New European review started for fluoxetine
European medicines regulators have started a new review of the use of fluoxetine (Prozac) in children and adolescents.
The review — an arbitration review by the European
Medicines Agency (EMEA) Committee for Medicinal Products for Human Use — follows
applications by Eli Lilly throughout the EU for the extension of Prozac’s
indications to include the treatment of major depressive episodes in
children and adolescents.
Prozac is licensed throughout the EU under its mutual recognition procedures
for national marketing authorisations. An EMEA spokeswoman said that
the company has applied to the national authorities for the licensed
indications to be changed on the basis of new clinical evidence. The
mutual recognition rules mean that all the national authorities are required
to come to the same conclusion.
The spokeswoman said that they had been unable to do so, and that the
French authorities had asked for the arbitration
review. She was unable to say how long the review might take. |
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