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Pregsure BVD vaccine for veterinary use: suspension of the marketing authorisation (MA)

Following the appearance of bovine neonatal pancytopenia reported after using Pregsure BVD, the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) has recommended the suspension of the marketing authorisation of this inactivated vaccine indicated for immunisation of cows to prevent transplacental infection caused by the bovine viral diarrhea virus. After evaluating all available data, the CVMP considered that the benefit-risk balance for Pregsure BVD was unfavourable. It has also recommended the recall of all batches at the wholesale level.

VIG-NEWS: November 2010 Edition

The new edition of the electronic newsletter "VIG-NEWS" of the Federal Agency for Medicines and Health Products (FAMHP) is now available. The VIG-NEWS is a selection of recent news concerning pharmacovigilance from different sources.

Draft circular concerning the request for authorisation of a clinical trial: call for comments

A new version of the document "Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (“CT-1 ")" was published on 30th March 2010. A draft circular giving instructions resulting from the transposition of this guidance in Belgium is submitted to the concerned partners for comments.

RotaTeq: positive benefit-risk balance

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has reassessed RotaTeq following the detection of DNA fragments of porcine circovirus (PCV) in this preventive vaccine against gastroenteritis due to rotavirus infection. The CHMP considers that these DNA fragments, which are found in very small quantities in RotaTeq does not present a risk to public health. The benefit-risk balance of this vaccine remains positive.

Octagam: EMA recommends suspending the marketing authorisation

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.

Rosiglitazone: EMA recommends suspending the marketing authorisation of Avandia, Avandamet and Avaglim

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.

New instructions for the submission of an application for renewing a marketing authorization

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.

Pandemrix: new pharmacovigilance data

A limited number of cases of narcolepsy have been reported, mainly in Sweden and Finland, in the context of vaccination against influenza A/H1N1 with the Pandemrix vaccine. No cases have been observed in Belgium. The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) will review all available data to determine if there is a causal link between vaccination with Pandemrix and the cases of narcolepsy reported.

Availability of drugs: a reminder of legal obligations

The Federal Agency for Medicines and Health Products (FAMHP) reminds the actors of the medicines distribution chain their legal obligations.

VIG-NEWS: August 2010 Edition

The new edition of the electronic newsletter "VIG-NEWS" of the Federal Agency for Medicines and Health Products (FAMHP) is now available. The VIG-NEWS is a selection of recent news concerning pharmacovigilance from different sources.

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