Evrópusambandið - íslenska - 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 - Æxlishemjandi lyf - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

chiesi farmaceutici spa - koffín salt - kæfisvefn - psychoanaleptics, - meðferð aðal kæfisvefn ótímabært börn.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - Önnur antianemic undirbúningur - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5. reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - eprinomectin, esafoxolaner, praziquantel - eprinomectin, combinations, , avermectins, antiparasitic products, insecticides and repellents - kettir - for cats with, or at risk from mixed infections by cestodes, nematodes and ectoparasites. dýralæknis lyf er eingöngu ætlað þegar allt þrjá hópa eru miða á sama tíma.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

laboratorios normon s.a. - cefepimum díhýdróklóríð mónóhýdrat - stungulyfs-/innrennslisstofn og leysir, lausn - 1 g

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

laboratorios normon s.a. - cefepimum díhýdróklóríð mónóhýdrat - stungulyfs-/innrennslisstofn og leysir, lausn - 2 g

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merial - fipronil, amitraz, (s)-methoprene - ectoparasiticides fyrir baugi nota, meðtalin. skordýraeitur - hundar - meðferð og koma í veg fyrir sníkjudýra í hunda af ticks (ixodes ricinus, dermacentor reticulatus, rhipicephalus sanguineus, ixodes scapularis, dermacentor variabilis, haemaphysalis elliptica, haemaphysalis longicornis, amblyomma americanum og amblyomma u) og flær (ctenocephalides sus og ctenocephalides canis). meðferð á sýkingum með því að tyggja lús (trichodectes canis). forvarnir gegn mengun á umhverfisflóa með því að hindra þróun allra flóru óþroskaðra stiga. varan er hægt að nota eins og hluti af meðferð áætlun til að stjórna fló-ofnæmi exem. brotthvarf flóa og flísar innan sólarhrings. ein meðhöndlun kemur í veg fyrir frekari smit í fimm vikur eftir ticks og í allt að fimm vikur með flórum. meðferð óbeint dregur úr hættu sendingu merkið-hafa sjúkdóma (hundur babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis og sjúkdómur) frá sýkt ticks fyrir fjórum vikum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

elanco gmbh - spinosad - Önnur ectoparasiticides fyrir almenn nota - dogs; cats - meðferð og forvarnir gegn flóaáföllum (ctenocephalides felis). forvarnaráhrif gegn endurteknum skaða eru afleiðing af fullorðinsvirkni og lækkun eggframleiðslu og viðvarandi í allt að 4 vikur eftir einni gjöf lyfsins. dýralyfið er hægt að nota sem hluti af meðferðaráætlun til að stjórna lungnæmisbólgu (fad).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - afoxólaner - isoxazolines, ectoparasiticides fyrir almenn nota - hundar - meðferð fló árás í hunda (ctenocephalides sus og c. canis) fyrir 5 vikur að minnsta kosti. varan er hægt að nota sem hluti af meðferðaráætlun til að stjórna lungnæmisbólgu (fad). meðferð merkið árás í hunda (dermacentor reticulatus, ixodes ricinus, ixodes hexagonus, rhipicephalus sanguineus). ein meðferð drepur ticks fyrir allt að einn mánuð. fleas og ticks verður að festa við gestgjafann og hefja fóðrun til að verða fyrir áhrifum virka efnisins. meðferð demodicosis (af völdum demodex canis). meðferð sarcoptic girl (af völdum sarcoptes scabiei var. canis).