ZYPREXA Powder for solution for injection Ref.[7438] Active ingredients: Olanzapine

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Product name and form

ZYPREXA 10 mg powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection.

Yellow lyophilised powder.

Qualitative and quantitative composition

Each vial contains 10 mg olanzapine. After reconstitution each ml of the solution contains 5 mg olanzapine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Olanzapine

Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.

List of Excipients

Lactose monohydrate
Tartaric acid, E334
Hydrochloric acid
Sodium hydroxide

Pack sizes and marketing

Type I, 5 ml glass vial.

One carton contains 1 or 10 vial(s).

Not all pack sizes may be marketed.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Marketing authorization dates and numbers

EU/1/96/022/016 – ZYPREXA – Powder for solution for injection. 1 vial
EU/1/96/022/017 – ZYPREXA – Powder for solution for injection. 10 vials

Date of first authorisation: 27 September 1996
Date of latest renewal: 12 September 2006

Drugs

Drug Countries
ZYPREXA Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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