Unia Europejska - duński - EMA (European Medicines Agency)

regeneron uk limited - rilonacept - cryopyrin-associerede periodiske syndromer - immunosuppressiva - rilonacept regeneron er indiceret til behandling af cryopyrin-associerede periodiske syndromer (caps) med svære symptomer, herunder familiær kolde auto-inflammatoriske syndrom (fcas) og muckle-wells syndrom (mws), hos voksne og børn i alderen 12 år og ældre.

Unia Europejska - duński - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - temozolomid - glioma; glioblastoma - antineoplastiske midler - temodal hårde kapsler er indiceret til behandling af:voksne patienter med nyligt diagnosticerede glioblastoma multiforme samtidig med strålebehandling og efterfølgende som monoterapi behandling;børn fra en alder af tre år, unge og voksne patienter med ondartet gliom, såsom glioblastoma multiforme eller anaplastisk astrocytom, der viser recidiv eller progression efter standardbehandling.

Unia Europejska - duński - EMA (European Medicines Agency)

pierre fabre medicament - busulfan - hematopoietisk stamcelletransplantation - antineoplastiske midler - busilvex efterfulgt af cyclophosphamid (bucy2) er indiceret som konditionerende behandling før konventionelle hæmatopoietiske stamceller celle transplantation (hpct) hos voksne patienter, når kombinationen er betragtes som den bedste tilgængelige mulighed. busilvex følgende fludarabine (fb) er angivet som condition behandling forud for hæmatopoietisk stamcelletransplantation (hpct) hos voksne patienter, der er kandidater til en reduceret intensitet conditioning (ric) opskrift. busilvex efterfulgt af cyclophosphamid (bucy4) eller melphalan (bumel) er angivet som condition behandling forud for konventionelle hæmatopoietisk stamcelletransplantation i pædiatriske patienter.

Unia Europejska - duński - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - thiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastiske midler - 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.

Unia Europejska - duński - EMA (European Medicines Agency)

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - antineoplastiske midler - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

Unia Europejska - duński - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimykotika til systemisk brug - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Unia Europejska - duński - EMA (European Medicines Agency)

csl behring gmbh - human normal immunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - immune sera og immunoglobuliner, - udskiftning terapi hos voksne, og børn og unge (0-18 år) i:primær immundefekt (pid) syndromer med nedsat antistof produktion;hypogammaglobulinaemia og recidiverende bakterieinfektioner hos patienter med kronisk lymfatisk leukæmi, i hvem profylaktiske antibiotika har fejlet;hypogammaglobulinaemia og gentagne bakterielle infektioner i plateau-fase-multiple myeloma patienter, der har undladt at reagere på pneumokok-vaccination;hypogammaglobulinaemia hos patienter efter allogen hæmatopoietisk-stamcelle transplantation (hsct);medfødt aids med recidiverende bakterielle infektioner. immunomodulation i voksne, og børn og unge (0-18 år) i:primær immun trombocytopeni (itp) hos patienter i høj risiko for blødning eller før en operation for at korrigere den blodplader;guillain-barré syndrom;kawasakis sygdom;kronisk inflammatorisk demyeliniserende polyneuropati (cidp). der er kun begrænsede erfaringer med anvendelse af intravenøs immunglobuliner i børn med cidp.

Unia Europejska - duński - EMA (European Medicines Agency)

takeda manufacturing austria ag - human normal immunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - immune sera og immunoglobuliner, - udskiftning terapi hos voksne, og børn og unge (0-18 år) i:primær immundefekt-syndromer med nedsat antistof produktion;hypogammaglobulinaemia og recidiverende bakterieinfektioner hos patienter med kronisk lymfatisk leukæmi, i hvem profylaktiske antibiotika har fejlet;hypogammaglobulinaemia og gentagne bakterielle infektioner i plateau-fase-multiple myeloma patienter, der har undladt at reagere på pneumokok-vaccination;hypogammaglobulinaemia hos patienter efter allogen hæmatopoietisk-stamcelle transplantation (hsct);medfødt aids og gentagne bakterielle infektioner. immunomodulation i voksne, og børn og unge (0-18 år) i:primær immun trombocytopeni (itp) hos patienter i høj risiko for blødning eller før en operation for at korrigere den blodplader;guillain barré syndrom;kawasakis sygdom;multifokal motorisk neuropati (mmn).

Unia Europejska - duński - EMA (European Medicines Agency)

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Unia Europejska - duński - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - lymfom, mantelcelle - antineoplastiske midler - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).