Change in side effects listed on statins label

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References

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Our Ref: FOI 09/473

Dear Mr Goldacre,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 1st December 2009.

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Dr Goldacre

Please find a preliminary reply attached.

Yours sincerely

Stephen Fawbert

Stephen Fawbert
Information for Public Health Group
Vigilance and Risk Management of Medicines (VRMM)
Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers 14-110
1, Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 2788

www.yellowcard.gov.uk

www.mhra.gov.uk

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Dear Dr Goldacre

Please find a reply attached.

Yours sincerely

Stephen Fawbert

Stephen Fawbert
Information for Public Health Group
Vigilance and Risk Management of Medicines (VRMM)
Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers 14-110
1, Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 2788

[1]www.yellowcard.gov.uk

[2]www.mhra.gov.uk

<<09 473 reply 2.pdf>>

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Communications via the GSi may be automatically logged, monitored and/or
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References

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2. file://www.mhra.gov.uk

Dear Dr Goldacre

Thank you for your email. Today is my last day in MHRA VRMM division
but I will ensure that one of my colleagues actions this request.
Yours sincerely

Stephen Fawbert

Stephen Fawbert
Information for Public Health Group
Vigilance and Risk Management of Medicines (VRMM)
Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers 14-110
1, Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 2788

www.yellowcard.gov.uk

www.mhra.gov.uk

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Dear Dr Goldacre

Attached is the MHRA's response to your FOI request about the update of
Statin SPCs.

<<Electronic letterhead- FOI response 09 473 (2).doc>> <<Redacted 09473 AZ
letter to MEB 2009.pdf>> <<Redacted 09473 AZ letter to MEB 2008.pdf>>
<<Redacted 09 473 document 3.pdf>>

Kindest Regards
Dr Nageen Hashmi

Tel: 020 7084 2664
14-148 MT, MHRA, 1 Nine Elms Lane, Vauxhall, London, SW5 8NQ. Fax: 020
7084 2293

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

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Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.