Official announcements
Recall
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Medicines
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14/02/2018
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…
Recall
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Medicines
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07/02/2018
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…
Recall
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Medicines
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07/02/2018
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.
Recall
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Medicines
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25/01/2018
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…
messages in brief
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03/01/2018
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…
messages in brief
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06/12/2017
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…
Recall
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Medicines
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28/11/2017
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…
Recall
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Medicines
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24/11/2017
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…
Recall
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Medicines
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23/11/2017
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…
Recall
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Medicines
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08/11/2017
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…