List of Influenza Vaccines for Which Supplements to New Drug Submissions Can Be Filed
Vaccines on the List of Influenza Vaccines for Which Supplements to New Drug Submissions Can Be Filed are eligible for a rolling review. A sponsor of an influenza vaccine included on this list may file a supplement to a new drug submission. This submission does not need to include all of the information and material required under C.08.003 if the sponsor is only seeking to update the strains of the influenza vaccine. A rolling review application package is not required for such submissions.
For more information on rolling reviews, please refer to the following guidance:
- Draft guidance on management of rolling reviews for drug submissions
- Guidance document: Annual update of seasonal influenza vaccines
This list is incorporated by reference into paragraph C.08.003(2)(b.1)of the Food and Drug Regulations. Health Canada maintains and updates this list as required.
|Product name||Company||Drug identification number||Anatomical Therapeutic Chemical Code||Viral subtypes for which changes to strains are permitted|
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