Evrópusambandið - íslenska - EMA (European Medicines Agency)

bayer ag - larotrectinib súlfat - kvið Æxli - Æxlishemjandi lyf - vitrakvi eitt og sér er ætlað til meðferð við fullorðna og börn sjúklinga með solid æxli að sýna taugavaxtar týrósín viðtaka nt (ntrk) gene samruna,sem hafa sjúkdóm sem er á staðnum háþróaður, sjúklingum eða hvar skurðaðgerð er líklegt að niðurstöðu í alvarlegum sjúkdómum, oghver hef enga fullnægjandi meðferð valkosti.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - thiotepa - hematopoietic stem cell transplantation; neoplasms - Æxlishemjandi lyf - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - Æxlishemjandi lyf - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

actavis group ptc ehf. - mycophenolatum mofetil - filmuhúðuð tafla - 500 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

intervet international b.v. - fluralaner, moxidectin - antiparasitic products, insecticides and repellents, endectocides, milbemycins - kettir - fyrir ketti við, eða í hættu, í bland sníkjudýra sníkjudýra af ticks eða flær og eyra maurum, maga pöddurnar eða heartworm. dýralæknis lyf er eingöngu ætlað þegar nota gegn ticks eða flær og einn eða fleiri af öðrum miða sníkjudýr er ætlað á sama tíma. fyrir meðferð merkið og fló sníkjudýra í kettir veita strax og viðvarandi fló (ctenocephalides sus) og merkið (ixodes ricinus) drepa virkni fyrir 12 vikum. fleas og ticks verður að festa við gestgjafann og hefja fóðrun til að verða fyrir áhrifum virka efnisins. varan er hægt að nota sem hluti af meðferðaráætlun fyrir flóaofnæmi húðbólgu (fad). fyrir meðferð sníkjudýra með eyra maurum (otodectes cynotis). fyrir meðferð sýkingum með þarma þráðormum (4 stig lirfur, óþroskaður fullorðnir og fullorðnir af toxocara cati) og lögð (4 stig lirfur, óþroskaður fullorðnir og fullorðnir af ancylostoma tubaeforme). Þegar gefið ítrekað á 12 vikna fresti, varan stöðugt í veg fyrir heartworm sjúkdómur af völdum dirofilaria immltís.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - Öll önnur lækningavörur - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

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.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

teva b.v.* - dronedaronum hýdróklóríð - filmuhúðuð tafla - 400 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharma a/s - alógliptín - sykursýki, tegund 2 - drugs used in diabetes, dipeptidyl peptidase 4 (dpp-4) inhibitors - vipidia er ætlað í fullorðnir 18 ára og eldri með tegund 2 sykursýki til að bæta blóðsykursstjórnun ásamt öðrum glúkósa lækka lyf þar á meðal insúlín, þegar þessir, saman með fæði og æfingu, ekki veita fullnægjandi blóðsykursstjórnun (sjá kafla 4. 4, 4. 5 og 5. 1 fyrir tiltæk gögn um mismunandi samsetningar).

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.