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Medicinal cannabis products by active ingredients
16 May 2022
Unapproved medicinal cannabis products by category of active ingredients during the period 1 July to 31 December 2021
The following lists provide the details of unapproved medicinal cannabis products supplied in Australia via the Special Access Scheme and Authorised Prescriber scheme during the period 1 July to 31 December 2021. The lists are based on mandatory sponsor six monthly reporting data submitted to the TGA.
These lists are designed to assist prescribers and pharmacists in prescribing and supplying medicinal cannabis products under the active ingredient categories. These lists should be used where TGA approval has been obtained and the prescriber requires assistance in choosing a product from the correct category, or the pharmacist wishes to ensure that the product on the prescription matches the category in the TGA approval letter. Inclusion in these lists does not guarantee the product is available.
Category of medicinal cannabis product
Categories of medicinal cannabis product have been determined based on proportion of cannabidiol content compared with the total cannabinoid content of the medicine. The graphic below illustrates the proportion of cannabidiol by category.
The category determination of products must be made in accordance with the stated content of active ingredients specified on the product label.
Product information has been self-declared by sponsors and the TGA cannot guarantee and assumes no legal liability or responsibility for the accuracy, currency, completeness or interpretation of the information. It is an offence to provide false or misleading information to a Government agency. The TGA will be conducting routine compliance assessments as part of ongoing compliance audits.
Category 1: CBD medicinal cannabis product (CBD ≥ 98%)
Products included in Category 1:
- are Schedule 4 Prescription Only medicines as per the Poisons Standard; and
- cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and
- any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and
- the medicine contains no other active ingredients
| Dosage form | Active ingredient(s) | Product trade name | Sponsor name |
|---|---|---|---|
|
Capsule |
CBD 15mg per Softgel |
Ananda Hemp 900mg THC free Broad Spectrum Softgels - 60ct |
Ecofibre Limited |
|
Capsule |
CBD 33.33mg/cap |
CDA CBD 33 Capsules |
Burleigh Heads Cannabis |
|
Capsule |
CBD 200mg |
Trigal Pharma GmbH CBD |
Orygen |
|
Capsule |
CBD 25mg, THC <1mg THC |
Cannatrek C25 CBD 60 Biocaps |
Cannatrek Medical Pty Ltd |
|
Inhalation |
CBD 990mg/g |
CDA CBD 99 – Crystal |
Burleigh Heads Cannabis |
|
Oral liquid |
CBD 100mg/mL, THC <1.0mg/mL |
Levin CBD+ |
Levin Health Limited |
|
Oral liquid |
CBD 20mg/mL |
Ananda Hemp 1000mg THC free Broad Spectrum Hemp Extract |
Ecofibre Limited |
|
Oral liquid |
CBD 82.5mg/mL Full Spectrum |
Grandiosa |
Grandiosa Imports |
|
Oral liquid |
CBD 40mg/mL Full Spectrum |
Grandiosa |
Grandiosa Imports |
|
Oral liquid |
CBD 250mg/mL Full Spectrum |
Grandiosa |
Grandiosa Imports |
|
Oral liquid |
CBD 240mg/mL |
CDA CBD 240 Oil |
Burleigh Heads Cannabis |
|
Oral liquid |
CBD 30mg/mL |
CDA CBD 30 Oil |
Burleigh Heads Cannabis |
|
Oral liquid |
CBD 100mg/mL |
Sunco Green CBD |
Sunco Green Pharmaceutical Pty Ltd |
|
Oral liquid |
CBD 50mg/mL, THC <1 mg/mL |
