natgillin/translations-raw huggingface dataset:
Triacellucax bacterial vaccine Part A
Triacellucax bacterial vaccine Part A
Chiron S. P. A.
Chiron S.p.A.
JO7AJ Active immunisation of children against diphteria, tetanus and pertussi
JO7AJ Pediatric vaccine for diphteria, tetanus and pertussi
Suspension for injection 0. 5 ml 6 Presentations
Suspension for injection diphtheria > 30 IU Tetanus > 40 IU Pertactin 2.5µ 1 presentation
20. 06. 97 23. 07. 98 188 Days 209 Days
20.6.1997 23.7.1998 188 days 209 days
Infergen interferon alphacon- 1 Part A
interferon alphacon-1 Part A
Yamanouchi Europe B. V.
Europe B.V.
Japan
JP
JO5AX Treatment of chronic hepatitis C
JO5AX Chronic hepatitis C
Solution for injection 9 µg +15 µg 6 Presentations
9 µg 3 presentations
25. 07. 97 23. 07. 98 182 Days 181 Days
23.7.1998 182 days 181 days
Micardis telmisartan Part B
Micardis telmisartan Part B
Boehringer Ingelheim C09CA0 International GmbH Treatment of DE hypertension
Boehringer Ingelheim International GmbH D
Tablets 40 mg, 80 mg 5 Presentations
Tablets 40 mg, 80 mg 8 presentations
24. 10. 97 23. 07. 98 188 Days 84 Days
24.10.1997 23.7.1998 188 days 84 days
Pritor telmisartan Part B
Pritor telmisartan Part B
Glaxo Group Ltd C09CA0 UK Treatment of hypertension
Glaxo Group Ltd UK
Tablets 40 mg, 80 mg 5 Presentations
Tablets 40 mg, 80 mg 10 presentations
Telmisartan Boehringer Ingelheim telmisartan Part B
Telmisartan Borhringer Ingelheim telmisartan Part B
Karvezide irbesartan /
5.10.1998 16.12.1998
hydrochlorotiazide Part B
Karvezide irbesartan/ hydrochlorotiazide Part B
Squibb SNC FR
Bristol-Myers Squibb Pharma EEIG F
essential hypertension
C09DA Essential hypertension
6 Presentations
Tablet 150/12.5 mg, 300/12.5 mg 6 presentations
153 Days 63 Days
19.12.1997 23.7.1998 153 days 63 days
CoAprovel irbesartan / hydrochlorotiazide Part B
CoAprovel irbesartan/ hydrochlorotiazide Part B
Bristol- Myers Squibb Pharma EEIG FR
Sanof i Pharma Bristol-Myers Squibb SNC F
C09DA Treatment of essential hypertension
C09DA Essential hypertension
Tablet 150/ 12. 5 mg, 300/ 12. 5 mg 6 Presentations
Tablet 150/12.5 mg, 300/12.5 mg 6 presentations
19. 12. 97 23. 07. 98 153 Days 63 Days
19.12.1997 23.7.1998 153 days 63 days
Handelsnavn INN Del A/ B
21.8.1998 15.10.1998
Forcaltonin recomb. salmon calcitonin Part A
Forcaltonin recomb. salmon calcitonin Part A
Unigene UK
Unigene UK
H05B A01 Treatment of disorders associated with increased bone resorption, hypercalcaemia of malignacy and osteoporosis
H05B A01 Hypercalcaemia of malignancy and Paget's Disease
Solution 50 IU/ 0. 5 ml 2 Presentations
Solution 50 IU/0.5 ml 2 presentations
26. 09. 97 17. 09. 98 210 Days 147 Days
26.9.1997 17.9.1998 210 days 147 days
Prometax carbamoylatine Part B
Prometax rivastigmine Part B
NO7 AA Treatment of Alzheimer Disease
NO7 AA Alzheimer disease
Hard capsule 1 mg, 1. 5 mg, 3 mg 4. 5 mg, 6 mg 20 Presentations
Hard capsule 1 mg, 1.5 mg, 3 mg, 4.5 mg, 6 mg 20 presentations
24. 07. 98 17. 09. 98 53 Days
24.7.1998 17.9.1998 53 days
........
1.10.1998 4.12.1998
Filmtablet
........
19. 11. 96
Part B
........
