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Update to listed medicine ingredients in December 2020
Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2020
16 December 2020
Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2020, which commenced on 16 December 2020. This determination replaces the previous instrument, the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2020.
This instrument is updated frequently and there may be a more recent version of the instrument. Ensure you are accessing the current version of the instrument through the Therapeutic Goods Determination page.
A complete list of the 84 changed ingredients is below.
Changed ingredients
| Ingredient | Change type | Change reason |
|---|---|---|
|
(R)-ALPHA-TERPINYL ACETATE |
Addition |
Safety review |
|
2-(6-METHYL-8-ISOPROPYL BICYCLO(2.2.2)OCT-5-ENE-2-YL)-1,3-DIOXOLANE |
Addition |
Safety review |
|
2,2'-METHYLENEBIS(4-METHYL-6-TERT-BUTYLPHENOL) |
Addition |
Safety review |
|
2-ETHOXY-9-METHYLENE-2,6,6-TRIMETHYLBICYCLO[3.3.1]NONANE |
Addition |
Safety review |
|
2-METHYL-4-(2,2,3-TRIMETHYLCYCLOPENT-3-EN-1-YL)PENT-4-EN-1-OL |
Addition |
Safety review |
|
3-(1-BUTENYL)-PYRIDINE |
Addition |
Safety review |
|
3,4-DIMETHYL PHENYLACETALDEHYDE |
Addition |
Safety review |
|
3-METHYLPENTANOIC ACID |
Addition |
Safety review |
|
4-(1-ETHOXYVINYL)-3,3,5,5-TETRAMETHYLCYCLOHEXANONE |
Addition |
Safety review |
|
4-(4-HYDROXY-4-METHYLPENTYL)-3-CYCLOHEXENE CARBOXALDEHYDE |
Change |
Clarification of requirements |
|
5-ETHYL-2,3-DIMETHYLPYRAZINE |
Addition |
Safety review |
|
6-ETHYLIDENEOCTAHYDRO 5,8-METHANO-2H-1-BENZOPYRAN |
Addition |
Safety review |
|
6-METHYLQUINOLINE |
Addition |
Safety review |
|
ACHILLEA MILLEFOLIUM |
Change |
Clarification of requirements |
|
ALPHA-SANTALOL |
Addition |
Safety review |
|
ARCTOSTAPHYLOS UVA-URSI |
Change |
Clarification of requirements |
|
BENZOTHIAZOLE |
Addition |
Safety review |
|
BORAX |
Change |
Clarification of requirements |
|
BORAX PENTAHYDRATE |
Change |
Clarification of requirements |
|
BORIC ACID |
Change |
Clarification of requirements |
|
CAFFEINE |
Change |
Clarification of requirements |
|
CAMELLIA SINENSIS |
Change |
Clarification of requirements |
|
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER |
Change |
Removal of expired market exclusivity provision |
|
Change of name from ASTER NOVI-BELGII to SYMPHYOTRICHUM NOVI-BELGII |
Change |
Update to ingredient name |
|
Change of name from CALLISTEMON CITRINUS to MELALEUCA CITRINA |
Change |
Update to ingredient name |
|
Change of name from CUPRESSUS MACROCARPA to HESPEROCYPARIS MACROCARPA |
Change |
Update to ingredient name |
|
Change of name from EICHHORNIA CRASSIPES to PONTEDERIA CRASSIPES |
Change |
Update to ingredient name |
|
Change of name from MESPILUS GERMANICA to CRATAEGUS GERMANICA |
Change |
Update to ingredient name |
|
Change of name from PLATANUS X ACERIFOLIA to PLATANUS X HISPANICA |
Change |
Update to ingredient name |
|
Change of name from SORBUS DOMESTICA to CORMUS DOMESTICA |
Change |
Update to ingredient name |
|
Change of name from YUCCA WHIPPLEI to HESPEROYUCCA WHIPPLEI |
Change |
Update to ingredient name |
|
Change of name from ULMUS PROCERA to ULMUS MINOR |
Change |
Update to ingredient name |