Sunco Green Flavus Plus Oil 1:50 |
Sunco Green Pharmaceutical Pty Ltd |
|
Oral liquid |
CBD 100mg/mL, THC ≤1.0mg/mL |
Provocatus CBD 100 |
Cann Group Limited |
|
Oral liquid |
CBD 33mg/mL |
Isospec RX 1000 |
Gamma Biomedical |
|
Oral liquid |
CBD 100mg/mL |
Isospec RX 3000 |
Gamma Biomedical |
|
Oral liquid |
CBD 16.67mg/mL |
NanoCBD |
Medlab Clinical Ltd |
|
Oral liquid |
CBD 100mg/mL |
Pharmadiol CBD 100 |
Cannvalate Pty Ltd |
|
Oral liquid |
CBD 100mg/mL |
Greenlab CBD 100 |
Cannvalate Pty Ltd |
|
Oral liquid |
CBD 100 mg/mL |
MEDIGROWTH CBD 100 |
MEDIGROWTH AUSTRALIA |
|
Oral liquid |
CBD 100mg/mL 50mL |
Spectrum White 100 Oil |
Anspec Pty Ltd |
|
Oral liquid |
CBD 100mg/mL |
Entoura CBD 10 Oil |
Entoura Pty Ltd |
|
Oral liquid |
CBD 200mg/mL |
Entoura CBD 20 Oil |
Entoura Pty Ltd |
|
Oral liquid |
CBD 50mg/mL, THC ≤1mg/mL |
Lumir CBD 50 Cannabis Oil |
Cannim Australia Pty Ltd |
|
Oral liquid |
CBD 100mg/mL |
MGC Pharma MP 100 |
MGC Research (AUS) Pty Ltd |
|
Oral liquid |
CBD 50mg/mL |
HAPA CBD 50 |
Health House International |
|
Oral liquid |
CBD 100mg/mL |
Dragonfly 1000mg |
Health House International |
|
Oral liquid |
CBD 100mg/mL |
Draginfly 3000mg |
Health House International |
|
Oral liquid |
CBD 100mg/mL |
Adaya CBD 100 Medicinal Cannabis Oil (MCT) |
CRONOS AUSTRALIA - Operations Pty Ltd |
|
Oral liquid |
CBD 100mg/mL |
MEDCAN FX05 Oil |
MEDCAN Australia |
|
Oral liquid |
CBD 25mg/mL (26.6mg/g), THC <0.1mg/mL (<0.1mg/g) |
Tilray Purified Oral Solution CBD25 |
Tilray Australia and New Zealand |
|
Oral liquid |
CBD 100mg/mL (106.4mg/g), THC <0.1mg/mL (<0.1mg/g) |
Tilray Purified Oral Solution CBD100 |
Tilray Australia and New Zealand |
|
Oral liquid |
CBD 10% |
MediCabilis CBD 100 |
Bod Australia |
|
Oral liquid |
CBD 100mg/mL |
Sativite CBD Oil 30mL |
SatiVite Pty Ltd |
|
Oral liquid |
CBD 100mg/mL, THC <1mg/mL |
Althea CBD100 |
Althea Company Pty Ltd |
|
Oral liquid |
CBD isolate 99%+ Pure |
MOCA CBD Isolate 99%+ CBD |
Medicinal Organic Cannabis Australia (MOCA) Pty Ltd |
|
Oral liquid |
CBD 100mg/mL, THC 0mg/mL |
Australian Elan |
ABC CAN PTY LTD |
|
Oral liquid |
CBD 100mg/mL, THC 1mg/mL |
LGP Classic 1:100 |
Little Green Pharma Ltd |
|
Oral liquid |
CBD 50mg/mL |
LGP Classic CBD 50 |
Little Green Pharma Ltd |
| Oral liquid | CBD 100 mg/mL | IndiMed Aztecs CBD 100 | MedReleaf Australia |
| Oral liquid | CBD 150mg/mL | Phytoca CBD150 | PHYTOCA PTY LTD |
| Oral liquid | CBD 100mg/mL | Extracts | PHYTOCA PTY LTD |
|
Solution, powder |
CBD 98‐100%, THC‐Free |
CBD Isolate 100g |
Cannatrek Medical Pty Ltd |
|
Tablet, chewable |
CBD 15mg/Tablet |
Entoura EMC CBD15 Chew |
Entoura Pty Ltd |
|
Tablet, chewable |
CBD 15mg/Tablet |
Entoura CBD15 Chew |
Entoura Pty Ltd |
|
Topical |
CBD 30mg/mL |
Isospec Lotion |
Gamma Biomedical |
|
Topical |
CBD 33mg/mL |
Isospec Salve |
Gamma Biomedical |
|
Wafer |
CBD 12.5mg, THC 0.0mg/wafer |
Xativa 12.5 |
iX Biopharma Pty ltd |
|
Wafer |
CBD 25mg/wafer |
Xativa 25 |
iX Biopharma Pty ltd |
| Wafer |
CBD 12.5mg |
Xativa CBD 60 wafers |
Cannatrek Medical Pty Ltd |
|
Wafer |
CBD 25mg |
25mg Xativa Wafer (60's) |
Cannatrek Medical Pty Ltd |
* In publishing this list, the TGA has applied the principles of the Therapeutic Goods Advertising Code (No.2) 2018. For more information please refer to specific guidance published about the Code and naming therapeutic goods https://www.tga.gov.au/advertising-code-and-naming-therapeutic-goods.