D
Treatment of mild or
NO7 Mild or moderate dementia of Alzheimer's type
300 mg
Filmtablet 300 mg 5 presentations
22. 10. 98
19.11.1996 22.10.1998 182 days 519 days
Part B
Part B
DE
D
moderate dementia of Alzheimer ’ type
NO7 Mild or moderate dementia of Alzheimer's type
5 Presentations
Filmtablet 300 mg 5 presentations
182 Days
19.11.1996 22.10.1998 182 days 519 days
s
Rescupase saruplase Part A
519 Days
Gruenenthal GmbH D
........
Powder and solvent for solution for injection 20 mg 1 presentation
NO7
25.07.1997 22.10.1998 212 days 243 days
Filmtablet
Product Brand name INN Part A/B
19. 11. 96
Company Name Origin
........
Therapeutic area ATC Indication
Treatment of mild or
Presentation Form Dose Number of presentations
300 mg
EMEA/CPMP Validation Opinion Active time Clock stop
22. 10. 98
Commission opinion received on Date of decision Date of notification OJ No.
Part B
Emadine emedastine Part B
FR
Alcon Laboratories (UK) Ltd UK
moderate dementia of Alzheimer ’ type
S01GX Allergic conjuctivitis
5 Presentations
Solution 0.05% 2 presentations
182 Days
19.12.1997 22.10.1998 182 days 127 days
519 Days
2.12.1998
Rescupase saruplase Part A
Temodal temozolomide Part B
Gruenenthal GmbH DE
SP Europe US
B01AD Thrombolytic therapy for acute myocardial infarction
L01AX03 Recurrent malignant glioma
Powder and solvent for solution for injection 20 mg 1 Presentation
Capsules 5 mg, 20 mg, 100 mg, 250 mg 8 presentations
25. 07. 97 22. 10. 98 239 Days 217 Days
30.1.1998 22.10.1998 203 days 60 days
Emadine emedastine Part B
25.11.1998
Alcon Laboratories (UK) Ltd UK
Wyeth Wyeth
S01GX Indicated for the prevention, immediate relief and treatment of the symptoms of allergic conjuctivitis
N05CH01
Solution 0. 05% 2 Presentations
Capsules
19. 12. 97 22. 10. 98 182 Days 127 Days
30.1.1998
Zaleplon Wyeth Wyeth Medica Ireland USA zaleplon Part B
Medica Ireland zaleplon Part B
N05CH01 Indicated for the short term treatment of insomnia
Short term treatment of insomnia
Capsules 5 mg, 10 mg 6 Presentations
5 mg, 10 mg 6 presentations
30. 01. 98 19. 11. 98 182 Days 113 Days
19.11.1998 182 days 113 days
Sonata Wyeth zaleplon USA Part B
Sonata zaleplon Part B
N05CH01 Indicated for the short term treatment of insomnia
N05CH01 Short term treatment of insomnia
Capsules 5 mg, 10 mg 6 Presentations
Capsules 5 mg, 10 mg 6 presentations
30. 01. 98 19. 11. 98 182 Days 113 Days
30.1.1998 19.11.1998 182 days 113 days
Beromun tasonermin Part A
Beromun tasonermin Part A
Boehringer Ingelheim L03AA International GmbH As an adjunct to surgery DE for subsequent removal of the tumour to prevent or delay amputation, for irresectable soft tissue sarcoma of the limbs
L03AA Adjunct to surgery for sarcoma of the limbs
Powder and solvent 0. 2 mg/ ml 1 Presentation
Powder and solvent 0.2 mg/ml 1 presentation
24. 10. 97 19. 11. 98 188 Days 204 Days
24.10.1997 19.11.1998 188 days 204 days
Zenapax dacliximab Part A
Zenapax dacliximab Part A
Roche Registration Ltd CH
Roche Registration Ltd CH
L04A Prophylaxis of acute organ rejection in patients Receiving renal transplants
L04A Prophylaxis of acute rejection in renal transplantation
Concentrate for solution for infusion 5mg/ ml 2 Presentations
Concentrate for solution for infusion 5mg/ml 2 presentations
26. 09. 97 16. 11. 98 205 Days 214 Days
26.9.1997 16.11.1998 205 days 214 days
Cetrotide cetrorelix Part B
Cetrotide cetrorelix Part B
Asta Medica DE
Asta Medica D
G03X Prevention of premature ovulation in patients undergoing fertilisation treatment
G03X Prevention of premature ovulation in fertilisation treatment
Powder and solvent for for solution for injection 0. 25 mg, 3 mg 4 Presentation
Powder and solvent for for solution for injection 0.25 mg, 3 mg 4 presentation
27. 02. 98 173 Days 121 Days
27.2.1998 17.12.1998 173 days 121 days
Refacto recombin. factor VIII Part A
Refacto recombin.factor VIII Part A
Genetics Institute USA
Genetics Institute US
B02BD02 indicated for the control and prevention of haemorrhagic episodes
B02BD02 Control and prevention of haemorrhagic episodes
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU 3 Presentations
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU 3 presentations
27. 02. 98 146 Days 148 Days
27.2.1998 17.12.1998 146 days 148 days
Regranex becaplermin
Regranex becaplermin Part A Annex 7
Janssen- Cilag International B. V.
