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Olanzapine Apotex (olanzapine) – Conditions or restrictions regarding supply and use - N05AH03

Updated on site: 08-Oct-2017

Medication nameOlanzapine Apotex
ATC CodeN05AH03
Substanceolanzapine
ManufacturerApotex Europe B.V.  

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Apotex Nederland B.V.

Archimedesweg 2

NL-2333 CN Leiden

Netherlands

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

D.CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

Not applicable.

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