The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by letter dated October 27, 2011, that all batches of the product Xigris are being recalled. The reason for this withdrawal is the results from a recently completed study that showed no statistical superiority of efficacy…

In a letter dated October 27, 2011, the marketing authorization holder informed its customers that a precautionary recall is being carried out due to an increased number of suspected cases of adverse drug reactions that occurred within a short period of time. The previous reports of adverse drug reactions mainly concerned hypersensitivity…

The marketing authorization holder informed its supplied customers in a letter dated October 24, 2011, that a precautionary recall is being carried out due to an increased number of suspected cases of adverse drug reactions that occurred within a short period of time. The previous reports of adverse drug reactions mainly concerned hypersensitivity…

On Oct. 11, 2011, the European Commission published revised proposals to amend Regulation (EC) No. 726/2004 and to amend Directive 2001/83/EC. The content of these proposals is to clarify the form in which companies may inform the public about prescription-only medicines. The growing interest of patients in their treatment and prescribed medicines…

The distributor has informed its supplied customers by letter dated 04.10.2011 that the affected batch has a labeling error: On the folding boxes, the expiration date is poorly legible and stamped with the wrong year (Aug. 31, 2013 instead of the correct Aug. 31, 2012). The bottles - as well as the label on the transport carton are correct.

Ophthalmologists have informed the Federal Office for Safety in Health Care that the drug Flurekain "Croma" Eye Drops is no longer available. See related files.

The BMF, BMI, BMG and BASG participated in this year's action week. The operation took place this year from 20.09. to 29.09.2011. A total of 84 countries participated in the organized action. The aim was to simultaneously and in a coordinated manner access illegal websites through which counterfeit medicines are distributed and to monitor other…

The World Health Organization (WHO) has recognized the EU Clinical Trials Register (CTR) as the primary registry for the International Clinical Trials Registry Platform (ICTRP), a web-based portal that contains information from a number of clinical trials registries from around the world. EU-CTR: Clinical Trials Information in the EEAWith the…

Commission Regulation (EC) No. 1234/2008 of Nov. 24, 2008, concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products (Variation-Regulation), governs variations to marketing authorizations for medicinal products for human use and veterinary medicinal…

Since 01.09.2011 the new harmonized validation criteria are in force. From now on, the validation of dossiers includes the following criteria: Pass/Fail (P/F) and Best Practice (BP). A dossier is considered valid if all Pass/Fail criteria have been met. If the Best Practice criteria are not met, a justification is desirable. The new e-Validator 3.1…