Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: February

Request Number: A-2021-000026

Request Summary: Documentation related to Zytiga 500 mg, film-coated tablets (abiraterone acetate, MAH = Janssen Inc, DIN: 02457113), namely the Synopsis of preclinical Study TOX9587 (“1-month Repeated Dose Oral Toxicity Study of JNJ-212082-AAA in the Rat with integrated Irwin observations (impurity qualification)”) and the specification of the Zytiga 500 mg, film-coated tablets (described in the registration dossier, part 32P51).

Disposition: Disclosed in part

Number of pages: 5

Back to Search 

Request a copy of records

Availability of records are subject to retention timelines as established by institutions. Requests made through this form are considered informal requests and are not subject to the same requirements as requests under the Access to Information Act. For additional information, please see the “About Access to information and privacy” webpage.

Personal information that you provide is protected under the federal Privacy Act. Please do not include sensitive personal information in the message, such as your Social Insurance Number, personal finance data, medical or work history, or the personal information of other individuals.

 
Read the Privacy Statement for this page.

The collection and use of your personal information is authorized by the Financial Administration Act. Collection and use of your personal information for this site is in accordance with the federal Privacy Act. Your personal information is used  to validate your use of GC datasets and for information on the development of the GC open data initiative, and may also be used to evaluate the effectiveness of the program in responding to client needs. In exceptional circumstances (e.g. network intrusion, or of individuals who make inappropriate remarks or threats, etc.), personal information may be disclosed without your consent pursuant to subsection 8(2) of the Privacy Act.

Any personal information that may be collected is described in the Standard Personal Information Banks entitled Public Communications, PSU 914, and Outreach Activities, PSU 938, which can be found in the Treasury Board of Canada Secretariat (TBS) publication: InfoSource.

Under the Privacy Act, you have the right of access to, and correction of, your personal information, if you have provided any. Note however, that to exercise either of these rights; you must make a request for access to your personal information. For more information about your right of access, please read about the Access to Information Program.

Any questions, comments, concerns or complaints you may have regarding this Statement, your privacy rights and the Privacy Act may be directed to the TBS Access to Information and Privacy Coordinator by email at atip.aiprp@tbs-sct.gc.ca or by calling 613-946-6260 or 1-866-312-1511. If you are not satisfied with TBS' response to your privacy concern, you may wish to contact the Office of the Privacy Commissioner by email at info@priv.gc.ca or by telephone at 1-800-282-1376. You have the right to complain to the Office of the Privacy Commissioner about TBS' handling of your personal information.

Select the category that best describes you.
?

This information is collected for statistical purposes and is published annually on the Government of Canada Info Source website. (www.infosource.gc.ca)

Academia: Those who are engaged in higher education and who require information for research purposes.

Business (Private Sector): Those who are employed by the private sector, including lawyers and consultants, and who require information for their business or on behalf of another individual.

Media: Those who are employed by a radio or television company, a newspaper or magazine, or any online newspaper or blog, etc., and who require information for media purposes.

Organization: Those who are working or volunteering for an organization and who require information for that organization.

Member of the Public: All other members of the public who require information for their own purposes.

Please note To the extent possible, the institution will return the requested records in the format selected, but it may not be able to accommodate all electronic formats due to size limitations.
Explain what you want or why you are contacting this organization.
Address
State/Province
Please Note: Institutions will work to respond to your request for this previously released package as soon as practical.
Date modified: