Iasibon Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

iasibon

pharmathen s.a. - ibandronsyra - hypercalcemia; fractures, bone; neoplasm metastasis; breast neoplasms - läkemedel för behandling av bensjukdomar - concentrate for solution for infusion prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. behandling av tumör-inducerad hypercalcaemia med eller utan metastaser. film-coated tablets prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Taltz Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

taltz

eli lilly and company (ireland) limited - ixekizumab - psoriasis - immunsuppressiva - plack psoriasistaltz är indicerat för behandling av måttlig till svår plackpsoriasis hos vuxna som är kandidater för systemisk terapi. psoriasisartrit arthritistaltz, ensamt eller i kombination med metotrexat är indicerat för behandling av aktiv psoriasisartrit hos vuxna patienter som svarat otillräckligt på, eller som är intoleranta mot en eller flera sjukdomsmodifierande antireumatiska läkemedel (dmard) terapier.

Opdivo Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

opdivo

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 - antineoplastiska medel - 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.

Oncaspar Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

oncaspar

les laboratoires servier - pegaspargas - prekursorcell lymfoblastisk leukemi-lymfom - antineoplastiska medel - oncaspar är indicerat som en del av antineoplastiska kombinationsbehandling vid akut lymfatisk leukemi (all) hos pediatriska patienter från födseln till 18 år, och vuxna patienter.

Panretin Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

panretin

eisai gmbh - alitretinoin - sarkom, kaposi - antineoplastiska medel - panretin gel är indicerat för topikal behandling av kutana lesioner hos patienter med förvärvade-immun-brist-syndrome (aids)-relaterat kaposis sarkom (ks) när:lesioner är inte sårigt eller lymphoedematous, och behandling av visceral ks behövs inte, och;lesioner är att inte svara på det systemiska antiretroviral behandling, strålbehandling eller kemoterapi inte är lämplig.

Lutathera Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

lutathera

advanced accelerator applications - lutetium (177lu) oxodotreotid - neuroendokrina tumörer - andra terapeutiska radioaktiva läkemedel - lutathera är indicerat för behandling av inoperabel eller metastaserande, progressiv, väl differentierad (g1 och g2), somatostatin receptor positiva gastroenteropancreatic neuroendokrina tumörer (gep‑nets) hos vuxna.

Bondronat Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

bondronat

atnahs pharma netherlands b.v. - ibandronsyra - hypercalcemia; breast neoplasms; neoplasm metastasis; fractures, bone - läkemedel för behandling av bensjukdomar - bondronat är indicerat för:förebyggande av skelett händelser (patologiska frakturer, ben komplikationer som kräver strålning eller operation) hos patienter med bröstcancer och benmetastaser, behandling av tumör-inducerad hypercalcaemia med eller utan metastaser.

Ibandronic acid Accord Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

ibandronic acid accord

accord healthcare s.l.u. - ibandronsyra - wounds and injuries; breast diseases; neoplastic processes; calcium metabolism disorders; water-electrolyte imbalance - läkemedel för behandling av bensjukdomar - ibandronic acid är indicerat hos vuxna forprevention av skelett händelser (patologiska frakturer, ben komplikationer som kräver strålning eller operation) hos patienter med bröstcancer och benmetastaser. behandling av tumör inducerad hypercalcaemia med eller utan metastaser. behandling av osteoporos hos postmenopausala kvinnor med ökad risk för fraktur (se avsnitt 5. en minskning i risken för vertebrala frakturer har visats effekt på brott på lårbenshalsen har inte fastställts.

Zoledronic acid medac Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

zoledronic acid medac

medac gesellschaft für klinische spezialpräparate mbh - zoledronsyramonohydrat - fractures, bone; cancer - läkemedel för behandling av bensjukdomar - förebyggande av skelettrelaterade händelser (patologiska frakturer, ryggradskompression, strålning eller operation till ben eller tumörinducerad hyperkalcemi) hos vuxna patienter med avancerade maligniteter som involverar ben. behandling av vuxna patienter med tumör-inducerad hypercalcaemia (tih).

Topotecan Hospira Umoja wa Ulaya - Kiswidi - EMA (European Medicines Agency)

topotecan hospira

pfizer europe ma eeig - topotekan - uterine cervical neoplasms; small cell lung carcinoma - andra antineoplastiska medel - topotecan monoterapi är indicerad för behandling av patienter med recidiverad lungcancer i lungcancer (sclc) för vilken återbehandling med förstalinjen inte anses lämplig. topotecan i kombination med cisplatin är indicerat för patienter med cancer i livmoderhalsen återkommande efter strålbehandling för patienter med stadium ivb sjukdom. patienter med tidigare exponering för cisplatin kräver en varaktig behandling-fria intervall för att motivera behandling med kombinationen.