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: febuxostat Serious hypersensitivity reactions have been reported under treatment with Adenuric^®. In most of the cases these reactions occurred during the first month of treatment with febuxostat.

Active substance: agomelatine Liver function tests are to be performed regularly in patients treated with agomelatine. The medicinal product should be discontinued immediately if an increase in transaminases exceeds 3 times the upper limit of normal or if typical symptoms of potential liver damage are observed.

Active substance: ambroxol, bromhexine On 14 January 2016, the European Commission decided to update the texts of the Summaries of Product Characteristics/Package Leaflets of medicinal products containing ambroxol and bromhexine.

Active substance: 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: amfepramone Following the recommendation of the Coordination Group on Mutual Recognition Procedures and Decentralised Procedures - Human (CMDh) on the revocation of marketing authorisations and prior to the final decision of the European Commission, all marketing authorisation holders of medicinal products containing amfepramone in Germany have declared a voluntary surrender of their marketing authorisations as of 01 December 2022.

Active substance: Amsacrine The pharmaceutical entrepreneur has issued information on a lack of availability of Amsidyl® until presumably 2015 due to the GMP deficiencies determined at the manufacturing site.

Active substance: adrenaline Lincoln Medical Limited is recalling all unexpired units of the a.m. medicinal product because of the risk of failure to deliver the adrenaline solution in an anaphylactic emergency situation.

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: misoprostol Reminder of the authorisation-compliant application.

Active substance: rosiglitazone In a decision dated 23 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the recall of anti-diabetics containing rosiglitazone from the trade chain in Germany down to the pharmacy level. Due to the necessity of switching patients to other medications, the recall is to become effective on 1 November 2010. This decision is based on the scientific conclusions of the Committee for Human Medicinal Products (CHMP) which has come to a negative risk-benefit ratio for these medicinal products because of cardiovascular risks and recommends suspension of their marketing authorisations.

Active substance: etoricoxib The company MSD is circulating information on altered dosage recommendations for the medicinal product Arcoxia®.

Active substance: losartan Azido impurity in losartan