15 June 2017 EMA/CVMP/PhVWP/251718/2017 Committee for Medicinal Products for Veterinary Use

List of changes to combined VeDDRA list of clinical terms

9

Application site sore

2602

Current Term Type1

Current LLT Key

Current Low Level Term (LLT)

New PT Key

New PT Term

Current PT Key

New HLT Key

Current Preferred Term (PT) Application site lesion

1: A: animal; C: common; H: human 2: A: addition; D: deletion; M: modification

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Action2

1

New Term Type1

Application site reactions

New HLT Term

Current HLT Key

Current High Level Term (HLT)

New SOC Key

New SOC Term

Current SOC Key 1

New LLT Key

Application site disorders

New LLT

1

Current System Organ Class (SOC) Term

Change no.

For reporting suspected adverse reactions in animal and humans to veterinary medicinal products for 2017

C

A

Action2

Application site disorders

1

Application site reactions

1

Application site feather change

1016

Application site feather loss

2604

A

A

4

Application site disorders

1

Injection site reactions

3

Injection site nodule

2605

C

A

5

Application site disorders

1

Injection site reactions

3

Injection site feather change

1017

Injection site feather change

2606

A

A

6

Application site disorders

1

Injection site reactions

3

Injection site feather change

1017

Injection site feather loss

2607

A

A

7

Skin and appendages disorders

18

Epidermal and dermal disorders

237

Biting - pruritus (see also 'Behavioural disorders')

2608

C

A

1 2

Injection site reaction NOS

Pruritus

59

577

New LLT Key

3

New LLT

A

Current LLT Key

A

New PT Key

2603

New PT Term

Application site feather change

Current PT Key

1016

New HLT Key

Application site feather change

New HLT Term

1

Current HLT Key

Application site reactions

New SOC Key

1

New SOC Term

New Term Type1

Current Term Type1

Current Low Level Term (LLT)

Current Preferred Term (PT)

Current High Level Term (HLT)

Current SOC Key

Current System Organ Class (SOC) Term Application site disorders

Change no. 2

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 2/15

Other behavioural disorders

6

Anxiety

10

Behavioural disorders

2

Other behavioural disorders

6

11

Behavioural disorders

2

Neurological disorders

14

Other behavioural disorders

6

Mental impairment

12

Behavioural disorders

2

Neurological disorders

14

Other behavioural disorders

6

Mental impairment

13

Neurological disorders

14

Mental impairment

217

1 2

2609

A

A

Anxiety

70

Panic

2610

A

A

217

Disorientation

401

Confusion

659

A

M

217

Disorientation

401

Disorientation

660

A

M

Mental confusion

747

Disoriented state

1418

C

M

Disorientation

401

Action2

Attention-seeking behaviour

New Term Type1

70

New LLT

A

New PT Key

112

New PT Term

Biting -aggression (see also 'Skin and appendages disorders')

New HLT Key

Current SOC Key

112

Current Term Type1

2

Biting

New LLT Key

Behavioural disorders

Current LLT Key

9

Current Low Level Term (LLT)

Current PT Key 69

New HLT Term

Aggression

Current HLT Key

Current Preferred Term (PT)

Current High Level Term (HLT)

6

New SOC Key

Other behavioural disorders

New SOC Term

2

Current System Organ Class (SOC) Term Behavioural disorders

Change no. 8

M

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 3/15

Behavioural disorders

2

Sleep disturbance

9

Sleep disturbance NOS

83

17

Blood and lymphatic system disorders

3

Disorders of red blood cells

212

Disorder of red blood cell NOS

745

18

Blood and lymphatic system disorders

3

Lymph node disorders

18

Lymphadenopathy

108

Enlarged lymph node

19

Blood and lymphatic system disorders

3

Lymph node disorders

18

Lymphadenopathy

108

Enlarged lymph node(s)

1 2

Respiratory tract disorders

17

Nasal cavity and sinus disorders

135

Nasal cavity disorder NOS

809

652

Snoring

2506

Circling - neurological disorder (see also 'Behavioural disorders')

652

Current SOC Key

Action2

16

Circling

2611

New Term Type1

400

Circling - behavioural disorder (see also 'Neurological disorders')

