natgillin/translations-raw huggingface dataset:
4.
31. 10. 1997 22. 01. 1998 22. 01. 1998 OJ No. C 63/ 4 of 27. 02. 1998
Solution for injection 1.5 ml, 2.3 ml, 3.1 ml 3 presentations
Solution for injection 1. 5 ml, 2. 3 ml, 3. 1 ml 3 Presentations
18.12.1996 22.10.1997 198 days 95 days
18. 12. 1996 22. 10. 1997 198 Days 95 Days
4.
26. 11. 1997 05. 02. 1998 10. 02. 1998 OJ No. C 63/ 4 of 27. 02. 1998
Primavax combined vaccines Part A
Primavax
Pasteur Merieux MSD F
Pasteur Merieux
J07CA Bacterial and viral combined vaccines
Bacterial and viral
Suspension for injection Diphtheria > 30 IU Tetanus > 40 IU r-HbsAG 5µg 1 presentation
Tetanus ≥ 40 IU
21.1.1997 22.10.1997 201 days 68 days
201 Days 68 Days
4.
10. 02. 1998 OJ No. C 63/ 4 of 27. 02. 1998
Roerig Farmaceutical I
Roerig Farmaceutical I I
J01M A Antibacterial agent
J01M A Antibacterial Agent
Tablets 100 mg, 200 mg 14 presentations
Tablets 100 mg, 200 mg 14 Presentations
18. 2.1997 22.10.1997 208 days 34 days
18. 02. 1997 22. 10. 1997 208 Days 34 Days
2.
05. 12. 1997 08. 07. 1998 09. 07. 1998 OJ No. C 240/ 2 of 31. 07. 1998
Turvel i.v. alatrofloxacin Part B
Turvel i. v. alatrofloxacin Part B
Concentrate for solution 100 mg, 200 mg, 300 mg 3 presentations
Concentrate for solution 100 mg, 200 mg, 300 mg 3 Presentations
2.
05. 12. 1997 03. 07. 1998 20. 07. 1998 OJ No. C 240/ 2 of 31. 07. 1998
Pf izer Ltd UK
Pfizer Ltd UK
2.
05. 12. 1997 03. 07. 1998 06. 07. 1998 OJ No. C 240/ 2 of 31. 07. 1998
Trovan i.v. alatrofloxacin Part B
Trovan i. v. alatrofloxacin Part B
JO5AX04 Treatment of HIV-1 infected adults
JO5AX04 Treatment of HIV- 1 infected adults
Tablets 200 mg 2 presentations
Tablets 200 mg 2 Presentations
20.6.1997 22.10.1997 125 days 0 days
20. 06. 1997 22. 10. 1997 125 Days 0 Days
4.
21. 11. 1997 05. 02. 1998 10. 02. 1998 OJ No. C 63/ 4 of 27. 02. 1998
BSIA
B. S. I. A.
18.12.1996
18. 12. 1996
13.2.1998
13. 02. 1998
C-urea Part B
C- urea Part B
100 mg 1 presentation
100 mg 1 Presentation
19.11.1997 163 days 158 days
19. 11. 1997 163 Days 158 Days
7.5.1998 8.5.1998 OJ C 164, 29.5.1998, p.
07. 05. 1998 08. 05. 1998 OJ No. C 164/ 2 of
2.
74
Combivir lamivudine/ zidovudine Part B
Combivir lamivudine / zidovudine Part B
Glaxo-Wellcome UK
Glaxo- Wellcome UK
Film-coated tablets 150 mg/300 mg 2 presentations
Film- coated tablets 150 mg/ 300 mg 2 Presentations
25.7.1997 19.11.1997 119 days 0 days
25. 07. 1997 19. 11. 1997 119 Days 0 Days
5.1.1998 18.3.1998 19.3.1998 OJ C 126, 24.4.1998.
05. 01. 1998 18. 03. 1998 19. 03. 1998 OJ No. C 126 of 24. 04. 1998
Rebif Interferon beta-1a Part A
Rebif
Serono CH
Serono
L03AA11 Multiple sclerosis
Multiple sclerosis
Solution for injection 6MIU 3 presentations
6MIU 3 Presentations
2 2.7.1996 17.12.1997 181 days 285 days
17. 12. 1997 181 Days 285 Days
13.2.1998 4.5.1998 5.5.1998 OJ C 164, 29.5.1998, p.
