Den europeiske union - norsk - EMA (European Medicines Agency)

vericel denmark aps - autologe dyrkede kondrocytter - frakturer, brusk - andre legemidler for forstyrrelser i muskel-skjelettsystemet - reparasjon av symptomatiske bruskdefekter i kneet.

Den europeiske union - norsk - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomid - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - immunsuppressive - flere myelomarevlimid som monoterapi er indisert for vedlikehold behandling av voksne pasienter med nydiagnostisert myelomatose som har gjennomgått autologous stilk cellen transplantasjon. revlimid som kombinasjonsbehandling med deksametason, eller bortezomib og dexamethasone, eller melphalan og prednison (se kapittel 4. 2) er indisert for behandling av voksne pasienter med tidligere ubehandlet myelomatose som ikke er kvalifisert for transplantasjon. revlimid i kombinasjon med deksametason er angitt for behandling av myelomatose hos voksne pasienter som har fått minst ett før behandling. myelodysplastic syndromesrevlimid som monoterapi er indisert for behandling av voksne pasienter med transfusjon avhengige av anemi på grunn av lav - eller middels-1-risiko myelodysplastic syndromer assosiert med en isolert sletting 5q cytogenetic unormalt når andre terapeutiske alternativer er utilstrekkelig eller inadekvat. mantelen celle lymphomarevlimid som monoterapi er indisert for behandling av voksne pasienter med tilbakefall eller ildfast mantelen celle lymfom. follicular lymphomarevlimid i kombinasjon med rituximab (anti-cd20-antistoff) er indisert for behandling av voksne pasienter med tidligere behandlet follicular lymfom (klasse 1 – 3a).

Den europeiske union - norsk - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastiske midler - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Den europeiske union - norsk - EMA (European Medicines Agency)

adienne s.r.l. s.u. - tiotepa - hematopoietisk stamcelletransplantasjon - antineoplastiske midler - i kombinasjon med annen kjemoterapi legemidler:med eller uten hele kroppen bestråling (tbi), som condition behandling før allogen eller autologous haematopoietic stamfar cellen transplantasjon (hpct) i haematological sykdommer i voksen og paediatric pasienter, når høy dose kjemoterapi med hpct støtte er aktuelle for behandling av solide svulster hos voksne og paediatric pasienter. det er foreslått at tepadina må forskrives av leger med erfaring i bad behandling før haematopoietic stamfar cellen transplantasjon.

Den europeiske union - norsk - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastom - antineoplastiske midler - unituxin er indisert for behandling av høy risiko neuroblastom hos pasienter i alderen 12 måneder til 17years, som tidligere har mottatt induksjon kjemoterapi og oppnås minst delvis svar, etterfulgt av myeloablative terapi og autologous stilk cellen transplantasjon (asct). det administreres i kombinasjon med granulocyt-makrofag kolonistimulerende faktor (gm-csf), interleukin-2 (il-2) og isotretinoin.

Den europeiske union - norsk - EMA (European Medicines Agency)

co.don gmbh - sfæroider av humane autologe matrisassosierte kondrocytter - brusk sykdommer - andre legemidler for forstyrrelser i muskel-skjelettsystemet - reparasjon av symptomatiske leddbruskdefekter i lårkondylen og knottens patella (international cartilage repair society [icrs] klasse iii eller iv) med defektstørrelser på opptil 10 cm2 hos voksne.

Norge - norsk - Statens legemiddelverk

curium netherlands b.v. - indium (111in) oksin - oppløsning - 37 mbq/ ml

Den europeiske union - norsk - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - antineoplastiske midler - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

Den europeiske union - norsk - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomid - multippelt myelom - immunsuppressive - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er indisert for behandling av voksne pasienter med tidligere ubehandlet myelomatose som ikke er kvalifisert for transplantasjon. lenalidomide avtalen i kombinasjon med deksametason er angitt for behandling av myelomatose hos voksne pasienter som har fått minst ett før behandling. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Den europeiske union - norsk - EMA (European Medicines Agency)

mylan ireland limited - lenalidomid - multippelt myelom - immunsuppressive - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).