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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 PERIOD OF REPORT FROM. /. /. MAH CASE REF CA CASE REF DATE OF TREATMENT/ VACCINATION EVENT NO. TREATED SPECIES AND AGE JUV/ADULT TO. /. /. a DIED b USED AS RECOMMENDED YES/NO OTHER PRODUCTS USED CONCURRENTLY VeDDRA PRESENTING SIGNS/ DIAGNOSIS Please ensure that this total is put in EEA REPORTS Country Code Organisation ID Case Number Ref Name Country BRIEF INFORMATIVE NARRATIVE AND MAH CONCLUSIONS CAUSALITY ABON CODE Please ensure these sections are completed OVERALL TOTAL OF ALL EEA PAGES Total no. of reports Total no. of animal reactions a THIRD COUNTRY FOR COMPETENT AUTHORITY USE ONLY REFERENCE VOLUME 9B Annexes 349758 DATE OF RECEIPT 140/165 HUMAN CA CASE NAME S OR UNIQUE PATIENT S IDENTIFICATION OCCUPATION EXPOSURE NATURE OF ACCIDENT/ VeDDRA REACTION/ SYMPTOMS OUTCOME OF BRIEF INFORMATIVE NUMBER OF INCIDENTS As appropriate according to national laws. /. /. MAH CASE REF CA CASE REF DATE OF TREATMENT/ VACCINATION EVENT NO. TREATED SPECIES AND AGE JUV/ADULT TO. /. /. a DIED b USED AS RECOMMENDED YES/NO OTHER PRODUCTS USED CONCURRENTLY VeDDRA PRESENTING SIGNS/ DIAGNOSIS Please ensure that this total is put in EEA REPORTS Country Code Organisation ID Case Number Ref Name Country BRIEF INFORMATIVE NARRATIVE AND MAH CONCLUSIONS CAUSALITY ABON CODE Please ensure these sections are completed OVERALL TOTAL OF ALL EEA PAGES Total no. /. /. a DIED b USED AS RECOMMENDED YES/NO OTHER PRODUCTS USED CONCURRENTLY VeDDRA PRESENTING SIGNS/ DIAGNOSIS Please ensure that this total is put in EEA REPORTS Country Code Organisation ID Case Number Ref Name Country BRIEF INFORMATIVE NARRATIVE AND MAH CONCLUSIONS CAUSALITY ABON CODE Please ensure these sections are completed OVERALL TOTAL OF ALL EEA PAGES Total no. of reports Total no. of animal reactions a THIRD COUNTRY FOR COMPETENT AUTHORITY USE ONLY REFERENCE VOLUME 9B Annexes 349758 DATE OF RECEIPT 140/165 HUMAN CA CASE NAME S OR UNIQUE PATIENT S IDENTIFICATION OCCUPATION EXPOSURE NATURE OF ACCIDENT/ VeDDRA REACTION/ SYMPTOMS OUTCOME OF BRIEF INFORMATIVE NUMBER OF INCIDENTS As appropriate according to national laws. /. /. MAH CASE REF CA CASE REF DATE OF TREATMENT/ VACCINATION EVENT NO. TREATED SPECIES AND AGE JUV/ADULT TO. /. /. a DIED b USED AS RECOMMENDED YES/NO OTHER PRODUCTS USED CONCURRENTLY VeDDRA PRESENTING SIGNS/ DIAGNOSIS Please ensure that this total is put in EEA REPORTS Country Code Organisation ID Case Number Ref Name Country BRIEF INFORMATIVE NARRATIVE AND MAH CONCLUSIONS CAUSALITY ABON CODE Please ensure these sections are completed OVERALL TOTAL OF ALL EEA PAGES Total no. of reports Total no. of animal reactions a THIRD COUNTRY FOR COMPETENT AUTHORITY USE ONLY REFERENCE VOLUME 9B Annexes 349758 DATE OF RECEIPT 140/165 HUMAN CA CASE NAME S OR UNIQUE PATIENT S IDENTIFICATION OCCUPATION EXPOSURE NATURE OF ACCIDENT/ VeDDRA REACTION/ SYMPTOMS OUTCOME OF BRIEF INFORMATIVE NUMBER OF INCIDENTS As appropriate according to national laws.

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