Europeiska unionen - svenska - EMA (European Medicines Agency)

medtronic biopharma b.v. - dibotermin alfa - tibial fractures; fracture fixation, internal; spinal fusion - läkemedel för behandling av bensjukdomar - inductos är indicerat för ryggradsfusion i en nivå i ländryggen som ersättare för autogent bentransplantat hos vuxna med degenerativ skivsjukdom som har haft minst 6 månader av icke-operativ behandling för detta tillstånd. inductos är indicerat för behandling av akuta tibia frakturer hos vuxna som ett komplement till vanlig vård med öppen fraktur minskning och intramedullära unreamed spik fixering.

Europeiska unionen - svenska - EMA (European Medicines Agency)

zoetis belgium sa - dibotermin alfa - benmorfogenetiska proteiner - hundar - osteoinduktivt medel för användning vid behandling av långbenskrubbningar som ett komplement till standardkirurgisk behandling med användning av öppen frakturreduktion hos hundar.

Europeiska unionen - svenska - EMA (European Medicines Agency)

olympus biotech international limited - eptotermin alfa - spondylolisthesis - läkemedel för behandling av bensjukdomar - opgenra är indicerat för posterolateral ryggradsspiralfusion hos vuxna patienter med spondylolistes, där autograft har misslyckats eller är kontraindicerat.

Europeiska unionen - svenska - EMA (European Medicines Agency)

olympus biotech international limited - eptotermin alfa - tibiala frakturer - läkemedel för behandling av skelettsjukdomar, ben morfogenetiska proteiner - behandling av nonunion av tibia med minst 9 månaders varaktighet, sekundär för trauma hos skelettmogna patienter, i de fall då tidigare behandling med autograft har misslyckats eller användning av autograft är oåtkomlig.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

united vaccines holding b.v. - valpsjukevirus (cdv), levande försvagat - frystorkat pulver och vätska till injektionsvätska, suspension - valpsjukevirus (cdv), levande försvagat 3 - 4,8 log10 eid50 aktiv substans; sorbitol hjälpämne - mink

Europeiska unionen - svenska - 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 - antineoplastiska medel - 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. patienter som har en låg eller mycket låg risk för återfall bör inte få adjuvant behandling. 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. förutom vid nyligen diagnostiserad kml kronisk fas, det finns inga kontrollerade studier som visar på en klinisk nytta eller ökad överlevnad för dessa sjukdomar.

Europeiska unionen - svenska - 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. förutom vid nyligen diagnostiserad kml kronisk fas, det finns inga kontrollerade studier som visar på en klinisk nytta eller ökad överlevnad för dessa sjukdomar. .

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

krka d.d., novo mesto - vardenafilhydrokloridtrihydrat - filmdragerad tablett - 10 mg - vardenafilhydrokloridtrihydrat 11,85 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

krka d.d., novo mesto - vardenafilhydrokloridtrihydrat - filmdragerad tablett - 5 mg - vardenafilhydrokloridtrihydrat 5,93 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

krka d.d., novo mesto - vardenafilhydrokloridtrihydrat - filmdragerad tablett - 20 mg - vardenafilhydrokloridtrihydrat 23,7 mg aktiv substans