Combined VeDDRA list of clinical terms for reporting ...

1 * Correction of double spacing in PT 1145: Palpebral oedema (for Allergic oedema see 'Immune system disorders') Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 17 June 2021 EMA/CVMP/PhVWP/10418 * Committee for Medicinal Products for Veterinary Use Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products Revision agreed by Pharmacovigilance Working Party (PhVWP-V) 25-26 May 2021 Adoption by CVMP 15-17 June 2021 Date for coming into effect 1 October 2021 Glossary of abbreviations used in VeDDRA : SOC: System organ class HLT: High level term PT: Preferred term LLT: Low level term NOS: Not otherwise specified LLT term types: A: animal C: common H: human 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009 Page 2/271 New line no.

2 System organ class (SOC) term SOC key High level term (HLT) HLT key Preferred term (PT) PT key Low level term (LLT) LLT key LLT term type1 1 Application site disorders 1 Application site reactions 1 Application site blister 3 Application site blister 4 C 2 Application site disorders 1 Application site reactions 1 Application site burn 934 Application site burn 2063 C 3 Application site disorders 1 Application site reactions 1 Application site erythema 4 Application site erythema 5 C 4 Application site disorders 1 Application site reactions 1 Application site erythema 4 Application site reddening 1332 C 5 Application site disorders 1 Application site reactions 1 Application site erythema 4 Application site rubra 6 C 6 Application site disorders 1 Application site reactions 1 Application site feather change 1016 Application site feather change 2603 A 7 Application site disorders 1 Application site reactions 1 Application site feather change 1016 Application site feather

3 Loss 2604 A 8 Application site disorders 1 Application site reactions 1 Application site fibrosis 917 Application site fibrosis 2003 C 9 Application site disorders 1 Application site reactions 1 Application site granuloma 5 Application site granuloma 7 C 10 Application site disorders 1 Application site reactions 1 Application site haemorrhage 7 Application site bleeding 12 C 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009 Page 3/271 New line no. System organ class (SOC) term SOC key High level term (HLT) HLT key Preferred term (PT) PT key Low level term (LLT) LLT key LLT term type1 11 Application site disorders 1 Application site reactions 1 Application site haemorrhage 7 Application site bruising 8 C 12 Application site disorders 1 Application site reactions 1 Application site haemorrhage 7 Application site haematoma 10 C 13 Application site disorders 1 Application site reactions 1 Application site haemorrhage 7 Application site haemorrhage 11 C 14 Application site disorders 1 Application site reactions 1 Application site haemorrhage 7 Application site petechiae 9 C 15 Application site disorders 1 Application site reactions 1 Application site hair change 2 Application site alopecia 2 C 16 Application site disorders 1 Application site reactions 1 Application site hair change 2 Application site greasy fur 2057 A 17 Application site disorders 1 Application site reactions 1 Application site hair change 2

4 Application site hair change 1878 C 18 Application site disorders 1 Application site reactions 1 Application site hair change 2 Application site hair coat discolouration 2519 A 19 Application site disorders 1 Application site reactions 1 Application site hair change 2 Application site hair loss 3 C 20 Application site disorders 1 Application site reactions 1 Application site hair change 2 Application site leukotrichia 2148 C 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009 Page 4/271 New line no. System organ class (SOC) term SOC key High level term (HLT) HLT key Preferred term (PT) PT key Low level term (LLT) LLT key LLT term type1 21 Application site disorders 1 Application site reactions 1 Application site hair change 2 Application site residue 2191 C 22 Application site disorders 1 Application site reactions 1 Application site infection 918 Application site abscess 2004 C 23 Application site disorders 1 Application site reactions 1 Application site infection 918 Application site infection 2005 C 24 Application site disorders 1 Application site reactions 1 Application site inflammation 8 Application site dermatitis 1934 C 25 Application site disorders 1 Application site reactions 1 Application site inflammation 8 Application site eczema 2064 C 26 Application site disorders 1 Application site reactions 1 Application site inflammation 8 Application site inflammation 13 C 27 Application site disorders 1 Application site reactions 1 Application site

5 Inflammation 8 Application site moist eczema 2065 C 28 Application site disorders 1 Application site reactions 1 Application site inflammation 8 Application site rash 1331 C 29 Application site disorders 1 Application site reactions 1 Application site inflammation 8 Application site warmth 2406 C 30 Application site disorders 1 Application site reactions 1 Application site lesion 9 Application site crust 16 C 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009 Page 5/271 New line no. System organ class (SOC) term SOC key High level term (HLT) HLT key Preferred term (PT) PT key Low level term (LLT) LLT key LLT term type1 31 Application site disorders 1 Application site reactions 1 Application site lesion 9 Application site lesion 14 C 32 Application site disorders 1 Application site reactions 1 Application site lesion 9 Application site scab 15 C 33 Application site disorders 1 Application site reactions 1 Application site lesion 9 Application site scar 2518 C 34 Application site disorders 1 Application site reactions 1 Application site lesion 9 Application site sore 2602 C 35 Application site disorders 1 Application site reactions 1 Application site mass NOS 1152 Application site lump 21 C 36 Application site disorders 1 Application site reactions 1 Application site mass NOS 1152 Application site mass NOS 2832 C 37 Application site disorders 1 Application site reactions 1 Application site mucopurulent discharge 10 Application site mucopurulent

