After December 31st 2011 Novo Nordisk stopped marketing the human insulin Mixtard 30 for commercial reasons. Mixtard 30 may be delivered in pharmacies while stocks last. Transition for a patient to another treatment should be under strict medical supervision.
Information for the attention of marketing authorization (MA) holders of medicinal products for human use
A document setting out the requirements for Type II variations of the marketing authorisation file, involving a revision of sections 4.6 (fertility, pregnancy and lactation), 5.3 (preclinical safety data) and 6.6 (special precautions for disposal of a used medicinal product or waste materials derived from such a medicinal product and other handling of the product) of the summary of product characteristics (SPC) is published on the page about variations in the column "Marketing authorization procedure" for medicines for human use.
The document entitled "FAMHP guideline on the method of delivery of antidepressants, antipsychotics, hypnotics, sedatives, anxiolytics and antiepileptics" (V 6.2.), is published on its website in the section on the procedures for marketing authorization for medicines for human use.
The FAMHP became aware of the recent evaluations carried out by the French Agency for Sanitary Safety of Health Products (AFSSAPS) on implants manufactured by POLY IMPLANT PROTHESE (PIP). As a precaution the FAMHP recommends that the monitoring of patients be reinforced and that women who have doubts consult their doctor.
Following the indexation of the fees and payments due for the missions of the Federal Agency for Medicines and Health Products (FAMHP), the tables have been adapted and came into effect on 01/01/2012.
Following the review of somatropin- containing medicines, the European Medicines Agency confirms that their benefit / risk balance remains positive. Prescribers are reminded to adhere strictly to the indications and recommended doses. The containing somatropin-containing medicines marketed in Belgium are: Genotropin, Humatrope, Norditropin, Nutropin Aq, Omnitrope and Zomacton.
Electronic submissions for marketing authorisations for medicinal products for human use : novelties
The new version (v2.11) of the national esubmission guideline is available. This guideline is applicable from 2nd December 2011 for all dossiers submitted at the FAMHP for human use with the exception for dossiers for homeopathic medicines and the psurs. The checker which is used for the technical validation of the dossiers and the CTD tree structure has also been adapted.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reviewed all available data at world level on the risk of fatal bleeding following administration of PRADAXA, an anticoagulant containing dabigatran. The risk of bleeding of the anticoagulants is well known and is already included in the summary of product characteristics (SPC) and Package Leaflet of PRADAXA. The CHMP considers it necessary to strengthen precautionary measures in case of kidney failure. The doctors were informed. The SPC and package leaflet will be adapted along those lines.
Following the suspicion of cross-sensitization between pholcodine and neuromuscular blocking agents used in surgery, which could be the cause of the occurrence of anaphylactic reactions, the Committee for Medicinal Products for Human Use of the European Medicines Agency has reviewed all the data on safety and efficiency of available pholcodine-containing medicines and advises that their benefit / risk balance remains positive.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended in May 2011 to suspend the marketing authorisation (MA) of the buflomedil-containing medicines, awaiting of the completion of the reassessment of their benefit / risk balance. In Belgium LOFTYL 150 mg (single presentation still marketed in May 2011) has since been withdrawn. CHMP has finished the review of buflomedil and confirms the recommendation of May 2011. Buflomedil-containing medicines can no longer be marketed.