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 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 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 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 marketing authorization holder informed its supplied customers in a letter dated 27.11.2017 that the stability test did not comply with the test for gastric juice resistance. The potential impact on patient safety is assessed as low. All other…

The distribution partner for the marketing authorization holder, "DSD Pharma GmbH", informed its supplied customers in a letter dated November 15, 2017, that the qualified person for batch 171115FDG01 has not issued a batch release and that the batch…

The marketing authorization holder has informed its supplied customers in a letter dated 22.11.2017 that deviations from the microbial limit values were detected in a batch marketed abroad. As a precautionary measure, all batches that were produced…