ZYPREXA Coated tablet Ref.[7011] 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 2.5 mg coated tablets.
ZYPREXA 5 mg coated tablets.
ZYPREXA 7.5 mg coated tablets.
ZYPREXA 10 mg coated tablets.
ZYPREXA 15 mg coated tablets.
ZYPREXA 20 mg coated tablets.

Pharmaceutical Form

Coated tablet.

ZYPREXA 2.5 mg coated tablets: Round, white, coated tablets imprinted with “LILLY” and a numeric identicode “4112”.

ZYPREXA 5 mg coated tablets: Round, white, coated tablets imprinted with “LILLY” and a numeric identicode “4115”.

ZYPREXA 7.5 mg coated tablets: Round, white, coated tablets imprinted with “LILLY” and a numeric identicode “4116”.

ZYPREXA 10 mg coated tablets: Round, white, coated tablets imprinted with “LILLY” and a numeric identicode “4117”.

ZYPREXA 15 mg coated tablets: Elliptical, blue, coated tablets debossed with “LILLY” and a numeric identicode “4415”.

ZYPREXA 20 mg coated tablets: Pink, elliptical, coated tablets debossed with “LILLY” and a numeric identicode, “4420”.

Qualitative and quantitative composition

ZYPREXA 2.5 mg coated tablets: Each coated tablet contains 2.5 mg olanzapine.

Excipient with known effect: Each coated tablet contains 102 mg lactose monohydrate.

ZYPREXA 5 mg coated tablets: Each coated tablet contains 5 mg olanzapine.

Excipient with known effect: Each coated tablet contains 156 mg lactose monohydrate.

ZYPREXA 7.5 mg coated tablets: Each coated tablet contains 7.5 mg olanzapine.

Excipient with known effect: Each coated tablet contains 234 mg lactose monohydrate.

ZYPREXA 10 mg coated tablets: Each coated tablet contains 10 mg olanzapine.

Excipient with known effect: Each coated tablet contains 312 mg lactose monohydrate.

ZYPREXA 15 mg coated tablets: Each coated tablet contains 15 mg olanzapine.

Excipient with known effect: Each coated tablet contains 178 mg lactose monohydrate.

ZYPREXA 20 mg coated tablets: Each coated tablet contains 20 mg olanzapine.

Excipient with known effect: Each coated tablet conatins 238 mg lactose monohydrate.

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

Tablet core:

Lactose monohydrate
Hyprolose
Crospovidone
Microcrystalline cellulose
Magnesium stearate

Tablet coat:

ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg coated tablets:

Hypromellose
Colour mixture white (hypromellose, titanium dioxide E171, macrogol, polysorbate 80)
Carnauba wax
Edible blue ink (shellac, ethanol anhydrous, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium hydroxide, indigo carmine E132)

ZYPREXA 15 mg coated tablets:

Hypromellose
Colour mixture light blue (titanium dioxide E171, lactose monohydrate, hypromellose, triacetin, indigo carmine colour (E132))
Carnauba wax

ZYPREXA 20 mg coated tablets:

Hypromellose
Colour mixture pink (titanium dioxide E171, macrogol, lactose monohydrate, hypromellose, synthetic red iron oxide)
Carnauba wax

Pack sizes and marketing

Cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.

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/1/96/022/002 – ZYPREXA 2.5 mg coated tablets – 28 tablets, per box.
EU/1/96/022/019 – ZYPREXA 2.5 mg coated tablets – 56 tablets, per box.
EU/1/96/022/023 – ZYPREXA 2.5 mg coated tablets – 35 tablets, per box.
EU/1/96/022/029 – ZYPREXA 2.5 mg coated tablets – 70 tablets, per box.
EU/1/96/022/035 – ZYPREXA 2.5 mg coated tablets – 98 tablets, per box.
EU/1/96/022/004 – ZYPREXA 5 mg coated tablets – 28 tablets, per box.
EU/1/96/022/020 – ZYPREXA 5 mg coated tablets – 56 tablets, per box.
EU/1/96/022/024 – ZYPREXA 5 mg coated tablets – 35 tablets, per box.
EU/1/96/022/030 – ZYPREXA 5 mg coated tablets – 70 tablets, per box.
EU/1/96/022/036 – ZYPREXA 5 mg coated tablets – 98 tablets, per box.
EU/1/96/022/011 – ZYPREXA 7.5 mg coated tablets – 28 tablets, per box.
EU/1/96/022/006 – ZYPREXA 7.5 mg coated tablets – 56 tablets, per box.
EU/1/96/022/025 – ZYPREXA 7.5 mg coated tablets – 35 tablets, per box.
EU/1/96/022/031 – ZYPREXA 7.5 mg coated tablets – 70 tablets, per box.
EU/1/96/022/037 – ZYPREXA 7.5 mg coated tablets – 98 tablets, per box.
EU/1/96/022/009 – ZYPREXA 10 mg coated tablets – 28 tablets, per box.
EU/1/96/022/010 – ZYPREXA 10 mg coated tablets – 56 tablets, per box.
EU/1/96/022/026 – ZYPREXA 10 mg coated tablets – 35 tablets, per box.
EU/1/96/022/032 – ZYPREXA 10 mg coated tablets – 70 tablets, per box.
EU/1/96/022/038 – ZYPREXA 10 mg coated tablets – 98 tablets, per box.
EU/1/96/022/012 – ZYPREXA 15 mg coated tablets – 28 tablets, per box.
EU/1/96/022/021 – ZYPREXA 15 mg coated tablets – 56 tablets, per box.
EU/1/96/022/027 – ZYPREXA 15 mg coated tablets – 35 tablets, per box.
EU/1/96/022/033 – ZYPREXA 15 mg coated tablets – 70 tablets, per box.
EU/1/96/022/039 – ZYPREXA 15 mg coated tablets – 98 tablets, per box.
EU/1/96/022/014 – ZYPREXA 20 mg coated tablets – 28 tablets, per box.
EU/1/96/022/022 – ZYPREXA 20 mg coated tablets – 56 tablets, per box.
EU/1/96/022/028 – ZYPREXA 20 mg coated tablets – 35 tablets, per box.
EU/1/96/022/034 – ZYPREXA 20 mg coated tablets – 70 tablets, per box.
EU/1/96/022/040 – ZYPREXA 20 mg coated tablets – 98 tablets, per box.

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, Croatia, 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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