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.

The marketing authorization holder has informed its supplied customers in a letter dated 02.01.2018 that the affected batch is being recalled as a precautionary measure due to a possible color deviation at the wholesaler level. No increased safety…

The marketing authorization holder has informed its supplied customers in a letter dated February 13, 2018, that a minor contamination with Iopamidol has been detected in batch PQ0968 of the medicinal product "Zoledronic Acid STADA 4 mg/100 ml…

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International ApS (DK257551) about the diseases of children conceived with the semen of the following sperm donors

The marketing authorization holder has informed its supplied customers in a letter dated 06.02.2018 that the translucent white cap on the tip of the BUCCOLAM application syringe can get stuck. This creates the possibility that administration may be…

The marketing authorization holder has informed its supplied customers in a letter dated 06.02.2018 that complaints about loose or rotating metal caps have been received. Therefore, the affected batches are recalled from the market as a precaution.

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International ApS (DK257551) about the disease of a child conceived with the semen of sperm donor 6932. The report of the disease describes a child with developmental delay. Genetic testing by aCGH (array - comparative genomic hybridization) revealed a 4.6Mb deletion on chromosome 3p22.

The Federal Office for Safety in Health Care was informed by the Danish authority that it was informed by the Danish tissue bank Cryos International ApS (DK257551) about the disease of a child conceived with the semen of sperm donor 3614. The report of the condition described a 6-year-old child diagnosed with Asperger syndrome with signs of ADHD (attention deficit hyperactivity disorder).