Janssen-Cilag International B.V.
D03...
B
Part A
D03...
healing of fullthickness Diabetic ulcers
Healing of full thickness Diabetic ulcers
1 Presentation
Gel 100 µg/g 1 presentation
188 Days 203 Days
21.11.1997 17.12.1998 188 days 203 days
EMEA/ MB/ 040/ 98 EMEA ’ årsberetning for 1998
CVMP OPINIONS ON MEDICINAL PRODUCTS FOR VETERINARY USE
Side 77
Centralised applications
s Bilag 7 CVMP- UDTALELSER OM VETERINÆRLÆGEMIDLER
Product (a) Brand name (b) INN (c) Part A/B
Centraliserede ansøgninger
Company (a) Name (b) Origin
Firma a) Handelsnavna) Navn b) INN b) Oprind. c) Del A/ B
Therapeutic area (a) Target species (b) Indication
Behandlingsomr. a) Målarter b) Indikation
Presentation (a) Form (b) Dosage (c) No of presentations
Præsentation a) Form b) Dosis c) Antal presentationer
EMEA/CVMP (a) Validation (b) Opinion (c) Active time (d) Clockstop
EMEA/ CVMP a) Godkendelse b) Udtalelse c) Nettotid d) Urstop
Commission (a) Opinion (b) Decision (c) Notification (d) Official Journal
Kommissionen a) Udtalelse modtaget den b) Afgørelse c) Meddelelse d) EFT nr.
(a) Nobi-vac-Porcoli (b) Inactivated vaccine (c) Part A
a) Nobi- vac - a) Intervet Porcoli International b) Inactivated b) NL vaccine c) Part A
(a) Intervet International (b) NL
a) Piglets b) Neonatal colibacillosis
(a) Piglets (b) Neonatal colibacillosis
a) Solution for injection b) Multidose c) 2
(a) Solution for injection (b) Multidose (c) 2
a) 01. 01. 95 b) 27. 07. 95 c) 107 days d) 94 days
(a) 1.1.1995 (b) 27.7.1995 (c) 107 days (d) 94 days
a) 24. 08. 95 b) 29. 02. 96 c) 04. 03. 96 d) OJ C 96, 29. 03. 96
(a) 24.8.1995 (b) 29.2.1996 (c) 4.3.1996 (d) OJ C 1996, 29.3.1996
a) Pentofel b) Vaccine c) Part A
(a) Pentofel (b) Vaccine (c) Part A
a) Fort Dodge a) Cats Laboratories b) Rhinotracheitis b) IRL
(a) Fort Dodge Laboratories (b) IRL
a) Solution for injection b) Monodose c) 3
(a) Solution for injection (b) Monodose (c) 3
a) 16. 06. 95 b) 18. 09. 96 c) 208 days d) 235 days
(a) 16.6.1995 (b) 18.9.1996 (c) 208 days (d) 235 days
a) 17. 10. 96 b) 05. 02. 97 c) 06. 02. 97 d) OJ C 63, 28. 02. 97
(a) 17.10.1996 (b) 5.2.1997 (c) 6.2.1997 (d) OJ C 63, 28.2.1997
a) Quadrisol a)
(a) Quadrisol (b) Vedaprofen (c) Part B
Intervet a) Horses
(a) Intervet International (b) NL
a) Oral gel
(a) Oral gel (b) 100mg/ml (c) 1
a) 07. 05. 96
(a) 7.5.1996 (b) 16.7.1997 (c) 209 days (d) 235 days
a) 14. 08. 97
(a) 14.8.1997 (b) 4.12.1997 (c) 5.12.1997 (d) OJ C 392, 24.12.1997
b) Vedaprofen c) Part B
(a) Metacam (b) Meloxicam
International b) NL
(a) Boehringer Ingelheim
b) Control of inflammation
(a) Cattle (b) Adjunctive
b) 100mg/ ml c) 1
(a) Solution for injection
b) 16. 07. 97 c) 209 days d) 235 days
