|Department of Health|
|MEDICINES CONTROL AGENCY|
|Market Towers 1 Nine Elms Lane London SW8 5NQ|
|Telephone 020 7 273 0267|
|Facsimile 020 7 273 0109||.|
|Our ref SK/seroxat.vmbO32000|
|4 July 2000|
Dear Mr Medawar,
RE: CIPRAMIL PL 0458/0057-0059
Further to Mrs Duddy's letter of 25 January 2000, I am writing to inform you that we have investigated this issue and I am now able to respond in full.
We have reviewed the advertisement for the above product which was issued in the BMJ on 13 November 1999. As part of the review we considered the following papers in support of the claims:
1. Patris et al., Citalopram versus fluoxetine: A Double-Blind, Controlled, Multicentre, Phase III Trail in Patients with Unipolar Major Depression Treated in General Practice. International Clinical Psychopharmacology 1996; 11: 129-136.
2. Edwards J G and Andersen I., Systematic Review and Guide to Selection of Selective Serotonin Reuptake Inhibitors Drugs 1999; 57(4): 507-533
3. PMCPA rulings concerning "Speed of Onset" claim.
We concluded that certain aspects were not substantiated.
You will be pleased to know that, as a result of our investigations and correspondence with the marketing Authorisation Holder (MAH), the advertisement has been amended. The company has agreed to remove the claim when fluoxetine doesn't" from all advertising materials issued in the future.
I would like to thank you for bringing this matter to our attention and to assure you that we at the MCA take all complaints seriously and consider it our responsibility to investigate them fully to a satisfactory conclusion.
|MRS JAN MACDONALD|
|Head, Product Information & Advertising|
|Post Licensing Division|
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