Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Etrivex 500 micrograms/g Shampoo |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex 500 micrograms/g Shampoo (clobetasol propionate) (batch number: 0114252, 0114277, 0114291) is missing the following safety information:
Section 2: What you need to know before you use Etrivex 500 micrograms/g shampoo
Warnings and precautions
Take special care with Etrivex 500 micrograms/g Shampoo
- Contact your doctor if you experience blurred vision or other visual disturbances.
Section 4: Possible side effects
Etrivex shampoo may cause the following side effects
Not known (frequency cannot be estimated from the available data)
- Blurred vision
Healthcare professionals should note that there is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing specific batches of the product. Where possible, provide an updated copy of the PIL to the patient and remind the patient to read the leaflet in its entirety before using the medicine.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-galderma-uk-limited-etrivex-500-micrograms-slash-g-shampoo-el-22-a-slash-51
In Hong Kong, Clobex Shampoo 0.05% (HK-53048) is a pharmaceutical product containing clobetasol propionate which is manufactured by Laboratoires Galderma. The product is registered by Galderma Hong Kong Limited. It is a prescription-only medicine. As confirmed with the company, the affected batches have not been imported into Hong Kong.
Ends/Wednesday, Dec 7, 2022
Issued at HKT 15:00
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