The marketing authorization holder has informed its supplied customers in a letter dated April 23, 2018, that a reduced ethanol content was detected during routine release testing. Therefore, the batch 7F307A on the market is recalled as a…

The European Medicines Agency ( EMA) has launched registration for the public consultation. The consultation will take place on 13/06/2018 at the EMA premises. It will be an opportunity for patients, physicians, healthcare professionals, nurses,…

The Federal Office for Safety in Health Care has been notified by the Danish authority that it has been informed by the Danish tissue bank Cryos International ApS (DK257551) of the disease of a child conceived with semen from donor 1291-KELD.The report of the disease described oculocutaneous albinism type 1 (OCA1) in the child, due to mutations in the TRY gene, which encodes the protein tyrinase.

World Hemophilia Day 2018 Hemophilia is a congenital, lifelong increased bleeding tendency in which a deficiency or complete absence of certain blood components (clotting factors) leads to a disturbance of normal hemostasis. Approximately 850,…

The marketing authorization holder has informed its supplied customers in a letter dated April 16, 2018, that a shortfall in the protein nitrogen content was detected during an internal quality control and that the affected batch of the Prick Test…

With regard to the APA report "APA0151 5 WI 0205 WB/CI" of Thursday, April 12, 2018, the Federal Office for Safety in Health Care (BASG) takes the liberty of making the following correction: The procedure in question is an official procedure of the…

The Federal Office for Public Health Safety has been informed by the French authority that a sharp increase in dengue virus cases has been recorded on Reunion Island since January 2018.

The marketing authorization holder has informed its supplied customers in a letter dated 23.03.2018 that increased anaphylactic reactions have been reported after administration of an identical product in France. For this reason, the above mentioned…

The marketing authorization holder has informed its supplied customers in a letter dated March 13, 2018, that cases of immune-mediated encephalitis and meningoencephalitis have been reported in patients treated with Zinbryta. This has resulted in an…

The marketing authorization holder has informed its supplied customers in a letter dated 22.02.2018 that it may not be possible to supply all doses. Therefore, the affected batch is recalled from the market as a precautionary measure.