Active substance: strontium ranelate The BfArM issues information on the implementing decision of the Commission within a European safety review in accordance with Article 20 of Regulation (EC-European Community) No. 726/2004.

Active substance: midazolam The company ViroPharma GmbH issues information on the recall of the medicinal product Buccolam^®. During a routine inspection at the manufacturing site, the potential risk of a cross-contamination with another medicinal product produced at the same site was discovered.

Active substance: metoclopramide On 20 December 2013, the European Commission decided that high dose medicinal products containing metoclopramide should be removed from the market.

Active substances: ambroxol | bromhexine The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC. This procedure was initiated at the request of the Belgian Federal Agency for Medicines and Health Products.

Active substance: combined hormonal contraceptives In its notice of 31 March 2014, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the corresponding implementing decisions of the EU Commission K(2014)307 of 16 January 2014.

Active substance: pelargonium After having conducted a hearing within a graduated plan ("Stufenplan") procedure, the BfArM has now issued a notice regarding the risk of liver damage due to medicinal products containing pelargonium root.

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.

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: 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: 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: 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: 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: 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: 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: 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.