Category 2: CBD dominant medicinal cannabis product (CBD ≥ 60% and < 98%)
Products included in Category 2:
- are Schedule 8 Controlled Drugs as per the Poisons Standard; and
- cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and
- other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and
- the medicine contains no other active ingredients
| Dosage form | Active ingredient(s) | Product trade name | Sponsor name |
|---|---|---|---|
|
Capsule |
CBD 15mg, THC less than 0.3% w/w per softgel |
Ananda Hemp Full Spectrum Softgels - 60ct |
Ecofibre Limited |
|
Capsule |
CBD 20mg/cap, THC<1mg/Cap 30 Caps |
Spectrum Yellow Cannabis Oil Soft gel |
Anspec Pty Ltd |
|
Capsule |
CBD 3.75mg, THC 2.5mg 60 caps |
Spectrum Blue 2.5mg Cannabis Oil Soft gel |
Anspec Pty Ltd |
|
Capsule |
CBD 25mg, THC <1mg |
Cannatrek C25 25mg CBD 60caps |
Cannatrek Medical Pty Ltd |
| Capsule | CBD 20mg | Medca 20mg Caps | PHYTOCA PTY LTD |
|
Herb, dried for vaporisation |
CBD 7.5% |
Bedrolite |
Novachem Pty Ltd |
|
Herb, dried for vaporisation |
CBD 140mg/g, THC less than 1mg/g |
Australian Eve |
ABC CAN PTY LTD |
| Herb, dried for vaporisation | CBD 12.2%, THC <0.5% | Aurora Tower Cannatonic | MedReleaf Australia |
| Herb, dried for vaporisation | CBD 13.6%, THC <1% | MedReleaf Vespera Dried | MedReleaf Australia |
| Herb, dried for vaporisation | CBD 6.5%, THC 4.3% | MedReleaf Nollia Dried | MedReleaf Australia |
|
Oral liquid |
CBD 30mg/mL, THC <1mg/mL |
Tikun CBD 30 Avidekel Oil 30mL (S8) |
Tikun Oceana Pty Ltd |
|
Oral liquid |
CBD 40mg, THC less than 0.3% w/w per mL |
Ananda Hemp 2000mg Full Spectrum Hemp Extract |
Ecofibre Limited |
|
Oral liquid |
CBD 15mg/mL, THC 10mg/mL |
Extracts 10:15 |
Cann Group Limited |
|
Oral liquid |
CBD 25mg/mL, THC <1 mg/mL |
Sunco Green Flavus Oil 1:25 |
Sunco Green Pharmaceutical Pty Ltd |
|
Oral liquid |
CBD 15mg/mL, THC 10 mg/mL |
Provocatus THC10:CBD15 |
Cann Group Limited |
|
Oral liquid |
CBD 166mg/mL |
Isospec PM 5000 |
Gamma Biomedical |
|
Oral liquid |
CBD 100mg/mL, THC 5mg/mL |
C100 Oral Liquid |
Tasmanian Botanics Pty Ltd |
|
Oral liquid |
CBD 100mg/mL, THC 5mg/mL |
C100 Elixir |
Tasmanian Botanics Pty Ltd |
|
Oral liquid |
CBD 20.0mg/mL, THC<1.0mg/mL 40mL |
Spectrum Yellow Cannabis Oil |
Anspec Pty Ltd |
|
Oral liquid |
CBD 15mg/mL, THC 10mg/mL 40mL |
Spectrum Blue Cannabis Oil |
Anspec Pty Ltd |
|
Oral liquid |
CBD 15mg/mL, THC 10mg/mL |
Entoura EMC 10:15 Oil |
Entoura Pty Ltd |
|
Oral liquid |
CBD 100mg/mL, THC 3mg/mL |
MGC Pharma MP 1:30 |
MGC Research (AUS) Pty Ltd |
|
Oral liquid |
CBD 100mg/mL, THC 5mg/mL |
MGC Pharma CANNEPIL PLUS |
MGC Research (AUS) Pty Ltd |
|
Oral liquid |
CBD 17mg, THC 25mg |
MGC Pharma CannEpil |
MGC Research (AUS) Pty Ltd |
|
Oral liquid |
CBD 25mg/mL, THC <1mg/mL |
Adaya 1:25 Medicinal Cannabis Oil (MTC) |
CRONOS AUSTRALIA - Operations Pty Ltd |
|
Oral liquid |
CBD 100mg/mL, THC 3.5mg/mL |
MEDCAN FX04 Oil |
MEDCAN Australia |
|
Oral liquid |
CBD 20mg/mL, THC 0.9mg/mL |
MEDCAN FX03 Oil |
MEDCAN Australia |
|
Oral liquid |
CBD 100mg/mL (106.4mg/g), THC 2mg/mL (2.1mg/g) |
Tilray Full Spectrum Oral Solution THC2:CBD100 |
Tilray Australia and New Zealand |
|
Oral liquid |
CBD 25mg/mL (26.6mg/g), THC 1mg/mL (1.1mg/g) |
Tilray Full Spectrum Oral Solution THC1:CBD25 |
Tilray Australia and New Zealand |
|
Oral liquid |
CBD 20mg/mL (21.3mg/g), THC 5mg/mL (5.3mg/g) |
Tilray Full Spectrum Oral Solution THC5:CBD20 |
Tilray Australia and New Zealand |
|
Oral liquid |
