Yhdysvallat - englanti - NLM (National Library of Medicine)

human genome sciences, inc. - raxibacumab (unii: 794pgl549s) (raxibacumab - unii:794pgl549s) - raxibacumab 50 mg in 1 ml - raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to bacillus anthracis in combination with appropriate antibacterial drugs. raxibacumab is also indicated for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. the effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. it is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax. [see clinical studies (14.1).] safety and pharmacokinetics (pk) of raxibacumab have been studied in adult healthy volunteers. there have been no trials of safety or pk of raxibacumab in the pediatric population. an extrapolation approach was used to derive dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults. [see use in specific populations (8.4).] raxibacumab binds to the protective antigen (pa) of b

Euroopan unioni - englanti - EMA (European Medicines Agency)

intervet international b.v. - bluetongue virus vaccine, serotype 8 (inactivated) - immunologicals for ovidae - cattle; sheep - sheepfor the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.cattlefor the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.*(cycling value (ct) ≥ 36 by a validated rt-pcr method, indicating no presence of viral genome)

Israel - englanti - Ministry of Health

roche pharmaceuticals (israel) ltd - atezolizumab - concentrate for solution for infusion - atezolizumab 60 mg/ml - urothelial carcinoma• tecentriq (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours have a pd-l1 expression ≥ 5%.• tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.- non-small cell lung cancer •tecentriq, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have high pd-l1 expression (pd-l1 stained ≥ 50% of tumor cells [tc ≥ 50%] or pd-l1 stained tumor-infiltrating immune cells [ic] covering ≥ 10% of the tumor area [ic ≥ 10%]), as determined by an approved test, with no egfr or alk genomic tumor aberrations.•tecentriq, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous nsclc with no egfr or alk genomic tumor aberrations.• tecentriq, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated only after failure of appropriate targeted therapies.• tecentriq is indicated for the treatment of patients with metastatic nsclc who are naïve to anti-pd-l1 or anti-pd-1 therapies and have disease progression during or following platinum-containing chemotherapy. patients with egfr or alk genomic tumor aberrations should have disease progression on approved therapy for nsclc harboring these aberrations prior to receiving tecentriq.• tecentriq as monotherapy, is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage ii to iiia nsclc whose tumors have pd-l1 expression on ≥ 50% of tumor cells (tcs).- locally advanced or metastatic triple-negative breast cancer tecentriq, in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumors have pd-l1 expression ≥1% and who have not received prior chemotherapy for metastatic disease.- small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc)."- hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.- melanomatecentriq, in combination with cobimetinib and vemurafenib, is indicated for the treatment of patients with braf v600 mutation-positive unresectable or metastatic melanoma.- alveolar soft part sarcoma tecentriq, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (asps).

Israel - englanti - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 100 mg - olaparib - ovarian cancer:lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumablynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either:• a deleterious or suspected deleterious brca mutation, and/or• genomic instability breast cancer:germline brca-mutated her2-negative metastatic breast cancerlynparza is indicated in patients with deleterious or suspected deleterious gbrcam, her2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. patients with hormone receptor (hr)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.adjuvant treatment of germline brca-mutated her2-negative high risk early breast cancer lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gbrcam human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. adenocarcinoma of the pancreas:first-line maintenance treatment of germline brca-mutated metastatic pancreatic adenocarcinomalynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.prostate cancer:• germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer (mcrpc) who have progressed following prior treatment with enzalutamide or abiraterone.• lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious hrr-mutated (hrrm) metastatic castration-resistant prostate cancer (mcrpc). select patients for therapy based on an approved companion diagnostic for lynparza

Israel - englanti - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 100 mg - olaparib - ovarian cancer:lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumablynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either:• a deleterious or suspected deleterious brca mutation, and/or• genomic instability breast cancer:germline brca-mutated her2-negative metastatic breast cancerlynparza is indicated in patients with deleterious or suspected deleterious gbrcam, her2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. patients with hormone receptor (hr)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.adjuvant treatment of germline brca-mutated her2-negative high risk early breast cancer lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gbrcam human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. adenocarcinoma of the pancreas:first-line maintenance treatment of germline brca-mutated metastatic pancreatic adenocarcinomalynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.prostate cancer:germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancerlynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer (mcrpc) who have progressed following prior treatment with enzalutamide or abiraterone.

