Island - islandčina - LYFJASTOFNUN (Icelandic Medicines Agency)

stada arzneimittel ag - azithromycinum díhýdrat - mixtúruduft, dreifa - 40 mg/ml

Európska únia - islandčina - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - Æxlishemjandi lyf - erbitux er ætlað fyrir sjúklinga með api vöxt þáttur viðtaka (egfr)-tjá, ras wild-tegund sjúklingum krabbameini:ásamt irínótecan byggir lyfjameðferð;í fyrsta lína ásamt folfox;eins og einn fulltrúi í sjúklingum sem hafa mistekist oxaliplatin - og irínótecan byggir meðferð og sem þola að irínótecan. nánari upplýsingar er að sjá kafla 5. erbitux er ætlað fyrir sjúklinga með æxli klefi krabbamein í höfðinu og hálsinn:ásamt geislameðferð fyrir staðnum háþróaður sjúkdómur;ásamt platínu-byggt lyfjameðferð fyrir endurteknum og/eða sjúklingum sjúkdómur.

Európska únia - islandčina - EMA (European Medicines Agency)

novartis europharm limited - basiliximab - graft rejection; kidney transplantation - Ónæmisbælandi lyf - simulect er ætlað til að fyrirbyggja bráðan líffæraútgáfu í nýsköpun á nýru í nýrum hjá fullorðnum og börnum (1-17 ára). Það er til þess að vera notuð samhliða með ciclosporin fyrir microemulsion - og barksteri byggir ónæmisbæling, í sjúklinga með spjaldið viðbrögð mótefni minna en 80%, eða þrefaldur viðhald ónæmisbælandi meðferð inniheldur ciclosporin fyrir microemulsion, krefur og annaðhvort azatíóprín eða mycofenolatmofetils.

Európska únia - islandčina - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - blóðrauði, ofsakláði - valdar ónæmisbælandi lyf - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Európska únia - islandčina - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - Ónæmiskerfið sera og mótefni, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Európska únia - islandčina - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - brjóstakrabbamein - Æxlishemjandi lyf - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Európska únia - islandčina - EMA (European Medicines Agency)

recordati netherlands b.v. - siltuximab - stór eitilfrumukrabbamein - Ónæmisbælandi lyf - sylvant er ætlað fyrir meðferð fullorðinn sjúklinga með multicentric castleman er sjúkdómur (mcd sem ert hiv veira (hiv) neikvæð og mönnum herpesveiru-8 (hhv-8) neikvæð.

Európska únia - islandčina - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - forvarnarfrumuæxli-eitilfrumuhvítblæði - Æxlishemjandi lyf - besponsa er ætlað sem einlyfjameðferð til meðferðar hjá fullorðnum með endurtekið eða eldfimt cd22-jákvætt b-frumufrumur bráð eitilfrumuhvítblæði (all). fullorðnir sjúklingar með fíkniefni jákvætt (ph +) endurkomið eða ónæmisbólgueyðandi frumur alla eiga að hafa misst meðferð með að minnsta kosti 1 tyrosínkínasahemli (tki).

Európska únia - islandčina - EMA (European Medicines Agency)

pfizer europe ma eeig - gemtuzumab ozogamicin - kyrningahvítblæði, mergbólga, bráð - Æxlishemjandi lyf - mylotarg er ætlað fyrir samsetning meðferð með daunorubicin (dnr) og cýtarabín (arac) fyrir meðferð sjúklinga aldri 15 ár og yfir með áður ómeðhöndlað, de new cd33-jákvæð bráð merg hvítblæði (aml), nema bráð promyelocytic hvítblæði (apl).

Európska únia - islandčina - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - heila-og mænusigg, köstum tilkynnt - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.