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Record Summary 123467 Eposoft
Sponsor Zifam Pinnacle Pty Ltd
Therapeutic Type Medicine
Product Category/ Class Listed
ARTG Start date 09/11/2005
Postal Address 21/ 38 Elizabeth Street,WETHERILL PARK, NSW,
2164
AustraliaBilling Address 21/ 38 Elizabeth Street, WETHERILL
PARK, NSW, 2164
Australia
Export alias names EPO 1000GLA 100Primera
Conditions
Colouring agents used in listed medicine for ingestion, other
than those listed for export only under section 25 of the
Therapeutic Goods Act 1989, shall beonly those included in the list
of 'Colourings permitted in medicines for oral use' available at ,
as amendedfrom time to time.
The sponsor shall keep records relating to this listed medicine
as are necessary to: (a) Expedite recall if necessary of any batch
of the listed medicine, (b)Identify the manufacturer(s) of each
batch of the listed medicine. Where any part of or step in
manufacture in Australia of the listed medicine issub-contracted to
a third party who is not the sponsor, copies of relevant Good
Manufacturing Practice agreements relation to such manufacture
shall bekept.
The sponsor shall retain records of the distribution of the
listed medicine for a period of five years and shall provide the
records or copies of the records tothe Head, Office of
Complementary Medicines, Therapeutic Goods Administration, upon the
head's request.
The sponsor of the listed medicine must not, by any means,
intentionally or recklessly advertise the medicine for an
indication other than those acceptedin relation to the inclusion of
the medicine in the Register.
All reports of adverse reactions or similar experiences
associated with the use or administration of the listed medicine
shall be notified to the Director,Adverse Drug Reactions Unit,
Therapeutic Goods Administration, as soon as practicable after the
sponsor of the goods becomes aware of those reports.Sponsors of
listed medicines must retain records of such reports for a period
of not less than 18 months from the day the Head, Office of
Medicines SafetyMonitoring is notified of the report or
reports.
The sponsor shall not supply the listed medicine after the
expiry date of the goods.
Where a listed medicine is distributed overseas as well as in
Australia, product recall or any other regulatory action taken in
relation to the medicineoutside Australia which has or may have
relevance to the quality, safety or efficacy of the goods
distributed in Australia, must be notified to the Head,Office of
Complementary Medicines, Therapeutic Goods Administration,
immediately the action or information is known to the sponsor.
Manufacturers
Name Certificate Id Address Steps
Catalent Australia Pty Ltd 217-221 Governor RoadBRAESIDE, VIC,
3195 Manufacture of dosage formTesting chemical and physicalTesting
microbial
Sphere Healthcare Pty Ltd 10-12 Church RoadMOOREBANK, NSW,
2170
Manufacture of dosage formPackaging and labellingRelease for
supplyTesting chemical and physicalTesting microbial
Vitex Pharmaceuticals Pty Ltd Units 1&2 11 Weld
StreetPRESTONS, NSW, 2170
Packaging and labellingRelease for supplySecondary packaging
Products
1.Eposoft
Product Type Single Medicine Product Status Current
Effective date 24/01/2008
Warnings
S If symptoms persist consult your healthcare practitioner (or
words to that effect).
VIT Vitamins can only be of assistance if the dietary vitamin
intake is inadequate. OR Vitamin supplements should not replace a
balanceddiet.
Standard Indications
Relief of pre-menstrual symptoms/syndrome. [Warning S
required]
Specific Indications
No Specific Indications included on Record
Specific Conditions
No Specific Conditions included on Record
Reco
rdSumm
ary
Page 1 of 2 Produced at 18.02.2009 at 09:03:01 EST
The details contained in this copy of the Record Summary reflect
the information held at the nominated date and time of printingThe
currency and accuracy of the details can be confirmed at
www.ebs.gov.au."
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Pack Size/Poison information
Pack Size Poison Schedule
Not recorded Not recorded
Components
1.Medicine Component
Dosage form Capsule, soft
Route of Administration Oral
Maximum daily dose 3
Maximum single dose 1
Weight of dividedpreparation
1.5g
Formulations
Active Ingredients Category Quantity Units
d-alpha-Tocopherol AAN 5.03 mg
Equivalent
d-alpha-Tocopherol 7.5 IU
Evening Primrose Oil AHS 1000 mg
Equivalent
gamma-Linolenic acid 100 mg
Excipient Ingredients Category Quantity Units
Gelatin ABN 328 mg
Glycerol AAN 145 mg
Water - purified AAN 41.1 mg
Reco
rdSumm
ary
Page 2 of 2 Produced at 18.02.2009 at 09:03:01 EST
The details contained in this copy of the Record Summary reflect
the information held at the nominated date and time of printingThe
currency and accuracy of the details can be confirmed at
www.ebs.gov.au."
