Palfium (dextromoramide) 5 mg tablets - public assessment report suspension of marketing authorisation

The Medicines Evaluation Board (MEB) decided to suspend the marketing authorisation for the medicinal product Palfium 5 mg tablets (dextromoramide, RVG 03170). This decision was taken because the preparation by the manufacturer did not meet the requirements as described in the authorisation dossier. As there is no immediate risk to health, the Dutch Health Care Inspectorate (IGZ) decided that batches of Palfium that had already been released may be sold for a period of 6 months. Palfium contains the active ingredient dextromoramide and is used in the treatment of severe, acute or chronic pain that necessitates treatment with opioids. There are no other products with this active ingredient authorised in the Netherlands. The suspension of the marketing authorisation can be lifted following approval of a variation to ensure that the dossier concurs with the production.