OZAPRAM Film-coated tablet Ref.[27867] Active ingredients: Olanzapine

Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Ozapram 5 mg film-coated tablets.

Ozapram 10 mg film-coated tablets.

Ozapram 20 mg film-coated tablets.

Pharmaceutical Form
Film-coated tablet. Ozapram 5 mg film-coated tablets : White to off white, round, film-coated tablets. Ozapram 10 mg film-coated tablets : White to off white, round, film-coated tablets. Ozapram 20 mg film-coated tablets: White to off white, oval, film-coated tablets.

Qualitative and quantitative composition

Ozapram 5 mg film-coated tablets:

Each film-coated tablet contains 5 mg olanzapine.

Ozapram 10 mg film-coated tablets:

Each film-coated tablet contains 10 mg olanzapine.

Ozapram 20 mg film-coated tablets:

Each film-coated tablet contains 20 mg olanzapine.

Excipient(s) with known effect

Ozapram 5 mg film-coated tablets: This product contains 108.347 mg lactose.

Ozapram 10 mg film-coated tablets: This product contains 216.694 mg lactose.

Ozapram 20 mg film-coated tablets: This product contains 433.388 mg lactose.

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
Core: Lactose monohydrate Hydroxy propyl cellulose Low substituted hydroxy propyl cellulose Microcrystalline cellulose Magnesium stearate Coating: Hypromellose Talc Titanium dioxide E171 Lactose monohydrate Polyethylene glycol 3000 Triacetin

Pack sizes and marketing

Aluminium/Aluminium blisters. Pack-sizes of 28 and 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Ozapram 5 mg film-coated tablets: 21833
Ozapram 10 mg film-coated tablets: 21835
Ozapram 20 mg film-coated tablets: 21837

Date of first authorisation: 19 July 2013
Date of latest renewal: 10 May 2019

Drugs

Drug	Countries
OZAPRAM	Cyprus, Malta

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