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This appendix applies to Part 1, Section 1.3, Product table.
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 |