|
CHIMAPHILA UMBELLATA |
Change |
Clarification of requirements |
|
CITRUS OIL TERPENES AND TERPENOIDS |
Addition |
Safety review |
|
COFFEA ARABICA |
Change |
Clarification of requirements |
|
COFFEA CANEPHORA |
Change |
Clarification of requirements |
|
COFFEE |
Change |
Clarification of requirements |
|
COLA ACUMINATA |
Change |
Clarification of requirements |
|
COLA NITIDA |
Change |
Clarification of requirements |
|
COUMARIN |
Change |
Clarification of requirements |
|
DECAHYDRO-1,1,7-TRIMETHYL-3A,7-METHANO-3AH-CYCLOPENTACYCLOOCT-3-YL FORMATE |
Addition |
Safety review |
|
DIETHYL HYDROGEN 2-HYDROXYPROPANE-1,2,3-TRICARBOXYLATE |
Addition |
Safety review |
|
DIMETHYL SULFATE |
Removal |
Safety review |
|
ETHYL PYRUVATE |
Addition |
Safety review |
|
FALLOPIA MULTIFLORA |
Removal |
Safety review |
|
GLYCEROL ESTER OF PARTIALLY HYDROGENATED WOOD ROSIN |
Addition |
Safety review |
|
ILEX PARAGUARIENSIS |
Change |
Clarification of requirements |
|
ISPAGHULA HUSK DRY |
Change |
Clarification of requirements |
|
ISPAGHULA HUSK POWDER |
Change |
Clarification of requirements |
|
KALMIA LATIFOLIA |
Change |
Clarification of requirements |
|
KHAYA SENEGALENSIS |
Change |
Removal of expired market exclusivity provision |
|
LEDUM PALUSTRE |
Change |
Clarification of requirements |
|
MALUS PUMILA |
Change |
Clarification of requirements |
|
MENTHADIENYL ACETATE |
Addition |
Safety review |
|
METHYLDIBROMO GLUTARONITRILE |
Removal |
Safety review |
|
MONOMENTHYL SUCCINATE |
Addition |
Safety review |
|
N,N'-BIS(SALICYLIDENE)PROPYLENEDIAMINE |
Addition |
Safety review |
|
OCTYL CROTONATE |
Addition |
Safety review |
|
ORIGANUM MAJORANA |
Change |
Clarification of requirements |
|
PARA-ETHYL CRESOXYACETATE |
Addition |
Safety review |
|
PAULLINIA CUPANA |
Change |
Clarification of requirements |
|
PLANTAGO AFRA |
Change |
Clarification of requirements |
|
PLANTAGO ARENARIA |
Change |
Clarification of requirements |
|
PLANTAGO ASIATICA |
Change |
Clarification of requirements |
|
PLANTAGO LANCEOLATA |
Change |
Clarification of requirements |
|
PLANTAGO MAJOR |
Change |
Clarification of requirements |
|
PLANTAGO OVATA |
Change |
Clarification of requirements |
|
PLANTAGO SEED DRY |
Change |
Clarification of requirements |
|
PSYLLIUM HUSK DRY |
Change |
Clarification of requirements |
|
PSYLLIUM HUSK POWDER |
Change |
Clarification of requirements |
|
PSYLLIUM SEED DRY |
Change |
Clarification of requirements |
|
PYRUS COMMUNIS |
Change |
Clarification of requirements |
|
PYRUS PYRIFOLIA |
Change |
Clarification of requirements |
|
RHODODENDRON FERRUGINEUM |
Change |
Clarification of requirements |
|
SODIUM PERBORATE |
Change |
Clarification of requirements |
|
SODIUM POLYACRYLATE STARCH |
Change |
Removal of expired market exclusivity provision |
|
TERPENE RESIN |
Addition |
Safety review |
|
THEOBROMA CACAO |
Change |
Clarification of requirements |
|
THYMOL METHYL ETHER |
Addition |
Safety review |
|
TRANS-2-OCTENAL |
Addition |
Safety review |
|
TURNERA DIFFUSA |
Change |
Clarification of requirements |
|
VACCINIUM VITIS-IDAEA |
Change |
Clarification of requirements |
|
VITEX AGNUS-CASTUS |
Change |
Clarification of requirements |
|
WITHANIA SOMNIFERA |
Change |
Clarification of requirements |