Official announcements
Search narrowed by
Recall
|
Medicines
|
12/03/2020
Recall due to increased reports of ring breakage
Recall
|
Medicines
|
03/03/2020
Recall due to particles affecting batches 8234, 8235 und 8236
Recall
|
Medicines
|
26/02/2020
Recall due to reduced active ingredient content
Safety warnings
|
Medicines
|
11/02/2020
The all-clear can be given, because samples of the active substance noscapine from manufacturer and affected pharmacies have been examined in the meantime.
Incidents with extemporaneously compounded noscapine cough syrup - Usage is strongly not recommended
Safety warnings
|
Medicines
|
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.
Medicines
|
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
|
Medicines
|
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
|
Medicines
|
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
|
Medicines
|
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.