CBD 5% |
Medicabilis CBD 5% |
Bod Australia |
|
Oral liquid |
CBD 25mg, THC 10mg |
Cybis 10:25 Oil 30mL |
Cymra Life Sciences Ltd |
|
Oral liquid |
CBD 25mg, THC 10mg |
Cybis 10:25 Oil 50mL |
Cymra Life Sciences Ltd |
|
Oral liquid |
CBD 25mg/mL, THC <2mg/mL |
Althea CBD25:THC2 Rideau Cannabis Oil |
Althea Company Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 5mg/mL |
Althea CBD10:THC5 Jasper Cannabis Oil |
Althea Company Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 5mg/mL |
Althea Jasper CBD10:THC5 Cannabis Oil |
Althea Company Pty Ltd |
|
Oral liquid |
CBD 12.5mg/mL, THC 10mg/mL |
Althea CBD12:THC10 Capilano Cannabis Oil |
Althea Company Pty Ltd |
|
Oral liquid |
CBD 25mg/mL, THC <2mg/mL |
ALTHEA CBD25 : THC2 |
Althea Company Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 5mg/mL |
ALTHEA CBD10 : THC5 |
Althea Company Pty Ltd |
|
Oral liquid |
CBD 115mg/mL, THC‐Free |
Cannatrek C115 CBD 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 100mg/mL, THC <4mg/mL |
Cannatrek C100 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 200mg/mL, THC <8mg/mL |
Cannatrek C200 Oil 10mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 25mg/mL, THC <2.5mg/mL |
Cannatrek C25 Refael Oil 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 20mg/mL, THC 5mg/mL |
C20T5 Oil 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 25mg/mL, THC <2.5mg/mL |
C25 CBD Oil 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 20mg/mL, THC <1mg/mL |
Cannatrek C20 CBD Oil 25mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 310mg/mL, THC <30mg/mL |
UrbanLeaf mCart CBD |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 20mg/mL, THC 1mg/mL |
LGP Classic 1:20 |
Little Green Pharma Ltd |
| Oral liquid | CBD 20 mg/mL, THC <1.1 mg/mL | CanniMed 1:20 | MedReleaf Australia |
| Oral liquid | CBD 28.5 mg/mL, THC <3 mg/mL | Aurora CBD Drops | MedReleaf Australia |
| Oral liquid | CBD 70mg/mL | Phytoca FS70 | PHYTOCA PTY LTD |
|
Topical |
CBD 50mg per 2g dose |
Ananda Hemp Endo Cream 1500mg Full Spectrum Hemp Extract |
Ecofibre Limited |
* In publishing this list, the TGA has applied the principles of the Therapeutic Goods Advertising Code (No.2) 2018. For more information please refer to specific guidance published about the Code and naming therapeutic goods https://www.tga.gov.au/advertising-code-and-naming-therapeutic-goods.
Category 3: Balanced medicinal cannabis product (CBD <60% and ≥ 40%)
Products included in Category 3:
- are Schedule 8 Controlled Drugs as per the Poisons Standard; and
- cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and
- other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and
- the medicine contains no other active ingredients
| Dosage form | Active ingredient(s) | Product trade name | Sponsor name |
|---|---|---|---|
| Capsule | CBD <4 mg, THC 2.6 mg | MedReleaf Equiposa Softgels | MedReleaf Australia |
|
Herb, dried for vaporisation |
CBD 60mg/g, THC 60mg/g |
Kind Medical Libra 6:6 Flower |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD 8%, THC 6% (w/w) |
THC6 CBD8 |
Tasmanian Botanics Pty Ltd |
|
Herb, dried for vaporisation |
CBD 70mg/g, THC 80mg/g 15g |
Tweed Penelope Cannabis Flower |
Anspec Pty Ltd |
|
Herb, dried for vaporisation |
CBD 8%, THC 6.3% |
Bediol |
Novachem Pty Ltd |
|
Herb, dried for vaporisation |
CBD 10.0%, THC 10.0% |
Tilray Whole Flower Dried Cannabis THC10:CBD10 |
Tilray Australia and New Zealand |
|
Herb, dried for vaporisation |
CBD 125mg/g, THC 115mg/g |
