Den europeiske union - finsk - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - teduglutide - malabsorptioireyhtymät - muut ruuansulatuselimistön sairauksien ja aineenvaihduntasairauksien lääkkeet, - revestive on tarkoitettu 1 vuoden ikäisten ja sitä vanhempien potilaiden hoitoon lyhytsuolen oireyhtymän (sbs). potilaiden tulee pysyä vakaana suoliston sopeuttamisen jälkeen leikkauksen jälkeen. revestive on tarkoitettu niiden potilaiden hoitoon, jotka ikäinen 1 vuosi ja edellä lyhyen suolen oireyhtymä. potilaiden tulee pysyä vakaana suoliston sopeuttamisen jälkeen leikkauksen jälkeen.

Den europeiske union - finsk - EMA (European Medicines Agency)

takeda gmbh - pantopratsoli - gastroesofageaalinen refluksi - protonipumpun estäjät - refluksi-oireiden lyhytkestoinen hoito (esim. närästys, hapon regurgitaatio) aikuisilla.

Den europeiske union - finsk - EMA (European Medicines Agency)

bayer pharma ag - regorafenib - paksusuolen vajaatoiminta - antineoplastic agents, protein kinase inhibitors - stivarga on tarkoitettu monoterapiana aikuispotilaille, joilla on:metastaattinen kolorektaalisyöpä (crc), jotka on aiemmin käsitelty, tai ei pidetä ehdokkaita, käytettävissä olevat hoidot - nämä ovat fluoropyrimidiini-pohjaista kemoterapiaa, anti-vegf-hoito ja anti-egfr-hoito;leikkaushoitoon tai metastaattisen ruoansulatuskanavan tukikudosten kasvaimet (gist), joka eteni tai jotka eivät siedä aikaisempi hoito imatinibi ja sunitinibi;maksasolusyövän (hcc), joka on aiemmin hoidettiin sorafenibilla.

Den europeiske union - finsk - 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.

Den europeiske union - finsk - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - karsinooma, ei-pienisoluinen keuhko - muut antineoplastiset aineet, proteiinikinaasin estäjät - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Den europeiske union - finsk - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastiset aineet - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Den europeiske union - finsk - EMA (European Medicines Agency)

les laboratoires servier - strontiumranelaatti - osteoporoosi, postmenopausaalinen - lääkkeet luusairauksien hoitoon - vaikean osteoporoosin hoito postmenopausaalisilla naisilla, joilla on suuri riski murtumasta selkäranka- ja lonkkamurtumien riskin vähentämiseksi. hoito vaikea osteoporoosi aikuisilla miehillä joilla on suurentunut murtumien riski. päätös määrätä strontiumranelaatti tulisi arvioinnin perusteella yksittäisen potilaan yleistä riskejä.

Den europeiske union - finsk - EMA (European Medicines Agency)

takeda gmbh - pantopratsoli - gastroesofageaalinen refluksi - protonipumpun estäjät - refluksi-oireiden lyhytkestoinen hoito (esim. närästys, hapon regurgitaatio) aikuisilla.

Den europeiske union - finsk - EMA (European Medicines Agency)

accord healthcare s.l.u. - pemetreksedi dinatrium hemipentahydraatti - carcinoma, non-small-cell lung; mesothelioma - antineoplastiset aineet - pahanlaatuinen keuhkopussin mesotheliomapemetrexed accord yhdistelmänä sisplatiinin kanssa on tarkoitettu hoitoon kemoterapiaa aiemmin hoitamattomat potilaat, joilla on leikattavissa oleva pahanlaatuinen keuhkopussin mesoteliooma. ei-pienisoluisen keuhkosyövän cancerpemetrexed accord yhdistelmänä sisplatiinin kanssa on tarkoitettu ensilinjan hoidoksi potilaille, joilla on paikallisesti pitkälle edennyt tai metastaattinen ei-pienisoluinen keuhkosyöpä muu kuin levyepiteelikarsinooma hallitsevana tyyppinä. pemetreksedin accord on tarkoitettu monoterapiana huolto hoito on paikallisesti edennyt tai metastasoitunut ei-pienisoluinen keuhkosyöpä muu kuin levyepiteelikarsinooma hallitsevana tyyppinä potilailla, joiden sairaus ei ole edennyt välittömästi platinapohjaisen kemoterapian. pemetreksedin accord on tarkoitettu monoterapiana toisen linjan hoidoksi potilaille, joilla on paikallisesti edennyt tai metastasoitunut ei-pienisoluinen keuhkosyöpä muu kuin levyepiteelikarsinooma hallitsevana tyyppinä.

Den europeiske union - finsk - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetreksedin ditromethamine - carcinoma, non-small-cell lung; mesothelioma - foolihappoa analogit, antimetaboliitit - pahanlaatuinen keuhkopussin mesotheliomapemetrexed hospira uk limited yhdistelmänä sisplatiinin kanssa on tarkoitettu hoitoon kemoterapiaa aiemmin hoitamattomat potilaat, joilla on leikattavissa oleva pahanlaatuinen keuhkopussin mesoteliooma. ei-pienisoluisen keuhkosyövän cancerpemetrexed hospira uk limited yhdistelmänä sisplatiinin kanssa on tarkoitettu ensilinjan hoito potilailla, joilla on paikallisesti pitkälle edennyt tai metastaattinen ei-pienisoluinen keuhkosyöpä muu kuin levyepiteelikarsinooma hallitsevana tyyppinä (ks. valmisteyhteenvedon kohta 5. pemetrexed hospira uk limited on tarkoitettu monoterapiana huolto hoito on paikallisesti edennyt tai metastasoitunut ei-pienisoluinen keuhkosyöpä muu kuin levyepiteelikarsinooma hallitsevana tyyppinä potilailla, joiden sairaus ei ole edennyt välittömästi platinapohjaisen kemoterapian (ks. valmisteyhteenvedon kohta 5. pemetrexed hospira uk limited on tarkoitettu monoterapiana toisen linjan hoidoksi potilaille, joilla on paikallisesti edennyt tai metastasoitunut ei-pienisoluinen keuhkosyöpä muu kuin levyepiteelikarsinooma hallitsevana tyyppinä (ks. valmisteyhteenvedon kohta 5.