(a) 24.6.1996 (b) 16.7.1997
b) 04. 12. 97 c) 05. 12. 97 d) OJ C 392, 24. 12. 97
(a) 14.8.1997 (b) 7.1.1998
a) Metacam b) Meloxicam c) Part B
(c) Part B
a) Boehringer Ingelheim b) DE
(b) D
a) Cattle b) Adjunctive therapy in acute respiratory infection
therapy in acute respiratory infection
a) Solution for injection b) 5mg/ ml c) 1
(b) 5mg/ml (c) 1
a) 24. 06. 96 b) 16. 07. 97 c) 208 days d) 180 days
(c) 208 d ays (d) 180 days
a) 14. 08. 97 b) 07. 01. 98 c) 08. 01. 98 d) OJ C 32, 30. 01. 98
(c) 8.1.1998 (d) OJ C 32, 30.1.1998
a) Dicural b) Difloxacin c) Part B
(a) Dicural (b) Difloxacin (c) Part B
a) Fort Dodge Animal Health b) NL
(a) Fort Dodge Animal Health (b) NL
a) Poultry b) Antibacterial for systematic use
(a) Poultry (b) Antibacterial for systematic use
a) Oral solution b) 100mg/ ml c) 2
(a) Oral solution (b) 100mg/ml (c) 2
a) 06. 12. 95 b) 11. 06. 97 c) 218 days d) 337 days
(a) 6.12.1995 (b) 11.6.1997 (c) 218 days (d) 337 days
a) 11. 07. 97 b) 16. 01. 98 c) 20. 01. 98 d) OJ C 63, 27. 02. 98
(a) 11.7.1997 (b) 16.1.1998 (c) 20.1.1998 (d) OJ C 63, 27.2.1998
a) Clomicalm a) b) Clomipramine
(a) Clomicalm (b) Clomipramine (c) Part B
Ciba- Geigy a) b) FR b)
(a) Ciba-Geigy (b) F
Dogs Treatment of
(a) Dogs (b) Treatment of anxieties
a) Tablets b) 5, 20 and 80mg
(a) Tablets (b) 5, 20 and 80mg (c) 3
a) 13. 11. 96 b) 12. 11. 97
(a) 13.11.1996 (b) 12.11.1997 (c) 210 days (d) 156 days
a) 12. 12. 97 b) 01. 04. 98
(a) 12.12.1997 (b) 1.4.1998 (c) 2.4.1998 (d) OJ C 126, 24.4.1998
c) Part B
(a) (b) (c)
anxieties
Neocolipor Inactivated vaccine Part A
c) 3
(a) (b)
c) 210 days d) 156 days
Rhône Mérieux F
c) 02. 04. 98 d) OJ C 126, 24. 04. 98
(a) (b)
a) Piglets b) Passive immunisation against neonatal colibacillosis
Piglets Passive immunisation against neonatal
a) Suspension for injection b) 2ml c) 5
(a) Suspension (b) 2ml (c) 5
a) 02. 10. 96 b) 10. 12. 97 c) 191 days d) 245 days
(a) 2.10.1996 (b) 10.12.1997 (c) 191 days (d) 245 days
a) 09. 01. 98 b) 14. 04. 98 c) 15. 04. 98 d) OJ C 126, 24. 04. 98
(a) 9.1.1998 (b) 14.4.1998 (c) 15.4.1998 (d) OJ C 126, 24.4.1998
a) Nobilis IB4- 91
(a) (b)
a) Intervet International
Intervet International
a) Poultry, chicken b) Live vaccine
Poultry, chickens
a) Solution b) 30ml/ 1000 doses
(a) Solution (b) 30ml/1000
a) 16. 10. 96 b) 12. 11. 97
(a) 12.12.1997 (b) 9.6.1998
a) 12. 12. 97 b) 09. 06. 98
(b)
b) Live vaccine b) NL c) Part B
Live vaccine against infectious
against infectious c) 5 bronchitis
doses (c) 5
c) 210 days d) 184 days
(c) 210 d ays (d) 184 days
(corrigendum 05. 08. 98) c) 10. 06. 98 d) OJ C 200, 26. 06. 98
(corrigendum 5.8.1998) (c) 10.6.1998 (d) OJ C 200, 26.6.1998
©
(a)
Vet. lægemid.
