Evrópusambandið - íslenska - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pacira limited - cýtarabín - meningeal æxli - Æxlishemjandi lyf - intrathecal meðferð á eitilæxlum heilahimnubólgu. Í meirihluta af sjúklingum slíka meðferð verður hluti af einkennum líknandi sjúkdómsins.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pacira ireland limited - bupivacaine - acute pain - amides, anesthetics, local - exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain. in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - degarelix - blöðruhálskirtli - innkirtla meðferð - firmagon is a gonadotrophin releasing hormone (gnrh) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

bluefish pharmaceuticals ab - ondansetronum hýdróklóríð - filmuhúðuð tafla - 4 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

bluefish pharmaceuticals ab - ondansetronum hýdróklóríð - filmuhúðuð tafla - 8 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

servier (ireland) industries ltd - agomelatine - Þunglyndi, major - psychoanaleptics, - meðferð við alvarlegum þunglyndisþáttum hjá fullorðnum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - Æxlishemjandi lyf - rituzena er ætlað í fullorðnir fyrir eftirfarandi vísbendingar:ekki hodgkins (fÓtbolta)rituzena er ætlað fyrir meðferð áður ómeðhöndlað sjúklinga með stigi iii iv tíðahvörf eitlaæxli ásamt lyfjameðferð. rituzena sér er ætlað fyrir meðferð sjúklinga með stigi iii iv tíðahvörf eitlaæxli sem eru í lyfjameðferð þola eða ert í öðrum eða síðari bakslag eftir lyfjameðferð. rituzena er ætlað fyrir sjúklinga með cd20 jákvæð dreifð stór b klefi ekki hodgkins ásamt hÖggva (cýklófosfamíði, doxórúbicíns, víncristín, prednisólóni) lyfjameðferð. langvarandi eitilfrumuhvítblæði (cll)rituzena ásamt lyfjameðferð er ætlað fyrir sjúklinga með áður ómeðhöndlað og fallið/svarar cll. aðeins takmörkuð gögn eru í boði á virkni og öryggi fyrir sjúklinga áður meðhöndluð með sjúklingum sem mótefni þar á meðal rituzenaor sjúklingar svarar til fyrri rituzena plús lyfjameðferð. granulomatosis með polyangiitis og smásjá polyangiitisrituzena, í blöndu með hvorum fyrir sig, er ætlað til að framkalla fyrirgefningar í fullorðinn sjúklinga með alvarlega, virk granulomatosis með polyangiitis (wegener er) (innkaup) og smásjá polyangiitis (mpa).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan ireland limited - abirateron asetat - blöðruhálskirtli - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

csl behring gmbh - manna eðlilegt immúnóglóbúlín (scig) - Ónæmisfræðilegir skortsyndar - Ónæmiskerfið sera og mótefni, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.