Current Term Type1

Ataxia

New LLT Key

98

New LLT

Coordination and balance signs

Current LLT Key

Current Low Level Term (LLT)

14

New PT Key

Neurological disorders

New PT Term

Current PT Key

15

New HLT Key

73

New HLT Term

Hyperactivity

Current HLT Key

Current Preferred Term (PT)

Current High Level Term (HLT)

6

New SOC Key

Other behavioural disorders

New SOC Term

2

Current System Organ Class (SOC) Term Behavioural disorders

Change no. 14

C

A

C

M

A

M

Spherocytosis

2612

C

A

2405

Enlarged lymph node (localised)

2405

C

M

2426

Enlarged lymph nodes (generalised)

2426

C

M

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 4/15

New Term Type1

Action2

Praying position

2615

C

A

28

Fluid in abdomen

627

Abdominal exudate

2616

C

A

Abdominal cavity disorders

28

Fluid in abdomen

627

Abdominal transudate

2617

C

A

Oral cavity disorders

34

Chewing

632

Chewing - oral cavity disorder (see also 'Pruritus')

1073

4

Circulatory disorders

24

Hypotension

22

Digestive tract disorders

5

Abdominal cavity disorders

28

23

Digestive tract disorders

5

Abdominal cavity disorders

24

Digestive tract disorders

5

25

Digestive tract disorders

5

2

Current Term Type1

163

Cardiovascular system disorders

Chewing

1073

New LLT Key

Abdominal pain

21

1018

New LLT

A

Increased red blood cell count

Current LLT Key

C

19

New PT Key

2614

Other blood disorders

New PT Term

Hypovolaemia

3

Current PT Key 139

New HLT Key

A

New HLT Term

C

Current HLT Key

2613

Blood and lymphatic system disorders

1

Current Low Level Term (LLT)

Current Preferred Term (PT)

Current High Level Term (HLT)

New SOC Key

New SOC Term

Current SOC Key

Current System Organ Class (SOC) Term

Change no.

Increased red blood cell count

20

C

M

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 5/15

Action2

5

Ruminant stomach disorders

36

Ruminant stomach disorder

202

Decreased ruminal activity

2619

A

A

28

Ear and labyrinth disorders

6

External ear disorders

41

External ear disorder NOS

223

Pinnal ulcer

2620

C

A

29

Ear and labyrinth disorders

6

Middle ear disorders

44

Tympanic alteration

1019

Tympanic alteration

2621

C

A

30

Ear and labyrinth disorders

6

Middle ear disorders

44

Tympanic alteration

1019

Tympanic discoloration

2622

C

A

31

Ear and labyrinth disorders

6

Middle ear disorders

44

Tympanic alteration

1019

Tympanic opacity

2623

C

A

1 2

Current SOC Key

Current Term Type1

Digestive tract disorders

New LLT Key

27

New LLT

A

Current LLT Key

New Term Type1

Current Low Level Term (LLT)

C

New PT Key

2618

New PT Term

Current PT Key

Chewing - pruritus (see also 'Oral cavity disorders')

New HLT Key

577

New HLT Term

Pruritus

Current HLT Key

Current Preferred Term (PT)

Current High Level Term (HLT)

237

New SOC Key

Epidermal and dermal disorders

New SOC Term

18

Current System Organ Class (SOC) Term Skin and appendages disorders

Change no. 26

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 6/15

New Term Type1

Action2

Current Term Type1

New LLT Key

A

33

Endocrine system disorders

7

Adrenal gland disorders

45

Hypoadrenocorticism

237

Hypocortisolaemia

2625

C

A

34

Hepato-biliary disorders

9

Gall bladder and bile duct disorders

65

Gall bladder mucocele

1020

Biliary sludge

2626

C

A

35

Hepato-biliary disorders

9

Gall bladder and bile duct disorders

65

Gall bladder mucocele

1020

Gall bladder mucocele

2627

C

A

36

Hepato-biliary disorders

9

Hepato-biliary neoplasms

69

Hepatic neoplasm

507

37

Impaired consciousness

99

Impaired consciousness

99

1 2

Systemic disorder

19

General signs or symptoms

154

Current LLT Key

C

New PT Key

2624

New PT Term

Hypercortisolaemia

Current PT Key 236

New HLT Key

Hyperadrenocorticism

New HLT Term

45

Current HLT Key

Adrenal gland disorders

New SOC Key

7

New SOC Term

New LLT

Current Low Level Term (LLT)