Suvaxyn Aujeszky 783+O/W
a) Suvaxyn Aujeszky
(a)
a) Solvay Duphar
Solvay Duphar
a) Pigs b) Vaccine against
Pigs Vaccine against
a) Solution for injection
(a) Solution for injection
a) 19. 10. 96 b) 08. 04. 98
(a) 19.10.1996 (b) 8.4.1998
a) 08. 05. 98 b) 07. 08. 98
(b) (c)
783+O/ W b) Live vaccine c) Part A
Live vaccine Part A
b) NL
NL
Aujeszky disease b) 2ml c) 3
(b) 2ml (c) 3
c) 208 days d) 328 days
(c) 208 days (d) 328 days
c) 10. 08. 98 d) OJ C 269, 28. 08. 98
(c) 10.8.1998 (d) OJ C 269, 28.8.1998
EMEA/ MB/ 040/ 98 EMEA ’ årsberetning for 1998
Establishment of maximum residue limits for new substances
Side 79
Substance a) INN
s Fastsættelse af maksimalgrænseværdier af restkoncentrationer af nye stoffer
Therapeutic area a) Target species
Stof Behandlingsområde EMEA/ CVMP Kommissionen a) INN a) Målarter a) Godkendelse a) Sendt til Kommissionen
EMEA/CVMP a) Validation b) Opinion c) Active time d) Clockstop
b) Dato for vedtagelse af forordningen c) EFT nr.
Commission a) Sent to Commission b) Date of regulation c) Official Journal
a) Difloxacin
a) Difloxacin
a) Chicken, turkeys
a) Chicken, turkeys
a) 16. 05. 95 b) 15. 12. 95 c) 134 days d) 49 days
a) 16.5.1995 b) 15.12.1995 c) 134 days d) 49 days
a) 13. 02. 96 b) 08. 07. 96 c) OJ L 170, 09. 07. 96
a) 13.2.1996 b) 8.7.1996 c) OJ L 170, 9.7.1996
a) Ketoprofen (extension)
a) Ketoprofen (extension)
a) Porcine
a) Porcine
a) 15. 05. 95 b) 22. 03. 96 c) 85 days d) 217 days
a) 15.5.1995 b) 22.3.1996 c) 85 days d) 217 days
a) 25. 04. 96 b) 06. 09. 96 c) OJ L 226, 07. 09. 96
a) 25.4.1996 b) 6.9.1996 c) OJ L 226, 7.9.1996
a) Diclazuril
a) Diclazuril
a) Ovine
a) Ovine
a) 12. 12. 95 b) 24. 04. 96 c) 104 days d) 0
a) 12.12.1995 b) 24.4.1996 c) 104 days d) 0
a) 24. 05. 96 b) 21. 10. 96 c) OJ L 269, 22. 10. 96
a) 24.5.1996 b) 21.10.1996 c) OJ L 269, 22.10.1996
a) Eprinomectin
a) Eprinomectin
a) Bovine
a) Bovine
a) 22. 02. 96 b) 25. 06. 96 c) 108 days d) 0
a) 22.2.1996 b) 25.6.1996 c) 108 days d) 0
a) 26. 07. 96 b) 08. 01. 97 c) OJ L 5, 09. 01. 97
a) 26.7.1996 b) 8.1.1997 c) OJ L 5, 09.1.1997
a) Doramectin (modification)
a) Doramectin (modif ication)
a) 14. 05. 96 b) 24. 07. 96 c) 70 days d) 0
a) 14.5.1996 b) 24.7.1996 c) 70 days d) 0
a) 23. 08. 96 b) 14. 02. 97 c) OJ L 45, 15. 02. 97
a) 23.8.1996 b) 14.2.1997 c) OJ L 45, 15.2.1997
a) Praziquantel
a) Praziquantel
a) 03. 08. 95 b) 18. 09. 96 c) 187 days d) 152 days
b) 18.9.1996 c) 187 d ays d) 152 days
a) 16. 10. 96 b) 25. 04. 97 c) OJ L 110, 26. 04. 97
b) 25.4.1997 c) OJ L 110, 26.4.1997
a) Moxidectin (modification)
a) Moxidectin (modif ication)
a) Bovine, Ovine
a) Bovine, ovine
a) 12. 06. 96 b) 18. 09. 96 c) 97 days d) 0
