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Derivatives of ergot-containing medicines: new restrictions

The Committee for Medicinal Products for Human Use of the European Medicines Agency has reviewed all available data on derivatives of ergot-containing medicines. This Committee believes that their benefit / risk balance is most favorable in the treatment of circulatory disorders, cognitive and neuro-sensory disorders as well as in the prevention of migraine. It recommends that physicians reassess the treatment of patients to whom these drugs are prescribed.

Falsified medicines: new legislation

Directive 2011/62/EU aimed at ighting against falsified medicines was transposed into Belgian law: the law of 20th June 2013 amending the Law of 25th March 1964 on medicines was published in the Belgian Official Journal on 26th June. Many of these provisions come into force on 1st and 2nd July 2013.

Validation des dossiers électroniques d’AMM des médicaments à usage humain : version « intermédiaire « du « checker ».

Le checker utilisé pour la validation technique des dossiers d’autorisation de mise sur le marché (AMM) des médicaments à usage humain a été adapté pour tenir compte des nouvelles règles de validation du NeeS (non eCTD electronic Submission) qui seront d’application à partir du 01/09/2013 . Une version « intermédiaire » (v.4) du checker a été développée. Les demandeurs qui le souhaitent peuvent appliquer les nouvelles règles à partir du 1er juillet 2013 et doivent alors utiliser cette version intermédiaire du checker.

Validation of the electronic MA files for medicines for human use: “Intermediate” version of the "checker".

The checker used for the technical validation of market authorization files (MA) for medicines for human use has been adapted to reflect the new validation rules NeeS (non-eCTD electronic Submission) that will apply to from 01/09/2013. An "intermediate" (v.4) version of the checker has been developed. Applicants may wish to apply the new rules from 1st July 2013 and must then use this intermediate version checker.

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.

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.

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.

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