Euroopan unioni - suomi - EMA (European Medicines Agency)

sandoz gmbh - trastutsumabi - breast neoplasms; stomach neoplasms - antineoplastiset aineet - treatment of metastatic and early breast cancer and metastatic gastric cancer (mgc).

Euroopan unioni - suomi - EMA (European Medicines Agency)

teva pharma b.v. - doketakseli - carcinoma, non-small-cell lung; breast neoplasms; prostatic neoplasms - antineoplastiset aineet - rintojen cancerdocetaxel teva pharma monoterapia on tarkoitettu niiden potilaiden hoitoon, jotka sairastavat paikallisesti levinnyttä tai metastasoivaa rintasyöpää, johon hoito. aiempi kemoterapia olisi pitänyt sisältää antrasykliini tai alkyloiva aine. non-small-cell lung cancerdocetaxel teva pharma on tarkoitettu niiden potilaiden hoitoon, jotka sairastavat paikallisesti levinnyttä tai metastasoivaa ei-small-cell lung cancer vikaannuttua ennen kemoterapiaa. docetaxel teva pharma yhdistelmänä sisplatiinin kanssa on tarkoitettu niiden potilaiden hoitoon, joilla on leikattavissa oleva, paikallisesti edennyt tai metastasoitunut ei-small-cell lung cancer, potilailla, jotka aiemmin eivät ole saaneet solunsalpaajahoitoa tähän sairauteen. eturauhasen cancerdocetaxel teva pharma yhdistelmänä prednisonin tai prednisolonin kanssa on tarkoitettu hoitoon metastasoineen eturauhassyövän.

Euroopan unioni - suomi - EMA (European Medicines Agency)

roche registration gmbh - trastutsumabi - stomach neoplasms; breast neoplasms - antineoplastiset aineet - rintojen cancermetastatic rintojen cancerherceptin on tarkoitettu potilaille, joilla on her2-positiivinen metastasoitunut rintasyöpä: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. hormoni-reseptori-positiivinen potilailla on myös epäonnistui, hormonihoito, ellei potilaat eivät sovellu näitä hoitoja;yhdessä paklitakselin kanssa hoitoon ne potilaat, jotka eivät aikaisemmin ole saaneet solunsalpaajahoitoa metastasoituneeseen tautiinsa ja joille antrasykliinit eivät sovi;yhdessä dosetakselin hoitoon ne potilaat, jotka eivät aikaisemmin ole saaneet solunsalpaajahoitoa metastasoituneeseen tautiinsa;yhdistettynä aromataasi-inhibiittoriin postmenopausaalisilla potilailla, joilla on hormonireseptori-positiivinen metastasoitunut rintasyöpä ja joita ei ole aikaisemmin hoidettu trastutsumabilla. varhainen rintojen cancerherceptin on tarkoitettu potilaille, joilla on her2-positiivinen varhaisen vaiheen rintasyöpä: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;yhdessä neoadjuvanttihoidon jälkeen seuraa adjuvantti herceptin-hoitoa, paikallisesti levinnyt (mukaan lukien tulehduksellinen) sairaus tai kasvaimia >2 cm halkaisijaltaan. herceptiniä saa käyttää vain potilailla, joilla oli metastasoitunut tai varhaisen vaiheen rintasyöpää, joiden kasvaimet ovat joko her2-yli-ilmentymän tai her2-geenin monistuma määritettynä tarkalla ja validoidulla määritysmenetelmällä. metastasoitunut mahalaukun cancerherceptin yhdessä kapesitabiinin tai 5-fluorourasiilin ja sisplatiinin kanssa on tarkoitettu niiden potilaiden hoitoon, joilla on her2-positiivinen metastasoitunut adenokarsinooma vatsaan tai ruokatorven risteyksessä, joka ei ole saanut ennen syövän hoitoa metastasoituneeseen tautiinsa. herceptiniä saa käyttää vain potilailla, joilla oli metastasoitunut mahasyöpä, joiden kasvaimet ovat her2-yli-ilmentymän määritelty ihc2+ ja uudistetun sish-tai fish-tulosta, tai ihc3+ tulos. tarkkaa ja validoitua menetelmää menetelmiä tulisi käyttää.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanooma - antineoplastiset aineet - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 ja 5. adjuvanttihoitona melanomadabrafenib yhdessä trametinib on tarkoitettu adjuvanttihoitona aikuisille potilaille, joilla on vaiheen iii melanooma on braf v600-mutaatio, seuraava täydellinen resektio. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

Suomi - suomi - Fimea (Suomen lääkevirasto)

accord healthcare b.v. accord healthcare b.v. - mitoxantroni hydrochloridum - infuusiokonsentraatti, liuosta varten - 2 mg/ml - mitoksantroni

Euroopan unioni - suomi - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil hydrochloride - paksusuolen vajaatoiminta - antineoplastiset aineet - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Suomi - suomi - Fimea (Suomen lääkevirasto)

meda oy - mitoxantroni hydrochloridum - infuusiokonsentraatti, liuosta varten - 2 mg/ml - mitoksantroni

Euroopan unioni - suomi - EMA (European Medicines Agency)

roche registration gmbh - trastutsumabin emtansiini - rintojen kasvaimet - antineoplastiset aineet - varhainen rintasyöpä (ebc)kadcyla, ainoana lääkkeenä, on tarkoitettu käytettäväksi liitännäishoitona hoito aikuisilla potilailla, joilla on her2-positiivinen varhaisen vaiheen rintasyöpä, joka on jäljellä invasiivisen sairauden, rintasyövän ja/tai imusolmukkeiden, kun neoadjuvant taxane-pohjainen ja her2-kohdennettua hoitoa. metastasoitunut rintasyöpä (mbc)kadcyla, ainoana lääkkeenä, on tarkoitettu aikuisille potilaille, joilla on her2-positiivinen, leikkaushoitoon soveltumattoman paikallisesti levinnyttä tai metastasoivaa rintasyöpää ja jotka aiemmin saanut trastutsumabia ja taxane, erikseen tai yhdessä. potilailla pitäisi olla joko:saaneet aiempaa hoitoa paikallisesti edenneen tai metastasoituneen taudin, ordeveloped taudin uusiutumisen aikana tai kuuden kuukauden kuluessa valmiiksi adjuvanttihoito.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastiset aineet - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karsinooma, squamous cell - antineoplastiset aineet - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.