141243

Record Summary

MAX DURA

Sponsor

Contract Manufacturing & Packaging Services Pty Ltd

Therapeutic Type

Medicine

Product Category/ Class

Listed

ARTG Start date

28/06/2007

Postal Address

1/38 Elizabeth Street,WETHERILL PARK, NSW, 2164

Australia

Billing Address

1/38 Elizabeth Street, WETHERILL PARK, NSW, 2164

Australia

Export alias names

Zover
Revital
Duramax
VIGOR
MAXDURA
Max Dura Performance

Conditions
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 Office of Complementary Medicines, Therapeutic Goods Administration, upon request.
The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted
in relation to the inclusion of the medicine in the Register.

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 Administration, immediately the action or information is known to the sponsor.
The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph
Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27). This condition does not apply to powdered or
dried leaf.
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 <http://www.tga.gov.au/meds/colourings.htm>, as amended
from time to time.
Manufacturers
Name

Address

Contract Manufacturing &

Packaging Services Pty Ltd

Unit 1 & 2 38 Elizabeth Street Manufacture of dosage form

WETHERILL PARK, NSW,
Packaging and labelling
2164
Release for supply
Australia
Secondary packaging

Manufacturing steps

Testing chemical and physical

Testing microbial
Vitex Pharmaceuticals Pty Ltd Unit 1 12 Weld Street
PRESTONS, NSW, 2170
Australia

Packaging and labelling

Release for supply

Products

1.MAX DURA
Product Type

Single Medicine Product

Status

Current

Effective date

28/06/2007

Warnings
CAFF

Contains caffeine [state quantity per dosage unit or per mL or per gram of product] [must be clear and legible].

If symptoms persist consult your healthcare practitioner (or words to that effect).

Standard Indications
Aids, assists or helps in the maintenance of general well-being
Specific Indications
No Specific Indications included on Record
Page 1 of

Produced at 08.10.2010 at 02:20:55 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 administration of the listed medicine shall be notified to the Head, Office
of Medicine Safety Monitoring, 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 Safety
Monitoring is notified of the report or reports.

Specific Conditions
No Specific Conditions included on Record
Pack Size information
Pack Size

Not recorded

Poison information
Poison

Not recorded

Additional Product information

Components
1. Medicine component
Dosage form

Capsule, hard

Route of Administration

Oral

Maximum daily dose

Maximum single dose

Weight of divided
preparation

620 mg

Formulations
Active Ingredients

Category

Quantity

Units

Epimedium sagittatum

AHN

50

mg

Concentration ratio

20:1
Qty

Units

20

mg

Plant details (origin)

Part

Preparation

leaf

Extract dry concentrate

Equivalent
Epimedium sagittatum (Dry)

Extract ingredient name

Ratio

Type

Epimedium sagittatum

20:1

CONCENTRATION

Extract step solvent

Ginkgo biloba
Concentration ratio
Plant details (origin)

AHN

Name

Water - purified

40

Ethanol

60

mg

50:1
Part

Preparation

leaf

Extract dry concentrate

Equivalent
Ginkgo biloba (Dry)

250

mg

Extract ingredient name

Ratio

Type

Ginkgo biloba

50:1

CONCENTRATION

Extract step solvent

Panax ginseng
Concentration ratio
Plant details (origin)

AHN

Name

Water - purified

50

Ethanol

50

35

mg

3:1
Part

Preparation

root

Extract dry concentrate

Equivalent
Panax ginseng (Dry)

105

mg

Extract ingredient name

Ratio

Type

Panax ginseng

3:1

CONCENTRATION

Extract step solvent

Name

Water - purified

30

Ethanol

70

100

mg

Paullinia cupana
Concentration ratio
Page 2 of

AHN
4:1

Produced at 08.10.2010 at 02:20:55 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

Carrier
Silica - colloidal anhydrous

Carrier
Maltodextrin
Plant details (origin)

Qty

Units

20

mg

Part

Preparation

seed

Extract dry concentrate

Equivalent
Paullinia cupana (Dry)

400

mg

Caffeine

10

mg

Extract ingredient name

Ratio

Type

Paullinia cupana

4:1

CONCENTRATION

Extract step solvent

Tribulus terrestris
Concentration ratio
Plant details (origin)

AHN

Name

Water - purified

30

Ethanol

70

150

mg

50:1
Part

Preparation

root and rhizome and stolon

Extract dry concentrate

Equivalent
Tribulus terrestris (Dry)

7.5

Extract ingredient name

Ratio

Type

Tribulus terrestris

50:1

CONCENTRATION

Extract step solvent

Name

Water - purified

100

Category

Quantity

Units

Calcium hydrogen phosphate

AAN

80

mg

Cellulose - microcrystalline

AAN

50

mg

Gelatin

ABN

96.9

mg

Animal Details

Part

Preparation

Country of Origin

Bovine

Skin

Not listed

United States Of America

Magnesium stearate

AAN

15

mg

Silica - colloidal anhydrous

AAN

15

mg

Page 3 of

Produced at 08.10.2010 at 02:20:55 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