Users of ONRELTEA in Canada who have bad reactions or `adverse events’ related to using this newly approved product are reminded in the ONRELTEA Product Monograph to report these events. The body responsible for supervising prescription drugs is the Canada Vigilance Program.
The Brimonidine based topical which is available in the US as Mirvaso has recently become available in Canada and is called ONRELTEA by Galderma.
It is difficult to gauge what proportion of users have experienced adverse reactions to Mirvaso, but samples of online reports seem to suggest higher bad reactions than reported in the Phase 3 Trials for Mirvaso.
Canadian users of ONRELTEA who suffer from adverse events should report their experiences as indicated below.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
Fax toll-free to 1-866-678-6789, or Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa,
Ontario K1A 0K9Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
User Comments
Also feel free to let others know how you are going with ONRELTEA at the ONRELTEA User Reviews page.
