patients from Studies C13004, C13006, C13007, and C13011 Important potential risks Infections: Routine Pharmacovigilance: signal detection, AE surveillance and reporting, literature Gastrointestinal infections surveillance and systemic infections against which the gut Additional Pharmacovigilance: MLN-0002_401: A constitute a defensive postmarketing, prospective, observational, cohort barrier safety study of vedolizumab versus other biologic agents for inflammatory bowel disease. C13008: Ongoing long-term safety extension study of patients from Studies C13004, C13006, C13007, and C13011 Other serious infections, Routine Pharmacovigilance: signal detection, including opportunistic PSURs, AE surveillance and reporting, literature infections such as surveillance progressive multifocal follow-up form for cases of leukoencephalopathy (PML) suspected neurologic symptoms/PML (annex 7) Additional Pharmacovigilance: MLN-0002_401: A postmarketing, prospective, observational, cohort safety study of vedolizumab versus other biologic agents for inflammatory bowel disease C13008: Ongoing long-term safety extension study of patients from Studies C13004, C13006, C13007, and C13011 Malignancies Routine Pharmacovigilance: signal detection, PSURs, AE surveillance and reporting, literature surveillance Additional Pharmacovigilance: MLN-0002_401: A postmarketing, prospective, observational, cohort safety study of vedolizumab versus other biologic agents for inflammatory bowel disease C13008: Ongoing long-term safety extension study of patients from Studies C13004, C13006, C13007, and C13011 Missing information Pregnancy and lactation Routine Pharmacovigilance: signal detection, AE surveillance and reporting, literature Paediatric surveillance Elderly Additional Pharmacovigilance: MLN-0002_401: A Use in patients with postmarketing, prospective, observational, cohort hepatic impairment safety study of vedolizumab versus other biologic agents for inflammatory bowel disease Use in patients with impairment
patients from Studies C13004, C13006, C13007, and C13011 Important potential risks Infections: Gastrointestinal infections and systemic infections against which the gut constitute a defensive barrier Routine Pharmacovigilance: signal detection, AE surveillance and reporting, literature surveillance Additional Pharmacovigilance: MLN-0002_401: A postmarketing, prospective, observational, cohort safety study of vedolizumab versus other biologic agents for inflammatory bowel disease. C13008: Ongoing long-term safety extension study of patients from Studies C13004, C13006, C13007, and C13011 Other serious infections, including opportunistic infections such as progressive multifocal leukoencephalopathy (PML) Routine Pharmacovigilance: signal detection, PSURs, AE surveillance and reporting, literature surveillance follow-up form for cases of suspected neurologic symptoms/PML (annex 7) Additional Pharmacovigilance: MLN-0002_401: A postmarketing, prospective, observational, cohort safety study of vedolizumab versus other biologic agents for inflammatory bowel disease C13008: Ongoing long-term safety extension study of patients from Studies C13004, C13006, C13007, and C13011 Malignancies Routine Pharmacovigilance: signal detection, PSURs, AE surveillance and reporting, literature surveillance Additional Pharmacovigilance: MLN-0002_401: A postmarketing, prospective, observational, cohort safety study of vedolizumab versus other biologic agents for inflammatory bowel disease C13008: Ongoing long-term safety extension study of patients from Studies C13004, C13006, C13007, and C13011 Missing information Pregnancy and lactation Paediatric Elderly Use in patients with hepatic impairment Use in patients with impairment Routine Pharmacovigilance: signal detection, AE surveillance and reporting, literature surveillance Additional Pharmacovigilance: MLN-0002_401: A postmarketing, prospective, observational, cohort safety study of vedolizumab versus other biologic agents for inflammatory bowel disease
auspar-vedolizumab-141117.docx