a) 12.6.1996 b) 18.9.1996 c) 97 days d) 0
a) 16. 10. 96 b) 25. 04. 97 c) OJ L 110, 26. 04. 97
a) 16.10.1996 b) 25.4.1997 c) OJ L 110, 26.4.1997
a) Difloxacin (modification)
a) Difloxacin (modif ication)
a) Chicken, Turkeys
a) Chicken, turkeys
a) 10. 07. 96 b) 23. 10. 96 c) 104 days d) 0
a) 10.7.1996 b) 23.10.1996 c) 104 days d) 0
a) 19. 11. 96 b) 25. 04. 97 c) OJ L 110, 26. 04. 97
a) 19.11.1996 b) 25.4.1997 c) OJ L 110, 26.4.1997
a) Ivermectin (extension)
a) Ivermectin (extension)
a) Deer
a) Deer
a) 20. 08. 96 b) 11. 12. 96 c) 86 days d) 0
a) 20.8.1996 b) 11.12.1996 c) 86 days d) 0
a) 09. 01. 97 b) 23. 04. 97 c) OJ L 106, 24. 04. 97
a) 9.1.1997 b) 23.4.1997 c) OJ L 106, 24.4.1997
a) Amitraz (extension)
a) Amitraz (extension)
a) Bees
a) Bees
a) 18. 10. 96 b) 12. 02. 97 c) 115 days d) 0
a) 18.10.1996 b) 12.2.1997 c) 115 days d) 0
a) 12. 03. 97 b) 24. 09. 97 c) OJ L 263, 25. 09. 97
a) 12.3.1997 b) 24.9.1997 c) OJ L 263, 25.9.1997
a) Doramectin (extension)
a) Doramectin (extension)
a) Swine, Ovine
a) Swine, ovine
a) 10. 06. 96 b) 12. 02. 97 c) 118 days d) 127 days
a) 10.6.1996 b) 12.2.1997 c) 118 days d) 127 days
Stof Behandlingsområde a) INN a) Målarter
a) Cefazolin (extension)
a) Cefazolin a) Ovine, Caprine (extension)
a) Ovine, caprine
a) 05. 06. 97 b) 10. 09. 97 c) 97 days d) 0
a) 5.6.1997 b) 10.9.1997 c) 97 days d) 0
a) 10. 10. 97 b) 16. 01. 98 c) OJ L 11, 17. 01. 98
a) 10.10.1997 b) 16.1.1998 c) OJ L 11, 17.1.1998
a) Isoflurane
a) Isoflurane
b) Equine
b) Equine
a) 13. 05. 96 b) 07. 05. 97 c) 200 days d) 158 days
a) 13.5.1996 b) 7.5.1997 c) 200 days d) 158 days
a) 05. 06. 97 b) 23. 02. 98 c) OJ L 53, 24. 02. 98
a) 5.6.1997 b) 23.2.1998 c) OJ L 53, 24.2.1998
a) Teflubenzuron
a) Teflubenzuron
a) Fish
a) Fish
a) 20. 01. 97 b) 07. 05. 97 c) 105 days d) 0
a) 20.1.1997 b) 7.5.1997 c) 105 days d) 0
a) Florfenicol (extension)
a) Florfenicol (extension)
a) 29. 01. 96 b) 16. 07. 97 c) 129 days d) 404 days
a) 29.1.1996 b) 16.7.1997 c) 129 days d) 404 days
a) 12. 08. 97 b) 18. 03. 98 c) OJ L 82, 19. 03. 98
a) 12.8.1997 b) 18.3.1998 c) OJ L 82, 19.3.1998
a) Moxidectin (extension)
a) Moxidectin (extension)
a) Equidae
a) Equidae
a) 09. 04. 97 b) 16. 07. 97 c) 96 days d) 0
a) 9.4.1997 b) 16.7.1997 c) 96 days d) 0
a) Praziquantel (extension)
a) Praziquantel (extension)
a) 15. 09. 97 b) 14. 01. 98 c) 120 days d) 0
a) 15.9.1997 b) 14.1.1998 c) 120 days d) 0
a) 09. 02. 98 b) 27. 05. 98 c) OJ L 154, 28. 05. 98
a) 9.2.1998 b) 27.5.1998 c) OJ L 154, 28.5.1998
a) Meloxicam
a) Meloxicam
a) 28. 03. 96 b) 11. 06. 97 c) 212 days d) 229 days
a) 28.3.1996 b) 11.6.1997 c) 212 days d) 229 days
a) 09. 07. 97 b) 17. 07. 98 c) OJ L 205, 22. 07. 98
a) 9.7.1997 b) 17.7.1998 c) OJ L 205, 22.7.1998
