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<p>Substances that may be used in Listed medicines in Australia</p> <p>December 2007</p> <p>Therapeutic Goods Administration</p> <p>About the Therapeutic Goods Administration (TGA)</p> <p> The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. The TGA investigates reports received by it to determine any necessary regulatory action. To report a problem with a medicine or medical device, please see the information on the TGA website.</p> <p> The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.</p> <p> The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.</p> <p> The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.</p> <p>Copyright Commonwealth of Australia 2011</p> <p>This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney Generals Department, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Page 2 of 305</p> <p>Therapeutic Goods Administration</p> <p>Substances that may be used in Listed medicines in Australia</p> <p>The following substances are eligible for use in medicines Listed on the Australian Register of Therapeutic Goods for supply in Australia. The list includes the approved role of the substance (ie. active, excipient, and/or component), and any restrictions and conditions that apply to the substance when used in Listed medicines.</p> <p>Please note substances marked as components (C) are not approved as substances for use in their own right and can only be used in conjunction with an approved source. For example, iodine is not approved as a substance in its own right but is permitted when expressed as a component of Fucus vesiculosus (Kelp), which is known to naturally contain iodine.</p> <p>A glossary of abbreviations is provided at the end of the document. For further information on Coded Warnings, refer to the following web page: https://www.ebs.tga.gov.au.</p> <p>Please note this list does not include substances that may be used as homoeopathic preparations. The Office of Complementary Medicines is currently conducting a review of homoeopathic substance permitted in Listed medicines, and this document will be updated upon completion of the review.</p> <p>Some substances are permitted as food excipients only. These substances (e.g. apple, pear) refer only to edible substances fit for human consumption as a food. Only certain preparations are permitted for most food excipients: fresh dry or powdered plant material and fresh, dried or concentrated juices. Juice preparations may only be named where the fresh plant part has a high water content. For further details, refer to the Introduction to the Herbal Substances AAN list in the TGA Approved Terminology for Medicines: http://www.tga.gov.au/industry/medicines-approved-terminology.htm.</p> <p>For further information on conditions related to provisional ingredients (PRVs), refer to the Australian Regulatory Guidelines for OTC Medicines: http://www.tga.gov.au/industry/otc-argom.htm.</p> <p>This list was updated on 12 December 2007 and is subject to change from time to time as new substances are approved for use in Listed medicines. Importantly, as a result of a safety concern, substances may be subject to new restrictions or may be removed from the list.</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Page 3 of 305</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>1-Dodecanol</p> <p>Use E E C E E E E E C C</p> <p>Restrictions</p> <p>1-Methylheptyl isostearate 1,1,1-Trichloroethane 1,2-Hexanediol 1,3-Butylene glycol 2-Ethoxyethanol</p> <p>10-Hydroxy-2-decenoic acid</p> <p>Approved for topical use only.</p> <p>PRV may only be used as an excipient in topical preparations.</p> <p>Product must contain 25% or less of designated solvents as defined in Part 1 of the SUSMP. Approved for topical use only. Concentration must not exceed 1%. Approved for topical use only.</p> <p>2-Amino-2-methyl-1-propanol</p> <p>(2S,3R,4S)-4-Hydroxyisoleucine (of Trigonella foenum-graecum) 4-Hydroxyisoleucine (of Trigonella foenum-graecum) 4-Methylbenzylidene camphor Abelmoschus moschatus Abies balsamea Abies nigra Abies pectinata</p> <p>Concentration must not exceed 0.016%. Residual solvent limit is 1.6 mg per MDD.</p> <p>A</p> <p>A, E A, E A, E A, E</p> <p>Sunscreen active permitted only in topical products. Concentration must not exceed 4%. Native species if exporting this product please contact the DSEWPC.