Mylan Pharmaceuticals ULC is the registry sponsor.
Innomar Strategies Inc. will coordinate and manage the registry on behalf of the sponsor. Staff from Innomar Strategies Inc. will coordinate with the healthcare providers (HCP) / physicians and collect information related to fingolimod treatment and maternal, fetal and infant outcomes.
Contact the Mylan-Fingolimod Pregnancy Registry by calling 1-888-246-5830, sending a fax to 1-833-677-0484 or sending an e-mail to MylanFPR@innomar-strategies.com
HCPs are encouraged to enroll pregnant women in the Mylan-Fingolimod Pregnancy Registry. Once Innomar Strategies Inc. receives a communication from the HCP, Innomar Strategies Inc. will then provide information on how to get involved and how patient data are being collected in the registry.
Fifty pregnant women will be enrolled over 5 years. On average, 10 enrollments per year are expected.
The current protocol does not include a control group. This registry is observational in nature. The nature of the study does not require the presence of a control group.
Please visit the Mylan.ca for more information.