The article reports that Health Canada has approved the manufacturing and distribution of Sanofi-Aventis SA's Eloxatin. The drug approval is based on several clinical data collected over several years, which demonstrates the effectiveness of the drug in combination with infusional 5-fluorouracil and ...
This indication follows the July 2022 Health Canada approval of RINVOQ for adults with active ankylosing spondylitis (AS) who have had an inadequate response to a biologic DMARD or when use of those therapies is inadvisable, making RINVOQ the first and only JAK...
non-inferiority study designed to assess the antiviral activity, safety and tolerability of a two-drug regimen of intramuscular, long-acting, injectable rilpivirine and cabotegravir in adults living with HIV who were virologically suppressed following 20 weeks...
“I am proud to announce the approval ofJORNAY PM™ in Canada. This exciting new launch, expected in the second half of 2025, represents a significant advancement for our Canadian business as we continue to expand our offerings for...
In the EU and the UK, the therapy is approved as an orphan drug under the brand name Aspaveli to treat PNH patients who are anaemic following C5 inhibitor treatment for a minimum of three months. Sobi Canada vice-president and general manager Bob McLay said: “The approval by Health Cana...
s regulatory application for marketing approval of its single-shot chikungunya vaccine candidate VLA1553 in persons aged 18 years and above, and has determined that the New Drug Submission (NDS) application is sufficiently complete to permit a substantive review. Based on Health Canada’s ...
List of Approved drugs containing Dalfampridine listed with Health Canada in the Drug Product Database (DPD)
Nora Pharma has received approval from Health Canada for the commercialization of NIOPEG® (a pegylated form of filgrastim) in Canada. The current market size of pegfilgrastim in Canada is approximately $88 million USD. NIOPEG® is a Biosimilar comparable to ...
Health Canada's approval was based on data from a prospective, open-label, single-group phase 2 clinical study (n = 28) showing that 32% (n = 9) of treated patients achieved more than 50% shrinkage of their largest SEGA tumor at 6 months, relative to baseline; 75% (n = 21) experi...
The version approved in the U.S. targets newer and more prevalent strains of the Omicron variant than the one submitted for approval in Canada. Canada has already purchased 12 million doses of Moderna’s version of the Omicron vaccine,which includes converting some existing orders for the origin...