Balfumon 120 mg drug sale suspended in Poland

The Chief Pharmaceutical Inspectorate (GIF) has issued an immediate precautionary suspension of the sale of Balfumon 120 mg (dimethyl fumarate) in 14-capsule packs across Poland. The decision affects all batches of this specific packaging version.

The suspension follows quality control testing by the National Institute of Drugs, which revealed discrepancies in how the active substance is released from the enteric capsules. Laboratory tests simulating the small intestine environment showed that the active ingredient was released more slowly than the approved product specification requires. This parameter is critical for the drug's bioavailability and overall quality.

Balfumon is used to treat relapsing-remitting multiple sclerosis. The responsible entity for the product is the Austrian company G. L. Pharma GmbH. The GIF clarified that this is a precautionary measure rather than a final market withdrawal.