European CHMP recommends approval of Harvoni (ledipasvir and sofosbuvir) for the treatment of paediatric patients with chronic hepatitis C

Harvoni is currently licensed for the treatment of chronic hepatitis C in adults and in adolescents aged 12 to < 18 years. The CHMP has issued a positive opinion, recommending its additional approval for use in paediatric patients aged 3 and above.

SPS commentary:

The CHMP has additionally recommended the approval of use of sofosbuvir (Sovaldi) in this wider age range, when used in combination with other medicines for the treatment of chonic hepatitis C.


European Medicines Agency

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Sovaldi opinion