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).
Medicines containing cyproterone and ethinylestradiol (Diane 35 and generics): the CMDh endorses the recommendations of PRAC
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.
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.
The Commission for medicinal products for human use conducted a reassessment of the risk-benefit balance of the mucolytics (acetylcysteine, carbocysteine or bromhexine-containing medicines) and made a new recommendation.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) confirms the positive benefit / risk balance of Diane 35 and generic medicines which contain cyproterone acetate and ethinyl estradiol for a specific group of patients and recommends measures to reduce the risk of thromboembolic events.
Beginning in 2013, the federal agency for medicines and health products (famhp) initiated a procedure to can possibly put under prescription the domperidone-containing medicines. Based on the evaluation of data submitted by the relevant companies and the various hearings, the Committee for Medicinal Products for Human Use of the famhp, during its meeting of April 2013, issued a final opinion on the delivery status (under prescription or not) of domperidone-containing medicines.
At its meeting from 8th to 11th April 2013 the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) formulated and sent to the Coordination Group for Mutual Recognition and Decentralized procedures - human (CMDh) the recommendation to suspend the marketing authorization of tetrazepam-containing medicines. A previous statement about it was published on our website on 15th April. The CMDh, which met on 22nd to 24th April 2013, confirms the position of the PRAC.
Following the release of 19th March 2012 concerning medicines against cough and colds in children, the famhp reminds people about the recommendations issued in this regard. These apply from 1st May 2013.
The routine reassessment of the risk-benefit balance of Protelos has shown an increased risk of cardiac complications, including myocardial infarction, the Pharmacovigilance Risk Assessment Committee (PRAC), which is the committee for the evaluation of risks in pharmacovigilance of the European Medicines Agency (EMA) recommends restricting the use of Protelos (strontium ranelate) used in the treatment of osteoporosis.