Israel - englanti - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 150 mg - olaparib - ovarian cancer:lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumablynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either:• a deleterious or suspected deleterious brca mutation, and/or• genomic instability breast cancer:germline brca-mutated her2-negative metastatic breast cancerlynparza is indicated in patients with deleterious or suspected deleterious gbrcam, her2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. patients with hormone receptor (hr)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.adjuvant treatment of germline brca-mutated her2-negative high risk early breast cancer lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gbrcam human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. adenocarcinoma of the pancreas:first-line maintenance treatment of germline brca-mutated metastatic pancreatic adenocarcinomalynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.prostate cancer:• germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer (mcrpc) who have progressed following prior treatment with enzalutamide or abiraterone.• lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious hrr-mutated (hrrm) metastatic castration-resistant prostate cancer (mcrpc). select patients for therapy based on an approved companion diagnostic for lynparza

Israel - englanti - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 150 mg - olaparib - ovarian cancer:lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumablynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either:• a deleterious or suspected deleterious brca mutation, and/or• genomic instability breast cancer:germline brca-mutated her2-negative metastatic breast cancerlynparza is indicated in patients with deleterious or suspected deleterious gbrcam, her2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. patients with hormone receptor (hr)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.adjuvant treatment of germline brca-mutated her2-negative high risk early breast cancer lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gbrcam human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. adenocarcinoma of the pancreas:first-line maintenance treatment of germline brca-mutated metastatic pancreatic adenocarcinomalynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.prostate cancer:germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancerlynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer (mcrpc) who have progressed following prior treatment with enzalutamide or abiraterone.

Israel - englanti - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - pembrolizumab - concentrate for solution for infusion - pembrolizumab 25 mg/ml - pembrolizumab - melanoma• keytruda is indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma.•keytruda is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage iib, iic, or iii melanoma following complete resection.non-small cell lung cancer• keytruda, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (nsclc) negative for egfr or alk genomic tumor aberrations.• keytruda, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound , is indicated for the first-line treatment of patients with metastatic squamous nsclc.• keytruda, as a single agent, is indicated for the treatment of patients with metastatic nsclc whose tumors express pd-l1 [tumor proportion score (tps) ≥50%)] as determined by a validated test. patients with egfr or alk genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving keytruda .• keytruda, as a single agent, is indicated for the treatment of patients with advanced nsclc whose tumors express pd-l1 as determined by a validated test, with disease progression on or after platinum containing chemotherapy. patients with egfr or alk genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving keytruda .• keytruda , as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage ib (t2a ≥4 cm), ii, or iiia nsclc.head and neck cancer• keytruda, in combination with platinum and fluorouracil (fu), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (hnscc).• keytruda, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent hnscc whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by a validated test .• keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic hnscc with disease progression on or after platinum-containing chemotherapy..classical hodgkin lymphoma• keytruda is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma (chl).• keytruda is indicated for the treatment of pediatric patients with refractory chl, or chl that has relapsed after 2 or more lines of therapyprimary mediastinal large b-cell lymphoma keytruda is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large b-cell lymphoma (pmbcl), or who have relapsed after 2 or more prior lines of therapy.limitation of use: keytruda is not recommended for treatment of patients with pmbcl who require urgent cytoreductive therapy.urothelial carcinoma• keytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express pd-l1 [combined positive score (cps ≥10) ] as determined by a validated test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of pd-l1 status. • keytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.microsatellite instability-high cancerkeytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (msi h) or mismatch repair deficient (dmmr). • solid tumors that have progressed following prior systemic treatment and who have no satisfactory alternative treatment options,or• colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.limitation of use: the safety and effectiveness of keytruda in pediatric patients with msi h central nervous system cancers have not been established. gastric cancer• keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction (gej) adenocarcinoma in adults whose tumors express pd-l1 with a cps ≥ 1.• keytruda ,as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gej whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by a validated test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, her2/neu targeted therapy.cervical cancer• keytruda, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express pd-l1 (cps ≥1) as determined by a validated test. • keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express pd-l1 (cps ≥1) as determined by a validated test.biliary tract carcinomakeytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma (btc).merkel cell carcinomakeytruda is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic merkel cell carcinoma (mcc).renal cell carcinoma• keytruda, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).• keytruda, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced rcc.• keytruda is indicated for the adjuvant treatment of patients with rcc at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.non-muscle invasive bladder cancer (nmibc)keytruda is indicated for the treatment of patients with bacillus calmette-guerin (bcg)-unresponsive, high-risk, non-muscle invasive bladder cancer (nmibc) with carcinoma in situ (cis) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.esophageal cancer• keytruda is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (gej) (siewert type i) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.• keytruda is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express pd-l1 (cps ≥10) as determined by a validated test, with disease progression after one or more prior lines of systemic therapy.cutaneous squamous cell carcinomakeytruda is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc that is not curable by surgery or radiationmicrosatellite instability-high or mismatch repair deficient colorectal cancer (crc)keytruda is indicated for the first-line treatment of patients with unresectable or metastatic msi-h or dmmr colorectal cancer (crc).tumor mutational burden-high cancerkeytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (tmb-h) [≥10 mutations/megabase (mut/mb)] solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.limitations of use: the safety and effectiveness of keytruda in pediatric patients with tmb-h central nervous system cancers have not been established.triple negative breast cancer• keytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (tnbc) whose tumors express pd-l1 (cps ≥10) as determined by a validated test• keytruda is indicated for the treatment of patients with high risk early stage triple negative breast cancer (tnbc) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.endometrial carcinomakeytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy and who are not candidates for curative surgery or radiation.

