Finalised safety procedure for methadone products containing povidone. The PRAC finalised the EU safety referral procedure for methadone medicinal products containing povidone. The review of the risk-benefit balance originated from the reports of misuse of methadone by injection which may result in potential harm from the accumulation of povidone in the internal organs. However, only high molecular weight povidone was associated with a risk of harm. The PRAC recommended the suspension of the marketing authorisation for all methadone oral solutions containing high molecular weight povidone and reformulation of the affected products. Methadone tablets containing low molecular weight povidone will remain on the market with the reinforced information that the product is for oral administration only.

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