</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Page 4 of 305</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>Abies sibirica</p> <p>Use A, E A A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E C</p> <p>Restrictions If the plant part is seed, the MRDD must contain 1 mg or less of the equivalent dry seed. If any other plant part, it is listable without restriction. May be a native species if exporting this product please contact the DSEWPC.</p> <p>Abrus cantoniensis Absidia ramosa Acacia Abutilon avicennae Acacia arabica</p> <p>Acacia baileyana Acacia catechu Acacia dealbata Acacia senegal</p> <p>Acacia longifolia Acalypha indica</p> <p>Native species if exporting this product (excluding oil) please contact the DSEWPC. Native species if exporting this product please contact the DSEWPC.</p> <p>Acanthopanax gracilistylus Acanthus mollis</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Acemannan (of Aloe barbadensis)</p> <p>Page 5 of 305</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>Acer campestre Acer negundo</p> <p>Use A, E A, E A, E A, E E E E E E E E E E A, E</p> <p>Restrictions</p> <p>Acer saccharinum Acer saccharum Acerola</p> <p>Acesulfame potassium Acetanisole Acetic acid</p> <p>Only Malpighia punicifolia fruit flesh is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Approved for topical use only.</p> <p>Acetic acid glacial Acetone</p> <p>Concentration must not exceed 0.5%. Concentration of acetic acid from all ingredients must not exceed 80%. Residual solvent limit is 50 mg per MDD. Concentration must not exceed 0.5%. Concentration of acetic acid from all ingredients must not exceed 80%. Residual solvent limit is 50 mg per MDD. Concentration should not exceed 0.5%. Residual solvent limit is 50 mg per MDD. Product must contain 25% or less of designated solvents as defined in Part 1 of the SUSMP. Approved for topical use only. Concentration must not exceed 0.01%. Approved for topical use only. Concentration must not exceed 0.5%. PRV may only be used as an excipient in topical preparations. When used as an active in oral or sublingual products, the label must include the statement VIT.</p> <p>Acetomenaphthone Acetyl dipeptide-1 cetyl ester Acetyl glucosamine Acetyl hexapeptide-3</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Page 6 of 305</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>Acetyl trifluoromethylphenyl valylglycine Acetylated lanolin Acetylated lanolin alcohol Acetylcysteine</p> <p>Use E E E E E</p> <p>Restrictions</p> <p>Approved for topical use only. Concentration must not exceed 0.5%. Approved for topical use only. Approved for topical use only.</p> <p>Acetylated monoglycerides</p> <p>Acetyllevocarnitine hydrochloride Achillea millefolium Achillea moschata Achillea ptarmica</p> <p>A, E A, E A, E A, E A, E A, E A, E E E</p> <p>Approved for topical use only. Concentration must not exceed 0.001%.</p> <p>Achyranthes aspera Achyranthes fauriei Acid green 25 Acid red 33</p> <p>Achyranthes bidentata</p> <p>May be a native species if exporting this product please contact the DSEWPC.</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Aconitum carmichaelii</p> <p>A</p> <p>Colour permitted only in topical preparations.</p> <p>Colour permitted only in topical preparations.</p> <p>Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%.</p> <p>Page 7 of 305</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>Aconitum ferox</p> <p>Use A A A C</p> <p>Restrictions</p> <p>Aconitum kusnezoffi Aconitum napellus Acrylamide</p> <p>Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%.</p> <p>Acrothecium arenarium Acrylamides copolymer Acrylates copolymer</p> <p>A, E E E E E E E E E</p> <p>Acrylamide/sodium acryloyldimethyltaurate copolymer Acrylates/acrylamide copolymer Acrylates/c10-30 alkyl acrylate crosspolymer Acrylates/dimethicone acrylate/ethylhexyl acrylate copolymer</p> <p>Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.</p> <p>Approved for topical use only. Concentration must not exceed 1.7%.</p> <p>Acrylates/C12-22 alkyl methacrylate copolymer Acrylates/dimethicone copolymer</p> <p>Approved for topical use only. Concentration must not exceed 5%. PRV may only be used as an excipient in topical preparations.