Search Page – Health Product Registry

This document is a French translation of the approved English document.

Summaries of Basis for Decision (SBD) provide information regarding the initial authorization of a product. THE SMD bearing on can be accessed below.

Recent activity related to

SMDs relating to authorized drugs following 1^is September 2012 will be updated to include information in the form of a Post Authorization Activity Table (PAAT). The TAPA will include brief summaries of activities such as new use submissions, as well as Health Canada decisions (positive or negative). TAPAs will be updated regularly with respect to post-authorization activities throughout the product lifecycle.

Table of post-authorisation activities (TAPA) relating to

Table of Post-Authorization Activities (TAPA)

RowNum	Type and number of activity or presentation	Date of presentation	Decision and date	Summary of activities

Summary of Basis for Decision (SBD) on

The following information pertains to the New Drug Submission for .

Drug Identification Number(s):

1 What is the authorization for?

2 Why was it allowed?

3 What are the steps that led to the authorization of ?

Submission Milestones:

Submission Milestone	Date

4 What follow-up actions will the proponent take?

5 What post-authorisation activities have been carried out with regard to ?

6 What other drug information is available?