Notice: Prescription Drug List (PDL): Levonorgestrel
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August 15, 2014
Our file number: 14-109977-622
The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Levonorgestrel under sex hormones on the Prescription Drug List (PDL). Only the Human part of the PDL is proposed to be revised. The proposed wording of the new listing is:
Drugs containing any of the following:
Including (but not limited to)
except Levonorgestrel when sold as a single ingredient in an oral dosage form containing no more than 1.5 milligrams (mg)
to be determined
Levonorgestrel is a synthetic progestogen and as a single ingredient is used as an emergency oral contraceptive (EOC). Currently, Levonorgestrel as an EOC, is sold as a non-prescription drug in tablets containing .75 milligrams (mgs) of Levonorgestrel with labelling instructions to take two tablets at one time, resulting in a total dose of 1.5 mgs. This proposal to amend the PDL will allow non-prescription status for the 1.5 mg tablet. The efficacy and safety of the 1.5 mg tablet are comparable to taking the two .75 mg tablets.
None of the criteria outlined in section C.01.040.3 of the Food and Drug Regulations apply to Levonorgestrel when sold for human use as a single medicinal ingredient for EOC in a tablet containing 1.5 milligrams of Levonoregestrel.
Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.
Comments on this proposed change to the Prescription Drug List should be provided to Health Canada, preferably in electronic format, within 75 days from the date of this notice.
Please send your comments to:
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
If all comments not in favour of this change can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Canada's intention to revise the PDL. The actual revision to the PDL would be made six months from the date of the Notice of Intent to Amend and communicated to stakeholders through a Notice of Amendment.
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