Olanzapine Glenmark Europe - olanzapine

What is Olanzapine Glenmark Europe?

Olanzapine Glenmark Europe is a medicine that contains the active substance olanzapine. It is available in round, circular orodispersible 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 medicine' 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 number of symptoms, including thought and speech disorders, hallucinations (seeing or hearing things that are not there), suspiciousness and delusions (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 also used to treat moderate to severe manic episodes (particularly high mood) in adults. The medicine can also be used to prevent these episodes from coming back (relapse) in adults with bipolar disorder (a mental disorder characterized by alternating euphoric and depressive phases) who have responded to the initial treatment.
The medicine can only be obtained with a prescription.

How is Olanzapine Glenmark Europe used?

The recommended starting dosage of Olanzapine Glenmark Europe varies according to the type of disorder treated: 10 mg per day for schizophrenia and the prevention of manic episodes, 15 mg per day for the treatment of manic episodes, unless used in combination. to other drugs, in which case the starting dose may be 10 mg per day. The dosage should be adjusted according to the patient's response and his degree of tolerance of the therapy. The usual dose can vary between 5 and 20 mg per day. The orodispersible tablets must be placed on the tongue, where they disperse in the saliva, or they can be dissolved in a little water before being taken. The starting dosage may need to be reduced to 5 mg per day in patients over 65 years of age 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 medicine. Known as an "atypical" antipsychotic, as it differs from 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 the nerve cells of the brain. This disrupts the signals transmitted between brain cells through “neurotransmitters”, ie the chemicals that allow nerve cells to communicate with each other. The beneficial effect of olanzapine is thought to be due to its ability to block the receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Since these neurotransmitters are implicated in schizophrenia and bipolar disorder, olanzapine contributes to normalization of " brain activity, reducing the symptoms of these diseases.

How has Olanzapine Glenmark Europe been studied?

As Olanzapine Glenmark Europe is a generic medicine, the studies were limited to providing evidence to show that the medicine is bioequivalent to the reference medicine, Zyprexa Velotab. Medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Olanzapine Glenmark Europe?

Since Olanzapine Glenmark Europe is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the medicine are assumed 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 under EU legislation, Olanzapine Glenmark Europe has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab. It is therefore the CHMP's view that, as in the case of Zyprexa and Zyprexa Velotab, the benefits outweigh the identified risks. The committee recommended the granting of a marketing authorization for Olanzapine Glenmark Europe.

Learn more about Olanzapine Glenmark Europe

On 3 December 2009, the European Commission granted Glenmark Generics (Europe) Limited a "Marketing Authorization" for Olanzapine Glenmark Europe, valid throughout the European Union. The "Marketing Authorization" is valid for five years. and after this period it can be renewed.
For the full version of the Olanzapine Glenmark Europe EPAR click here.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 10-2009


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