Olanzapine is indicated for the treatment of schizophrenia and is said to be effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is also indicated for the treatment of moderate to severe manic episode.
The Committee for Medicinal Products for Human Use, on the basis of the data submitted, considers that there is a favourable benefit risk balance for Olanzapine Mylan, and therefore recommends the granting of the marketing authorization.
Olanzapine Mylan is a generic of Zyprexa, which has been authorized in the EU since September 27, 1996. Studies have demonstrated the satisfactory quality of Olanzapine Mylan, and its bioequivalence with Zyprexa.