Health
Health Canada authorizes TNKase® (tenecteplase) for the treatment of Acute Ischemic Stroke (AIS)
Hoffmann-La Roche Limited (Roche Canada) is proud to announce that Health Canada has granted market authorization for TNKase® (tenecteplase), a thrombolytic (clot-dissolving) agent, effective November 13, 2025 for the treatment of acute ischemic stroke (AIS) in adults. Treatment is to be initiated within 4.5 hours from the onset of AIS symptoms and after exclusion of intracranial haemorrhage. Roche will also be introducing a new 25 mg vial configuration in the coming months to support the approv
About this update from Roche Holding Ltd
[{"type":"text","content":"The approval marks the first new stroke treatment authorized in nearly 27 years, offering an additional option for managing acute ischemic stroke in Canada.","length":156,"tagName":"p"},{"type":"text","content":"MISSISSAUGA, ON, Dec. 17, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is proud to announce that Health Canada has granted market authorization for TNKase® (tenecteplase), a thrombolytic (clot-dissolving) agent, effective November 13, 2025 for the treatment of acute ischemic stroke (AIS) in adults. Treatment is to be initiated within 4.5 hours from the onset of AIS symptoms and after exclusion of intracranial haemorrhage. Roche will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS. This important approval marks TNKase as the first stroke medicine authorized by Health Canada in nearly 27 years.1, 6","length":683,"tagName":"p"},{"type":"image","alt":"Roche logo (CNW Group/Hoffmann-La Roche Limited (Roche Canada))","displaySize":"","headline":null,"caption":"Roche logo (CNW Group/Hoffmann-La Roche Limited (Roche Canada))","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":208,"url":"https://media.zenfs.com/en/cnwgroup.com/a1f75ef7efed143360a923fd6ee86463"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/MZWbq2__ul4Jp5dEuezi4g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM2NztjZj13ZWJw/https://media.zenfs.com/en/cnwgroup.com/a1f75ef7efed143360a923fd6ee86463","width":400,"height":208}},"href":"https://mma.prnewswire.com/media/2846974/Hoffmann_La_Roche_Limited__Roche_Canada__Health_Canada_authorize.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Stroke is one of the leading causes of death and the number one cause of long-term disability in adults. Each year, approximately 109,000 strokes occur in Canada, which is roughly one stroke every five minutes. Currently, around one million Canadians are living with the long-term effects of a stroke, and this number continues to grow due to an aging population and increase in risk factors among younger individuals.2","length":419,"tagName":"p"},{"type":"text","content":"The approval of TNKase for the treatment of stroke is based on the AcT trial (Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke), a multicenter, open-label, parallel-gr...