Adverse event reports for mefloquine hydrochloride ('Lariam') between 1980 ans 2018

Jane Quinn made this Freedom of Information request to Therapeutic Goods Administration

The request was successful.

From: Jane Quinn

Delivered

Dear Therapeutic Goods Administration,

The DAEN database identifies 240 adverse event reports lodged for the antimalarial drug mefloquine hydrochloride, also known by the trade name 'Lariam' lodged between 1 January 1980 and 17 February 2018.

The search engine, whilst producing a table of adverse event results for this drug, does not provide more detailed information on the date of event or co-reporting of categories of adverse reactions by submission.

Please could you provide me with a detailed list of all adverse events reported for this medication, including date, age of subject and list of adverse event categories selected.

I do not require any personal information or individual patient identifiers.

I look forward to your timely response to this request.

Yours faithfully,

Dr Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration


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Dear Dr Quinn

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act).

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after the date your request was received in which to provide a decision in
response to your request for access.

A decision is currently due on or before 14 JULY 2018.

However, where there is requirement to undertake consultation with
affected third parties, this timeframe is extended by a further 30 days.
It may also be extended in certain circumstances, including with your
agreement or where the Department applies to the Office of the Australian
Information Commissioner for an extension].

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit.

 

You will be notified by the agency if charges are liable to pay a charge
and/or if third party consultation is required.

any queries, you can contact the FOI team on (02) 6232 8720, or via email
at [1][email address].

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [2][email address]

 

[3]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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From: TGA FOI
Therapeutic Goods Administration


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Attachment credit card payment authorisation.pdf
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Attachment FOI361 1718 Estimate of Charges.pdf
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Dear Dr Quinn

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

Heather

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

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From: Jane Quinn

Delivered

Dear TGA FOI,

I have paid the fee by direct deposit on 19/06/2018 and emailed the address in your letter to confirm this accordingly.

I look forward to receiving the information requested in this FOI in due course.

Yours sincerely,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration

Dear Dr Quinn,

Thank you for your email.

As notified in the Estimate of Charges (Charges) dated 15 June 2018, the processing timeframe was suspended under section 31(2)(a) between the time the Charges was issues and the deposit was paid.

Accordingly, a decision is currently due on or before 17 July 2018.

If you have any questions, please do not hesitate to contact the FOI Team.

Kind regards,

Freedom of Information
(02) 6232 8720
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: TGA FOI
Therapeutic Goods Administration


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Attachment ATTACHMENT B.pdf
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Attachment Review Rights.pdf
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Attachment Document 1 AR.pdf
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Attachment FOI361 1718 Notice of Decision.pdf
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Attachment FOI361 1718 Schedule of Relevant Documents FINAL.pdf
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Dear Dr Quinn

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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