Eposoft_listing.pdf 235653
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Record Summary
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 Australia
Billing Address
21/ 38 Elizabeth Street, WETHERILL PARK, NSW, 2164 Australia
Export alias names
EPO 1000 GLA 100 Primera
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 be only those included in the list of 'Colourings permitted in medicines for oral use' available at
, as amended from 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 is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept. 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 to the Head, Office of Complementary Medicines, Therapeutic Goods istration, upon the head's request. The sponsor of the listed medicine must not, by any means, intentionally or recklessly the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the .
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 medicine outside 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 istration, immediately the action or information is known to the sponsor. Manufacturers Name
Certificate Id
Catalent Australia Pty Ltd
Address
Steps
217-221 Governor Road BRAESIDE, VIC, 3195
Manufacture of dosage form Testing chemical and physical Testing microbial
Sphere Healthcare Pty Ltd
10-12 Church Road MOOREBANK, NSW, 2170
Manufacture of dosage form Packaging and labelling Release for supply Testing chemical and physical Testing microbial
Vitex Pharmaceuticals Pty Ltd
Units 1&2 11 Weld Street PRESTONS, NSW, 2170
Packaging and labelling Release for supply Secondary 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 balanced diet.
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 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 printing The currency and accuracy of the details can be confirmed at www.ebs.gov.au."
Record Summary
All reports of adverse reactions or similar experiences associated with the use or istration of the listed medicine shall be notified to the Director, Adverse Drug Reactions Unit, Therapeutic Goods istration, 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 Safety Monitoring is notified of the report or reports.
Pack Size/Poison information Pack Size
Poison Schedule
Not recorded
Not recorded
Components 1. Medicine Component Dosage form
Capsule, soft
Route of istration
Oral
Maximum daily dose
3
Maximum single dose
1
Weight of divided preparation
1.5 g
Formulations Active Ingredients
Category
Quantity
Units
d-alpha-Tocopherol
AAN
5.03
mg
7.5
IU
1000
mg
100
mg
Equivalent d-alpha-Tocopherol Evening Primrose Oil
AHS
Equivalent gamma-Linolenic acid
Category
Quantity
Units
Gelatin
ABN
328
mg
Glycerol
AAN
145
mg
Water - purified
AAN
41.1
mg
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 printing The currency and accuracy of the details can be confirmed at www.ebs.gov.au."
Record Summary
Excipient Ingredients
Record Summary
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 Australia
Billing Address
21/ 38 Elizabeth Street, WETHERILL PARK, NSW, 2164 Australia
Export alias names
EPO 1000 GLA 100 Primera
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 be only those included in the list of 'Colourings permitted in medicines for oral use' available at
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 medicine outside 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 istration, immediately the action or information is known to the sponsor. Manufacturers Name
Certificate Id
Catalent Australia Pty Ltd
Address
Steps
217-221 Governor Road BRAESIDE, VIC, 3195
Manufacture of dosage form Testing chemical and physical Testing microbial
Sphere Healthcare Pty Ltd
10-12 Church Road MOOREBANK, NSW, 2170
Manufacture of dosage form Packaging and labelling Release for supply Testing chemical and physical Testing microbial
Vitex Pharmaceuticals Pty Ltd
Units 1&2 11 Weld Street PRESTONS, NSW, 2170
Packaging and labelling Release for supply Secondary 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 balanced diet.
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 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 printing The currency and accuracy of the details can be confirmed at www.ebs.gov.au."
Record Summary
All reports of adverse reactions or similar experiences associated with the use or istration of the listed medicine shall be notified to the Director, Adverse Drug Reactions Unit, Therapeutic Goods istration, 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 Safety Monitoring is notified of the report or reports.
Pack Size/Poison information Pack Size
Poison Schedule
Not recorded
Not recorded
Components 1. Medicine Component Dosage form
Capsule, soft
Route of istration
Oral
Maximum daily dose
3
Maximum single dose
1
Weight of divided preparation
1.5 g
Formulations Active Ingredients
Category
Quantity
Units
d-alpha-Tocopherol
AAN
5.03
mg
7.5
IU
1000
mg
100
mg
Equivalent d-alpha-Tocopherol Evening Primrose Oil
AHS
Equivalent gamma-Linolenic acid
Category
Quantity
Units
Gelatin
ABN
328
mg
Glycerol
AAN
145
mg
Water - purified
AAN
41.1
mg
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 printing The currency and accuracy of the details can be confirmed at www.ebs.gov.au."
Record Summary
Excipient Ingredients
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