Australian Juno |
ABC CAN PTY LTD |
| Herb, dried for vaporisation | CBD 8.3%, THC 9% | MedReleaf Equiposa Dried | MedReleaf Australia
|
|
Oral liquid |
CBD 10mg/mL, THC 10mg/mL |
Levin 10:10 |
Levin Health Limited |
|
Oral liquid |
CBD 12mg/mL, THC 10mg/mL |
Levin 10:12 |
Levin Health Limited |
|
Oral liquid |
CBD 10mg/mL, THC 10mg/mL |
Heyday 10:10 Oil |
Heyday Rx Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 10mg/mL |
Sunco Green Viridis Oil 10:10 |
Sunco Green Pharmaceutical Pty Ltd |
|
Oral liquid |
CBD 8.93mg/mL, THC 8.93mg/mL |
NanaBis |
Medlab Clinical Ltd |
|
Oral liquid |
CBD 12.5mg/mL, THC 12.5mg |
Greenlab 12.5:12.5 |
Cannvalate Pty Ltd |
|
Oral liquid |
CBD 12.5mg/mL, THC 12.5mg |
GFI Pharma Plus 12.5:12.5 |
Cannvalate Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 10mg |
INFLAMMEX, 10:10 CBD:THC |
Cannvalate Pty Ltd |
|
Oral liquid |
CBD 12.5 mg/mL,THC 12.5mg/mL |
MEDIGROWTH |
MEDIGROWTH AUSTRALIA |
|
Oral liquid |
CBD 25mg/mL, THC 25mg/mL |
T25 C25 Oral Liquid |
Tasmanian Botanics Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 10mg/mL |
T10 C10 Oral Liquid |
Tasmanian Botanics Pty Ltd |
|
Oral liquid |
CBD 25mg/mL, THC 25mg/mL |
T25 C25 Elixir |
Tasmanian Botanics Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 10mg/mL |
T10 C10 Elixir |
Tasmanian Botanics Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 10mg/mL |
Lumir 10:10 Cannabis Oil |
Cannim Australia Pty Ltd |
|
Oral liquid |
CBD 25mg/mL, THC 25mg/mL |
Lumir 25:25 Cannabis Oil |
Cannim Australia Pty Ltd |
|
Oral liquid |
CBD 5mg/mL, THC 5mg/mL |
1 |
Zelira Therapeutics Ltd |
|
Oral liquid |
CBD 25mg/mL, THC 25mg/mL |
MGC Pharma 1:1 |
MGC Research (AUS) Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 10mg/mL |
HAPA 10:10 |
Health House International |
|
Oral liquid |
CBD 10mg/mL, THC 10mg/mL |
Adaya 10:10 Medicinal Cannabis Oil (MTC) |
CRONOS AUSTRALIA - Operations Pty Ltd |
|
Oral liquid |
CBD 8mg/mL, THC 5mg/mL |
MEDCAN FX02 Oil |
MEDCAN Australia |
|
Oral liquid |
CBD 10mg/mL (10.6mg/g), THC 10mg/mL (10.6mg/g) |
Tilray Full Spectrum Oral Solution THC10:CBD10 |
Tilray Australia and New Zealand |
|
Oral liquid |
CBD 25mg/mL (26.6mg/g), THC 25mg/mL (26.6mg/g) |
Tilray Full Spectrum Oral Solution THC25:CBD25 |
Tilray Australia and New Zealand |
|
Oral liquid |
CBD 12.5mg/mL, THC 10mg/mL |
ALTHEA CBD12 : THC10 |
Althea Company Pty Ltd |
|
Oral liquid |
CBD 12.5mg/mL, THC 12.5mg/mL |
Cannatrek C12T12 Sapir Oil 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 12.5mg/mL, THC 12.5mg/mL |
Cannatrek C12T12 Oil ‐ 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 200mg/mL, THC 200mg/mL |
UrbanLeaf mCart BLEND‐L |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 200mg/mL, THC 200mg/mL |
UrbanLeaf mCart BLEND‐S |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 10mg/mL, THC 10mg/mL |
LGP Classic 10:10 |
Little Green Pharma Ltd |
| Oral liquid | CBD 9.9 mg/mL, THC 9.8 mg/mL | CanniMed 10:10 | MedReleaf Australia |
| Oral liquid | CBD <15 mg/mL, THC 12.5 mg/mL | MedReleaf Equiposa Oil | MedReleaf Australia |
|
Spray, solution |
CBD 17mg, THC 25mg |
MGC Pharma Cognicann |
MGC Research (AUS) Pty Ltd |
* In publishing this list, the TGA has applied the principles of the Therapeutic Goods Advertising Code (No.2) 2018. For more information please refer to specific guidance published about the Code and naming therapeutic goods https://www.tga.gov.au/advertising-code-and-naming-therapeutic-goods.
