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27 June 2008 /Side effects and trials
EMEA warns against the use of epoetins in cancer patients
The European Medicines Agency (EMEA) recommends that the product information for epoetin-containing medicines be updated with a new warning for their use in cancer patients stating that blood transfusion should be the preferred methods of correcting anaemia in cancer patients.
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26 June 2008 /Side effects and trials
EMEA recommends new warnings and contraindications for ergot-derived dopamine agonists
The European Medicines Agency (EMEA) has recommended updating the product information for ergot-derived dopamine agonists with new warnings and contraindications in relation to the risk of fibrosis.
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26 June 2008 /Side effects and trials
EMEA strengthens warnings and contraindications for etoricoxib-containing medicines
The European Medicines Agency (EMEA) has finalised a review of the benefits and risks of etoricoxib-containing medicines. The EMEA has concluded that these medicines can be used to treat rheumatoid arthritis and ankylosing spondylitis (Bechterew disease), but has recommended that their product information should be updated concerning the risk of cardiovascular side effects.
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12 June 2008 /Side effects and trials
Renewed focus on adverse drug reactions from the use of Champix® (vareniciline)
A report published on 21 May 2008 by the private American non-profit organisation Institute for Safe Medication Practices (ISMP) has spurred a renewed interest in possible adverse drug reactions from the use of Champix® (varenicline), which is a medicinal product for smoking cessation treatment.
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04 June 2008 /Authorisation and supervision
Updating of Danish QRD templates for summaries of product characteristics and package leaflets
On the EMA website, you can find the QRD templates that the industry must use to draw up summaries of product characteristics and package leaflets.
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04 June 2008 /Product information
EMEA recommends changes in the storage conditions for Neupro® (rotigotine)
The European Medicines Agency (EMEA) has recommended the immediate implementation of changes to the product information for Neupro® (rotigotine), from Schwarz Pharma Ltd., stating that it must be stored in a refrigerator (at a temperature of between 2ºC and 8ºC).
