TORONTO, July 30, 2015 /CNW/ - Linepharma International Limited has today announced that it has received Health Canada Approval (in the form of a Notice of Compliance) for Mifegymiso (a combination product comprised of mifepristone and misoprostol) in Canada. The product will be distributed by Celopharma Inc. with commercial availability expected in January 2016.
Mifepristone (RU-486) was first approved in France and China in 1988 and is widely available in more than 57 countries throughout the world. Both mifepristone and misoprostol are included in the World Health Organization's Model List of Essential Medicines.1 The most common Canadian regimen of medical abortion prescribed has been a combination of methotrexate and misoprostol, which were prescribed "off-label" for medical abortion.2 After Australia, Canada is the second country to approve a combi-pack containing both drugs.
The Notice of Compliance indicates that Mifegymiso (mifepristone and misoprostol) has met Health Canada's regulatory requirements for safety, efficacy and quality and can now be prescribed for medical abortions.
In a commentary titled Medical abortion in Canada: behind the times3 published in the Canadian Medical Association Journal, Dr. Sheila Dunn, MD, MSc, and Rebecca Cook, JD, JSD, identify mifepristone as the internationally recognized "gold standard" for medical abortion. According to the commentary, availability to mifepristone can improve access to abortion and improve the capacity of the health care system to provide medical abortions earlier, when they are safest.
Physicians will be available to speak to the media with regard to this announcement.
- Dr. Edith Guilbert, Senior Medical Adviser, National Institute of Public Health and Associate Professor, Department of Obstetrics and Gynecology, Laval University
- Dr. Dustin Costescu, Assistant Professor, Department of Obstetrics and Gynaecology, McMaster University
- Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynecologists (SOGC)
- Dr. André Ulmann, Lead Scientist on RU-486 at Linepharma, the manufacturer of Mifegymiso
Subject areas include:
- Information on the use of Mifegymiso;
- Issues related to the access to safe abortion care for Canadian women;
- Differences and improvement over the current Canadian medical abortion regimen.
1 World Health Organization. WHO Model List of Essential Medicines. June 2015. http://www.who.int/selection_medicines/committees/expert/20/EML_2015_FINAL_amended_JUN2015.pdf?ua=1
2 Cook, R., Dunn, S., Guilbert, E., Reid, R., Shaw, D. and Trouton, K. Expert Report: The Case for Mifepristone in Canada. November 25, 2011.
3 Dunn, S. and Cook, R. The Canadian Medical Association Journal. Medical abortion in Canada: behind the times. January 7, 2014. http://www.cmaj.ca/content/186/1/13.full.
SOURCE Linepharma International Limited
For further information: To arrange an interview, please contact: 416-425-9143 ext. 24