What is Olanzapine Glenmark Europe?
Olanzapine Glenmark Europe is a medicine containing the active substance olanzapine. It is available as round, orodispersible, round tablets (5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.
Olanzapine Glenmark Europe is a "generic medicine". This means that Olanzapine Glenmark Europe is similar to a "reference drug" already authorized in the European Union (EU) called Zyprexa Velotab.
What is Olanzapine Glenmark Europe used for?
Olanzapine Glenmark Europe is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental disorder characterized by a series of symptoms, including thought and speech disorders, hallucinations (seeing or hearing non-existent things), suspiciousness and fixations (false beliefs). Olanzapine Glenmark Europe is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.
Olanzapine Glenmark Europe is equally used for the treatment of manic episodes (particularly euphoric mood) from moderate to severe in adults. The medicine can also be used to prevent the recurrence of such episodes (relapse) in adults with bipolar disorder (a mental disorder characterized by the alternation of euphoric phases and depressive phases) that have responded to the initial treatment.
The medicine can only be obtained with a prescription.
How is Olanzapine Glenmark Europe used?
The recommended initial dosage of Olanzapine Glenmark Europe varies according to the type of disorder being treated: 10 mg a day for schizophrenia and the prevention of manic episodes, 15 mg a day for the treatment of manic episodes, unless used in combination to other drugs, in which case the starting dose may be 10 mg a day. The dosage should be adjusted according to the patient's response and the degree of tolerance of the therapy. The usual dose may vary between 5 and 20 mg a day. The orodispersible tablets must be placed on the tongue, where they are dispersed in the saliva, or they can be dissolved in a little water before being taken. The initial dosage may need to be reduced to 5 mg per day in patients over 65 and in patients with liver or kidney problems.
How does Olanzapine Glenmark Europe work?
The active substance in Olanzapine Glenmark Europe, olanzapine is an antipsychotic drug. Known as an "atypical" antipsychotic, as it differs from the traditional antipsychotic drugs available since the 1950s. Although the exact mechanism of action of olanzipine is not known, it attaches itself to various receptors present on the surface of nerve cells in the brain. In this way the signals transmitted between the brain cells are disturbed through the "neurotransmitters", ie the chemicals that allow nerve cells to communicate with each other. It is believed that the beneficial effect of olanzapine is due to its ability to block receptors for neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Because these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine contributes to the normalization of brain activity, reducing the symptoms of these diseases.
How has Olanzapine Glenmark Europe been studied?
Because Olanzapine Glenmark Europe is a generic medicine, the studies have been limited to providing evidence to show that the drug is bioequivalent to the reference medicine, Zyprexa Velotab. Medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Olanzapine Glenmark Europe?
Because Olanzapine Glenmark Europe is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the drug are supposed to be the same.
Why has Olanzapine Glenmark Europe been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements laid down under Community legislation, Olanzapine Glenmark Europe has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab. It is therefore the opinion of the CHMP that, as in the case of Zyprexa and Zyprexa Velotab, the benefits outweigh the risks identified. The Committee recommended the granting of a marketing authorization for Olanzapine Glenmark Europe.
More information on Olanzapine Glenmark Europe
On 3 December 2009, the European Commission granted a marketing authorization valid throughout the European Union to Glenmark Generics (Europe) Limited for Olanzapine Glenmark Europe. The marketing authorization is valid for five years and can be renewed after this period.
The full EPAR for Olanzapine Glenmark Europe can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 10-2009
