In view of increased thrombo-embolic reactions reported following administration of Octagam, which is a medicine containing 5 or 10% of normal human immunoglobulin, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends temporarily suspending the marketing authorisation of the various presentations of this medicine. It also recommends that health professionals no longer use it and opt for another medicine containing normal human immunoglobulin. In agreement with the FAMHP, the marketing authorisation holder will proceed to recall the batches on the market.
As announced in our press release dated 22/07/2010, the findings of the evaluation of all data on the benefit / risk balance for rosiglitazone-containing medicines are now available. Data from recent studies confirm the increased cardiovascular risk associated with the administration of these medicines for which precautionary measures and restrictions have already been taken. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) believes that the benefits of rosiglitazone no longer outweigh its risks and recommends the suspension of the marketing authorisation of the medicines.
Since 1st September 2010 any application for renewal of a marketing authorisation (MA) for a medicine for human use, granted under the national procedure, must be submitted to the Marketing Authorisation Division – Variations & Renewals of the FAMHP.