6 Discharge 17 C 38 Application site disorders 1 Application site reactions 1 Application site necrosis 11 Application site necrosis 18 C 39 Application site disorders 1 Application site reactions 1 Application site oedema 12 Application site oedema 19 C 40 Application site disorders 1 Application site reactions 1 Application site oedema 12 Application site swelling 20 C 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009 Page 6/271 New line no. System organ class (SOC) term SOC key High level term (HLT) HLT key Preferred term (PT) PT key Low level term (LLT) LLT key LLT term type1 41 Application site disorders 1 Application site reactions 1 Application site pain 13 Application site burning sensation 2555 H 42 Application site disorders 1 Application site reactions 1 Application site pain 13 Application site pain 22 C 43 Application site disorders 1 Application site reactions 1 Application site pain 13 Immediate pain upon application 2408 C 44 Application site disorders 1 Application site reactions 1 Application site paraesthesia 948 Application site numbness 2192 C 45 Application site disorders 1 Application site reactions 1 Application site paraesthesia 948 Application site paraesthesia 2112 C 46 Application site disorders 1 Application site reactions 1 Application site paraesthesia 948 Application site tingling 2193 H 47 Application site disorders 1 Application site reactions 1 Application site pruritus 14

7 Application site itching 23 C 48 Application site disorders 1 Application site reactions 1 Application site pruritus 14 Application site pruritus 25 C 49 Application site disorders 1 Application site reactions 1 Application site pruritus 14 Application site scratching 26 C 50 Application site disorders 1 Application site reactions 1 Application site pyoderma 15 Application site hot spot 2407 A 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009 Page 7/271 New line no. System organ class (SOC) term SOC key High level term (HLT) HLT key Preferred term (PT) PT key Low level term (LLT) LLT key LLT term type1 51 Application site disorders 1 Application site reactions 1 Application site pyoderma 15 Application site pustule 27 C 52 Application site disorders 1 Application site reactions 1 Application site pyoderma 15 Application site pyoderma 28 C 53 Application site disorders 1 Application site reactions 1 Application site reaction NOS 16 Application site irritation 24 C 54 Application site disorders 1 Application site reactions 1 Application site reaction NOS 16 Application site reaction NOS 29 C 55 Application site disorders 1 Application site reactions 1 Application site sarcoma 17 Application site sarcoma 30 C 56 Application site disorders 1 Application site reactions 1 Application site self trauma 18 Application site excoriation 2194 C 57 Application site disorders 1 Application site reactions 1 Application site self trauma 18

8 Application site self trauma 31 C 58 Application site disorders 1 Application site reactions 1 Application site self trauma 18 Licking at application site 1973 A 59 Application site disorders 1 Application site reactions 1 Application site serosanguinous discharge 19 Application site serosanguinous discharge 33 C 60 Application site disorders 1 Application site reactions 1 Application site serosanguinous discharge 19 Application site weeping (see also 'skin') 32 C 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009 Page 8/271 New line no. System organ class (SOC) term SOC key High level term (HLT) HLT key Preferred term (PT) PT key Low level term (LLT) LLT key LLT term type1 61 Application site disorders 1 Application site reactions 1 Application site serous discharge 20 Application site serous discharge 34 C 62 Application site disorders 1 Application site reactions 1 Application site skin change 963 Application site dry skin 2514 C 63 Application site disorders 1 Application site reactions 1 Application site skin change 963 Application site hyperkeratosis 2516 C 64 Application site disorders 1 Application site reactions 1 Application site skin change 963 Application site papule 2195 C 65 Application site disorders 1 Application site reactions 1 Application site skin change 963 Application site pigmentation disorders 2517 C 66 Application site disorders 1 Application site reactions 1 Application site skin change 963 Application site skin change NOS 2200 C 67 Application site disorders 1 Application

9 Site reactions 1 Application site skin change 963 Application site skin discolouration 2197 C 68 Application site disorders 1 Application site reactions 1 Application site skin change 963 Application site skin scaling 2198 C 69 Application site disorders 1 Application site reactions 1 Application site skin change 963 Application site skin squamosis 2199 C 70 Application site disorders 1 Application site reactions 1 Application site skin change 963 Application site stickiness 2750 C 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009 Page 9/271 New line no. System organ class (SOC) term SOC key High level term (HLT) HLT key Preferred term (PT) PT key Low level term (LLT) LLT key LLT term type1 71 Application site disorders 1 Application site reactions 1 Application site skin change 963 Application site thickening 2515 C 72 Application site disorders 1 Application site reactions 1 Application site twitching 964 Application site twitching 2196 C 73 Applicat