其 他 安 全 警 示
|
| |
| The United Kingdom: Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension (English only) |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Atnahs Pharma UK Limited has informed the MHRA that the following batches of Clobazam Atnahs Oral Suspension do not contain the most up to date safety information:
- Clobazam Atnahs 5mg/5ml Oral Suspension (batch number: 230001)
- Clobazam Atnahs 10mg/5ml Oral Suspension (batch number: 230002)
The Summary of Product Characteristics (SmPC) and the Patient Information Leaflets (PIL) present in the pack are missing significant information. This is in relation to the use of the product in children (contraindicated), pregnancy, depression, drug dependence, numerous interactions and adverse effects which are missing from the PIL present in the pack and in the SmPC. For details of the missing information, please refer to the website in MHRA.
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to check if patients belong to any of the groups at risk and provide advice accordingly or do not prescribe and/or dispense this product. Where appropriate, healthcare professionals should provide a copy of the PIL when supplying any remaining stock to patients.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-atnahs-pharma-uk-limited-clobazam-atnahs-5mg-slash-5ml-and-10mg-slash-5ml-oral-suspension-el-23-a-slash-43
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Dec 14, 2023
Issued at HKT 15:30
|
| |
