DEMECAN 20:01 FLORESTURA

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
cannabidiol,tetrahydrocannabinol
Available from:
Little Green Pharma Ltd
Authorization status:
Listed (Export Only)
Authorization number:
352225

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Public Summary

Summary for ARTG Entry:

352225

DEMECAN 20:01 FLORESTURA

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Little Green Pharma Ltd

Postal Address

PO Box 690, West Perth, WA, 6872

Australia

ARTG Start Date

23/12/2020

Product Category

Medicine

Status

Active

Approval Area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on

the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and

support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation

Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i) each

overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each overseas

importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1 . DEMECAN 20:01 FLORESTURA

Product Type

Single Medicine Product

Effective Date

23/12/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

There is growing evidence that medicinal cannabis may have a role in several medical conditions. These include intractable chronic pain insufficiently

responsive to other analgesics, pain associated with spasticity in multiple sclerosis (MS), pain associated with cancer in palliative care, nausea and vomiting

caused by cancer treatment, appetite loss, sleep disturbance, post-traumatic stress disorder (PTSD), body wasting. Your doctor may have prescribed LGP

medicinal cannabis dried flower for another reason.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Jar/Can

HDPE

6 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 .

Dosage Form

Herb, dried

Route of Administration

Inhalation

Visual Identification

15 grams of dried, trimmed and cured cannabis flower

Public Summary

Page 1 of

Produced at 11.01.2021 at 07:39:29 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Active Ingredients

cannabidiol

.01 g/g

tetrahydrocannabinol

.2 g/g

Other Ingredients (Excipients)

air

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 11.01.2021 at 07:39:29 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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