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The Marketing Authorisation Holder, in agreement with the MHRA, would like to inform you of the following:
The difference is in the shape of the flange of the pre-filled syringe. When viewing it is seen that the flange is not circular and that 2 sides are partly flattened.
- Due to increase demand of this critical care product during this COVID-19 crisis, we increased the production to meet the demand
- In order to meet this increased demand we have manufactured a batch 0125555 where the appearance of the pre-filled syringe may be different to other batches that you have received previously
The difference is in the shape of the flange of the pre-filled syringe. When viewing it is seen that the flange is not circular and that 2 sides are partly flattened.
- The way the product is intended to be used remain unchanged
- There are no additional safety concerns due to this change