</p> <p>Approved for topical use only. Concentration must not exceed 0.3%.Page 8 of 305</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>Acrylates/octylacrylamide copolymer Acrylates/steareth-20 methacrylate copolymer Actaea pachypoda Actaea spicata</p> <p>Use E E</p> <p>Restrictions</p> <p>Approved for topical use only.</p> <p>Actinidia chinensis</p> <p>A, E A, E A, E A A A A A A A A A</p> <p>Approved for topical use only. Concentration must not exceed 0.1%.</p> <p>Ademetionine disulfate ditosylate dihydrate Ademetionine disulfate tosylate</p> <p>(S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry).</p> <p>Ademetionine disulfate tritosylate dihydrate</p> <p>Ademetionine hexasulfate dihydrate</p> <p>Ademetionine hexatosylate dihydrate Ademetionine pentasulfate dihydrate Ademetionine tetrasulfate dihydrate</p> <p>Ademetionine pentatosylate dihydrate Ademetionine tetratosylate dihydrate</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Page 9 of 305</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>Ademetionine trisulfate ditosylate dihydrate Adenophora stricta Adenophora tetraphylla Adenophora verticillata Adenosine phosphate</p> <p>Use A</p> <p>Restrictions</p> <p>A, E A, E A, E E E E</p> <p>(S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry).</p> <p>Adenosine triphosphate Adhatoda vasica Adipic acid</p> <p>Adenosine triphosphate disodium Adiantum capillus veneris</p> <p>Approved for topical use only. Concentration must not exceed 0.1%. Approved as an excipient for topical use only. Approved for topical use only.</p> <p>A, E A, E E E E</p> <p>Adipic acid/diethylene glycol/glycerin crosspolymer Adonis vernalis Adzuki bean</p> <p>Native species if exporting this product please contact the DSEWPC. Approved for topical use only. Concentration must not exceed 5%.</p> <p>A A, E</p> <p>Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Only Phaseolus angularis seed (bean) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.</p> <p>Aegopodium podagraria</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Page 10 of 305</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>Aesculus chinensis Aesculus glabra</p> <p>Use A, E A, E A, E A, E A, E A, E A, E A, E C A, E A, E A, E A, E A, E A, E A, E</p> <p>Restrictions</p> <p>Aesculus hippocastanum Aesculus x carnea Agar Aethusa cynapium Agastache rugosa Agave americana Agnuside</p> <p>Agrimonia eupatoria Agrimonia repens Agrostis tenuis Agropyron repens</p> <p>Ailanthus altissima Ajuga chamaepitys Ajuga reptans</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Page 11 of 305</p> <p>Therapeutic Goods Administration</p> <p>Ingredient Alanine</p> <p>Ajuga turkestanica whole plant extract Alantolactone</p> <p>Use E C A, E A, E A, E A, E E A, E A, E A, E C C</p> <p>Restrictions</p> <p>Approved for topical use only. Concentration must not exceed 0.08%.</p> <p>Alaria esculenta Albizia lebbek Albumen</p> <p>Albizia julibrissin</p> <p>Iodine is a mandatory component of this ingredient (see separate entry).</p> <p>Alchemilla alpina</p> <p>Alchemilla arvensis Alchemilla vulgaris</p> <p>Requires pre-clearance from TGAL.</p> <p>Aldehydes calculated as cinnamaldehyde Aletris farinosa Aletris spicata Alginic acid</p> <p>Aldehydes calculated as citral</p> <p>A, E A, E EPage 12 of 305</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>Alisma orientale</p> <p>Use A, E A, E E C C C C C C C</p> <p>Restrictions</p> <p>Alisma plantago aquatica Alizarin cyanine green F</p> <p>Alkaloids calculated as berberine Alkaloids calculated as emetine</p> <p>Colour permitted only in topical preparations.</p> <p>Alkaloids calculated as hydrastine Alkaloids calculated as protopine Alkaloids calculated as quinine Alkanna officinalis Allantoin Allicin Alliin</p> <p>Alkaloids calculated as hyoscyamine</p> <p>Concentration must not exceed 300 micrograms/Kg or 300 micrograms/L or 0.00003%.</p> <p>Alkylamides (of Echinacea angustifolia and E. purpurea) Alliaria petiolata</p> <p>A, E E C C Approved for topical use only.</p> <p>A, E</p> <p>Substances that may be used in Listed medicines in Australia December 2007</p> <p>Page 13 of 305</p> <p>Therapeutic Goods Administration</p> <p>Ingredient</p> <p>Allium ascalonicum Allium cepa Allium fistulosum Allium odorum Allium porrum</p> <p>Use A, E A, E A, E A, E A, E A, E A, E A, E A, E E E C E</p> <p>Restrictions</p> <p>Allium macrostemon</p> <p>Allium sativum</p> <p>Allium schoenoprasum Allium ursinum Allura...</p>