Summary for ARTG Entry:
Eszopiclone 2 mg Tablet Bottle
ARTG entry for
Medicine Listed (Export Only)
Alphapharm Pty Ltd
PO Box R1462,ROYAL EXCHANGE, NSW, 1225
ARTG Start Date
Export only Medicines
Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods
on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to
substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription
Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No. 8 and condition No. 9.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No.11
The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)
each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each
overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.
This product must not be supplied for sale in Australia, including supply via duty free outlets.
1. Eszopiclone 2 mg Tablet Bottle
Single Medicine Product
No Warnings included on Record
No Specific Indications included on Record
Additional Product information
Pack Size/Poison information
Tablet, film coated
Route of Administration
6.5 mm, normal convex, buff film coated tablet debossed "EZ" over "2" on
one side and "M" on the other.
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Produced at 26.11.2017 at 03:46:09 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
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