PSUR line listing template - PSUR Line listing for suspected adverse events in animals VETERINARY PHARMACOVIGILANCE SCHEME - PERIODIC SAFETY UPDATE REPORT MARKETING AUTHORISATION HOLDER FORM FOR REPORTS OF ANIMAL ADVERSE EVENTS TO A VETERINARY MEDICINAL PRODUCT PRODUCT: MARKETING AUTHORISATION HOLDER: Marketing AUTHORISATION NO: PERIOD OF REPORT FROM .../.../... TO .../.../.... MAH CA Case DATE OF DATE OF NO. SPECIES NO. NO. WAS PRODUCT OTHER VeDDRA BRIEF CAUSALITY CASE REF Ref EVENT TREATED AND AGE REACTED DIED USED AS PRODUCTS INFORMATIVE (ABON (Juv/Adult) (a) (b) RECOMMENDED USED NARRATIVE CODE) YES/NO AND MAH CONCLUSION EEA (Please (Please REPORTS ensure that ensure that this total is this total is (COUNTRY put in) put in) CODE ID + NAME & COUNTRY) OVERALL TOTAL OF ALL (EEA) PAGES Total no of (reports): Total no of animal reactions (a): Total no of animals died (b): MAH CA Case DATE OF DATE OF NO. SPECIES NO. NO. WAS PRODUCT OTHER VeDDRA BRIEF CAUSALITY CASE REF Ref EVENT TREATED AND AGE REACTED DIED USED AS PRODUCTS INFORMATIVE (ABON (Juv/Adult) (a) (b) RECOMMENDED USED NARRATIVE CODE) YES/NO AND MAH CONCLUSION
PSUR line listing template - PSUR Line listing for suspected adverse events in animals VETERINARY PHARMACOVIGILANCE SCHEME - PERIODIC SAFETY UPDATE REPORT MARKETING AUTHORISATION HOLDER FORM FOR REPORTS OF ANIMAL ADVERSE EVENTS TO A VETERINARY MEDICINAL PRODUCT PRODUCT: MARKETING AUTHORISATION HOLDER: Marketing AUTHORISATION NO: PERIOD OF REPORT FROM .../.../... TO .../.../.... MAH CASE REF CA Case Ref DATE OF DATE OF EVENT NO. TREATED SPECIES AND AGE (Juv/Adult) NO. REACTED (a) NO. DIED (b) WAS PRODUCT USED AS RECOMMENDED YES/NO OTHER PRODUCTS USED VeDDRA BRIEF INFORMATIVE NARRATIVE AND MAH CONCLUSION CAUSALITY (ABON CODE) EEA REPORTS (COUNTRY CODE ID + NAME & COUNTRY) (Please ensure that this total is put in) (Please ensure that this total is put in) OVERALL TOTAL OF ALL (EEA) PAGES Total no of (reports): Total no of animal reactions (a): Total no of animals died (b): MAH CASE REF CA Case Ref DATE OF DATE OF EVENT NO. TREATED SPECIES AND AGE (Juv/Adult) NO. REACTED (a) NO. DIED (b) WAS PRODUCT USED AS RECOMMENDED YES/NO OTHER PRODUCTS USED VeDDRA BRIEF INFORMATIVE NARRATIVE AND MAH CONCLUSION CAUSALITY (ABON CODE)
957640_PSUR_Template.DOCX