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The Committee for Medicinal Products for Human Use (CHMP) has recommended a new contraindication for the narcolepsy drug Xyrem.
CHMP suggests that Xyrem, which is approved in Europe to reduce daytime sleepiness and cataplexy, should not be given to patients with major depression.
The full contraindications for Xyrem recommended by the CHMP include patients with hypersensitivity to the active substance or to any of the excipients; patients with major depression; patients with succinic semialdehyde dehydrogenase deficiency and patients being treated with opioids or barbiturates.
Detailed conditions for its use will be described inthe updated summary of product characteristics (SmPC), which will bepublished in the revised European public assessment report (EPAR).
It will also be available in all official European Union languages after thevariation to the marketing authorisation has been granted by theEuropean Commission.