Evrópusambandið - íslenska - EMA (European Medicines Agency)

gedeon richter plc. - relugolix, norethisterone acetate, estradiol hemihydrate - leiomyoma - hinsveiflur og heilahimnubólur og hliðstæður - ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

zoetis belgium - bedinvetmab - verkjalyf - hundar - for the alleviation of pain associated with osteoarthritis in dogs.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

zoetis belgium sa - frunevetmab - verkjalyf - kettir - for the alleviation of pain associated with osteoarthritis in cats.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - Æxlishemjandi lyf - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. sjúklingar sem hafa lítil eða mjög lítil hætta á endurkomu ætti ekki að fá viðbótar meðferð. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. nema í nýlega greind langvarandi áfanga cml, það eru ekki stjórnað rannsóknir sýna klínískum gagnast eða jókst að lifa fyrir þessum sjúkdómum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan ire healthcare limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Æxlishemjandi lyf - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Evrópusambandið - íslenska - 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.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

exeltis healthcare s.l. - drospirenonum inn; ethinylestradiolum inn - filmuhúðuð tafla - 3 mg/ 0,03 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

bayer ab* - levonorgestrelum inn; ethinylestradiolum inn - tafla

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

pfizer aps (p) - gestodenum inn; ethinylestradiolum inn - tafla - 75 míkróg+ 20 míkróg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

teva b.v.* - drospirenonum inn; ethinylestradiolum inn - filmuhúðuð tafla - 3 mg/0,02 mg