Israel - englanti - Ministry of Health

merck sharp & dohme israel ltd - pembrolizumab - powder for solution for infusion - pembrolizumab 50 mg/vial - pembrolizumab - - melanoma:keytruda (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma.- non-small cell lung cancer:• keytruda, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (nsclc) negative for egfr or alk genomic tumor aberrations.• keytruda, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous nsclc. • keytruda, as a single agent, is indicated for the treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors express pd-l1 [tumor proportion score (tps) ≥50%)] as determined by a validated test. patients with egfr or alk genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving keytruda.• keytruda, as a single agent, is indic

Australia - englanti - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 250 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; sodium chloride; mannitol; pentetic acid; polysorbate 80; hydrochloric acid; sodium hydroxide; water for injections - melanoma,opdivo, as monotherapy, is indicated for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected stage iib, iic, iii or iv melanoma.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,opdivo, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,non-small cell lung cancer (nsclc),opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (nsclc).,opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (nsclc) with no egfr or alk genomic tumour aberrations.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy. in patients with tumour egfr or alk genomic aberrations, opdivo should be used after progression on or after targeted therapy.,malignant pleural mesothelioma (mpm),opdivo, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,renal cell carcinoma (rcc),opdivo, in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,opdivo, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.,opdivo, as monotherapy, is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.,classical hodgkin lymphoma (chl),opdivo, as monotherapy, is indicated for the treatment of patients with relapsed or refractory classical hodgkin lymphoma (chl) after autologous stem cell transplant and treatment with brentuximab vedotin. the approval of this indication is based on objective response rate in a single arm study.,squamous cell carcinoma 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 patients progressing on or after platinum based therapy.,urothelial carcinoma (uc),opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with muscle invasive urothelial carcinoma (miuc) who are at high risk of recurrence after undergoing radical resection of miuc.,opdivo, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. the approval of this indication is based on objective response rate and duration of response in a single arm study.,hepatocellular carcinoma (hcc),opdivo, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.,oesophageal squamous cell carcinoma (oscc),opdivo in combination with ipilimumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.,adjuvant oesophageal cancer (oc) or gastro-oesophageal junction cancer (gojc),opdivo, as monotherapy, is indicated for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.,gastric cancer (gc), gastro-oesophageal junction cancer (gojc), or oesophageal adenocarcinoma (oac),opdivo, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is indicated for the first-line treatment of patients with her2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.