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Mandatory Patient Package Inserts
In a July 21, 1999 communication, Health Canada has advised that Patient Package Inserts have been made mandatory as part of the marketing authorizations, Notice of Compliance (NOC) and/or Drug Identification Number for the drugs listed below. The mandatory documents would have been submitted to the Therapeutic Products Program by the manufacturer with its application to market a drug product, and reviewed as part of the submission.
The patient information material supplied by the manufacturer should be dispensed with:
- Prescription Drugs:
- Drugs delivered with the assistance of a device ( i.e. inhalers, transdermal patches)
- Isotretinoin and other oral tretinoids, except those used in oncology
- Methotrexate for rheumatoid arthritis
- Nonsteroidal anti-inflammatory drugs (NSAIDS)
- Oral contraceptives
- Ticlopidine
- Biologicals- all drugs intended for self-administration including:
- Erythropoietin
- Gonadotropins
- Human Growth Hormone
- Insulins
- Interferons
- Wound Healing Factors
- All drugs where the Product Monograph or Prescribing Information indicates that a patient information document is available.
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