Active substance: Dimethylfumarat The BfArM issues information that the variation worksharing procedure regarding progressive multifocal leukoencephalopathy in connection with the use of medicinal products containing dimethyl fumarate has been concluded.

Active substance: dimethyl fumarate The BfArM issues information that in Germany up to now overall 9 cases of PML (progressive multifocal leukoencephalopathy) have been reported in connection with the administration of Fumaderm^® and 2 cases in connection with the administration of Tecfidera^®.

Active substance: isotretinoin The BfArM considers it necessary to add information on the risk of severe skin reactions to the product informations of medicinal products containing isotretinoin. This information was compiled by the Pharmacovigilance Working Party (PHVWP) of the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA).

Active substance: somatropin In the course of the risk assessment procedure for medicinal products containing somatropin, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a recommendation confirming that the benefit/risk balance of these medicinal products remains positive. However, the CHMP does consider it necessary to remind prescribers to adhere strictly to the approved indications and dosage recommendations and to consider warnings and precautions carefully when administering medicines containing somatropin.

Active substance: metformin The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) issues information that the Summaries of Product Characteristics/Package Leaflets of medicinal products containing metformin have been updated with regard to the contraindication for patients with impaired renal function.

Active substance: methotrexate The study commissioned by the EMA to review the effectiveness of mandated measures to minimise medication errors in therapy with methotrexate-containing medicinal products has been completed. The study results and possible resulting safety measures will be described and discussed in detail in the next PSUSA procedure for methotrexatehaleradministered by the BfArM.

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.

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 updated its recommendations on contraceptive measures for women and men taking medicinal products that contain mycophenolate.

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: 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: 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: 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: 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: 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.