Den Europæiske Union - dansk - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastiske midler - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

ipsen pharma - cabozantinib - thyroid neoplasms - antineoplastiske midler - behandling af voksne patienter med progressiv, inoperabel lokalt fremskreden eller metastatisk medullær thyroid carcinoma.

Den Europæiske Union - dansk - 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 - antineoplastiske midler - 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 Europæiske Union - dansk - EMA (European Medicines Agency)

hra pharma rare diseases - ketoconazol - cushing syndrome - antimykotika til systemisk brug - ketoconazol hra er indiceret til behandling af endogent cushings syndrom hos voksne og unge over 12 år.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - antineoplastiske midler - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

accord healthcare s.l.u. - voriconazol - aspergillosis; candidiasis; mycoses - antimykotika til systemisk brug, triazol-derivater - voriconazol, er et bredt spektrum, triazol-svampemidler agent og er indiceret hos voksne og børn på to år og derover, som følger:behandling af invasiv aspergillosis;behandling af candidaemia i ikke-neutropenic patienter, behandling af fluconazol-resistente alvorlige invasive candida infektioner (herunder c. krusei);behandling af alvorlige svampeinfektioner forårsaget af scedosporium spp.. og fusarium spp.. voriconazol overenskomst bør administreres primært til patienter med progressive, eventuelt livstruende infektioner.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

hikma farmaceutica (portugal) s.a. - voriconazol - bacterial infections and mycoses; aspergillosis; candidiasis - antimykotika til systemisk brug - voriconazol, er et bredt spektrum, triazol-svampemidler agent og er angivet i voksne og børn i alderen 2 år og derover, som følger:behandling af invasiv aspergillosis;behandling af candidaemia i ikke-neutropenic patienter, behandling af fluconazol-resistente alvorlige invasive candida infektioner (herunder c. krusei);behandling af alvorlige svampeinfektioner forårsaget af scedosporium spp.. og fusarium spp.. voriconazol bør administreres primært til patienter med progressive, eventuelt livstruende infektioner. profylakse af invasive svampeinfektioner i høj risiko allogen hæmatopoietisk stamcelletransplantation (hsct)modtagere.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pfizer europe ma eeig - voriconazol - candidiasis; mycoses; aspergillosis - antimykotika til systemisk brug - voriconazol, er et bredt spektrum, triazol-svampemidler agent og er angivet i voksne og børn i alderen 2 år og derover, som følger:behandling af invasiv aspergillosis;behandling af i candidaemianon-neutropenic patienter, behandling af fluconazol-resistente alvorlige invasive candida infektioner (herunder c. krusei);behandling af alvorlige svampeinfektioner forårsaget af scedosporium spp.. og fusarium spp.. vfend bør administreres primært til patienter med progressive, eventuelt livstruende infektioner. profylakse af invasive svampeinfektioner i høj risiko allogen hæmatopoietisk stamcelletransplantation (hsct) modtagere.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - itraconazol - kapsler, hårde - 100 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

janssen-cilag a/s - itraconazol - kapsler - 100 mg