The provinces of Bologna and Modena were added to the already known risk areas.

B. Braun Austria Ges.m.b.H. has informed its supplied customers in a letter dated August 5, 2013, that a customer complaint has informed the marketing authorization holder about a leaking Ecoflac plus infusion container in batch 13103411. Since it cannot be ruled out that other infusion containers of the above batch are affected by a possible leak,…

Metoclopramide-containing medicinal products are approved in a number of Member States in various indications, including nausea and vomiting (for example, after chemotherapy or radiotherapy, surgery, or for migraine) and gastrointestinal motility disorders. The European Medicines Agency (EMA) is recommending new directions for use, including…

Please note the new account number of the Federal Office for Safety in Health Care (BASG) / AGES Medizinmarktaufsicht: BAWAG P.S.K. AG IBAN: AT59 6000 0000 9605 1496 BIC: OPSKATWW DVR: 2112611 Inquiries: E-mail: qmgt@ages.at

First confirmed infection recorded in Greece, Attiki.

Number of cases increased to 201 ill persons by July 4, 2013 and thus now epidemic.

The marketing authorization holder informed its supplied customers in a letter dated July 9, 2013, that in the course of quality assurance measures it was determined that in batch 1200758 isolated ampoules with yellowish discolored contents and thus a possible reduced active ingredient content were observed. Other batches of this product are not…

The distribution partner "sanofi-aventis GmbH" informed its supplied customers in a letter dated 04.07.2013 that the retained samples of the above batch showed deviations. After a storage time of 26 months, aggregates above the permissible limit of 5% were detected. As the batch is still within the period of 36 months, a recall was carried out.

Ergot derivatives (various preparations)

The marketing authorization holder informed its supplied customers in a letter dated 17.06.2013 that a decrease in gentamicin content was observed in a batch of Soligental after 14 months of use (85.1%; specification: 95-105%) and that all batches of the product are therefore being recalled as a precautionary measure until the cause of the problem…