Current Preferred Term (PT)

Current High Level Term (HLT)

Current SOC Key

Current System Organ Class (SOC) Term Endocrine system disorders

Change no. 32

Hepato-biliary neoplasm

100 9

Hepatic neoplasm

2575

Dysphoria

997

Dysphoria

2531

C

M

C

M

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 7/15

New LLT Key

New Term Type1

Action2

12

Electrolyte and fluid balance disorders

79

Electrolyte disorder

951

High sodiumpotassium ratio (Na:K ratio)

2629

C

A

40

Metabolism and nutrition disorders

12

Electrolyte and fluid balance disorders

79

Electrolyte disorder

951

Low sodiumpotassium ratio (Na:K ratio)

2630

C

A

41

Metabolism and nutrition disorders

12

Electrolyte and fluid balance disorders

79

Electrolyte disorder

951

Hyperkalemic condition

1944

Hyperkalaemia

1944

C

42

Metabolism and nutrition disorders

12

Electrolyte and fluid balance disorders

79

Electrolyte disorder

951

Hypokalemic condition

1945

Hypokalaemia

2418

A

43

Musculoskeletal disorders

13

Muscular disorders

89

Myositis

376

Polymyositis

2631

1 2

Current SOC Key

Current Term Type1

New LLT

Metabolism and nutrition disorders

Current LLT Key

39

Current Low Level Term (LLT)

A

New PT Key

A

New PT Term

2628

Current PT Key

Teat ulcer

Current Preferred Term (PT)

334

New HLT Key

Current HLT Key

External teat disorder

New HLT Term

Current High Level Term (HLT)

77

New SOC Key

Teat disorders

New SOC Term

11

Current System Organ Class (SOC) Term Mammary gland disorders

Change no. 38

M

C

M

C

A

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 8/15

14

46

Systemic disorders

47

98

19

General signs or symptoms

Neurological disorders

14

48

Neurological disorders

49

Neurological disorders

1 2

2632

Current Term Type1

Current LLT Key

Current Low Level Term (LLT)

New PT Key

New PT Term

Current PT Key

Current Preferred Term (PT)

New HLT Key

New HLT Term

Current HLT Key

Coordination and balance signs

Plantigrade posture

Action2

Neurological disorders

Current High Level Term (HLT)

90

New Term Type1

45

New SOC Key

Musculoskeletal disorders

New LLT Key

13

New LLT

Musculoskeletal disorders

New SOC Term

Current SOC Key

Current System Organ Class (SOC) Term

Change no. 44

A

A

Musculoskeletal disorder NOS

640

Abnormal posture NOS

644

154

Abnormal posture NOS

644

Wide-base stance

2633

C

A

Coordination and balance signs

98

Ataxia

400

Cerebellar ataxia

2634

C

A

14

Impaired consciousness

99

Impaired consciousness

663

Staring

2635

C

A

14

Impaired consciousness

99

Impaired consciousness

663

Vacant

2636

C

A

Systemic disorders

19

General signs or symptoms

154

Abnormal posture NOS

1132

C

M

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 9/15

Cardiovascular system disorders

4

Circulatory disorders

24

Circulatory shock

137

Circulatory collapse

223

Circulatory collapse (see also 'Neurological' and 'Systemic disorders')

223

C

M

52

Systemic disorders

19

General signs or symptoms

154

Collapse NOS

599

Collapse NOS (see also 'Cardio-vascular')

1001

Collapse NOS (see also 'Cardio-vascular' and 'Neurological disorders')

1001

C

M

53

Neurological disorders

14

Neuromuscular disorders

101

Nystagmus

414

Rotatory nystagmus

2637

C

A

54

Neurological disorders

14

Neuromuscular disorders

101

Nystagmus

414

Vertical nystagmus

2638

C

A

55

Renal and urinary disorders

15

Urinary bladder disorders

109

Urinary retention

437

Bladder distension

2639

C

A

1 2

Current SOC Key

Action2

Current Term Type1

51

New Term Type1

New LLT Key

M

New LLT

Current LLT Key

C

New PT Key

668

New PT Term

Collapse (see also 'Cardio-vascular' and 'Systemic disorders')