04. 05. 1998 05. 05. 1998 OJ No. C 164/ 2 of 29. 05. 1998
2.
75
MabThera rituximab Part A
MabThera rituximab Part A
Hoffmann La Roche CH
Hoffmann La Roche CH
L01 XX Stage III-IV follicular lymphoma
L01 XX Antineoplastic Agent
Concentration for solution for infusion 100 mg, 500 mg 2 presentations
Concentration for solution for infusion 100 mg, 500 mg 2 Presentations
21.3.1997 28.1.1998 179 days 132 days
21. 03. 97 28. 01. 98 179 Days 132 Days
17.
09. 03. 98 02. 06. 98 03. 06. 98 OJ No. C 200/ 17 of 26. 06. 98
Optison octafluoroprop- ane Part B
Optison
Mallinckrodt Medical D
Mallinckrodt
V08D Ultrasound contrast Agent for use in echocardiography
Ultrasound contrast Agent
Suspension for injection 0.22 mg/ml 2 presentations
2 Presentations
21.3.1997 28.1.1998 192 days 122 days
28. 01. 98 192 Days 122 Days
17.
18. 05. 98 19. 05. 98 OJ No. C 200/ 17 of 26. 06. 98
Exelon rivastigmine
Exelon carbamoylatine Part B
Novartis Europharm
Novartis Europharm CH
NO7 AA
NO7 AA treatment of Alzheimer Disease
Hard capsule 1.5 mg, 3 mg,
Hard capsule 1mg, 1. 5 mg, 3 mg, 4. 5 mg, 6 mg 20 Presentations
186 days 97 days
18. 04. 97 28. 01. 98 186 days 97 days
12.5.1998 OJ C 164, 29.5.1998, p.
03. 03. 98 12. 05. 98 12. 05. 98 OJ No.
2.
C 164/ 2 of 29. 05. 98
Pylori-chek 13
Pylori- chek 13
20.6.1997
20. 06. 97
1.4.1998
01. 04. 98
25.2.1998 194 days 56 days
25. 02. 98 194 Days 56 Days
17.
15. 06. 98 16. 06. 98 OJ No. C 200/ 17 of 26. 06. 98
Echogen dodecafluoro- pentane Part B
Echogen dodecafluoro - Pentane Part B
V08DA Ultrasound contrast Agent for use in echocardiography
V08DA Ultrasound contrast Agent
Aqueous emulsion for injection 20 mg/ml 1 presentations
Aqueous emulsion for injection 20 mg/ ml 2 Presentations
18.1 2.1996 25.3.1998 176 days 270 days
18. 12. 96 25. 03. 98 176 Days 270 Days
2.
05. 05. 98 17. 07. 98 20. 07. 98 OJ No. C 269/ 2 of 28. 08. 98
orlistat Part B
Xenical orlistat Part B
Roche CH
Hoffmann - La Roche CH
Antiobesity
A08 A Antiobesity
120 mg 6 presentations
Capsule 120 mg 3 Presentations
25.3.1998 183 days 255 days
02. 01. 97 25. 03. 98 183 Days 255 Days
2.
05. 05. 98 29. 07. 98 30. 07. 98 OJ No. C 269/ 2 of 28. 08. 98
Sanof i Pharma Bristol-Myers Squibb SNC F
Sanofi Pharma Bristol- Myers Squibb SNC FR
BO1 AC04 Prevention of vascular ischaemia
BO1 AC04 Prevention of vascular ischaemic events
Film-coated tablets 75 mg 3 presentations
Film- coated tablets 75 mg 6 Presentations
16.5.1997 25.3.1998 200 days 112 days
16. 05. 97 25. 03. 98 200 Days 112 Days
2.
