Product HV2P is available in two dosage strengths: 15 mg and 30 mg. The TMA states that the recommended starting dose is 15 mg with the option to titrate to 30 mg depending on individual patient efficacy and tolerability.
Case 1a: Trial used a starting dose of 30 mg; trial results are presented in the TMA
Study results can be presented in advertising. The advertising presentation is limited to the content from the TMA. Disclosure of the recommended starting dose should be made; the level of prominence required for this disclosure (e.g. body copy vs. footnote, positioning, etc.) will be assessed based on content/context.
Case 1b: Trial used a starting dose of 30 mg; trial results are not presented in the TMA
PAAB will question this trial as off-label.
Case 2: Trial evaluated the 30 mg dose; patients were appropriately titrated from 15 mg
Regardless of whether the trial is in the TMA or not, study results can be presented in advertising. The dose titration should be captured in the study description.
Never miss an update. Get the latest PAAB info delivered right to your email address.
In an effort to constantly serve our clients better, PAAB has unveiled a new electronic submission process(eFiles). Effective January 2, 2008 all submissions will have to be submitted via the eFiles system. Please have a Senior Official (Director level) send an email to the administration team at review@paab.ca with the contact information of the person(s) who will be designated as administrator(s) for your company. Click on eFiles, on the menu, then eFiles Tutorial for a tutorial on how eFiles works.
Please contact the admin team at PAAB if you need assistance with eFiles
The Accelerated Preclearance Pathway
Learn more and share your feedback by April 14
Click here to provide feedback