Current PT Key

668

Current Preferred Term (PT)

Collapse

New HLT Key

405

New HLT Term

Loss of consciousness

Current HLT Key

Current Low Level Term (LLT)

Current High Level Term (HLT)

99

New SOC Key

Impaired consciousness

New SOC Term

14

Current System Organ Class (SOC) Term Neurological disorders

Change no. 50

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 10/15

Reproductive system disorders

16

Scrotal and penile disorders

127

Preputial oedema

58

Respiratory tract disorders

17

Bronchial and lung disorders

132

59

Respiratory tract disorders

17

Nasal cavity and sinus disorders

135

60

Respiratory tract disorders

17

Thoracic cavity disorders

61

Respiratory tract disorders

17

Thoracic cavity disorders

1 2

A

Dyspnoea

506

Orthopnoea

2641

C

A

Rhinitis

522

140

Hydrothorax

535

Thoracic exudate

2642

C

A

140

Hydrothorax

535

Thoracic transudate

2643

C

A

Respiratory tract disorders

138

Respiratory tract disorder NOS

650

Nasal discharge

871

Action2

C

New Term Type1

2640

New LLT Sheath oedema

New PT Key

998

New PT Term

A

New HLT Key

1913

New HLT Term

Oestrus following foetal resorption

Current HLT Key

Current SOC Key

1913

Current Term Type1

57

Oestrus

New LLT Key

468

Current LLT Key

Current PT Key

Foetal resorption

Current Low Level Term (LLT)

Current Preferred Term (PT)

Current High Level Term (HLT)

125

New SOC Key

Pregnancy and parturition

New SOC Term

16

Current System Organ Class (SOC) Term Reproductive system disorders

Change no. 56

M

C

M

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 11/15

Respiratory tract disorders

17

Tracheal and laryngeal disorders

137

Tracheitis

531

Tracheal oedema

2644

C

A

64

Systemic disorders

19

General signs or symptoms

154

Malaise

608

Quiet

2645

C

A

65

Systemic disorders

19

General signs or symptoms

154

Malaise

608

Subdued

2646

C

A

66

Systemic disorders

19

General signs or symptoms

154

Suspected reversal to virulence

2647

A

A

67

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy (bacteria NOS)

2648

A

A

1 2

Suspected reversal to virulence

Lack of efficacy

614

1021

C

Current SOC Key

Action2

Current LLT Key

63

New Term Type1

Current Low Level Term (LLT)

1184

Current Term Type1

New PT Key

Pleural effusion

New LLT Key

New PT Term

535

New LLT

Current PT Key

Hydrothorax

New HLT Key

536

New HLT Term

Pleuritis

Current HLT Key

Current Preferred Term (PT)

Current High Level Term (HLT)

140

New SOC Key

Thoracic cavity disorders

New SOC Term

17

Current System Organ Class (SOC) Term Respiratory tract disorders

Change no. 62

M

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 12/15

New Term Type1

Action2

69

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (ectoparasite)

2436

Lack of efficacy (endoparasite NOS)

2436

A

M

70

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (flea)

2649

A

A

71

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (fly)

2650

A

A

72

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (lice)

2651

A

A

73

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (mite)

2652

A

A

1 2

Current SOC Key

Current Term Type1

M

New LLT Key

A

New LLT

2492

Current LLT Key

Lack of efficacy (ectoparasite NOS)

Current Low Level Term (LLT)

2492

New PT Key

Current PT Key

Lack of efficacy (ectoparasite)

New PT Term

Current Preferred Term (PT)

614

New HLT Key

Current HLT Key

Lack of efficacy

New HLT Term

Current High Level Term (HLT)

155

New SOC Key

Lack of efficacy

New SOC Term

19

Current System Organ Class (SOC) Term Systemic disorders

Change no. 68

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 13/15

New Term Type1

Action2

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (mycoplasma NOS)

2654

A

A

76

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (protozoa)

2655

A

A

77

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (roundworm)

2656

A

A

78

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (tapeworm)