28. 04. 98 15. 07. 98 16. 07. 98 OJNo. C 240/ 2 of 31. 07. 98
Bristol-Myers Squibb Pharma EEIG F
Bristol- Myers Squibb Pharma EEIG FR
BO1 AC04 Prevetnion of vascular ischaemia
BO1 AC04 Prevetnion of vascular ischaemic events
28.4.1998 15.7.1998 16.7.1998 OJ C 240, 31.7.1998, p.
28. 04. 98 15. 07. 98 16. 07. 98 OJ No. C 240/ 2 of 31. 07. 98
2.
76
Hoffmann La Roche CH
Hoffmann - La Roche CH
JO5 AX Combined treatment of advanced HIV
JO5 AX Treatment of Zidovudine - Exp.
Capsule 200 mg 1 presentation
Capsule 200 mg 1 Presentation
20.6.1997 22.4.1998 209 days 97 days
20. 06. 97 22. 04. 98 209 Days 97 Days
25.5.1998 20.8.1998
25. 05. 98 20. 08. 98
Eli Lilly Nederlands B.V.
Eli Lilly Nederlands B. V.
ATC not yet available Prevention on post- menopausal osteoporosis
Not yet available Prevention of Osteoporosis in postmeno- pausal women
Film-coated tablets 60 mg 4 presentations
Film- coated tablets 60 mg 4 Presentations
25.7.1997 2 2.4.1998 188 days 84 days
25. 07. 97 22. 04. 98 188 Days 84 Days
2.
25. 05. 98 05. 08. 98 07. 08. 98 OJ No. C 269/ 2 of 28. 08. 98
2.
25. 05. 98 05. 08. 98 06. 08. 98 OJ No. C 269/ 2 of 28. 08. 98
A10BX02 Type 2 diabetis
A10BX02 Treatment of type 2 diabetis or NIDDM
Tablets 0.5 mg, 1 mg, 2 mg 7 presentations
Tablets 0. 5 mg, 1 mg, 2 mg 7 Presentations
25.7.1998 2 2.4.1998 199 days 97 days
25. 07. 98 22. 04. 98 199 Days 97 Days
2.
05. 06. 98 17. 08. 98 18. 08. 98 OJ No. C 297/ 2 of 25. 09. 98
V09IX Imaging of carcinoma of colon or rectum
Not yet available Radiopharmaceutical imaging agent
Powder and solvent for solution for injection 10 mg 1 presentation
Solution for injection 12 mg 1 Presentation
22.1 1.1996 27.5.1998 145 days 407 days
22. 11. 96 27. 05. 98 145 Days 407 Days
1.
10. 07. 98 25. 09. 98 29. 09. 98 OJ No. C 331/ 1 of 29. 10. 98
Orion FIN
Orion FIN `
N04BX02 Management of Parkinson disease
Not yet available Management of Parkinson disease
Film-coated tablet 200 mg 4 presentations
Film- coated tablet 200 mg 5 Presentations
18.4.1997 27.5.1998 214 days 188 days
18. 04. 97 27. 05. 98 214 Days 188 Days
1.
03. 07. 98 16. 09. 98 18. 09. 98 OJ No. C 331/ 1 of 29. 10. 98
1.
03. 07. 98 22. 09. 98 23. 09. 98 OJ No. C 331/ 1 of 29. 10. 98
Laboratories 3M Sante F
Laboratories 3M Sante FR
LO3A A External genital/ perianal warts
LO3A A Topical treatment of external genital/ perianal warts
Cream 5%w/w 12.5 mg 1 presentation
Cream 12. 5 mg 1 Presentation
20.6.1997 27.5.1998 209 days 132 days
20. 06. 97 27. 05. 98 209 Days 132 Days
1.
30. 06. 98 18. 09. 98 22. 09. 98 OJ No. C 331/ 1 of 29. 10. 98
Zartra
Zartra imiquinod Part B
Laboratories 3M
Laboratories 3M Sante FR
LO3A A
LO3A A Topical treatment of external genital/ perianal warts
Cream 5%w/w
Cream 12. 5 mg 1 Presentation
20.6.1997
20. 06. 97 27. 05. 98 209 Days 132 Days
30.6.1998
EMEA/ MB/ 040/ 98 EMEAn vuosikertomus 1998
imiquinod Part B
© EMEA 1999
Sante F
77
External genital/ perianal warts
Tuote Kauppanimi INN Osa A/ B
12.5 mg 1 presentation
Yritys Nimi Alkuperä
27.5.1998 209 days 132 days
Hoitoalue ATC Indikaatio
18.9.1998 22.9.1998 OJ C 331, 29.10.1998, p.
