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

accord healthcare ltd - memantine hydrochloride - oral solution - 10mg/1ml

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

rosemont pharmaceuticals ltd - memantine hydrochloride - oral solution - 10mg/1ml

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

genus pharmaceuticals ltd - memantine hydrochloride - oral solution - 10mg/1ml

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 255.6 mg; relatlimab, quantity: 85.2 mg - injection, concentrated - excipient ingredients: histidine hydrochloride monohydrate; water for injections; pentetic acid; sucrose; polysorbate 80; histidine - opdualag is indicated for the treatment of patients with unresectable or metastatic melanoma who are at least 12 years old.

Iżrael - Ingliż - Ministry of Health

bristol, myers squibb (israel) limited, israel - nivolumab - concentrate for solution for infusion - nivolumab 10 mg/ml - nivolumab - unresectable or metastatic melanoma:opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and pediatric patients 12 years and older.adjuvant treatment of melanoma:opdivo is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage iib, iic, iii, or iv melanoma.metastatic non-small cell lung cancer:- opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (nsclc), with no egfr or alk genomic tumor aberrations.- opdivo is indicated for the treatment of adult patients with metastatic non small cell lung cancer (nsclc) with progression on or after platinum-based chemotherapy.renal cell carcinoma:- opdivo as a single agent is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) in patients who have received prior anti-angiogenic therapy.- opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with intermediate or poor risk, advanced renal cell carcinoma (rcc).- opdivo, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced rcc.classical hodgkin lymphoma:opdivo is indicated for the treatment of adult patients with classical hodgkin lymphoma (chl) that has relapsed or progressed after:* autologous hematopoietic stem cell transplantation (hsct) and brentuximab vedotin, or* 3 or more lines of systemic therapy that includes autologous hsct.squamous cell carcinoma of the head and neck:opdivo is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (scchn) with disease progression on or after platinum-based therapy.microsatellite instability-high (msi-h) or mismatch repair deficient(dmmr) metastatic colorectal cancer:opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) metastatic colorectal cancer (crc) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.urothelial carcinoma:- opdivo is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (uc) who are at high risk of recurrence after undergoing radical resection of uc.- opdivo (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: * have disease progression during or following platinum-containing chemotherapy * have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.hepatocellular carcinoma:opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (hcc) child-pugh a who have been previously treated with sorafenib.esophageal cancer:-opdivo is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (crt). -opdivo is indicated for the treatment of adult patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.- opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal 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 esophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.malignant pleural mesothelioma:opdivo, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma:opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.neoadjuvant treatment of resectable non-small cell lung cancer:opdivo, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (nsclc).

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - nivolumab 10 mg/ml;  ;  ;   - concentrate for infusion - 100 mg/10ml - active: nivolumab 10 mg/ml       excipient: hydrochloric acid mannitol pentetic acid polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - opdivo, as monotherapy is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, in combination with yervoy (ipilimumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - nivolumab 10 mg/ml;  ;  ;   - concentrate for infusion - 40 mg/4ml - active: nivolumab 10 mg/ml       excipient: hydrochloric acid mannitol pentetic acid polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - opdivo, as monotherapy is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, in combination with yervoy (ipilimumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Unjoni Ewropea - Ingliż - 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 - antineoplastic agents - 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.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

promius pharma, llc - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - sernivo spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. none. pregnancy category c there are no adequate and well-controlled studies in pregnant women. sernivo spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. the abnormalities observed included umbilical hernias, cephalocele, and cleft palate. systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when sernivo spray is administered to a nursing woman. safet

Stati Uniti - Ingliż - NLM (National Library of Medicine)

encore dermatology inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - sernivo spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. none. risk summary there are no available data on sernivo spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that sernivo spray may increase the risk of having a low birthweight infant and to use sernivo spray on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis (see data ). the available data do not allow the calculation of relevant comparis