Evrópusambandið - íslenska - EMA (European Medicines Agency)

biogen netherlands b.v. - natalízúmab - margvísleg sclerosis - valdar ónæmisbælandi lyf - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 og 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - samgena cd34+ klefi inniheldur íbúa sem inniheldur blóðmyndandi stofnfrumur transduced með lentiglobin bb305 lentiviral vektor kóðun beta-a-t87q-glóbín gene - beta-thalassemia - other hematological agents - zynteglo er ætlað fyrir meðferð sjúklinga 12 ára og eldri með blóðgjöf-háð beta thalassaemia (tdt) sem hafa ekki β0/β0 arfgerð, fyrir hvern skurðaðgerðir stafa klefi (hsc) ígræðslu er rétt en hvítra manna antigen (hla)-samsvörun tengjast hsc gjafa er ekki í boði.

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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - Önnur lyf í taugakerfinu - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ceva santé animale - inactivated fimbrial adhesins of escherichia coli f4ab, inactivated fimbrial adhesins of escherichia coli f4ac, inactivated fimbrial adhesins of escherichia coli f5, inactivated fimbrial adhesins of escherichia coli f6 - Ónæmissjúkdómar fyrir suidae - svín - for the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce clinical signs (severe diarrhoea) and mortality caused by escherichia coli strains expressing the fimbrial adhesins f4ab, f4ac, f5 and f6.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinal stromal tumors - Æxlishemjandi lyf - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

kyowa kirin holdings b.v. - fentanylum cítrat - tungurótartafla - 800 míkróg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

kyowa kirin holdings b.v. - fentanylum cítrat - tungurótartafla - 600 míkróg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

kyowa kirin holdings b.v. - fentanylum cítrat - tungurótartafla - 400 míkróg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

kyowa kirin holdings b.v. - fentanylum cítrat - tungurótartafla - 300 míkróg