17 June 2021 EMA/CVMP/PhVWP/10418/2009-Rev.12-corr* 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 * 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 Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. 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New LLT System organ class SOC Preferred term line High level term (HLT) HLT key PT key Low level term (LLT) LLT key term (SOC) term key (PT) no. type1 Application site Application site 1 1 1 Application site blister 3 Application site blister 4 C disorders reactions Application site Application site 2 1 1 Application site burn 934 Application site burn 2063 C disorders reactions Application site Application site Application site Application site 3 1 1 4 5 C disorders reactions erythema erythema Application site Application site Application site Application site 4 1 1 4 1332 C disorders reactions erythema reddening Application site Application site Application site 5 1 1 4 Application site rubra 6 C disorders reactions erythema Application site Application site Application site Application site feather 6 1 1 1016 2603 A disorders reactions feather change change Application site Application site Application site Application site feather 7 1 1 1016 2604 A disorders reactions feather change loss Application site Application site Application site 8 1 1 917 Application site fibrosis 2003 C disorders reactions fibrosis Application site Application site Application site Application site 9 1 1 5 7 C disorders reactions granuloma granuloma Application site Application site Application site 10 1 1 7 Application site bleeding 12 C disorders reactions haemorrhage 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 LLT System organ class SOC Preferred term line High level term (HLT) HLT key PT key Low level term (LLT) LLT key term (SOC) term key (PT) no. type1 Application site Application site Application site 11 1 1 7 Application site bruising 8 C disorders reactions haemorrhage Application site Application site Application site Application site 12 1 1 7 10 C disorders reactions haemorrhage haematoma Application site Application site Application site Application site 13 1 1 7 11 C disorders reactions haemorrhage haemorrhage Application site Application site Application site Application site 14 1 1 7 9 C disorders reactions haemorrhage petechiae Application site Application site Application site hair 15 1 1 2 Application site alopecia 2 C disorders reactions change Application site Application site Application site hair Application site greasy 16 1 1 2 2057 A disorders reactions change fur Application site Application site Application site hair Application site hair 17 1 1 2 1878 C disorders reactions change change Application site Application site Application site hair Application site hair 18 1 1 2 2519 A disorders reactions change coat discolouration Application site Application site Application site hair 19 1 1 2 Application site hair loss 3 C disorders reactions change Application site Application site Application site hair Application site 20 1 1 2 2148 C disorders reactions change leukotrichia 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 LLT System organ class SOC Preferred term line High level term (HLT) HLT key PT key Low level term (LLT) LLT key term (SOC) term key (PT) no. type1 Application site Application site Application site hair 21 1 1 2 Application site residue 2191 C disorders reactions change Application site Application site Application site 22 1 1 918 Application site abscess 2004 C disorders reactions infection Application site Application site Application site Application site 23 1 1 918 2005 C disorders reactions infection infection Application site Application site Application site Application site 24 1 1 8 1934 C disorders reactions inflammation dermatitis Application site Application site Application site 25 1 1 8 Application site eczema 2064 C disorders reactions inflammation Application site Application site Application site Application site 26 1 1 8 13 C disorders reactions inflammation inflammation Application site Application site Application site Application site moist 27 1 1 8 2065 C disorders reactions inflammation eczema Application site Application site Application site 28 1 1 8 Application site rash 1331 C disorders reactions inflammation Application site Application site Application site 29 1 1 8 Application site warmth 2406 C disorders reactions inflammation Application site Application site 30 1 1 Application site lesion 9 Application site crust 16 C disorders reactions 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 LLT System organ class SOC Preferred term line High level term (HLT) HLT key PT key Low level term (LLT) LLT key term (SOC) term key (PT) no. type1 Application site Application site 31 1 1 Application site lesion 9 Application site lesion 14 C disorders reactions Application site Application site 32 1 1 Application site lesion 9 Application site scab 15 C disorders reactions Application site Application site 33 1 1 Application site lesion 9 Application site scar 2518 C disorders reactions Application site Application site 34 1 1 Application site lesion 9 Application site sore 2602 C disorders reactions Application site Application site Application site mass 35 1 1 1152 Application site lump 21 C disorders reactions NOS Application site Application site Application site mass Application site mass 36 1 1 1152 2832 C disorders reactions NOS NOS Application site Application site Application site Application site 37 1 1 mucopurulent 10 17 C disorders reactions mucopurulent discharge discharge Application site Application site Application site 38 1 1 11 Application site necrosis 18 C disorders reactions necrosis Application site Application site Application site 39 1 1 12 Application site oedema 19 C disorders reactions oedema Application site Application site Application site 40 1 1 12 Application site swelling 20 C disorders reactions oedema 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 LLT System organ class SOC Preferred term line High level term (HLT) HLT key PT key Low level term (LLT) LLT key term (SOC) term key (PT) no. type1 Application site Application site Application site burning 41 1 1 Application site pain 13 2555 H disorders reactions sensation Application site Application site 42 1 1 Application site pain 13 Application site pain 22 C disorders reactions Application site Application site Immediate pain upon 43 1 1 Application site pain 13 2408 C disorders reactions application Application site Application site Application site Application site 44 1 1 948 2192 C disorders reactions paraesthesia numbness Application site Application site Application site Application site 45 1 1 948 2112 C disorders reactions paraesthesia paraesthesia Application site Application site Application site 46 1 1 948 Application site tingling 2193 H disorders reactions paraesthesia Application site Application site Application site 47 1 1 14 Application site itching 23 C disorders reactions pruritus Application site Application site Application site 48 1 1 14 Application site pruritus 25 C disorders reactions pruritus Application site Application site Application site Application site 49 1 1 14 26 C disorders reactions pruritus scratching Application site Application site Application site 50 1 1 15 Application site hot spot 2407 A disorders reactions pyoderma 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 LLT System organ class SOC Preferred term line High level term (HLT) HLT key PT key Low level term (LLT) LLT key term (SOC) term key (PT) no. type1 Application site Application site Application site 51 1 1 15 Application site pustule 27 C disorders reactions pyoderma Application site Application site Application site Application site 52 1 1 15 28 C disorders reactions pyoderma pyoderma Application site Application site Application site Application site 53 1 1 16 24 C disorders reactions reaction NOS irritation Application site Application