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

aventis pharma s.a. - telithromycin - sinusitis; tonsillitis; bronchitis, chronic; pharyngitis; community-acquired infections; pneumonia, bacterial - antibakterielle midler til systemisk brug, - ved ordination af ketek skal der tages hensyn til officiel vejledning om passende anvendelse af antibakterielle midler og lokal forekomst af resistens. ketek er indiceret til behandling af følgende infektioner:hos patienter over 18 år og oldercommunity-erhvervet pneumoni, mild eller moderat. ved behandling af infektioner forårsaget af kendt eller mistænkt beta-lactam - og / eller makrolid-resistente stammer (ifølge historien af patienter eller nationale og / eller regionale modstand data), der er omfattet af den antibakterielle spektrum af telithromycin:akut forværring af kronisk bronkitis;akut bihulebetændelse;hos patienter på 12 år og oldertonsillitis / halsbetændelse forårsaget af streptococcus pyogenes, som et alternativ, når beta-lactam antibiotika er ikke relevant i lande / regioner, der med en betydelig udbredelse af makrolid resistente s. pyogenes, når medieret af ermtr eller mefa.

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

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastiske midler - 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 og 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%.

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

yes pharmaceutical development services gmbh - doxorubicinhydrochlorid - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - antineoplastiske midler - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

klinge pharma gmbh - ezetimib, simvastatin - tabletter - 10+20 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

klinge pharma gmbh - ezetimib, simvastatin - tabletter - 10+40 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

klinge pharma gmbh - ezetimib, simvastatin - tabletter - 10+80 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

taw pharma (ireland) ltd - amlodipinbesilat - oral suspension - 1 mg/ml

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

vital pharma nordic aps - cloxacillinnatriummonohydrat - pulver til injektions-/infusionsvæske, opløsning - 2 g

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

teva pharma b.v. - gabapentin - kapsler, hårde - 300 mg

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

eco animal health europe limited - tylvalosin - antiinfectives til systemisk brug, antibakterielle midler til systemisk brug, makrolider - pheasants; chicken; turkeys; pigs - pigstreatment og methaphylaxis af svin enzootisk pneumoni, behandling af porcin proliferativ enteropathy (ileitis);behandling og methaphylaxis af svin, dysenteri. chickenstreatment og methaphylaxis for respiratorisk sygdom, der er forbundet med mycoplasma gallisepticum i kyllinger. pheasantstreatment for respiratorisk sygdom, der er forbundet med mycoplasma gallisepticum. turkeystreatment for respiratorisk sygdom, der er forbundet med tylvalosin følsomme stammer af ornithobacterium rhinotracheale i kalkuner.