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Electronic submission of MA dossiers via CESP: What does that mean?

From 1st July 2013 the famhp encourages the marketing authorization (MA) applicants for medicines to use the "Common European Submission Platform" (CEPA) for the electronic submission of MA dossiers of medicines for human or veterinary use as homeopathic or herbal medicines. This makes the submission quick, safe and easy.

Codeine against pain in children: PRAC recommends restricting the use

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends a series of measures to minimize the risks of codeine-containing medicines when they are used for pain control in children.

The antimicrobials for veterinary use: vigilance

The indiscriminate and excessive use of antibiotics in veterinary medicine presents a risk to public health and animal health because it promotes the emergence of resistant strains of bacteria. To promote a fair and reasonable use of these medicines and educate veterinary professionals to this problem, the famhp collaborates with the University of Gent to monitor the consumption rates of antibiotics in the veterinary sector based on distribution data. The fourth BelVet-Sac report (Belgian Veterinary Surveillance of Antibiotic Consumption) is now available.

Solutions for infusion containing hydroxyethyl starch: PRAC recommends suspending their marketing authorization (MA)

The Pharmacovigilance Risk Assessment Comittee (PRAC) of the European Medicines Agency (EMA: European Medicines Agency) concluded, after a review of the available data, that the benefits of infusion solutions containing hydroxyethyl starch (HES) no longer outweigh the risks. It therefore recommends suspending market authorizations for these medicines.

Diclofenac: measures to minimize the cardiovascular risk

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA: European Medicines Agency) estimates that the benefits of diclofenac, an anti-inflammatory medicine (NSAIDs), outweigh the risk of thromboembolic events. PRAC recommends the same measures as those in place to minimize the cardiovascular risk of selective COX-2 (another group of anti-inflammatory).

Medicines containing cyproterone and ethinylestradiol (Diane 35 and generics): the CMDh endorses the recommendations of PRAC

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) confirms the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) by a majority vote (26/1). The benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 mcg) and its generic outweigh the risks, provided that several measures are taken to minimize the risk of thromboembolism (blood clots in the blood vessels).

Retigabine (Trobalt) : restricting its use

The European Medicines Agency has reassessed the benefit / risk balance of retigabine, the antiepileptic medicine approved under the name TROBALT. It remains positive for patients who cannot be adequately treated by other medicines. The limited use of this medicine is recommended due to the risk of retinal pigmentation.

The external satisfaction survey has been launched!

The federal agency for medicines and health products (famhp) launched a first external satisfaction survey (partners and clients) to assess the quality of its services and products. The results of this will be communicated at the end of 2013 and will be used to improve the delivery of services of famhp.

Removing a batch of an uncertified officinal preparation against motion sickness issued by a pharmacy in Borgerhout

The federal agency for medicine and health products (famhp) was informed by the Pharmacist Gielen in Borgerhout of a risk of significant overdose of the active ingredient in a batch of preparations of officinal capsules used against motion sickness with theoretically 0,3 mg of scopolamine hydrobromide per capsule.

VIG-NEWS: May 2013 edition

The new edition of the electronic newsletter "VIG-NEWS" of the federal agency for medicines and health products (famhp) is now available. VIG-NEWS is a selection of recent news of pharmacovigilance from different sources.

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