoitoja. hormonireseptori-positiivisilla potilailla on myös epäonnistui, hormonihoito, ellei potilaat eivät sovellu näiden treatmentsin paklitakselin kanssa hoitoon ne potilaat, jotka eivät aikaisemmin ole saaneet solunsalpaajahoitoa metastasoituneeseen tautiinsa ja joille antrasykliinit eivät suitablein doketakselin kanssa hoitoon ne potilaat, jotka eivät aikaisemmin ole saaneet solunsalpaajahoitoa niiden metastasoitunut diseasein yhdistettynä aromataasi-inhibiittoriin postmenopausaalisilla potilailla, joilla on hormonireseptori-positiivinen mbc, joita ei ole aikaisemmin hoidettu trastutsumabilla. varhainen rintasyöpä ogivri on tarkoitettu aikuisille potilaille, joilla on her2-positiivinen varhaisen vaiheen rintasyöpä (ebc):leikkauksen jälkeen, kemoterapia (neoadjuvant tai adjuvantti) ja sädehoidon (jos sovellettavissa)seuraavat adjuvanttihoitoa doksorubisiinin ja syklofosfamidin kanssa yhdessä paklitakselin kanssa tai docetaxelin yhdistelmä, jossa on adjuvanttia kemoterapiaa, joka koostuu dosetakselin ja karboplatiinin. yhdessä neoadjuvanttihoidon jälkeen seuraa adjuvantti ogivri hoito, paikallisesti levinnyt (mukaan lukien tulehduksellinen) sairaus tai kasvaimia > 2 cm halkaisijaltaan. ogivri tulisi käyttää vain potilailla, joilla oli metastasoitunut tai ebc, joiden kasvaimet ovat joko her2-yli-ilmentymän tai her2-geenin monistuma määritettynä tarkalla ja validoidulla määritysmenetelmällä. metastasoitunut mahalaukun cancerogivri yhdessä kapesitabiinin tai 5-fluorourasiilin ja sisplatiinin kanssa on tarkoitettu aikuispotilaille, joilla on her2-positiivinen metastasoitunut adenokarsinooma vatsaan tai ruokatorven risteyksessä, joka ei ole saanut ennen syövän hoitoa metastasoituneeseen tautiinsa. ogivri tulisi käyttää vain potilailla, joilla oli metastasoitunut mahasyöpä (mgc), joiden kasvaimet ovat her2-yli-ilmentymän määritelty ihc2+ ja uudistetun sish-tai fish-tulosta, tai ihc 3+ tulos. tarkkaa ja validoitua menetelmää menetelmiä tulisi käyttää.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - treosulfan - hematopoieettiset kantasolutransplantaatiot - antineoplastiset aineet - treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastutsumabi - breast neoplasms; stomach neoplasms - antineoplastiset aineet - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. ennen kemoterapia on oltava mukana vähintään antrasykliini-ja taxane ellei potilaat eivät sovellu näitä hoitoja. hormonireseptori-positiivisilla potilailla on myös epäonnistui, hormonihoito, ellei potilaat eivät sovellu näitä hoitoja.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. yhdessä dosetakselin hoitoon ne potilaat, jotka eivät aikaisemmin ole saaneet solunsalpaajahoitoa metastasoituneeseen tautiinsa. yhdistettynä aromataasi-inhibiittoriin postmenopausaalisilla potilailla, joilla on hormonireseptori-positiivinen mbc, joita ei ole aikaisemmin hoidettu trastutsumabilla. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). leikkauksen jälkeen, kemoterapia (neoadjuvant tai adjuvantti) ja sädehoidon (jos sovellettavissa). seuraavat adjuvanttihoitoa doksorubisiinin ja syklofosfamidin kanssa, yhdessä paklitakselin tai doketakselin. yhdessä adjuvanttihoitoa koostuu dosetakselin ja karboplatiinin. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. tarkkaa ja validoitua menetelmää menetelmiä tulisi käyttää.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - ruoansulatuskanavan stromal-kasvaimet - muut antineoplastiset aineet, proteiinikinaasin estäjät - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Unjoni Ewropea - Finlandiż - 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).

Unjoni Ewropea - Finlandiż - 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.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - rintojen kasvaimet - antineoplastiset aineet - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Unjoni Ewropea - Finlandiż - 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.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

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

Unjoni Ewropea - Finlandiż - 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.