Active substance: buflomedil The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended suspending the marketing authorisation for oral use of medicines containing buflomedil in EU Member States.

Active substance: ondansetron BfArM issues a notice within the graduated plan procedure ("Stufenplanbescheid") concerning the implementation of information on contraindications and interactions if used concomitantly with apomorphine.

Active substance: somatropin The Federal Institute for Drugs and Medical Devices (BfArM) refers to counterfeits of the medicinal product Omnitrope® 15 mg / 1.5 ml solution for injection by the company Sandoz reported in France, Denmark and Mexico. The medicinal product normally contains the active substance somatropin and is a growth hormone used for the treatment of growth hormone deficiency.

Active substance: omega-3 fatty acids The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the implementing decision of the European Commission in its notification of 14 June 2019.

Active substance: simeprevir, sofosbuvir In accordance with the evaluation of cardiac safety of the concomitant administration of Harvoni®, Daklinza® and Sovaldi® with amiodarone, the Pharmacovigilance Risk Assessment Committee (PRAC) has also revised the medicinal product Olysio® (simeprevir) with regard to the risk of bradycardias.

Active substance: obeticholic acid Current information on marketability.

Active substance: nutrient solution for term infants and children up to 2 years of age The company Baxter Deutschland GmbH is sending out information that administration of the medicinal product Numeta G 16% E^® to term infants and children up to 2 years of age can possibly lead to the risk of hypermagnesemia.

Active substance: somatropin The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the medicinal product Norditropin® SimpleXx® 15 mg/1,5 ml solution for injection by the company Novo Nordisk has been discovered in the illegal distribution chain in Germany.

Active substance: nitrosamine EMA finalises opinion on presence of nitrosamines in medicines.

Active substance: pegfilgrastim The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has received information via the "Land" authority ("Landesbehörde") of Bavaria and via the EU's Rapid Alert System (RAS) that counterfeits of the medicinal product Neulasta^® have possibly reached Germany.

Active substance: naltrexone, bupropion EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), regarding the potential long-term cardiovascular risk (affecting the heart and blood circulation).

Active substance: naltrexon, bupropion The European Medicines Agency (EMA) draws attention to the risks of using the weight loss medication Mysimba in combination with opioids.

Active substance: mycophenolate The European Medicines Agency (EMA) has updated its recommendations on contraceptive measures for women and men taking medicinal products that contain mycophenolate.

Active substance: Mycophenolat The BfArM is issuing further information as a follow-up to the reinforced warning of 26 October 2015 regarding the use of mycophenolate (mycophenolate mofetil or mycophenolic acid) during pregnancy.

Active substance: mycophenolate The European Medicines Agency (EMA) has issued a warning that the active substance mycophenolate used in transplantation medicine must not be administered during pregnancy if other treatment alternatives are available.