<Competent Authority Logo> Select assessment report <PSUR type - choose from drop down list> for Medicinal product for veterinary use <PRODUCT NAME> Active substance(s)/international non-proprietary name(s): <Insert INN> Marketing authorisation holder(s): <NAME> Authorisation type <and procedure number, if applicable>: <Choose from drop down list> MA number(s): <Insert number> Time period covered in the PSUR: DD-MM-YYYY - DD-MM-YYYY Author: <NAME> <Reference Member State, if applicable:> <Concerned Member State(s), if applicable:> <Date of assessment report [day – month – year] Date of submission for next PSUR [day – month – year]> <Attachment: Latest approved Summary of Product Characteristics> 1. Data review [Very brief and conclusive overall summary of available reports or statement of their absence. Detailed summary descriptions of specific parts of the data would only be introduced in support of questions or comments to the MAH on the data, or to support conclusions for recommended actions. N.B. Lack of expected efficacy is defined according to recommended use of the product. Concerning Tables, please follow instructions in Annex] 1.1. Adverse events in target species [including events of lack of expected efficacy and those events occurring after off-label use in target species] 1.1.1. After recommended use 1.1.2. After non-recommended use [off-label, including overdose] 1.2. Adverse events in humans 1.3. Other pharmacovigilance fields 1.3.1. Adverse events in non-target species 1.3.2. Potential environmental problems 1.3.3. Investigations of the validity of withdrawal periods 1.3.4. Transmission of infectious agents Page 2/8 1.4. Non-spontaneous reports [overview of available data from other sources e.g. pre-authorisation studies, post authorisation safety studies, published adverse event reports] 1.5. Other information [Adverse events arising from prescription errors or medication errors, including those due to invented names of veterinary medicinal products (VMPs) or similar appearance (e.g. mix-up with another VMP)] 1.6. Exposure [i.e. No. of animals treated based on ‘standard’ use of the product. Where applicable, by presentation, target species or categories (e.g. cattle and calves); Refer to Volume 9B (when available) for standardised bodyweights] 1.7. Incidence [1) Crude world-wide ratio (number of animals:number of doses) (A, B or O, including O1, N); 2) Incidence. Mainly, it is important that there is consistency in the approach to incidence calculation between PSURs for the product in question. N.B. consider if there is an unusually high proportional number of reports coded as unlikely related (N) or unassessable (O) as it may indicate a signal or a systematic bias] 2. Evaluation of the adverse reactions in view of the warnings included in the SPC [Consider also any increases in incidence relative to previous PSURs and comment on assessment of MAH’s benefit-risk evaluation]. <There is <no> concern to be addressed via amendment of the product literature regarding> evidence of previously unidentified toxicity or safety concerns, <a> change in frequency of known toxicity or expected undesirable effects, evidence of veterinary medicinal product (VMP) interactions, evidence of new undesirable effects associated with off-label use, including aspects of overdose Page 3/8 evidence of clinical human symptoms associated with the use of the product, evidence of lack of expected efficacy, [See Volume 6C http://ec.europa.eu/health/documents/eudralex/vol-6/index_en.htm]> and therefore the following sections of the SPC need to be amended as follows: 3. Overall conclusion <As no adverse effect was observed so far, there are no changes to the evaluation of the benefits and risks afforded by the product. The MAH has concluded that the benefit-risk balance <remains unchanged, has changed> and that <the following, no> actions are necessary: <insert actions> The conclusion of this assessment is <not> in agreement with the conclusion of the MAH <and actions are recommended as listed below>. <e.g. amendments to the SPC (as detailed in Section 2), advice is requested from the PhVWP-V, other [to be specified]> 4. Questions or comments to be addressed to the MAH [If there are questions or comments for the MAH to address prior to finalisation of the AR, the draft AR will be forwarded with the request to the MAH] <There are no questions/comments to be addressed to the MAH.> 5. Recommended action [Consider if there is a need for action e.g. amendments to the SPC (as detailed previously in Section 2), recommendations to MAH in view of preparations of future PSURs, other action (please specify)] <No changes to the product literature or other regulatory actions are necessary.