Official announcements
Medicines
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16/12/2019
Marketing authorisation holders of homeopathic human medicinal products are informed that from 01.01.2020 [i.e. from the Data Lock Point: 30.09.2019] no further PSUR submissions are necessary, unless they are ordered by the BASG on a case-by-case basis.
Recall
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Veterinary Medicines
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13/12/2019
Incorrect designation of the medicinal product on one side of the outer packaging.
Safety warnings
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Veterinary Medicines
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12/12/2019
The BASG was alerted to an incident in Denmark where Porcine Reproductive and Respiratory Syndrome (PRRS) had broken out in PRRS-negative pig herds.
Recall
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Medicines
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06/12/2019
The manufacturer informed its customers on 04 December, 2019, that the stated value of the active pharmaceutical ingredient content was too high.
Recall
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Medicines
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06/12/2019
The manufacturer informed its customers on 03 December, 2019, that the listed batches of active pharmaceutical ingredients are recalled as a precautionary measure due to the withdrawal of the manufacturer's certificate of the Indian original manufacturer "Mehta API Pvt. Ltd.".
Recall
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Veterinary Medicines
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26/11/2019
"Richter Pharma AG" has informed its customers on November 22, 2019 that the below mentioned batch of "Ivertin" will be recalled due to a possible reduced content of Ivermectin, which results from a deficiency of the vials.
Recall
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Medicines
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20/11/2019
Die Zulassungsinhaberin hat die belieferten Kundinnen und Kunden mit Schreiben vom 20.11.2019 informiert, dass aufgrund von eingeleiteten Untersuchungen auf europäischer Ebene eine Verunreinigung des Wirkstoffes Ranitidin mit N-Nitrosodimethylamin (NDMA) bei oben angeführten Zulassungen von Ulsal nicht ausgeschlossen werden kann.