Európai Unió - izlandi - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Európai Unió - izlandi - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (ret) fusion-positive advanced non-small cell lung cancer (nsclc) not previously treated with a ret inhibitor.

Európai Unió - izlandi - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dímetýl fúmarat - heila-og mænusigg, köstum tilkynnt - Ónæmisbælandi lyf - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Európai Unió - izlandi - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - eitilæxli, follicular - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

Európai Unió - izlandi - EMA (European Medicines Agency)

immunocore ireland limited - tebentafusp - uveal neoplasms - Æxlishemjandi lyf - kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (hla)-a*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Európai Unió - izlandi - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Európai Unió - izlandi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Európai Unió - izlandi - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - kyrningahvítblæði, mergbreytilegt, langvinnt, bcr-abl jákvætt - Æxlishemjandi lyf - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Európai Unió - izlandi - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - Æxlishemjandi lyf - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Európai Unió - izlandi - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemophilia b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.