Europska Unija - islandski - EMA (European Medicines Agency)

sandoz gmbh - rivastigmin - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - einkennum meðferð vægt til nokkuð alvarlega alzheimer heilabilun. einkennum meðferð vægt til nokkuð alvarlega heilabilun í sjúklinga með sjálfvakin parkinsonsveiki.

Europska Unija - islandski - EMA (European Medicines Agency)

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

Europska Unija - islandski - 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.

Europska Unija - islandski - EMA (European Medicines Agency)

novartis europharm limited - rivastigmin - alzheimer disease; parkinson disease; dementia - psychoanaleptics, - einkennum meðferð vægt til nokkuð alvarlega alzheimer heilabilun. einkennum meðferð vægt til nokkuð alvarlega heilabilun í sjúklinga með sjálfvakin parkinsonsveiki.

Europska Unija - islandski - EMA (European Medicines Agency)

actavis group ptc ehf - rivastigmin vetnis tartrat - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - einkennum meðferð vægt til nokkuð alvarlega alzheimer heilabilun. einkennum meðferð vægt til nokkuð alvarlega heilabilun í sjúklinga með sjálfvakin parkinsonsveiki.

Europska Unija - islandski - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastoma - Æxlishemjandi lyf - unituxin er ætlað fyrir meðferð hár-hættu taugakímfrumuæxli í sjúklinga á aldrinum 12 mánuði að 17years, sem hafa áður fengið framkalla lyfjameðferð og náð að minnsta kosti að hluta svar, eftir myeloablative meðferð og samgena stafa klefi ígræðslu (asct). Það er gefið í samsettri meðferð með kólesteról-kólesteról-örvandi þáttum (gm-csf), interleukin-2 (il-2) og ísótretínóín.

Europska Unija - islandski - EMA (European Medicines Agency)

amgen europe b.v. - panitumumab - litlaræxli - Æxlishemjandi lyf - vectibix is indicated for the treatment of adult patients with wild-type ras metastatic colorectal cancer (mcrc): , in first-line in combination with folfox or folfiri. , í öðru-línu í ásamt folfiri fyrir sjúklinga sem hafa fengið fyrsta lína fluoropyrimidine byggir lyfjameðferð (án irínótecan). , eitt og sér eftir bilun fluoropyrimidine-, oxaliplatin-og irínótecan-inniheldur lyfjameðferð meðferð.

Europska Unija - islandski - EMA (European Medicines Agency)

alnylam netherlands b.v. - patisiran járn - amyloidosis, Ættingja - Önnur lyf í taugakerfinu - onpattro er ætlað fyrir meðferð arfgenga transthyretin-miðlað amyloidosis (hattr amyloidosis) í fullorðinn sjúklinga með stigi 1 eða stigi 2 polyneuropathy.

Europska Unija - islandski - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft rejection - Ónæmisbælandi lyf - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Europska Unija - islandski - EMA (European Medicines Agency)

alnylam netherlands b.v. - vutrisiran sodium - amyloid neuropathies, familial - Önnur lyf í taugakerfinu - treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.