Since the market launch of "Velactis" in March 2016, serious side effects have been reported. the Scientific Committee for Medicinal Products for Veterinary Use of the European Medicines Veterinary Use) of the European Medicines Agency (EMA) has decided to notify the European Commission of a a suspension of the marketing authorization and a precautionary recall of all batches on the market. recommended.

The marketing authorization holder has informed its supplied customers that a recall of all batches of "Velactis" on the market will be carried out, as serious side effects have been reported since market launch. The Scientific Committee for…

The distribution company has informed its supplied customers in a letter dated 21.07.2016 that in the instructions for use of this batch the wrong daily maximum dose of ten capsules is indicated. The correct maximum is five capsules per day. This…

Follow-up message Important information from the Federal Office for Safety in Health Care about the occurrence of serious adverse reactions to Velactis

The marketing authorization holder has informed its supplied customers in a letter dated 14.07.2016 that the title of the leaflet is incorrect. The active strength is listed as 5 mg instead of 10 mg and therefore the affected batches of "Amlodipine…

The distributor of the marketing authorization holder has informed the customers supplied in the period 04.05.2016 to 19.05.2016 that due to a wrong delivery of batch 117 a batch of "Dorzo-Vision 20 mg/ml Eye Drops" in the presentation of the German…

Given the current circulation of Zika virus; the evidence of an association between Zika virus infection during pregnancy and congenital malformations of the central nervous system (CNS); the association between Zikavirus infection and Guillain–Barré Syndrome(GBS)and the risk of local vector-borne transmission in Europe during the 2016 summer season, EU/EEA Member States are recommended to consider a range of mitigation measures.

VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing) is a research and development project in which new, innovative tests for the quality control of human and veterinary vaccines are being developed. The primary goal of the…

Wichtige Information des Bundesamtes für Sicherheit im Gesundheitswesen über das Auftreten von schwerwiegenden Nebenwirkungen zu Velactis Schwerwiegende Nebenwirkungen sind kurz nach Markteinführung von Velactis im März 2016 gemeldet worden. Die gemeldeten Symptome sind Festliegen, Hypothermie, Hypokalzämie, Funktionsstörung des Pansens, Diarrhö, periphere Durchblutungsstörungen, Ataxie, Adipsie und Ausbleiben der erwarteten Wirksamkeit. 22 Rinder sind nach der Anwendung verstorben.

The marketing authorization holder informed its supplied customers in a letter dated June 20, 2016, that a precautionary recall is being carried out due to the potential risk of glass particles in the vials.