Pakkaus Muoto Annos Pakkaustapojen määrä
1.
EMEA/ CPMP Validointi Lausunto Aktiivinen aika Kellon pysäytys
75
komissio Lausunto saatu Päätöksen päivämäärä Ilmoituspäivämäärä EYVL N: o
Viagra sildenaf il Part B
Viagra sildenafil Part B
Pf izer Limited UK
Pfizer Limited UK
G04B E Erectile dysfunction
G04B E Treatment of erectile dysfunction
Film-coated tablet 25 mg, 50 mg, 100 mg 12 presentations
Film- coated tablet 50 mg 7 Presentations
24.10.1997 27.5.1998 188 days 28 days
24. 10. 97 27. 05. 98 188 Days 28 Days
2.
26. 06. 98 14. 09. 98 15. 09. 98 OJ No. C 269/ 2 of 28. 08. 98
Patrex sildenaf il Part B
Patrex sildenafil Part B
Roerig Pharmaceutici Italiana S.p.A.
Roerig Pharmaceutici Italiana S. p. A.
I
IT
2.
26. 06. 98 14. 09. 98 16. 09. 98 OJ No. C 269/ 2 of 28. 08. 98
L04 AA02 Prophylaxis of acute rejection in renal transplantation
L04 A1 Prophylaxis of acute organ rejection in the novorenal transplantation
Powder and Solvent for solution for infusion 20 mg 1 presentation
Powder and Solvent 20 mg 1 Presentation
24.10.1997 24.6.1998 153 days 91 days
24. 10. 97 24. 06. 98 153 Days 91 Days
1.
03. 08. 98 09. 10. 98 14. 10. 98 OJ No. C 331/ 1 of 29. 10. 98
Chiron S.p.A.
Chiron S. P. A.
JO7AJ Pediatric vaccine for diphteria, tetanus and pertussi
JO7AJ Active immunisation of children against diphteria, tetanus and pertussi
Suspension for injection diphtheria > 30 IU Tetanus > 40 IU Pertactin 2.5µ 1 presentation
Suspension for injection 0. 5 ml 6 Presentations
20.6.1997 23.7.1998 188 days 209 days
20. 06. 97 23. 07. 98 188 Days 209 Days
interferon alphacon-1 Part A
Infergen interferon alphacon- 1 Part A
Europe B.V.
Yamanouchi Europe B. V.
JO5AX Chronic hepatitis C
JO5AX Treatment of chronic hepatitis C
9 µg 3 presentations
Solution for injection 9 µg +15 µg 6 Presentations
23.7.1998 182 days 181 days
25. 07. 97 23. 07. 98 182 Days 181 Days
Boehringer Ingelheim International GmbH D
Boehringer Ingelheim C09CA0 International GmbH Treatment of DE hypertension
Tablets 40 mg, 80 mg 8 presentations
Tablets 40 mg, 80 mg 5 Presentations
24.10.1997 23.7.1998 188 days 84 days
24. 10. 97 23. 07. 98 188 Days 84 Days
Glaxo Group Ltd UK
Glaxo Group Ltd UK
C09CA0 Hypertension
C09CA0 Treatment of hypertension
Tablets 40 mg, 80 mg 10 presentations
Tablets 40 mg, 80 mg 5 Presentations
Telmisartan Borhringer Ingelheim telmisartan Part B
Telmisartan Boehringer Ingelheim telmisartan Part B
Karvezide irbesartan/ hydrochlorotiazide Part B
Karvezide irbesartan / hydrochlorotiazide Part B
Bristol-Myers Squibb Pharma EEIG F
Sanofi Pharma Bristol- Myers Squibb SNC FR
C09DA Essential hypertension
C09DA Treatment of essential hypertension
Tablet 150/12.5 mg, 300/12.5 mg 6 presentations
Tablet 150/ 12. 5 mg, 300/ 12. 5 mg 6 Presentations
19.12.1997 23.7.1998 153 days 63 days
19. 12. 97 23. 07. 98 153 Days 63 Days
21.8.1998 17.10.1998
21. 08. 98 17. 10. 98