> Page 4/8 Annex: table(s) [delete annex if no tables are needed for this PSUR Assessment Report] [This section includes templates for tables for use if necessary. The table templates below are included as examples for those situations when the assessor feels some of the MAH data from the PSUR needs to be presented in the assessment report. Data should be presented only when it is necessary to explain or clarify an issue that is likely to lead to a question or recommendation to the MAH or would require some other specific action. In such circumstances any suitable template table should be completed in Annex and reference to the table(s) included in the text of the assessment report. The assessor may create other, more suitable tables. Data should not be routinely presented in the assessment report, but reference to data in the PSUR should be sufficient in most circumstances.] Table 1: Comparison over time of the ratio of animals reported for <SARs, lack of expected efficacy> during a period to the amount of product sold by period <and by year, if data is available> Period PSUR 1 <Year PSUR 2 Year Year Year Year Year> Number of animals <reacting, experiencing lack of efficacy> during the period <Number of doses sold during period, sales volume*> (<insert sort e.g. Litres, Doses>) Ratio (number of animals : number of doses) * Sales volume only where it is not feasible to estimate the number of doses. Every attempt should be made to estimate the doses sold. Table 2: Sales volume, estimated number of treated animals, number of animals reacting (animal count) and incidence of suspected adverse reactions during the reporting period by country and region Country* Total sales Number of animals Number of animals volume treated ** reacted in SARs Incidence*** assessed A, B or O Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Page 5/8 Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden United Kingdom Iceland Liechtenstein Norway Total EU/EEA Third countries Total * This table includes details only on those countries of the EU/EEA where the product has been sold during the reporting period. Countries with zero (0) sales have been deleted. ** <please explain here assumptions underlying the estimated number of treated animals > *** <please explain here the assumptions underlying the incidence calculation– see also Volume 9 of the Rules governing medicinal products in the European Union, Part II. 1. Pharmacovigilance of Veterinary Medicinal Products – Notice to Marketing Authorisation Holders (to be replaced by Volume 9B, when available)> Table 3: Report, animal and mortality count for all reports received on any suspected adverse reaction during the reporting period in any species, including human beings. All causality categories (A,B,O,N) are included. Reports Community (EU/EEA) Third Countries (Non EU/EEA) Reports Number of reported Deaths Reports Number of reported Deaths (N) animals (N) (N) (N) animals (N) (N) Target species Non-target species Human Total Table 4. Report count of serious and non-serious suspected adverse reactions reports received during the period. All causality categories (A, B, O, N) are included. This table excludes reports of lack of expected efficacy Use of product Category of species As recommended in <Insert Target SPC species> Number of reports Serious Non-serious Total Page 6/8 Off label use <Insert Target species> <Insert Non-Target species. Unknown <Insert Target species> Total All Table 5: Number of animals affected and nature of reports by causality category in <non->target species received during the reporting period (animal count) Reports A (probable) + B (possible) + N (unlikely) O (unclassifiable) Number of reported Deaths Number of reported Deaths animals (N) (N) animals (N) (N) Suspected adverse reactions Lack of expected efficacy Total Table 6: Number and nature of suspected adverse reactions in any species received during the PSUR period (report, animal and mortality count) Reports Community (EU/EEA) Third Countries (Non EU/EEA) Reports Number of Deaths Reports Number of Deaths (N) reported (N) (N) reported (N) animals (N) animals (N) Target species Used as recommended Off label use Unknown Non-target species Total Page 7/8 Table 7: Event count of clinical signs reported as <Serious, Serious unexpected, Non-serious unexpected (unlisted)> adverse reactions (animal count) by species and VeDDRA terminology Species Clinical sign Number of events* VeDDRA terms, <SOC, HLT, PT > level * Number of times the clinical sign was reported (i.e. occurrences, citations, occasions etc.) Page 8/8