Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

actavis group ptc ehf. - topiramatum inn - filmuhúðuð tafla - 25 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

actavis group ptc ehf. - topiramatum inn - filmuhúðuð tafla - 50 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - topiramatum inn - filmuhúðuð tafla - 25 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - topiramatum inn - filmuhúðuð tafla - 50 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gsk vaccines s.r.l. - ytri himnu frá neisseria meningitidis hópur b (álag nýja-sjáland 98/254), skal læknir hafa neisseria meningitidis hópur b fhbp samruna prótín, skal læknir hafa neisseria meningitidis hópur b nada prótín, skal læknir hafa neisseria meningitidis hópur b nhba samruna prótín - meningitis, meningococcal - meningókokka bóluefni - virkt ónæmisaðgerðir gegn innrásarsjúkdómum af völdum neisseria meningitidis serogroup-b stofnanna.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

glaxosmithkline pharma a/s - pertussis toxoid; filamentous haemagglutinin; pertactin; diphtheria toxoid; tetanus toxoid - stungulyf, dreifa - áfyllt sprauta

Evrópusambandið - íslenska - EMA (European Medicines Agency)

n.v. organon - corifollitropin alfa - reproductive techniques, assisted; ovulation induction; investigative techniques - hormón kynlíf og stillum kynfæri - controlled ovarian stimulation (cos) in combination with a gnrh antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (art) program. elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human chorionic gonadotropin (hcg).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir - lifrarbólga c, langvinn - veirueyðandi lyf til almennrar notkunar - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients 3 years of age and older (see sections 4. 2, 4. 4 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult 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. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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 dfsp. 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. .

Evrópusambandið - íslenska - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. , Áhrif imatinib á niðurstöðu beinmerg ígræðslu hefur ekki verið ákveðið. imatinib actavis is indicated for: , 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 dfsp. reynslu með imatinib í sjúklinga með stýrð útgjöld/mpd tengslum við pdgfr gene aftur fyrirkomulag er mjög takmarkað. Það eru ekki stjórnað rannsóknir sýna klínískum gagnast eða jókst að lifa fyrir þessum sjúkdómum.