The marketing authorization holder has informed its supplied customers in a letter dated 05.07.2018 that an impurity was detected during the review at the active ingredient level. This impurity is classified as potentially carcinogenic. Therefore, a…

In a letter dated July 5, 2018, the marketing authorization holder informed its customers that the active ingredient manufacturer had detected the production-related impurity N-nitrosodimethylamine (NDMA) in the active ingredient valsartan.…

The marketing authorization holder has informed its customers in a letter dated December 31, 2009, that a production-related impurity has arisen at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…

The marketing authorization holder informed its supplied customers in a letter dated December 31, 2009, that a production-related impurity occurred during a synthesis step at the active ingredient manufacturer's. The impurity is…

The Federal Office for Safety in Health Care (BASG) was obligated within the framework of a conciliation procedure pursuant to Section 14 of the Federal Disability Equality Act (Bundes-Behindertengleichstellungsgesetz) to request the holders of…

The European Medicines Agency ( EMA) held the public consultation on the impact of potential adverse reactions to fluoroquinolones, a group of antibiotics commonly prescribed in the European Union (EU) (such as ciprofloxacin, ofloxacin, etc.) on June…

The Federal Office for Safety in Health Care was informed by the Danish authority that it was informed by the Danish tissue bank "European Sperm Bank (formerly Nordic Cryobank)" (DK267572) about the disease of a sperm donor. Investigations showed that sperm donor 8311 / Bonne is heterozygous for mutation c.1062 + 5G> A in the FAH gene and thus a carrier of tyrosinemia type 1 (hepatorenal tyrosinemia, HT-1).

On the occasion of the 100th meeting of the EMA Management Board, it was not only a matter of efficiently dealing with an extensive agenda, but also of bringing together all former Management Board Chairs and EMA Directors in view of this…

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) about the disease of a 2-year-old child conceived with semen from donor 8151. The report of the disease describes a child with autism spectrum disorder (ASD).

The marketing authorization holder has informed its supplied customers in a letter dated 11.06.2018 that visible particles were found in part of a production batch during quality control. For this reason, the above batch is being recalled as a…