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21 December 2011 /Authorisation and supervision
Recall of Vistide® deliveries causes no supply issues
The European Medicines Agency (EMA) has found that quality issues may have arisen in the production of the medicine Vistide® from the US company Ben Venue. EMA has therefore recommended that the company recall all affected deliveries (batches) of Vistide® until the quality can be assured.
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12 December 2011 /Authorisation and supervision
No supply problems caused by recall of batches of Luminity® and Ecalta®
The European Medicines Agency (EMA) has found that a quality problem may have occurred during the manufacturing of the two medicines Luminity® and Ecalta® from the US-based company Ben Venue.
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07 December 2011 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of citalopram
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for citalopram. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Furthermore, marketing authorisation holders of citalopram must implement the new text by submitting variation applications for all relevant products.
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07 December 2011 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information concerning use of antipsychotics during pregnancy
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for antipsychotics. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Marketing authorisation holders of antipsychotics must implement the new text by submitting variation applications for all relevant products.
