Summary Basis of Decision - - Health Canada
Summary Basis of Decision (SBD) for
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Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The SBD for is located below.
Recent Activity for
SBDs written for eligible drugs approved after September 1, 2012 will be updated to include post-authorization information. This information will be compiled in a Post-Authorization Activity Table (PAAT). The PAAT will include brief summaries of activities such as submissions for new uses of the product, and whether Health Canada's decisions were negative or positive. PAATs will be updated regularly with post-authorization activity throughout the product's life cycle.
Post-Authorization Activity Table (PAAT) for
Updated:
| RowNum | Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|
Summary Basis of Decision (SBD) for
Date SBD issued:
The following information relates to the new drug submission for .
Drug Identification Number (DIN):
1 What was approved?
2 Why was approved?
3 What steps led to the approval of ?
Submission Milestones:
| Submission Milestone | Date |
|---|
4 What follow-up measures will the company take?
5 What post-authorization activity has taken place for ?
6 What other information is available about drugs?
7 What was the scientific rationale for Health Canada's decision?
7.1 Clinical Basis for Decision
7.2 Non-Clinical Basis for Decision
7.3 Quality Basis for Decision
7.1 Quality basis for decision
7.2 Non-clinical basis for decision
7.3 Clinical basis for decision
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