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

eli lilly nederland b.v. - ramucirumab - mave neoplasmer - antineoplastiske midler - gastrisk cancercyramza i kombination med paclitaxel er indiceret til behandling af voksne patienter med fremskreden gastrisk kræft eller gastro-øsofagus krydset adenocarcinom med sygdommens progression efter forudgående platin og fluoropyrimidine kemoterapi. cyramza monoterapi er indiceret til behandling af voksne patienter med fremskreden gastrisk kræft eller gastro-øsofagus krydset adenocarcinom med sygdommens progression efter forudgående platinum eller fluoropyrimidine kemoterapi, for hvem behandling i kombination med paclitaxel er ikke passende. tyk-og endetarmskræft cancercyramza, i kombination med folfiri (irinotecan, folinic syre, og 5‑fluorouracil), er indiceret til behandling af voksne patienter med metastatisk kolorektal cancer (mcrc) med sygdommens progression på eller efter tidligere behandling med bevacizumab, oxaliplatin og en fluoropyrimidine. ikke-småcellet lungekræft cancercyramza i kombination med docetaxel er indiceret til behandling af voksne patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft med sygdommens progression efter platin-baseret kemoterapi. belyser den hepatocellulære carcinomacyramza monoterapi er indiceret til behandling af voksne patienter med avanceret eller inoperabel hepatocellulært carcinom, der har en serum alfa-fetoprotein (afp) i ≥ 400 ng/ml og som tidligere har været behandlet med sorafenib.

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

sun pharmaceutical industries europe b.v. - docetaxel - stomach neoplasms; adenoma; breast neoplasms; carcinoma, non-small-cell lung; prostatic neoplasms - antineoplastiske midler - bryst cancerdocetaxel i kombination med doxorubicin og cyclophosphamid er angivet for den adjuverende behandling af patienter med betjenes node-positiv brystkræft. docetaxel i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, der ikke tidligere har modtaget cytotoksisk behandling for denne tilstand. docetaxel monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter svigt af cytotoksiske terapi. tidligere kemoterapi skulle have inkluderet et anthracyclin eller et alkyleringsmiddel. docetaxel i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystcancer, hvis tumorer over hurtig her2, og som ikke tidligere har modtaget kemoterapi for metastatisk sygdom. docetaxel i kombination med capecitabin, er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi. tidligere behandling skulle have inkluderet en antracyklin. ikke-småcellet lungekræft cancerdocetaxel er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft efter svigt af før kemoterapi. docetaxel i kombination med cisplatin er indiceret til behandling af patienter med inoperabel lokalt fremskreden eller metastatisk ikke-småcellet lungekræft, hos patienter, der ikke tidligere har modtaget kemoterapi for denne tilstand. prostata cancerdocetaxel i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormon-refraktær metastatisk prostatakræft. gastrisk adenocarcinomadocetaxel i kombination med cisplatin og 5-fluorouracil er indiceret til behandling af patienter med metastatisk gastrisk adenocarcinom, herunder adenocarcinoma af gastroøsofageal vejkryds, der ikke har modtaget forudgående kemoterapi for metastatisk sygdom. hoved og hals cancerdocetaxel i kombination med cisplatin og 5-fluorouracil er indiceret til induktion behandling af patienter med lokalt fremskreden pladecellekræft i hoved og hals.

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

n.v. organon - alendronsyre, colecalciferol - osteoporose, postmenopausale - narkotika til behandling af knoglesygdomme - behandling af postmenopausal osteoporose hos patienter med risiko for vitamin d-insufficiens. fosavance reducerer risikoen for vertebrale og hoftebrud.

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)

n.v. organon - alendronsyre, colecalciferol - osteoporose, postmenopausale - narkotika til behandling af knoglesygdomme - behandling af postmenopausal osteoporose hos patienter med risiko for vitamin d-insufficiens. vantavo reducerer risikoen for vertebrale og hoftebrud. behandling af postmenopausal osteoporose hos patienter, der ikke får d-vitamin d-tilskud, og er i risiko for d-vitamin d-insufficiens. vantavo reducerer risikoen for vertebrale og hoftebrud.

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

novartis europharm limited - tislelizumab - esophageal squamous cell carcinoma - antineoplastiske midler - oesophageal squamous cell carcinoma (oscc) tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

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

astellas pharma europe b.v. - micafungin - candidiasis - antimykotika til systemisk brug - mycamine er indiceret til:voksne, unge ≥ 16 år og elderlytreatment af invasiv candidiasis behandling af øsofagus candidiasis hos patienter, for hvem intravenøs behandling er hensigtsmæssig forebyggelse af candida infektioner hos patienter, der gennemgår allogen hæmatopoietisk stamcelle transplantation eller patienter, der forventes at få neutropeni (absolut neutrophil count < 500 celler/µl) for 10 eller flere dage. børn (herunder nyfødte) og unge < 16 år agetreatment af invasiv candidiasis. forebyggelse af candida infektioner hos patienter, der gennemgår allogen hæmatopoietisk stamcelle transplantation eller patienter, der forventes at få neutropeni (absolut neutrophil count < 500 celler/µl) for 10 eller flere dage. beslutningen om at bruge mycamine bør tage hensyn til en potentiel risiko for udvikling af tumorer i leveren. mycamine bør derfor kun anvendes, hvis andre antimykotika ikke er hensigtsmæssige.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - natriumibandronatmonohydrat - filmovertrukne tabletter - 150 mg

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

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - midler til dermatitis, undtagen kortikosteroider - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

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

takeda gmbh - pantoprazol - gastroøsofageal tilbagesvaling - proton pumpe hæmmere - kortvarig behandling af reflukssymptomer (f.eks. halsbrand, syreregurgitation) hos voksne.