Category 4: THC dominant medicinal cannabis product (THC 60% - 98%)
Products included in Category 4:
- are Schedule 8 Controlled Drugs as per the Poisons Standard; and
- other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise 60% or more and 98% or less of the total cannabinoid content of the medicine; and
- cannabidiol derived from cannabis comprises 2% or more and less than 40% of the total cannabinoid content of the medicine; and
- the medicine contains no other active ingredients
| Dosage form | Active ingredient(s) | Product trade name | Sponsor name |
|---|---|---|---|
|
Capsule |
CBD<1mg/cap, THC 2.5mg/cap 60 Caps |
Spectrum Red No 1 2.5 mg soft gel |
Anspec Pty Ltd |
|
Capsule |
CBD <1mg/cap, THC 10mg/cap 30 caps |
Spectrum Red No 1 10mg Cannabis Oil Soft gel |
Anspec Pty Ltd |
|
Herb, dried for vaporisation |
THC 25%, CBN 1.3%, CBG 0.3%, |
Releaf Flower |
Releaf Dispensaries Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 20% mg/mL |
Sunco Green Pollens Dried Flower 20% THC |
Sunco Green Pharmaceutical Pty Ltd |
|
Herb, dried for vaporisation |
THC 18% |
ALTHEA THC18 |
Althea Company Pty Ltd |
|
Herb, dried for vaporisation |
THC 18% |
Althea THC18 Henik Dried Cannabis |
Althea Company Pty Ltd |
|
Extract, concentrated |
THC 850mg/mL |
T81 Distillate 50g |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD <1mg/mL, THC 30mg/mL |
Tikun THC 30 Erez Oil 30ml (S8) |
Tikun Oceana Pty Ltd |
|
Oral liquid |
CBD 1mg/mL, THC 20mg/mL |
Heyday 20:1 Oil |
Heyday Rx Pty Ltd |
|
Oral liquid |
CBD 1mg/mL, THC 26mg/mL |
Heyday 26:1 Oil |
Heyday Rx Pty Ltd |
|
Oral liquid |
THC 26mg/mL |
Extracts THC-26 |
Cann Group Limited |
|
Oral liquid |
CBD <1mg/mL, THC 20mg/mL |
Sunco Green Rufus Oil 20:1 |
Sunco Green Pharmaceutical Pty Ltd |
|
Oral liquid |
THC 26mg/mL |
Provocatus THC 26 |
Cann Group Limited |
|
Oral liquid |
CBD <1mg/mL, THC 26.3mg/mL 40mL |
Spectrum Red No 1 Cannabis Oil |
Anspec Pty Ltd |
|
Oral liquid |
CBD 1mg/mL, THC 20mg/mL, CBN 2mg/mL |
Zenivol |
Zelira Therapeutics Ltd |
|
Oral liquid |
CBD 1.7mg/mL, THC 8.3mg/mL |
2 |
Zelira Therapeutics Ltd |
|
Oral liquid |
CBD <1mg/mL, THC 20mg/mL |
Adaya 20:1 Medicinal Cannabis Oil (MTC) |
CRONOS AUSTRALIA - Operations Pty Ltd |
|
Oral liquid |
CBD 0.9mg/mL, THC 20mg/mL |
MEDCAN FX01 Oil |
MEDCAN Australia |
|
Oral liquid |
CBD <1mg/mL, THC 20mg/mL |
Althea CBD1:THC20 Champlain Cannabis Oil |
Althea Company Pty Ltd |
|
Oral liquid |
CBD <1mg/mL, THC 20mg/mL |
ALTHEA THC20 : CBD1 |
Althea Company Pty Ltd |
|
Oral liquid |
CBD <1mg/mL, THC 25mg/mL |
Cannatrek T25 Shiloh Oil 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD <20mg/mL, THC 400mg/mL |
UrbanLeaf mCart THC |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD 5mg/mL, THC 20mg/mL |
LGP Classic 20:5 |
Little Green Pharma Ltd |
* In publishing this list, the TGA has applied the principles of the Therapeutic Goods Advertising Code (No.2) 2018. For more information please refer to specific guidance published about the Code and naming therapeutic goods https://www.tga.gov.au/advertising-code-and-naming-therapeutic-goods.
Category 5: THC medicinal cannabis product (THC >98%)
Products included in Category 5:
- are Schedule 8 Controlled Drugs as per the Poisons Standard; and
- cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise more than 98% of the total cannabinoid content of the medicine; and
- cannabidiol comprises less than 2% less of the total cannabinoid content of the medicine; and
- the medicine contains no other active ingredients
| Dosage form | Active ingredient(s) | Product trade name | Sponsor name |
|---|---|---|---|
|
Capsule |
THC 8mg per capsule |
MEDCAN GC01 Capsule |
MEDCAN Australia |
| Capsule | CBD <0.2 mg, THC 5mg | MedReleaf Softgels | MedReleaf Australia |
| Capsule | CBD <0.2 mg, THC 5mg | MedReleaf Sedaprem Softgels | MedReleaf Australia |
|
Herb, dried for vaporisation |
THC 19% |
Heyday Flower |
Heyday Rx Pty Ltd |
|
Herb, dried for vaporisation |
THC 19% |
Heyday Flower |
Heyday Rx Pty Ltd |
|
Herb, dried for vaporisation |
THC 20.23% |
Grandiosa Dry Flower |
Grandiosa Imports |
|
Herb, dried for vaporisation |
CBD <1%, THC 19% |
Releaf Flower |
Releaf Dispensaries Pty Ltd |
