Singapore - English - HSA (Health Sciences Authority)

ipsen pharma singapore pte. ltd. - cabozantinib (s)-malate 50.69mg eqv cabozantinib - tablet, film coated - cabozantinib (s)-malate 50.69mg eqv cabozantinib 40mg

Singapore - English - HSA (Health Sciences Authority)

ipsen pharma singapore pte. ltd. - cabozantinib (s)-malate 76.03mg eqv cabozantinib - tablet, film coated - cabozantinib (s)-malate 76.03mg eqv cabozantinib 60mg

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

bristol-myers squibb australia pty ltd - ipilimumab, quantity: 213 mg - injection, concentrated - excipient ingredients: trometamol hydrochloride; sodium chloride; mannitol; pentetic acid; polysorbate 80; sodium hydroxide; hydrochloric acid; water for injections - melanoma,yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,yervoy, in combination with nivolumab, 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.,renal cell carcinoma (rcc),yervoy, in combination with nivolumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,non-small cell lung cancer (nsclc),yervoy, in combination with nivolumab 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.,malignant pleural mesothelioma (mpm),yervoy, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,oesophageal squamous cell carcinoma (oscc),yervoy in combination with nivolumab 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 greater than or equal to 1% as determined by a validated test.

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

bristol-myers squibb australia pty ltd - ipilimumab, quantity: 53.5 mg - injection, concentrated - excipient ingredients: trometamol hydrochloride; sodium chloride; mannitol; pentetic acid; polysorbate 80; sodium hydroxide; hydrochloric acid; water for injections - melanoma,yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,yervoy, in combination with nivolumab, 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.,renal cell carcinoma (rcc),yervoy, in combination with nivolumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,non-small cell lung cancer (nsclc),yervoy, in combination with nivolumab 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.,malignant pleural mesothelioma (mpm),yervoy, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,oesophageal squamous cell carcinoma (oscc),yervoy in combination with nivolumab 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 greater than or equal to 1% as determined by a validated test.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastic agents - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.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 (see sections 4.4 and 5.1).renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).non-small cell lung cancer (nsclc)yervoy in combination with nivolumab 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.malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab 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 (see section 5.1).oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab 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%.

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

sun pharma anz pty ltd - memantine hydrochloride -

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

sun pharma anz pty ltd - memantine hydrochloride -

Israel - English - Ministry of Health

medison pharma ltd - cabozantinib as (s) malate - film coated tablets - cabozantinib as (s) malate 20 mg - cabozantinib - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for advanced renal cell carcinoma- as first-line treatment of adult patients with intermediate or poor risk, per imdc criteria.- in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc), in adults with child-pugh class a hepatic impairment who have previously been treated with sorafenib.differentiated thyroid carcinoma (dtc)cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (dtc), refractory or not eligible to radioactive iodine (rai) who have progressed during or after prior systemic therapy.

Israel - English - Ministry of Health

medison pharma ltd - cabozantinib as (s) malate - film coated tablets - cabozantinib as (s) malate 40 mg - cabozantinib - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for advanced renal cell carcinoma- as first-line treatment of adult patients with intermediate or poor risk, per imdc criteria.- in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc), in adults with child-pugh class a hepatic impairment who have previously been treated with sorafenib.differentiated thyroid carcinoma (dtc)cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (dtc), refractory or not eligible to radioactive iodine (rai) who have progressed during or after prior systemic therapy.

Israel - English - Ministry of Health

medison pharma ltd - cabozantinib as (s) malate - film coated tablets - cabozantinib as (s) malate 60 mg - cabozantinib - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for advanced renal cell carcinoma- as first-line treatment of adult patients with intermediate or poor risk, per imdc criteria.- in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc), in adults with child-pugh class a hepatic impairment who have previously been treated with sorafenib.differentiated thyroid carcinoma (dtc)cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (dtc), refractory or not eligible to radioactive iodine (rai) who have progressed during or after prior systemic therapy.