Active substance: vismodegib Important information on the labelling of the bottle and the Package Leaflet as a precautionary measure to ensure safe administration.

Active substance: linezolid The company Pfizer Pharma GmbH is circulating information that with immediate effect the medicinal product Zyvoxid^® i.v. is available to a limited extent.

Active substance: flupirtine In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding medicinal products with the active substance flupirtine.

Active substance: gestagen components: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin, norgestimat In coordination with the European Medicines Agency and the Federal Institute for Drugs and Medical Devices, the pharmaceutical manufacturers concerned are circulating information on new aspects of the risk of blood clots (venous thromboembolic events, VTE) associated with the use of combined hormonal contraceptives depending on the gestagen component.

Active substance: carboplatin The company Medac Gesellschaft für klinische Spezialpräparate m.b.H. points out that the a.m. batch of the medicinal product Carbomedac 10 mg/ml^® is being recalled due to insoluble crystalline particles. The concentrate for solution for infusion must be free of visible particles.

Active substance: iron In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding iron-containing medicinal products for parenteral use.

Active substance: emulsion for infusion for parenteral nutrition The company Baxter Deutschland GmbH points out that the posology given in the Package Leaflets and Summaries of Product Characteristics of Olimel Peri/Olimel nutrient solutions is to be altered with regard to the maximal infusion rate of lipids per hour in children between the ages of 2 and 11 years, as the current statements are not in agreement with the recommendations of the 2005 ESPGHAN/ESPEN guidelines for this age group.

Active substance: isotonic saline solution The company Baxter Deutschland GmbH points out that Baxter has recently received an increased number of customer complaints referring to leakage of the Emoluer valves of Clear-Flex containers.

Active substance: doripenem The company Janssen-Cilag GmbH points out that it will discontinue distribution of the medicinal product Doribax^® 250 mg/500 mg (active substance: doripenem). The entire stock still on the market will be recalled on pharmacy level. This recall will begin the end of February 2014 and shall be completed by the end of March 2014.

Active substance: domperidone The BfArM issues information on the PRAC's recommendation within a European safety review in accordance with Article 31 of Directive 2001/83/EC.

Active substance: isotonic saline In addition to the safety information of 18 February 2014, the company Baxter Deutschland GmbH is circulating information on the recall of several batches of the medicinal product Isotonic Saline Solution Baxter.

Active substance: diacerein The BfArM issues information on the PRAC's recommendation within the re-examination procedure following a European safety review in accordance with Article 31 of Directive 2001/83/EC.

Active substance: strontium ranelate The company Servier Deutschland GmbH is circulating information that use of Protelos is now restricted to the treatment of severe osteoporosis in postmenopausal women and adult men with a high risk of fractures who cannot be treated with other medicinal products licensed for osteoporosis therapy.

Active substance: lenograstim The company Chugai Pharma Marketing is circulating information on the occurrence of capillary leak syndrome (CLS) following administration of lenogastrim (as also in the case of other G-CSF products) in patients undergoing chemotherapy, as well as in a healthy donor during mobilisation of peripheral blood stem cells.

Active substance: dihydroergotoxine The company Sigma-Tau Arzneimittel GmbH is circulating information that there are several indications for which medicinal products with the active substance dihydroergotoxine must no longer be prescribed in the future.