CONCORD, ON, Nov. 7, 2017 /CNW/ - Celopharma Inc, in collaboration with the sponsor, Linepharma International Limited, wish to provide an official update on MIFEGYMISO, the combination of mifepristone and misoprostol tablets used for the early termination of a pregnancy.
On November 7th, 2017 Health Canada completed its review of a new submission filed in December 2016 to modify the indication and update the Risk Management Plan. A summary of the information that supported these changes can be found in the Regulatory Decision Summary of Health Canada website.
The revised monograph reflects modifications to the product indication, which may now be used for the medical termination of a pregnancy up to 63 days of gestational age, and steps to follow prior to prescribing MIFEGYMISO.
A Risk Communication was issued on November 7,2017 to health professionals to clarify information found in the product monograph and inform them about modifications to the MIFEGYMISO product monograph and the Risk Management Plan including extension of the indication and changes to the Distribution and Education Program in Canada. This is a follow up to the communication issued on May 18, 2017 (available at: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/63330a-eng.php).
"Celopharma is pleased with the revised product monograph and indication. We have been working diligently to ensure that women have timely ease of access to Mifegymiso in urban and rural settings across Canada. These approved changes to the Product Monograph and Risk Management plan have helped to facilitate these goals."
Celopharma Inc., is a privately held, Canadian owned pharmaceutical company specializing in the licensing, regulatory, marketing and distribution of niche pharmaceutical products with a primary focus on women's health. www.celopharma.com
SOURCE Celopharma Inc
For further information: Celopharma Inc., 1-877-230-4227, www.celopharma.com