Tags : Health Canada

Vertex‘s Orkambi (lumacaftor/ivacaftor) Receives Health Canada Approval for Cystic Fibrosis

Shots: The approval is based on P-III study results assessing Orkambi in 60 patients with CF, who have two copies of the F508del CFTR mutation aged 6 to 11 years for 24 wks. The P-III study demonstrated in reduction of sweat chloride by 31.7 mmol/L and was well-tolerated, Presented at European Cystic Fibrosis Society Conference in June 2018 Orkambi is a combination […]Read More

Indivior Receives Health Canada Approval for Sublocade (SC) (Buprenorphine Extended-Release)

Shots: The approval of Sublocade(qmt) in combination with medication-assisted treatment (MAT) is indicated to treat OUD in adults, using Atrigel delivery system The clinical trials demonstrated, that Injection site reactions were reported in 16% of the patients. None of the injection site reactions were serious and one led to study treatment discontinuation Health Canada has […]Read More

Novo Nordisk’s Tresiba Receives Health Canada Approval for Type 1

Shots: Novo Nordisk’s Tresiba has received an approval for indication expansion by Health Canada for the treatment of pediatric patients (>2 years of age) with Type 1 diabetes The expanded indication follows its last approval in Canada on Aug 2017 for the treatment of adults with Type 1 and Type 2 diabetes Tresiba (insulin degludec injection) is […]Read More

Ipsen’s Cabometyx Receives Health Canada’s Approval for the Treatment of

Shots: Approval of Cabometyx (cabozantinib) is based on results of the P-III METEOR trial assessing Cabometyx vs everolimus for advanced (RCC) previously received vascular endothelial growth factor (VEGF) targeted therapy, demonstrated significant and clinical improvement in OR, PFS, ORR Cabometyx received priority review status from Health Canada further assisted its approval. In 2017, the US […]Read More

Pharmacosmos’ Monoferric 1000 mg IV Receives Health Canada Marketing Approval

Shots:  Monoferric is being approved for anaemic adult patients intolerant or unresponsive to iron oral therapy with an expection to reach market by Nov 2018 In 2015, Pharmacosmos signed Canada commercialization rights of Monoferric to Pfizer Canada Monoferric IV has a novel matrix structure of linear isomaltoside chains interspersed with Fe3+ and already being marketed […]Read More