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…

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…

AGES MEA experts took the rapporteur role for the development of the new EMA document: "Reflection Paper on statistical methodology for the comparative assessment of quality attributes in drug development" (EMA/CHMP/138502/2017). Over the past 2.5…

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…

The marketing authorization holder informed its supplied customers in a letter dated November 8, 2017, that a production-related crack at the valve connection seal to the bag may occur in "Physioneal Clear-Flex bags". On the one hand, the crack could…

As of November 1, 2017, parts of the Mutual Recognition Agreement (MRA) between the EU and the US entered into force. This agreement updates the original, unratified 1998 agreement and enables mutual recognition of inspection results (Good…

In a letter dated September 27, 2017, the marketing authorization holder informed its customers that an incorrect expiration date was printed on batch 7103 of "Coldan Nasal Spray". The expiration date was printed incorrectly as "2022-06" (June 2022),…

Vienna (OTS) - The Ministry of Health and AGES Medizinmarktaufsicht/Federal Office for Safety in Health Care Austria, together with the Ministry of the Interior and the Ministry of Finance, were again able to seize numerous illegal medicines this…