Rozlytrek Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

rozlytrek

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.

Xofluza Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

xofluza

roche registration gmbh - baloxavir marboxil - inflúensu, manna - veirueyðandi lyf til almennrar notkunar - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Phesgo Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

phesgo

roche registration gmbh - pertuzumab, trastuzumab - brjóstakrabbamein - Æxlishemjandi lyf - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Enspryng Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

enspryng

roche registration gmbh - satralizumab - neuromyelitis optica - Ónæmisbælandi lyf - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Evrysdi Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

evrysdi

roche registration gmbh  - risdiplam - vöðvaáfall, mænu - Önnur lyf við sjúkdómum í stoðkerfi - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

Ronapreve Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

ronapreve

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - Ónæmiskerfið sera og mótefni, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. sjá kafla 4. 4 og 5.

Lunsumio Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

lunsumio

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.

Vabysmo Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

vabysmo

roche registration gmbh - faricimab - wet macular degeneration; macular edema; diabetes complications - augnlækningar - vabysmo is indicated for the treatment of adult patients with:neovascular (wet) age-related macular degeneration (namd),visual impairment due to diabetic macular oedema (dme).

Metojectpen (Metoject) Stungulyf, lausn í áfylltum lyfjapenna 7,5 mg Īslande - īslandiešu - LYFJASTOFNUN (Icelandic Medicines Agency)

metojectpen (metoject) stungulyf, lausn í áfylltum lyfjapenna 7,5 mg

medac gesellschaft für klinische spezialpräparate gmbh - methotrexatum inn - stungulyf, lausn í áfylltum lyfjapenna - 7,5 mg

Metojectpen (Metoject) Stungulyf, lausn í áfylltum lyfjapenna 20 mg Īslande - īslandiešu - LYFJASTOFNUN (Icelandic Medicines Agency)

metojectpen (metoject) stungulyf, lausn í áfylltum lyfjapenna 20 mg

medac gesellschaft für klinische spezialpräparate gmbh - methotrexatum inn - stungulyf, lausn í áfylltum lyfjapenna - 20 mg