|
Herb, dried for vaporisation |
CBD ≤1% w/w , THC 20% w/w |
Extracts THC-20 |
Cann Group Limited |
|
Herb, dried for vaporisation |
CBD <1%, THC 150mg/g |
Beacon Medical THC Flower 15% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 180mg/g |
Beacon Medical THC Flower 18% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 200mg/g |
Beacon Medical THC Flower 20% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 200mg/g |
Beacon Medical THC Flower 20% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 200mg/g |
Beacon Medical THC Flower 20% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 220mg/g |
Beacon Medical THC Flower 22% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 250mg/g |
Beacon Medical THC Flower 25% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 250mg/g |
Beacon Medical THC Flower 25% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 200mg/g |
BHC Noosa Heads THC Flower 20% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 220mg/g |
BHC Point Flower THC 22% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 220mg/g |
BHC Sunshine Coast Flower THC 22% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
CBD <1%, THC 180mg/g |
Kind Medical Stella THC Flower 18% |
Burleigh Heads Cannabis |
|
Herb, dried for vaporisation |
THC 21% (w/w) |
THC 21 |
Tasmanian Botanics Pty Ltd |
|
Herb, dried for vaporisation |
THC 16% (w/w) |
THC 16 |
Tasmanian Botanics Pty Ltd |
|
Herb, dried for vaporisation |
THC 200mg/g 15g |
Spectrum Red No 1 Cannabis Flower |
Anspec Pty Ltd |
|
Herb, dried for vaporisation |
THC 170mg/g 15g |
Spectrum Red No 2 Cannabis Flower |
Anspec Pty Ltd |
|
Herb, dried for vaporisation |
THC 200mg/g 15g |
Tweed Bakerstreet Cannabis Flower |
Anspec Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 22% |
Bedrocan |
Novachem Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 13.5% |
Bedrobinol |
Novachem Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 14% |
Bedica |
Novachem Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 20% |
HummingBud Spring - Dried Cannabis Flower |
Cannim Australia Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 21% |
HummingBud Grove - Dried Cannabis Flower |
Cannim Australia Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 14% |
HummingBud Bay - Dried Cannabis Flower |
Cannim Australia Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 23.1% |
Lumir SX6/31 - Dried Cannabis Flower |
Cannim Australia Pty Ltd |
|
Herb, dried for vaporisation |
THC 20% |
MGC Pharma THC 20 Whole Flower |
MGC Research (AUS) Pty Ltd |
|
Herb, dried for vaporisation |
THC 19% w/w |
Adaya THC 19 Medicinal Cannabis Flower |
CRONOS AUSTRALIA - Operations Pty Ltd |
|
Herb, dried for vaporisation |
THC 30% w/w |
Adaya THC 30 Medicinal Cannabis Flower |
CRONOS AUSTRALIA - Operations Pty Ltd |
|
Herb, dried for vaporisation |
THC 24% |
MEDCAN CC01 Dried Flower |
MEDCAN Australia |
|
Herb, dried for vaporisation |
THC 22% |
MEDCAN SC01 Dried Flower |
MEDCAN Australia |
|
Herb, dried for vaporisation |
THC 20% |
MEDCAN WPA49 Dried Flower |
MEDCAN Australia |
|
Herb, dried for vaporisation |
THC 23% |
MEDCAN MDC01 Dried Flower |
MEDCAN Australia |
|
Herb, dried for vaporisation |
THC 27% |
MEDCAN ETG01 Dried Flower |
MEDCAN Australia |
|
Herb, dried for vaporisation |
CBD 0.0mg/g, THC 242mg/g |
Holigenn Dried Bud 7.0g |
TCann Pty Ltd t/a Promethean Biopharma |
|
Herb, dried for vaporisation |
CBD (<1.0%), THC 17.0% |
Tilray Whole Flower Dried Cannabis THC17 |
Tilray Australia and New Zealand |
|
Herb, dried for vaporisation |
CBD (<1.0%), THC 25.0% |
Tilray Whole Flower Dried Cannabis THC25 |
Tilray Australia and New Zealand |
|
Herb, dried for vaporisation |
CBD <0.1% , THC 22.7% |
Sativa dried Cannabis Flower 3.5g |
SatiVite Pty Ltd |
|
Herb, dried for vaporisation |
CBD less than 1.0%, THC 20.9% |
Sativa dried Cannabis Flower 7g |
SatiVite Pty Ltd |
|
Herb, dried for vaporisation |
CBD <0.1%, THC 19.6% |
lndica dried cannabis Flower 3.5g |
SatiVite Pty Ltd |
|
Herb, dried for vaporisation |
CBD less than 1.0%, THC 21.4% |
lndica dried cannabis Flower 7g |
SatiVite Pty Ltd |
|
Herb, dried for vaporisation |
CBD less than 1.0%, THC 24.6% |
