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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

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 decision was 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:

Post-Authorization Activity Table (PAAT)
RowNum Activity/submission type, control number Date submitted Decision and date Summary of activities
Summary basis of decision for

Date SBD issued:

The following information relates to the original authorization of 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

Date modified: