Written answers
Thursday, 26 May 2022
Department of Health
Medicinal Products
Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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80. To ask the Minister for Health the number of approved medical products that are now prescribable under the Medical Cannabis Access Programme; if he will provide the details of each; and if he will make a statement on the matter. [26940/22]
Stephen Donnelly (Wicklow, Fianna Fail)
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On 16thMay 2022, the Minister for Health signed SI 237/2022 the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) (Amendment) Regulations 2022 amending Schedule 1 of the 2019 Regulations (S.I. No. 262 of 2019) and adding a new product to the Schedule of products that meet the specifications as set out in the regulation. There are now a total of 7 products in Schedule 1 as set out in the table below.
Specified Controlled Drugs
| Name of Cannabis product or preparation and brand name | Dosage form | Concentration of THC (percentage, weight/weight or weight/volume) | Name of manufacturer |
|---|---|---|---|
| Aurora High CBD Oil Drops | Oral solution | Less than 3% w/v (< 30mg/ml) This product also contains cannabidiol (CBD) 60% w/v (600mg/ml) | Aurora Cannabis Enterprises Inc.,4439 Township Road 304,Cremona, Alberta,Canada, T0M 0R0 |
| CannEpil ™ | Oral solution | 0.5% w/v (5mg/ml) This product also contains cannabidiol (CBD) 10% w/v (100mg/ml) | MGC Pharmaceuticals d.o.o.,Kamniška ulica 29, 1000, Ljubljana, Slovenia |
| Tilray Oral Solution THC10:CBD10 25ml | Oral solution | 1% w/v (10mg/ml) This product also contains cannabidiol (CBD) 1% w/v (10mg/ml) | Tilray Canada Ltd., 1100 Maughan Road, Nanaimo, BC, V9X 1J2, Canada |
| Aurora Sedamen Softgels | Capsules | 5mg/capsule This product also contains cannabidiol (CBD) less than 0.2mg/capsule | Aurora Cannabis Enterprises Inc.4250 14th Avenue,Markham, Ontario, CanadaL3R 0J3 |
| Oleo Bedrobinol | Dried Flower | 13.5% w/w (135mg/g) This product also contains cannabidiol (CBD) less than 1.0% w/w (less than 10mg/g) | Bureau voor Medicinale Cannabis Postbus 16114 2500 BC DEN HAAG The Netherlands |
| Oleo Bedrocan | Dried Flower | 22% w/w(220mg/g) This product also contains cannabidiol (CBD) less than 1.0% w/w (less than 10mg/g) | Bureau voor Medicinale Cannabis Postbus 16114 2500 BC DEN HAAG The Netherlands |
| Althea CBD12:THC10(50ml) | Oil | 1% w/v THC(10mg/ml) This product also contains 1.25% w/v (12.5mg/ml) cannabidiol (CBD) | Tasmanian Alkaloids pty Ltd T/A Extractas Bioscience, Westbury, Tasmania, Australia 7303 |
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