This appendix applies to Part 1, Section 1.3, Product table.
On this page: Variations | Multiple products | Multi-ingredient products | Multi-component products
Variations
Where applicants are seeking a variation to an existing registration, an AUST R number must be included.
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
123456 | Amoxycillin (as trihydrate) | Cillin-X | 250 mg | capsule | blister pack |
123457 | Amoxycillin (as trihydrate) | Cillin-X | 500 mg | capsule | blister pack |
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Amoxycillin (as trihydrate) | Cillin-X | 250 mg and 500 mg | capsule | blister packs |
Where an application seeks variations to existing registrations and new registrations, the AUST R number must be included for the existing registrations. An empty AUST R field indicates a new registration.
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
123456 | Amoxycillin (as trihydrate) | Cillin-X | 250 mg | capsule | blister pack |
Amoxycillin (as trihydrate) | Cillin-X | 1 mg | powder for injection | vial |
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Amoxycillin (as trihydrate) | Cillin-X | 250 mg | capsule | blister pack | |
Amoxycillin (as trihydrate) | Cillin-X | 1 mg | powder for injection | vial |
Multiple products
For new registrations, some products may be combined into a single line where all details but one are common.
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Amoxycillin (as trihydrate) | [tradename A] | 250 mg | capsule | blister packs and bottles | |
Amoxycillin (as trihydrate) | [tradename B] | 500 mg | capsule | blister pack | |
Amoxycillin (as trihydrate) | [tradename C] | 500 mg | capsule | blister pack |
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Amoxycillin (as trihydrate) | [tradename A]/ [tradename B]/ [tradename C] |
250 mg/ 500 mg |
capsule | blister packs and bottles |
Multi-ingredient products
Where there are multiple active ingredients, the active ingredient amounts must be recorded in the same order in which they are listed in the table.
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Amoxycillin (as trihydrate)/ Clavulanic Acid |
[tradename A] | 250 mg/ 125 mg |
capsule | blister packs and bottles | |
Amoxycillin (as trihydrate)/ Clavulanic Acid |
[tradename B] | 500 mg/ 125mg |
capsule | blister pack |
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Amoxycillin (as trihydrate)/ Clavulanic Acid |
[tradename A] | 125 mg/ 250 mg |
capsule | blister packs and bottles | |
Amoxycillin (as trihydrate)/ Clavulanic Acid |
[tradename B] | 500 mg/ 125 mg |
capsule | blister pack |
Multi-component products
Multi-component products can be recorded in a number of ways. Each method requires that the components are clearly identified in the table.
For example, a mixture of single and multiple component products containing the same active ingredients can be recorded as follows:
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Somatropin | [tradename] | 10mg | powder for injection | vial | |
Somatropin | [tradename] |
1-10 mg 2-2 mL |
1 - powder for injection 2 - diluent |
1 - vial 2 - syringe |
|
Somatropin | [tradename] |
1 - 20 mg 2 - 4 mL |
1 - powder for injection 2 - diluent |
1 - vial 2 - ampoule |
For a multi-active, multi-component product, details can be recorded as follows:
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Ethinyloestradiol/ levonorgestrel |
[tradename] - component 1 |
0.03 mg/0.125 mg | tablet | blister pack | |
Ethinyloestradiol/ levonorgestrel |
[tradename] - component 2 |
0.03 mg/0.05 mg | tablet | blister pack | |
Ethinyloestradiol/ levonorgestrel |
[tradename] - component 3 |
0.04 mg/0.075 mg | tablet | blister pack | |
placebo | [tradename] - component 4 |
N/A | tablet | blister pack |
Or, where there is more than one product proposed:
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Ethinyloestradiol/ levonorgestrel |
[tradename] (28 day) |
1 - 0.03 mg/0.125 mg 2 - 0.03 mg/0.05 mg 3 - 0.04 mg/0.075 mg 4 – 0/0 (placebo) |
1 - tablet 2 - tablet 3 - tablet 4 - tablet |
blister pack | |
Ethinyloestradiol/ levonorgestrel |
[tradename] (21 day) |
1 - 0.03 mg/0.125 mg 2 - 0.03 mg/0.05 mg 3 - 0.04 mg/0.075 mg |
1 - tablet 2 - tablet 3 - tablet |
blister pack |
For a multi-component product with different actives in different components:
AUST R | Active | Trade name | Strength | Dosage form | Pack |
---|---|---|---|---|---|
Risedronate sodium/ calcium carbonate |
[tradename] |
1 – 35 mg risedronate sodium 2 – 2500 mg calcium carbonate |
1 - tablet 2 - tablet |
blister pack |