Yaandi - lndica dried Cannabis Flower 7g |
SatiVite Pty Ltd |
|
Herb, dried for vaporisation |
CBD less than 1.0%, THC 21.0% |
Nula Nula 21- lndica dried Cannabis Flower 7g |
SatiVite Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 18% |
Cannatrek T18 Flower 18% THC |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 17% |
Cannatrek T17 Flower 17% THC |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 17% |
Cannatrek T17 Flower 17% THC |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 18% |
Cannatrek T18 Flower 18% THC |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 27% |
Cannatrek T25 Flower 25% THC |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD 1%, THC 15% |
T15 Flower (Sativa Acadia) ‐ 10g |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD 1%, THC 17% |
Cannatrek T17 Flower 17%THC ‐ 10g |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD 1%, THC 19% |
Cannatrek T19 Flower 19%THC ‐ 10g |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 18% |
Cannatrek T18 Flower ‐ 10g |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD <1%, THC 20% |
T20 Flower ‐ 10g |
Cannatrek Medical Pty Ltd |
|
Herb, dried for vaporisation |
CBD less than 1mg/g, THC 300mg/g |
Australian |
ABC CAN PTY LTD |
|
Herb, dried for vaporisation |
CBD less than 1mg/g, THC 220mg/g |
Australian |
ABC CAN PTY LTD |
|
Herb, dried for vaporisation |
CBD less than 1mg/g, THC 140mg/g |
Australian |
ABC CAN PTY LTD |
|
Herb, dried for vaporisation |
THC 22% w/w |
LGP Flower THC 22% |
Little Green Pharma Ltd |
| Herb, dried for vaporisation | CBD <1%, THC 21.5% | MedReleaf Stellio Dried | MedReleaf Australia |
| Herb, dried for vaporisation | CBD <1%, THC 22.1% | MedReleaf Dried | MedReleaf Australia |
| Herb, dried for vaporisation | CBD <1%, THC 16% | IndiMed Tempo (Indica) Dried | MedReleaf Australia |
| Herb, dried for vaporisation | CBD <1%, THC 16% | IndiMed Tempo (Sativa) Dried | MedReleaf Australia |
| Herb, dried for vaporisation | CBD <1%, THC 21.3% | MedReleaf Sedaprem Dried | MedReleaf Australia |
| Herb, dried for vaporisation | CBD <1%, THC 13.0% | MedReleaf Rex Dried | MedReleaf Australia |
|
Inhalation |
THC 600mg/g |
Cannatrek T55 ‐ 3g |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
THC 25mg/mL |
GFI Pharma THC 25 |
Cannvalate Pty Ltd |
|
Oral liquid |
THC 10mg/mL |
MEDIGROWTH THC10 |
MEDIGROWTH AUSTRALIA |
|
Oral liquid |
THC 25mg/mL |
T25 Oral Liquid |
Tasmanian Botanics Pty Ltd |
|
Oral liquid |
THC 25mg/mL |
T25 Elixir |
Tasmanian Botanics Pty Ltd |
|
Oral liquid |
THC 26mg/mL |
Entoura EMC THC 26 Oil |
Entoura Pty Ltd |
|
Oral liquid |
CBD ≤1mg/mL, THC 27mg/mL |
Lumir THC 27 Cannabis Oil |
Cannim Australia Pty Ltd |
|
Oral liquid |
CBD 1.7mg/mL, THC 25mg/mL |
MGC Pharma MP 15:1 |
MGC Research (AUS) Pty Ltd |
|
Oral liquid |
THC 25mg/mL |
MGC Pharma MP 25T |
MGC Research (AUS) Pty Ltd |
|
Oral liquid |
CBD <10mg/mL, THC 26mg/mL |
Adaya THC 26 Medicinal Cannabis Oil (MTC) |
CRONOS AUSTRALIA - Operations Pty Ltd |
|
Oral liquid |
CBD <0.5mg/mL (<0.5mg/g), THC 25mg/mL (26.6mg/g) |
Tilray Full Spectrum Oral Solution THC25 |
Tilray Australia and New Zealand |
|
Oral liquid |
CBD <1mg/mL, THC 25mg/mL |
T25 THC Oil ‐ 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD <1mg/mL, THC 25mg/mL |
T25 THC Oil ‐ 30mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD <1mg/mL, THC 20mg/mL |
Cannatrek T20 Indica Oil 25mL |
Cannatrek Medical Pty Ltd |
|
Oral liquid |
CBD <2mg/mL, THC 400mg/mL |
UrbanLeaf mCart THC |
Cannatrek Medical Pty Ltd |
| Oral liquid | CBD <1 mg/mL, THC 28.5 mg/mL | Aurora THC Drops (Indica) | MedReleaf Australia |
| Oral liquid | CBD <1 mg/mL, THC 28.5 mg/mL | Aurora THC Drops (Sativa) | MedReleaf Australia |
| Oral liquid | CBD <0.2 mg/mL, THC 18.3 mg/mL | CanniMed 18:0 | MedReleaf Australia |
| Oral liquid | CBD <0.9 mg/mL, THC 24mg/mL | MedReleaf Oil | MedReleaf Australia |
* In publishing this list, the TGA has applied the principles of the Therapeutic Goods Advertising Code (No.2) 2018. For more information please refer to specific guidance published about the Code and naming therapeutic goods https://www.tga.gov.au/advertising-code-and-naming-therapeutic-goods.