Translation of:
Product Information (complete set of annexes) for medicinal product for human and veterinary use (summary of product characteristics, package leaflet, labeling) registered via CP, DCP, MRP and national registration procedure
Clinical Trials (case reports, communication between the sponsor and health agency)
RMP (Risk Management Plan)
"Dear Health Care Professional Letter"
Alert cards for health care professionals
Alert cards for patients
Pharmacovigilance reports
Operating manuals for medical devices |