Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - Ónæmisörvandi, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemophilia b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

viatris limited - adrenalinum bítartrat (epinephrinum bítartrat) - stungulyf, lausn - 1 mg/ml

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

viatris aps - adrenalinum (epinephrinum inn) - stungulyf, lausn - 150 míkróg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

aspen pharma trading limited - azathioprinum inn - filmuhúðuð tafla - 25 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

aspen pharma trading limited - azathioprinum inn - filmuhúðuð tafla - 50 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alk-abelló a/s - adrenalinum bítartrat (epinephrinum bítartrat) - stungulyf, lausn í áfylltum lyfjapenna - 150 míkróg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alk-abelló a/s - adrenalinum bítartrat (epinephrinum bítartrat) - stungulyf, lausn í áfylltum lyfjapenna - 300 míkróg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - forvarnarfrumuæxli-eitilfrumuhvítblæði - Æxlishemjandi lyf - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

recordati rare diseases - carglumic acid - amino acid metabolism, inborn errors; propionic acidemia - Önnur meltingarvegi og efnaskipti vörur, - hjá er ætlað í meðferð:hyperammonaemia vegna n-acetylglutamate-þétti aðal skort;hyperammonaemia vegna isovaleric skal;hyperammonaemia vegna methymalonic skal;hyperammonaemia vegna skal propionic.