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).

The marketing authorization holder informed its supplied customers in a letter dated January 23, 2018, that "Saroten 10mg Film-Coated Tablets" was placed on the market with an incorrect dosage information for the treatment of depressive disorders…

The 2016/2017 yellow fever outbreak in Brazil was declared over in September 2017. The upsurge of human cases since December 2017 and non-human primate epizootics since September 2017 indicates a resurgence of the circulation of yellow fever virus in Brazil, and more particularly in São Paulo State.

AGES MEA experts are continuously working on the third revision of the international guideline ICH S5(R2) "Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility", which has now been made available for public…

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 5971.