Interim Order Respecting the Sale of Oseltamivir Phosphate - Expanded use for Children under One Year of Age

Expired July 20, 2010

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;

Therefore, the Minister of Health, pursuant to subsection 30.1(1)^a of the Food and Drugs Act^b, hereby makes the annexed Interim Order Respecting the Sale of Oseltamivir Phosphate - Expanded Use for Children Under One Year of Age.

Ottawa, July 20, 2009

Original signed by:
Leona Aglukkaq
Minister of Health

Interim Order Respecting The Sale Of Oseltamivir Phosphate - Expanded Use For Children Under One Year Of Age

Interpretation

1. Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Food and Drug Regulations.

Expanded Use

2. The sale of oseltamivir phosphate for the expanded use as a prophylaxis or treatment for children under one year of age, for infection caused by the novel influenza A H1N1 virus, is not subject to section C.08.003 of the Food and Drug Regulations.

Supplementary Information

3. The Minister shall make available to health care providers and the public supplementary information pertaining to oseltamivir phosphate for the expanded use that includes:

1. a statement of the expanded use;
2. a statement of the known and potential benefits and the known and potential risks;
3. the recommended dose;
4. the recommended duration of use, if any; and
5. the drug identification number that has been issued for oseltamivir phosphate with which the expanded use is associated.

Submission Of Information

4. The manufacturer shall submit the following to the Minister in a form and manner, and with a frequency, that enables the Minister to assess the safety and effectiveness of oseltamivir phosphate for the expanded use:

1. any information in the possession of or available to the manufacturer concerning the safety or effectiveness of oseltamivir phosphate for the expanded use; and
2. information for the purpose of updating the supplementary information referred to in section 3.

Application Of Section C.08.003

5. (1)The sale of oseltamivir phosphate for the expanded use is subject to section C.08.003 of the Food and Drug Regulations if the Minister considers that

1. in light of the information available, the known and potential benefits of the expanded use do not outweigh the known and potential risks; or
2. the conditions set out in section 4 have not been met.

(2)If subsection (1) applies, the Minister shall notify the manufacturer, health care providers and the public that the sale of oseltamivir phosphate for the expanded use is subject to section C.08.003 of the Food and Drug Regulations.

Explanatory Note

(This note is not part of the Interim Order.)

The recent outbreak of the novel influenza A H1N1 virus has required a review of all therapies that could be used to treat the infection. Novel influenza A H1N1 infection is currently believed to be a serious and life-threatening disease which has been associated with several fatalities.

Tamiflu (oseltamivir phosphate) is a drug currently authorized for sale in Canada for the treatment and prophylaxis of uncomplicated acute illness due to influenza infection in adults, adolescents and paediatric patients 1 year and older who have been symptomatic for no more than 2 days.

Tamiflu may be useful in the treatment of novel influenza A H1N1 infection. However, because of the limited data available on the use of Tamiflu in children under 1 year of age, the drug is not indicated for use in this population. Given the limited options for the treatment of this newly identified virus, the lack of this approved use could represent a critical gap. Furthermore, the current label of Tamiflu does not provide health care providers with information about the use of the drug in children under 1 year of age.

In response to the novel influenza A H1N1 outbreak, the United States has issued an Emergency Use Authorization in respect of Tamiflu for use in children under 1 year of age. Similarly, the European Medicines Agency has declared that the drug can be used in this population, given the urgent nature of the novel influenza A H1N1 pandemic.

This Order will allow the sale of Tamiflu under the Food and Drug Regulations for the expanded use as a prophylaxis or treatment of infection caused by the novel influenza A H1N1virus in children under 1 year of age. The Minister of Health will make available to health care providers and the public supplementary information about the use of Tamiflu in children under 1 year of age. The manufacturer of Tamiflu will provide Health Canada with new information, as it becomes available, about the safety and effectiveness of Tamiflu when used in children under 1 year of age.

The sale of Tamiflu for the expanded use would no longer be allowed under the Food and Drug Regulationswhere the Minister considers that the known and potential benefits of using the drug for the expanded use no longer outweigh the known and potential risks. The Minister would then notify the manufacturer, health care providers and the public.

a L.C. 2004, ch. 15, art. 66
b L.R., ch. F-27