Evrópusambandið - íslenska - EMA (European Medicines Agency)

orphelia pharma sas - clofarabin - forvarnarfrumuæxli-eitilfrumuhvítblæði - Æxlishemjandi lyf - meðferð af bráðu eitilfrumuhvítblæði hvítblæði (allir) í börn sjúklingar sem hafa fallið eða þrálátan eftir að hafa fengið að minnsta kosti tvær áður en meðferð og þar sem það er engin önnur meðferð valkostur ráð fyrir að leiða í varanlegur svar. Öryggi og verkun hafa verið metin í rannsóknum sjúklinga ≤ 21 ára gamall á upphaflegu greininguna.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. sjá kafla 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - Æxlishemjandi lyf - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - Æxlishemjandi lyf - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ruxolitinib phosphate - vitiligo - aðrar húðsjúkdómar - opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

medac gesellschaft für klinische spezialpräparate gmbh - methotrexatum inn - stungulyf, lausn í áfylltum lyfjapenna - 7,5 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

medac gesellschaft für klinische spezialpräparate gmbh - methotrexatum inn - stungulyf, lausn í áfylltum lyfjapenna - 20 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

medac gesellschaft für klinische spezialpräparate gmbh - methotrexatum inn - stungulyf, lausn í áfylltum lyfjapenna - 25 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

medac gesellschaft für klinische spezialpräparate gmbh - methotrexatum inn - stungulyf, lausn í áfylltum lyfjapenna - 17,5 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

medac gesellschaft für klinische spezialpräparate gmbh - methotrexatum inn - stungulyf, lausn í áfylltum lyfjapenna - 30 mg