Active substance: 3-Bromopyruvate Medicinal products for human use with effects not generally known in medical science only to be dispensed upon prescription by a physician.

Active substance: acitretin On a European level it is currently being discussed that the 2-year period of pregnancy prevention in patients of childbearing potential is possibly not sufficient and must therefore be extended to 3 years after end of treatment.

Active substance: Acitretin The BfArM issues information on the result of the European PSUR worksharing procedure for the active substance acitretin. It was determined that the current 2-year period of pregnancy prevention after end of treatment is not sufficient and must therefore be extended to 3 years.

Active substance: angiotensin-receptor-antagonists In June 2010 “Lancet Oncology“ published the results of a meta-analysis (Sipahi et al., 2010), in which the authors observed a slightly increased risk for new cases of cancer under angiotensin-receptor-antagonist therapies.

Active substance: losartan Azido impurity in losartan

Active substances: benzodiazepines | opioids The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) recommends texts for the product informations of benzodiazepines/benzodiazepine like products and opioids.

Active substance: According to information available to the BfArM, large amounts of the medicinal product "Ukrain" are still being marketed illegally in Germany and other EU Member States.

Active substance: bufexamac Assessment of medicinal products containing bufexamac for topical use in the authorised indications has revealed a negative overall benefit-risk ratio. Therefore the authorisations are revoked

Active substance: bufexamac A two-year period for selling bufexamac-containing products cannot be granted according to BfArM’s Feststellungsbescheid (ascertainment decision). Prior to the BfArM order the authorisation holders had abandoned their marketing authorisations in Germany.

Active substance: Carboplatin The company Medac Gesellschaft für klinische Spezialpräparate mbH has submitted documents to the BfArM proving that filtering the medicinal product Carbomedac® prior to use as recommended until now by the BfArM is no longer necessary.

Active substance: carboplatin Extensive measures for risk minimisation have been introduced because of the occurrence of insoluble particles in numerous medicinal products from several pharmaceutical entrepreneurs that contain carboplatin.

Active substance: carboplatin Further measures have been introduced due to the persisting occurrence of insoluble particles in numerous medicinal products containing carboplatin and because of a possible shortage of medicinal products containing carboplatin.

Active substance: carboplatin Further measures have been introduced due to the persisting occurrence of insoluble particles in numerous medicinal products containing carboplatin and because of a possible shortage of medicinal products containing carboplatin.

Active substance: varenicline The benefits of Champix^® as a smoking-cessation medicine outweigh the reported slight increase in cardiovascular events. The European Medicines Agency has confirmed that the benefit-risk balance for Champix^® (varenicline) remains positive, despite the results of a recent meta-analysis on cardiovascular side effects of the medicinal product.

Active substance: tadalafil The Federal Institute for Drugs and Medical Devices (BfArM) calls attention to cases of counterfeits from Greece of Cialis 20 mg film-coated tablets for treatment of erectile dysfunction. This concerns packages with the lot numbers C334146 and C543049 on the outer package and the lot numbers A05673 and A05668 on the inner package.