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Deactivation of superseded herbal ingredient names

7 June 2012

Background

In March 2012 the TGA wrote to sponsors seeking their authorisation (as a request under subsection 9D(1) of the Therapeutic Goods Act 1989) to correct the names of herbal ingredients used in formulations of their medicines.

Correction of herbal ingredient names and deactivation of superseded herbal ingredient names

The TGA has completed changes to the ARTG entries of medicines affected by the update to herbal ingredient names and deactivation of superseded herbal ingredient names was finalised on 30 May 2012. From now, any variation to a formulation containing a superseded ingredient name will fail to validate in the Electronic Listing Facility (ELF). Superseded names will be recorded in the ingredient code tables as synonyms of the updated names, and will no longer be able to be used in an ARTG listing nor should they be used on new medicine labels. Sponsors are reminded that they are required to update the labels of any medicines containing ingredients subject to name change at the next print run, or within two years of the superseded ingredient names being deactivated (i.e. 30 May 2014).

A full list of herbal ingredient names used in medicines on the ARTG requiring correction is below.

List of herbal ingredient names used in medicines on the ARTG requiring correction
Current name in ARTG (requiring correction) New authenticated name
Acacia arabica Acacia nilotica
Acanthopanax gracilistylus Eleutherococcus nodiflorus
Adenophora tetraphylla Adenophora triphylla
Adenophora verticillata Adenophora triphylla
Adhatoda vasica Justicia adhatoda
Agropyron repens Elymus repens
Albizia lebbek Albizia lebbeck
Aloe barbadensis Aloe vera
Alpinia katsumadai Alpinia hainanensis
Amorphophallus rivieri Amorphophallus konjac
Ananas sativus Ananas comosus
Anthemis nobilis Chamaemelum nobile
Aquilaria agallocha Aquilaria malaccensis
Arundo mauritianica Ampelodesmos mauritanicus
Asparagus lucidus Asparagus cochinchinensis
Barosma betulina Agathosma betulina
Belamcanda chinensis Iris domestica
Benincasia cerifera Benincasa hispida
Betonica officinalis Stachys officinalis
Bletia hyacinthina Bletilla striata
Buddleia officinalis Buddleja officinalis
Butyrospermum parkii Vitellaria paradoxa
Canarium indicum L. var. indicum Canarium indicum
Cassia angustifolia Senna alexandrina
Cassia senna Senna alexandrina
Cassia tora Senna tora
Celosia argentia Celosia argentea
Cephaelis ipecacuanha Carapichea ipecacuanha
Cereus grandiflorus Selenicereus grandiflorus
Cimicifuga foetida Actaea cimicifuga
Cimicifuga heracleifolia Actaea heracleifolia
Cimicifuga racemosa Actaea racemosa
Cimicifuga simplex Actaea simplex
Cinnamomum zeylanicum Cinnamomum verum
Clematis sinensis Clematis chinensis
Clerodendron trichotomum Clerodendrum trichotomum
Commiphora molmol Commiphora myrrha
Cyclamen europaeum Cyclamen purpurascens
Cynomorium songariorum Cynomorium songaricum
Cypripedium pubescens Cypripedium parviflorum var. pubescens
Dioscorea batatas Dioscorea polystachya
Dioscorea hypoglauca Dioscorea collettii var. hypoglauca
Dioscorea opposita Dioscorea oppositifolia
Elscholtzia splendens Elsholtzia splendens
Erigeron canadensis Conyza canadensis
Eschscholtzia californica Eschscholzia californica
Eucalyptus citriodora Corymbia citriodora
Evodia lepta Melicope pteleifolia
Evodia rutaecarpa Tetradium ruticarpum
Fraxinus rhynchophylla Fraxinus chinensis subsp. rhynchophylla
Gardenia florida Gardenia jasminoides
Gleditsia officinalis Gleditsia sinensis
Hedyotis diffusa Oldenlandia diffusa
Kochia scoparia Bassia scoparia
Krameria triandra Krameria lappacea
Lavandula intermedia Lavandula x intermedia
Lavandula spica Lavandula angustifolia subsp. angustifolia
Ledebouriella divaricata Saposhnikovia divaricata
Lippia citriodora Aloysia citrodora
Malpighia punicifolia Malpighia glabra
Malus x domestica Malus domestica
Marsdenia reichenbaachi Marsdenia cundurango
Matricaria recutita Matricaria chamomilla
Millettia reticulata Callerya reticulata
Moghania macrophylla Flemingia macrophylla
Murraya exotica Murraya paniculata
Myroxylon pereirae Myroxylon balsamum var. pereirae
Nelumbium speciosum Nelumbo nucifera
Nephelium longana Dimocarpus longan
Nuphar luteum Nuphar lutea
Oroxylon indicum Oroxylum indicum
Panax quinquefolium Panax quinquefolius
Patrinia scabiosaefolia Patrinia scabiosifolia
Persea gratissima Persea americana
Peucedanum decursivum Angelica decursiva
Phaseolus angularis Vigna angularis var. angularis
Phaseolus calcaratus Vigna umbellata
Phragmites communis Phragmites australis
Phytolacca decandra Phytolacca americana
Pinus tabulaeformis Pinus tabuliformis
Piper futokadsura Piper kadsura
Platycodon grandiflorum Platycodon grandiflorus
Polygonum chinense Persicaria chinensis
Polygonum cuspidatum Fallopia japonica
Polygonum multiflorum Fallopia multiflora
Prinsepia unifloria Prinsepia uniflora
Psoralea corylifolia Cullen corylifolium
Pueraria pseudohirsuta Pueraria montana var. lobata
Pulsatilla vulgaris Anemone pulsatilla
Rhamnus purshianus Frangula purshiana
Rosa centifolia Rosa x centifolia
Rosa damascena Rosa x damascena
Sargassum tortile Sargassum siliquastrum
Sarothamnus scoparius Cytisus scoparius
Schizandra chinensis Schisandra chinensis
Siler divaricatum Saposhnikovia divaricata
Siratia grosvenorii Siraitia grosvenorii
Smilax medica Smilax aristolochiifolia
Sophora angustifolia Sophora flavescens
Sophora japonica Styphnolobium japonicum
Sophora subprostrata Sophora tonkinensis
Sterculia platanifolia Firmiana simplex
Tabebuia avellanedae Handroanthus impetiginosus
Tabebuia heptophylla Handroanthus heptaphyllus
Tabebuia impetiginosa Handroanthus impetiginosus
Tanacetum cineriifolium Tanacetum cinerariifolium
Tetrapanax papyrifera Tetrapanax papyrifer
Vetiveria zizanioides Chrysopogon zizanioides
Zizyphus jujuba Ziziphus jujuba
Zizyphus spinosa Ziziphus jujuba var. spinosa