Evrópusambandið - íslenska - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - Æxli í eggjastokkum - Æxlishemjandi lyf - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca er ætlað eitt og sér til að viðhalda meðferð fullorðinn sjúklinga með platínu-viðkvæm fallið hágæða þekju blöðrur, eggjaleiðara, eða aðal kviðarholi krabbamein sem eru í svar (heill eða hluta) til að platínu-byggt lyfjameðferð.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - Æxlishemjandi lyf - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

alfasigma s.p.a. - metýlþíóníumklóríð - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - ofsabjúgur, arfgengur - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pfizer europe ma eeig - nirmatrelvir, ritonavir - covid-19 virus infection - paxlovid is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe covid 19.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - avacopan - microscopic polyangiitis; wegener granulomatosis - Ónæmisbælandi lyf - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - Æxlishemjandi lyf - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amgen europe bv - sotorasib - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

Evrópusambandið - íslenska - 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.

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.