Lilly's Prozac should be approved for the treatment of children and adolescents with depression, according to the European Commission's Committee for Medicinal Products for Human Use.
The CHMP issued a positive opinion on Lilly's application to extend approval of Prozac (fluoxetine) to include children aged eight or over, although it said Lilly should carry out additional studies to keep an eye on the safety profile of the drug in these patients.
Lilly filed for approval to extend Prozac's indications to include children at the request of the UK as part of a move to identify drugs which may be safe for use in the paediatric medicine setting.
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