Euroopan unioni - suomi - EMA (European Medicines Agency)

masitinib - ruoansulatuskanavan stromal-kasvaimet - proteiinikinaasin estäjät - hoito, jota ei voitu leikata ja/tai metastasoituneen pahanlaatuisen gastrointestinaalinen stroomakasvain (gist).

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - everolimuusi - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - antineoplastiset aineet - hormoni-reseptori-positiivinen kehittynyt rinta cancerafinitor on tarkoitettu hoitoon hormoni-reseptori-positiivinen, her2/neu-negatiivisen pitkälle edennyt rintasyöpä, yhdessä exemestane, post-vaihdevuodet ohittaneilla naisilla ilman oireista viskeraalista sairautta, kun uusiutumista tai etenemistä seuraavat ei-steroidaalinen aromataasin estäjä. neuroendokriinisiä kasvaimia haiman originafinitor on tarkoitettu hoitoon leikkaushoitoon tai metastaattisen, hyvin tai kohtalaisen eriytetty neuroendokriinisiä kasvaimia haiman alkuperää aikuisilla, joilla on etenevä sairaus. neuroendokriinisten kasvainten ruoansulatuskanavan tai keuhkojen originafinitor on tarkoitettu hoitoon leikkaushoitoon tai metastaattisen, hyvin eriytetty (grade 1 tai grade 2) ei-toiminnalliset neuroendokriinisiä kasvaimia ruoansulatuskanavan tai keuhkojen alkuperää aikuisilla, joilla on etenevä sairaus. munuaisten-cell carcinomaafinitor on tarkoitettu niiden potilaiden hoitoon, joilla on pitkälle edennyt munuaisten-cell carcinoma, joiden sairaus on edennyt, tai hoidon jälkeen vegf-täsmähoitoihin.

Euroopan unioni - suomi - EMA (European Medicines Agency)

roche registration gmbh - sakinaviiri - hiv-infektiot - antiviraalit systeemiseen käyttöön - invirase on tarkoitettu hiv-1-tartunnan saaneiden aikuispotilaiden hoidossa. invirasea tulee antaa vain yhdessä ritonaviirin ja muiden antiretroviraalisten lääkevalmisteiden kanssa.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumabi - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastiset aineet - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 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 (see sections 4. 4 ja 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab 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. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab 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 (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab 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%.

Euroopan unioni - suomi - EMA (European Medicines Agency)

accord healthcare s.l.u. - vorikonatsoli - aspergillosis; candidiasis; mycoses - systeemiset sienilääkkeet, triatsolijohdokset - vorikonatsoli on laajakirjoinen, triatsoli sienilääkettä ja on tarkoitettu aikuisille ja lapsille kaksi vuotta ja yli seuraavasti:invasiivisen aspergilloosin hoito;hoito kandidemia kun potilaalla ei ole neutropeniaa;hoitoon flukonatsolille resistentti, vakavien, invasiivisten candida-infektiot (mukaan lukien c. krusei);hoito vakavien sieni-infektioiden aiheuttamia scedosporium. ja fusarium spp. voriconazole accord tulee annostella pääasiallisesti potilaille, joilla on progressiivisia, mahdollisesti henkeä uhkaavia infektioita.

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)

hikma farmaceutica (portugal) s.a. - vorikonatsoli - bacterial infections and mycoses; aspergillosis; candidiasis - antimykoottiset aineet systeemiseen käyttöön - vorikonatsoli on laajakirjoinen triatsoli sienilääkettä ja on tarkoitettu aikuisille ja lapsille 2 vuotta ja yli seuraavasti:invasiivisen aspergilloosin hoito;hoito kandidemia kun potilaalla ei ole neutropeniaa;hoitoon flukonatsolille resistentti, vakavien, invasiivisten candida-infektiot (mukaan lukien c. krusei);hoito vakavien sieni-infektioiden aiheuttamia scedosporium. ja fusarium spp. vorikonatsolia tulisi annostella pääasiallisesti potilaille, joilla on progressiivisia, mahdollisesti henkeä uhkaavia infektioita. syvien sieni-infektioiden vaara on suuri allogeenisen hematopoieettisen kantasolujen siirteen (hsct)saaneilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatiitti c, krooninen - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 ja 5. hepatiitti c-virus (hcv) genotyyppi-erityisiä aktiivisuus ks. kohdat 4. 4 ja 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer europe ma eeig - vorikonatsoli - candidiasis; mycoses; aspergillosis - antimykoottiset aineet systeemiseen käyttöön - vorikonatsoli on laajakirjoinen triatsoli sienilääkettä ja on tarkoitettu aikuisille ja lapsille 2 vuotta ja yli seuraavasti:invasiivisen aspergilloosin hoito;hoito vuonna candidaemianon-neutropenia, hoito flukonatsolille resistentti, vakavien, invasiivisten candida-infektiot (mukaan lukien c. krusei);hoito vakavien sieni-infektioiden aiheuttamia scedosporium. ja fusarium spp. vorikonatsolia tulisi annostella pääasiallisesti potilaille, joilla on progressiivisia, mahdollisesti henkeä uhkaavia infektioita. syvien sieni-infektioiden vaara on suuri allogeenisen hematopoieettisen kantasolujen siirteen (hsct) saaneilla.

Suomi - suomi - Fimea (Suomen lääkevirasto)

janssen-cilag oy - itraconazole - kapseli, kova - 100 mg - itrakonatsoli