Palfium® 5 mg tablets

09 December 2014

In 2014 ACE Pharmaceuticals was informed by the Dutch Medicines Evaluation Board (CBG) that the marketing authorisation for Palfium® 5 mg tablets (dextromoramide tartrate, NL-RVG 03170) would be suspended as from 28th November 2014.

The decision for suspension was taken because the manufacturing did not comply with the dossier; the active pharmaceutical ingredient was sourced from a supplier who was not stated in the dossier. To add this supplier to the dossier, a variation on the dossier was submitted earlier but was unfortunately rejected.

There is no direct health risk. Therefore, the Dutch Healthcare Inspectorate has decided that the batches already released can be sold for a final period of 6 months after the date of suspension. This means that Palfium will be supplied to the pharmaceutical wholesalers until 27th May 2015.

If the dossier is amended to comply with the current manufacturing procedure, the suspension could be lifted. ACE Pharmaceuticals strives to submit this variation as soon as possible.

Palfium contains the active pharmaceutical ingredient dextromoramide tartrate and is used to treat severe, sudden or prolonged pain if treatment with opioids is needed. In the Netherlands there are no other licensed medicines with dextromoramide tartrate.