Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Sandoz Ltd., Linezolid 600 mg film-coated tablets |
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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 Linezolid 600 mg film-coated tablets (batch number: NS2637).
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 medicine 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 & PIL on the existing clinical concepts and take this into account when prescribing.
If the medicine listed in this notification is supplied or dispensed, ensure that patients are aware of the information missing from the PIL on warnings prior to taking Linezolid and possible side-effects. It is important to advise patients that if they experience any of the symptoms listed in this notification, they should seek immediate medical advice.
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-linezolid-600-mg-film-coated-tablets-el-24-a-slash-48
In Hong Kong, Linezolid Sandoz Tablets 600mg (HK-64990) is a pharmaceutical product registered by Sandoz Hong Kong Limited (Sandoz). The product is a prescription-only medicine. Sandoz has been contacted regarding the above issue and their reply is pending.
Ends/ Saturday, Oct 12, 2024
Issued at HKT 14:00
As confirmed with Sandoz, the affected batch has not been imported into Hong Kong.
Content last updated: Monday, Oct 14, 2024
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