2657

A

A

79

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (tick)

2658

A

A

1 2

Current SOC Key

Current Term Type1

Systemic disorders

New LLT Key

75

New LLT

A

Current LLT Key

A

Current Low Level Term (LLT)

2653

New PT Key

Current PT Key

Lack of efficacy (mosquito)

New PT Term

Current Preferred Term (PT)

614

New HLT Key

Current HLT Key

Lack of efficacy

New HLT Term

Current High Level Term (HLT)

155

New SOC Key

Lack of efficacy

New SOC Term

19

Current System Organ Class (SOC) Term Systemic disorders

Change no. 74

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 14/15

New Term Type1

Action2

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (virus NOS)

2660

A

A

1 2

Current SOC Key

Current Term Type1

Systemic disorders

New LLT Key

81

New LLT

A

Current LLT Key

A

Current Low Level Term (LLT)

2659

New PT Key

Current PT Key

Lack of efficacy (trematode)

New PT Term

Current Preferred Term (PT)

614

New HLT Key

Current HLT Key

Lack of efficacy

New HLT Term

Current High Level Term (HLT)

155

New SOC Key

Lack of efficacy

New SOC Term

19

Current System Organ Class (SOC) Term Systemic disorders

Change no. 80

: A: animal; C: common; H: human : A: addition; D: deletion; M: modification

List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/251718/2017

Page 15/15

(VeDDRA) list of - European Medicines Agency - Europa EU

Jun 15, 2017 - List of changes to combined VeDDRA list of clinical terms. For reporting suspected .... Mental impair- ment. 217. Mental confusion. 747. Disorienta- tion. 401. Disoriented state. 1418. C. M ... cal disorder (see also 'Behavioural.

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SPOR - European Medicines Agency - Europa EU
Feb 7, 2017 - Add an existing Tag to a specific Term . ...... This service creates an email body (text/html) of a user's notification data, a notification is based on.

ATMP - European Medicines Agency - Europa EU
Nov 24, 2017 - E8. 09/08/2017. 10/08/2017. 24/08/2017 17/08/2017 22/08/2017. 24/08/2017. 30/08/2017. 01/09/2017. 04/09/2017. 08/09/2017. 14/09/2017.

Agenda - European Medicines Agency - Europa EU
Feb 9, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union ... product information. For information: Summary of opinion. 2.2. Oral explanations and list of outstanding issues. •. Product

Agenda - European Medicines Agency - Europa EU
Oct 23, 2017 - Page 2/61. Table of contents. 1. Introduction. 11. 1.1. Welcome and declarations of interest of members, alternates and experts .......... 11. 1.2. Agenda of the meeting on 23-26 October 2017 . ...... different database to study the ri

Evofosfamide - European Medicines Agency - Europa EU
Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply). (possible) lack of ...

Agenda - European Medicines Agency - Europa EU
17 Jan 2018 - Expert meeting on adeno-associated viral vectors, 06 September 2017, EMA, London. CAT: Martina Schüßler-Lenz. Scope: report of the meeting that took place on 6 September 2017. Action: for adoption. 7.6.3. Environmental assessment of g

minoxidil - European Medicines Agency - Europa EU
Jun 14, 2018 - Page 2/26. Product Name (in authorisation country). MRP/DCP Authorisation number. National Authorisation. Number. MAH of product in the.

Influenza vaccine - European Medicines Agency - Europa EU
Oct 26, 2017 - Injektionssuspension in einer Fertigspritze. Influenza-Impfstoff. (Spaltimpfstoff, inaktiviert, in Zellkulturen hergestellt) not available. BE393556. NANOTHERAPEUTICS. BOHUMIL, S.R.O.. BE. Preflucel injektionsvätska, suspension i för

latanoprost - European Medicines Agency - Europa EU
May 13, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name (in authorisation ..... Xaloptic Free. NL/H/3193/001.

Cyproterone/ethinylestradiol - European Medicines Agency - Europa EU
March 2016 a joint database drug utilisation final study report to the European .... With regards to prescription of CPA/EE for contraceptive management, ...

ganciclovir - European Medicines Agency - Europa EU
Feb 9, 2017 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name (in authorisation ... not available. 20010180.