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Tech Alert: Transition reminder – Vitamin B6 - maximum dose and warnings; Artemisinin containing ingredients - pregnancy warning statement; Mollusc-derived ingredients - warning

27 Sep 2022 10:17 AM | Anonymous member (Administrator)

Members are reminded that the end of the transition period for existing products that contain Vitamin B6, certain Artemisinin containing ingredients and Mollusc-derived ingredients is 28 Feb 2023Sponsors have been provided a 12-month transition period from 1 March 2022 to bring existing listed medicines into compliance. From 1 March 2023:

- The maximum recommended daily dose (MRDD) for products that contain vitamin B6 has been changed to 100 mg pyridoxine/day. Existing products that contain vitamin B6 must include a warning statement if the medicine contains more than 10 mg of pyridoxine per maximum recommended daily dose (MRDD).

- Existing products that contain certain Artemisinin containing ingredients must include a pregnancy warning statement.

- Existing products that contain Mollusc derived ingredients must include a new warning statement.

Please read today’s technical alert for more details

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