Quantitative composition of a drug product

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Dear Medicines and Healthcare products Regulatory Agency,

Could you please advise the quantitative composition of Tertroxin Tablets 20mcg?

Many thanks for your assistance.

Yours faithfully,

Marilyn Brown

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 15/162
       
Dear Ms Brown,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 2 April 2015. 
       
I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.
       

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Ms Brown

Our Ref: FOI 15/162 - Tertroxin Tablets

Thank you for your email of 2nd April where you requested information about Tertroxin 20mcg tablets.

I can confirm that the agency holds this information, however this information is exempt under section 43 of the Freedom of Information Act and is therefore being withheld. Section 43 exempts information whose disclosure would be likely to prejudice the commercial interests of any person. It also includes a specific exemption for trade secrets. The full quantitative details for any medicine is a trade secret belonging to the manufacturer. The substances contained in Tertroxin tablets are as listed in the Patient Information Leaflet and I reproduce them here for your convenience: the active ingredient is liothyronine sodium (20 micrograms).

The other ingredients are lactose, maize starch, powdered acacia, sodium chloride, magnesium stearate, industrial methylated spirit, and purified water. Note that the substances 'industrial methylated spirit' and 'purified water' are residual solvents from the manufacturing process and so the quantity per tablet is negligible. If there is one particular ingredient you are concerned about we may be able to provide you with the quantity per tablet with the permission of the manufacturer.

We have considered the public interest and do not consider there to be any overriding public interest in releasing the full quantitative details, the agency's decision is therefore to withhold the information.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of receipt of the response to your original request and should be addressed to: [MHRA request email] Please remember to quote the reference number above in any future communications.

If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF

Yours Sincerely,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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