The marketing authorization holder informed its supplied customers in a letter dated November 20, 2013, that the above-mentioned batches would be…

The company responsible for distribution, sigma-tau ArzneimittelGmbH, 40212 Düsseldorf, Germany, informed its supplied customers on November 15, 2013,…

Due to a possible quality defect, the companies Sigma-Tau Arzneimittel GmbH and Sigma-Tau Rare Diseases S.A. have decided to recall the above…

Due to a technical defect, there is a possibility in a small number of Jext epinephrine auto-injectors that the epinephrine is not correctly applied…

In a small number (0.04% corresponds to 4/10,000) of Jext® pre-filled pens, the adrenaline injection may not be carried out in case of need due to a…

Due to a manufacturing problem during the filling of the cartridges, individual products of the above mentioned batches of "NovoMix® 30 FLexPen®" may…

The marketing authorization holder has informed its supplied customers in a letter dated 11.10.2013 that complaints have arisen describing the…

On October 8, 2013, the marketing authorization holder informed its customers that injection vials may have an externally invisible defect under the…

During a routine quality check, a small number of prefilled syringes were found to contain particles consisting mainly of cellulose fibers. The…

The marketing authorization holder has informed its supplied customers in a letter dated 13.09.2013 that investigations have shown that the optimal…