Evrópusambandið - íslenska - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - kólesterólhækkun - lipid breytandi lyf - hvert er ætlað sem viðbót til að lágt‑feitur mataræði og öðrum fitu‑lækka lyf með eða án lágt-þéttleiki-lípóprótein (gegn) apheresis í fullorðinn sjúklinga með tilbúin ættingja hypercholesterolaemia (hofh). erfðafræðilega staðfestingu á hofh ætti að vera fæst þegar það er mögulegt. annars konar aðal hyperlipoproteinaemia og efri veldur hypercholesterolaemia (e. nýrungaheilkenni, of) verður að vera útilokað.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - krabbamein, squamous cell - Æxlishemjandi lyf - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amryt pharmaceuticals dac - metreleptin - fitukyrkingi, fjölskyldu hluta - Önnur meltingarvegi og efnaskipti vörur, - myalepta er ætlað sem viðbót til að mataræði eins og skipti meðferð til að meðhöndla fylgikvillar ki skort í fitukyrkingi (ld) sjúklingar:með staðfest meðfædda almenn ld (berardinelli-seip heilkenni) eða keypt almenn ld (lawrence heilkenni) í fullorðna og börn 2 ára aldri og abovewith staðfest ættingja hluta ld eða keypt hluta ld (barraquer-simons heilkenni), í fullorðna og börn 12 ára og eldri fyrir hvern standard meðferðir hefur ekki tekist að ná fullnægjandi efnaskiptum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - Ónæmisbælandi lyf - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amryt pharmaceuticals dac - octreotide acetate - acromegaly - hinsveiflur og heilahimnubólur og hliðstæður - mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - sýkingar í öndunarvegi - sýklalyf fyrir almenn nota, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

teva b.v.* - paracetamolum inn; codeini phosphas hemihydricus - filmuhúðuð tafla - 500 mg/30 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

zoetis belgium sa - ceftiofur - sýklalyf til almennrar notkunar - pigs; cattle - pigstreatment of bacterial respiratory disease associated with actinobacillus pleuropneumoniae, pasteurella multocida, haemophilus parasuis and streptococcus suis. meðferð við blóðeitrun, fjölhreyfingu eða fjölsetraæxli í tengslum við streptococcus suis sýkingu. cattletreatment of acute interdigital necrobacillosis in cattle also known as panaritium or foot rot. meðferð við bráðri mænuþvagleka hjá nautgripum, þegar meðferð með öðru sýklalyfjum hefur mistekist.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

bayer animal health gmbh - imidaclopridum inn; flumethrin - lyfjahálsól - 1,25 g / 0,56 g

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

bayer animal health gmbh - imidaclopridum inn; flumethrin - lyfjahálsól - 4,5 g / 2,03 g