a) Tilmicosin (extension)
a) Tilmicosin (extension)
a) Chickens
a) Chickens
a) 14. 07. 97 b) 12. 11. 97 c) 111 days d) 0
a) 14.7.1997 b) 12.11.1997 c) 111 days d) 0
a) 12. 12. 97 b) 09. 09. 98 c) OJ L 250, 10. 09. 98
a) 12.12.1997 b) 9.9.1998 c) OJ L 250, 10.9.1998
a) Valnemulin
a) Valnemulin
a) 02. 08. 96 b) 06. 05. 98 c) 207 days d) 435 days
a) 2.8.1996 b) 6.5.1998 c) 207 days d) 641 days
a) 05. 06. 98 b) 27. 11. 98 c) OJ L 320, 28. 11. 98
a) 5.6.1998 b) 27.11.1998 c) OJ L 320, 18.11.1998
a) Alfaprostol (extension)
a) Alfaprostol (extension)
a) Rabbits
a) Rabbits
a) 15. 05. 97 b) 06. 05. 98 c) 200 days d) 156 days
a) 15.5.1997 b) 6.5.1998 c) 200 days d) 362 days
a) 05. 06. 98 b) 27. 11. 98 c) OJ L 320, 28. 11. 98
a) 5.6.1998 b) 27.11.1998 c) OJ L 320, 28.11.1998
a) Rifaximin
a) Rifaximin
a) All mammalian food producing species
a) All mammalian food producing species
a) 09. 01. 97 b) 06. 05. 98 c) 180 days d) 303 days
a) 9.1.1997 b) 6.5.1998 c) 180 days d) 508 days
a) Bronopol
a) Bronopol
a) Salmonidae
a) Salmonidae
a) 07. 05. 97 b) 10. 06. 98 c) 198 days d) 202 days
a) 7.5.1997 b) 10.6.1998 c) 198 days d) 202 days
a) 10. 07. 98 b) 11. 12. 98 c) OJ L 337, 12. 12. 98
a) 10.7.1998 b) 11.12.1998 c) OJ L 337, 12.12.1998
a) Flumethrin
a) Flumethrin
a) Bovine, Ovine Caprine, Honey bees
a) Bovine,ovine, caprine, honey bees
11. 11. 96 10. 06. 98 197 days 380 days
a) 11.11.1996 b) 10.6.1998 c) 197 days d) 380 days
a) Enrofloxacin (modification)
a) Enrofloxacin (modif ication)
a) Bovine, Porcine, Poultry
a) Bovine, porcine, poultry
a) 03. 02. 97 b) 08. 07. 98 c) 183 days d) 336 days
a) 3.2.1997 b) 8.7.1998 c) 183 days d) 336 days
a) 30. 07. 98 b) 17. 12. 98 c) OJ L 343, 18. 12. 98
a) 30.7.1998 b) 17.12.1998 c) OJ L 343, 18.12.1998
a) Enrofloxacin (extension)
a) Enrofloxacin (extension)
a) Dairy cattle, Ovine, Rabbits
a) Dairy cattle, ovine, rabbits
a) Sodium 2- methyl- 2 - phenoxy- propionate
a) Sodium 2-methyl- 2-phenoxy- propionate
a) Bovine, Porcine, Caprine, Equidae
a) Bovine, porcine, caprine, equidae
a) 26. 11. 96 b) 08. 07. 98 c) 201 days d) 388 days
a) 26.11.1996 b) 8.7.1998 c) 201 days d) 388 days
a) Ivermectin (extension)
a) Ivermectin
a) 20. 08. 96 b) 08. 07. 96 c) 170 days d) 518 days
a) 20.8.1996 b) 8.7.1996 c) 170 days d) 518 days
a) Diethylene glycol monoethyl ether
a) Diethylene glycol monoethyl ether
a) Bovine, Porcine
a) Bovine, porcine
a) 14. 02. 97 b) 08. 07. 98 c) 170 days d) 337 days
a) 14.2.1997 b) 8.7.1998 c) 170 days d) 337 days
s Bilag 8 REFERENCEDOKUMENTER
Annex 8
©
REFERENCE DOCUMENTS
a) Officielle EU- publikationer
(a) EU official publications
2309/ 93 med senere ændringer (EFT nr.
