Európai Unió - izlandi - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - Æxlishemjandi lyf - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. sjúklingar sem hafa lítil eða mjög lítil hætta á endurkomu ætti ekki að fá viðbótar meðferð. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. nema í nýlega greind langvarandi áfanga cml, það eru ekki stjórnað rannsóknir sýna klínískum gagnast eða jókst að lifa fyrir þessum sjúkdómum.

Európai Unió - izlandi - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - Æxlishemjandi lyf - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Európai Unió - izlandi - EMA (European Medicines Agency)

n.v. organon - colecalciferol, alendronic acid (as sodium trihydrate) - beinþynning, eftir tíðahvörf - lyf til að meðhöndla beinsjúkdóma - meðferð við beinþynningu eftir tíðahvörf hjá sjúklingum í hættu á d-vítamínskorti. hættan dregur úr hættu hryggjarliðum og mjöðm beinbrot.

Európai Unió - izlandi - EMA (European Medicines Agency)

n.v. organon - alendronic sýru, colecalciferol - beinþynning, eftir tíðahvörf - lyf til að meðhöndla beinsjúkdóma - meðferð við beinþynningu eftir tíðahvörf hjá sjúklingum í hættu á d-vítamínskorti. fosavance dregur úr hættu hryggjarliðum og mjöðm beinbrot.

Európai Unió - izlandi - EMA (European Medicines Agency)

dechra regulatory b.v. - betamethasone acetate, terbinafine, florfenicol - krefur og antiinfectives í samsetning - hundar - meðferð við bráðri utanbólgu.

Európai Unió - izlandi - EMA (European Medicines Agency)

recordati rare diseases - sink - hepatolenticular hrörnun - Önnur meltingarvegi og efnaskipti vörur, - meðferð við wilson-sjúkdómum.

Európai Unió - izlandi - EMA (European Medicines Agency)

n.v. organon - alendronic sýru, colecalciferol - beinþynning, eftir tíðahvörf - lyf til að meðhöndla beinsjúkdóma - meðferð við beinþynningu eftir tíðahvörf hjá sjúklingum í hættu á d-vítamínskorti. vantavo dregur úr hættu hryggjarliðum og mjöðm beinbrot. meðferð tíðahvörf beinbrot í sjúklingum sem eru ekki fá vítamín-d viðbót og eru í hættu á d-d lungnastarfsemi. vantavo dregur úr hættu hryggjarliðum og mjöðm beinbrot.

Európai Unió - izlandi - EMA (European Medicines Agency)

bayer animal health gmbh - florfenicol, terbinafin stutt og long-term, mometasone furoate - otologicals, krefur og antiinfectives í samsetning - hundar - fyrir meðferð bráð hundur bólgu í ytra eða bráð tilvikum endurtekin eyrnabólga af völdum blandað sýkingar næm stofnum bakteríur viðkvæm florfenicol (Þegar pseudintermedius) og sveppi viðkvæm terbinafin (malassezia pachydermatis).

Izland - izlandi - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - buprenorphinum inn - forðaplástur - 5 míkróg/klst.

Izland - izlandi - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - buprenorphinum inn - forðaplástur - 10 míkróg/klst.