Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - nivolumab - solution for infusion - 10mg/1ml

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - nivolumab - solution for infusion - 10mg/1ml

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

amgen ltd - talimogene laherparepvec - solution for injection - 100mega u/1ml

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

amgen ltd - talimogene laherparepvec - solution for injection - 1mega u/1ml

Kanada - Ingliż - Health Canada

novartis pharmaceuticals canada inc - nilotinib (nilotinib hydrochloride monohydrate) - capsule - 50mg - nilotinib (nilotinib hydrochloride monohydrate) 50mg - antineoplastic agents

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - breast neoplasms - antineoplastic agents - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1).in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Iżrael - Ingliż - Ministry of Health

amgen europe b.v. - talimogene laherparepvec - solution for injection - talimogene laherparepvec 10^8 pfu / 1 ml - talimogene laherparepvec - imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic ( stage iiib, iiic and ivm1a) with no bone, brain, lung or other visceral disease.

Iżrael - Ingliż - Ministry of Health

amgen europe b.v. - talimogene laherparepvec - solution for injection - talimogene laherparepvec 10^6 pfu / 1 ml - talimogene laherparepvec - imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic ( stage iiib, iiic and ivm1a) with no bone, brain, lung or other visceral disease.

Awstralja - Ingliż - 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.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinal stromal tumors - antineoplastic agents - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.