Other safety alerts
|
| |
| The United Kingdom: Class 4 Medicines Defect Information: Sandoz Ltd., Rosuvastatin 20mg, 40mg Tablets |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Rosuvastatin 20mg Tablets (batch number: NL8148, NW1590, NW1591) and Rosuvastatin 40mg Tablets (batch number: NJ2462, NU8004, NX2653, NU8003).
For details of the missing safety information, please refer to the website in MHRA.
There is no risk to product quality or impact to safety of the medicines listed in this notification because of this missing information. Healthcare professionals are advised to review the content of this notification, as it provides information that is missing from the current SmPC and PIL on the existing clinical concepts and take this into account when prescribing.
If the medicines listed in this notification are supplied or dispensed, ensure that patients are aware of the information missing from the PIL on interaction with other medicines. Advise patients that if they are taking any of the medications listed in this notification they should discuss this with their prescribing healthcare professional before they start taking the medication.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-ltd-dot-rosuvastatin-20mg-40mg-tablets-el-24-a-slash-45
In Hong Kong, Rosuvastatin Sandoz Tab 20mg (HK-61143) is a pharmaceutical product registered by Sandoz Hong Kong Limited (Sandoz). The product is a prescription-only medicine. As confirmed by Sandoz, the affected batches have not been imported into Hong Kong.
Ends/Wednesday, Oct 2, 2024
Issued at HKT 16:15
|
| |
