Dear Doctor Letter (Rote-Hand-Brief) on Vigil® (modafinil): Restricted indication and important safety information
2011.02.11
Active substance: modafinil
A safety review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has lead to a restriction of the indications of Vigil® (modafinil) to adults with excessive sleepiness associated with narcolepsy, with and without cataplexy.
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