- Council Regulation (EEC) No 2309/93 as amended (OJ L 214, 24.8.1993, p.1)
2377/ 90 med senere ændringer (EFT nr.
- Council Regulation (EEC) No 2377/90 as amended (OJ L 224, 18.8.1990, p.1)
L 147 af 9. 6. 1975, s. 13)
- Council Directive 75/319/EEC as amended (OJ L 147, 9.6.1975, p.13)
- Rådets direktiv 81/ 851/ EØF med senere ændringer (EFT L 317 af 6. 11. 1981, s. 1)
- Council Directive 81/851/EEC as amended (OJ L 317, 6.11.1981, p.1)
L 345 af 19. 12. 1998, s. 3)
- Council Regulation (EC) No 2743/98 (OJ L 345, 19.12.1998, p.3)
- Oversigt over indtægter og udgifter for Det Europæiske Agentur for Lægemiddelvurdering for regnskabsåret 1998
- EMEA budget statement for the financial year 1998 (OJ L 57, 26.2.1998, p.1)
Ovennævnte tekster og andre bestemmelser findes også i seriepublikationen gældende regler for lægemidler i Det De Europæiske Fællesskab.
The texts of these and other provisions may be also be found in the series ‘Rules governing medicinal products in the European Community’.
Disse publikationer og kopier af De Europæiske Fællesskabers Tidende kan rekvireres ved henvendelse til:
These publications, along with copies of the Official Journal, are available from:
Kontoret for De Europæiske Fællesskabers Officielle Publikationer 2, rue de Mercier L - 2985 Luxembourg
Office for Official Publications of the European Communities 2, rue de Mercier L -2985 Luxembourg
Teksterne findes også på følgende EudraLex- Internetsite: http: // dg3. eudra. org/ eudralex/ index. htm
The texts are also available on the EudraLex Internet site at http://dg3.eudra.org/eudralex/index.htm 81 (b) EMEA documents
b) EMEA- dokumenter
- First General Report on the Activities of the European Agency for the Evaluation of Medicinal
- Første almindelige beretning om aktiviteterne i Det Europæiske Agentur for Lægemiddelvurdering 1995
Products 1995 (ISBN 92-827-7491-0, Office for Official Publications of the EU)
(ISBN 92- 827- 7491- 0, Kontoret for De Europæiske Fællesskabers Officielle Publikationer)
- Second General Report on the Activities of the European Agency for the Evaluation of
- Anden almindelige beretning om aktiviteterne i Det Europæiske Agentur for Lægemiddelvurdering 1996
Medicinal Products 1996 (ISBN 92-9155-002-7, Office for Official Publications of the EU)
(ISBN 92- 9155- 002- 7, Kontoret for De Europæiske Fællesskabers Officielle Publikationer)
- Third General Report on the Activities of the European Agency for the Evaluation of
- Tredje almindelige beretning om aktiviteterne i Det Europæiske Agentur for Lægemiddelvurdering 1997
Medicinal Products 1997 (ISBN 92-9155-010-8, Office for Official Publications of the EU)
- Redegørelse for principperne for partnerskabet mellem de nationale kompetente myndigheder og Det Europæiske
- Statement of principles governing the partnership between the national competent authorities
Agentur for Lægemiddelvurdering (EMEA/ MB/ 013/ 97)
and the EMEA (EMEA/MB/013/97)
- Finansforordningen, som finder anvendelse på EMEA ’ budget
- Financial Regulation applicable to the budget of the EMEA (EMEA/MB/011/97)
- Den administrerende direktørs afgørelse af 3. december 1997 om regler for aktindsigt i EMEA ’ dokumenter
- Decision of the Executive Director of 3 December 1997 on rules on access to documents of
s
the EMEA
Disse og andre dokumenter findes på Internettet på følgende adressehttp: // www. eudra. org/ emea. html eller kan rekvireres ved skriftlig henvendelse til:
These and other documents are available either on the Internet at http://www.eudra.org/emea.html or by writing to: