The preparations Xenical and Alli Vimpat (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults with overweight (body mass index BMI≥28 kg/m2 in combination with a mildly hypocaloric, low-fat diet. The European Medicines Agency (EMA) has started to review the risk-benefit…

The marketing authorization holder informed its supplied customers in a letter dated September 15, 2011, that crystalline particles may be present in the amino acid chamber of the three batches mentioned and that a recall is therefore being carried out as a precautionary measure.

The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by fax dated September 14 that all batches of Vimpat Syrup are being recalled. The reason for this recall is precipitation of the active ingredient observed in some batches of the syrup. Note: Please also refer to the…

The QRD (Quality Review of Documents) working group of the European Medicines Agency (EMA) published the new version of the QRD template for central procedures at the end of July 2011. The template for MR/DC or referral procedures followed at the end of August 2011. In the changes to the template, the main focus was on the package leaflet. The…

The proposals are intended to harmonize the pharmacovigilance system provided for in Regulation (EU) No. 1235/2010 and Directive 2010/84/EU. To this end, implementing measures have been developed by the European Commission in the following areas: the content and maintenance of the pharmacovigilance system master file by the marketing authorization…

The marketing authorization holder informed its supplied customers in a letter dated 07.09.2011 that due to individual reports of an unpleasant, moldy odor, a further batch must be recalled. This odor emanates from the primary packaging (plastic bottles) and is due to contamination with traces of 2,4,6-tribromoanisole (TBA). TBA is a degradation…

Orally administered isotretinoin is highly teratogenic and strictly contraindicated in pregnancy. Reliable pregnancy prevention is therefore essential when using isotretinoin (Ciscutan®, various generics). Prescribing, dispensing and taking isotretinoin requires special precautions. More information: uptodate_issue August 2011

The distribution company has informed its supplied customers by letter dated August 29, 2011, that the batches indicated above may be contaminated with particles and are therefore recalled as a precautionary measure.

With the new DCP-slot alert mailing list applicants have the opportunity to be informed immediately whenever a new version of the availability matrix has been published. In the availability matrix free resources in the different assessor groups for DCPs with AT as RMS are shown. Due to the number of slot-requests and due to short-term cancellations…

The marketing authorization holder has informed its supplied customers by letter dated 23.08.2011 that a replacement will be carried out due to crystallization of the calcium solution. Note: On 06.06.2011, the batches L108003 and L118002 were already exchanged by Fresenius Kabi Austria GmbH. A letter to this effect was sent to the customers…