Official announcements
Incidents with extemporaneously compounded noscapine cough syrup - Usage is strongly not recommended
Safety warnings
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Medicines
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06/02/2020
Due to recent incidents with extemporaneously compounded products prepared noscapine cough syrup, it is recommended not to use extemporaneously compounded products noscapine cough syrup or suppositories from now on.
messages in brief
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24/01/2020
The National Immunization Schedule 2020 is now available.
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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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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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.
Recall
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Medicines
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29/10/2019
The marketing authorisation holder informed its customers on October 29, 2019 that some of the three-chamber bags show deviations in pH value, colouring and emulsion quality.
Recall
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Medicines
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24/10/2019
The marketing authorisation holder informed its customers on October 24, 2019 that a review of ranitidine medicines after tests showed that below mentioned batches may contain an impurity called N-nitrosodimethylamine (NDMA).
Recall
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Medicines
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24/10/2019
The marketing authorisation holder informed its customers on October 24, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).