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11 Feb 2008
Problems have been identified with these heart-lung bypass devices that are used in heart surgery.
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11 Feb 2008
Medicinal products manufactured in the UK must be produced on a site that holds an appropriate manufacturer's licence (ML).
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06 Feb 2008
Changes have been made to the maximum pack size of paracetamol 5% oral suspension presented in unit dose packaging. Also changes have been made to the additional product information requirements for ibuprofen and sumatriptan.
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04 Feb 2008
Companies that hold authorisations for antidepressant products will shortly be receiving letters requesting Type II variations to update the warnings on suicidal thoughts and behaviour in line with European agreements.
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04 Feb 2008
A list of letters sent to healthcare professionals in January 2008, to inform of new safety information and advice.
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04 Feb 2008
We have recently been involved in the development, under the auspices of the UKCRC, of a new integrated research application system (IRAS), which was launched last week.
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04 Feb 2008
The February issue of ‘Drug Safety Update’ includes: drug safety advice for statins and the smoking-cessation drug varenicline; a hot topic article on biosimilar medicines; and a summary of important emerging drug safety information, including the suspension of the Marketing Authorisation for Duphaston (dydrogesterone).
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04 Feb 2008
The February issue of Drug Safety Update communicates that Duphaston/Duphaston HRT (dydrogesterone) is to be withdrawn from the market from March 2008 for commercial reasons.
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04 Feb 2008
We are pleased to announce the launch of Directives Bulletin 3 ‘Guidance on the operation of the EU vigilance system in the UK’ and MORE II - the next step in electronic medical device givilance reporting and collaboration.
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04 Feb 2008
This new edition incorporates references to revision 5 of the MEDDEV.