CoAprovel irbesartan/ hydrochlorotiazide Part B
CoAprovel irbesartan / hydrochlorotiazide Part B
Sanof i Pharma Bristol-Myers Squibb SNC F
Bristol- Myers Squibb Pharma EEIG FR
21.8.1998 15.10.1998
Yritys Nimi Alkuperä
H05B A01 Hypercalcaemia of malignancy and Paget's Disease
H05B A01 Treatment of disorders associated with increased bone resorption, hypercalcaemia of malignacy and osteoporosis
Solution 50 IU/0.5 ml 2 presentations
Solution 50 IU/ 0. 5 ml 2 Presentations
26.9.1997 17.9.1998 210 days 147 days
26. 09. 97 17. 09. 98 210 Days 147 Days
Prometax rivastigmine Part B
Prometax carbamoylatine Part B
NO7 AA Alzheimer disease
NO7 AA Treatment of 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
24.7.1998 17.9.1998 53 days
24. 07. 98 17. 09. 98 53 Days
1.10.1998 4.12.1998
........
........
Filmtablet
Part B
19. 11. 96
................
........
D
DE
NO7 Mild or moderate dementia of Alzheimer's type
moderate dementia of Alzheimer ’ type
Filmtablet 300 mg 5 presentations
5 Presentations
19.11.1996 22.10.1998 182 days 519 days
519 Days
........
19. 11. 96
D
FR
NO7 Mild or moderate dementia of Alzheimer's type
Treatment of mild or moderate dementia of Alzheimer ’ type
Filmtablet 300 mg 5 presentations
300 mg 5 Presentations
19.11.1996 22.10.1998 182 days 519 days
22. 10. 98 182 Days
Rescupase saruplase Part A
Rescupase saruplase Part A
Gruenenthal GmbH D
Gruenenthal GmbH DE
B01AD Thrombolytic therapy for acute myocardial infarction
B01AD Thrombolytic therapy for acute myocardial infarction
Powder and solvent for solution for injection 20 mg 1 presentation
Powder and solvent for solution for injection 20 mg 1 Presentation
Therapeutic area ATC Indication
25. 07. 97 22. 10. 98 239 Days 217 Days
Emadine emedastine Part B
Emadine emedastine Part B
Alcon Laboratories (UK) Ltd UK
Alcon Laboratories (UK) Ltd UK
S01GX Allergic conjuctivitis
S01GX Indicated for the prevention, immediate relief and treatment of the symptoms of allergic conjuctivitis
Solution 0.05% 2 presentations
Solution 0. 05% 2 Presentations
19.12.1997 22.10.1998 182 days 127 days
19. 12. 97 22. 10. 98 182 Days 127 Days
Temodal temozolomide Part B
Temodal temozolomide Part B
SP Europe US
SP Europe US
L01AX03 Recurrent malignant glioma
L01AX03 Recurrent malignant glioma
Capsules 5 mg, 20 mg, 100 mg, 250 mg 8 presentations
Capsules 5 mg, 20 mg 100 mg, 250 mg 8 Presentations
30.1.1998 22.10.1998 203 days 60 days
30. 01. 98 22. 10. 98 203 Days 60 Days
Capsules
25. 11. 98
Medica Ireland zaleplon Part B
Zaleplon Wyeth Wyeth Medica Ireland USA zaleplon Part B
Short term treatment of insomnia
N05CH01 Indicated for the short term treatment of insomnia
5 mg, 10 mg 6 presentations
Capsules 5 mg, 10 mg 6 Presentations
19.11.1998 182 days 113 days
30. 01. 98 19. 11. 98 182 Days 113 Days
Sonata zaleplon Part B
Sonata zaleplon Part B
Wyeth US
Wyeth USA
N05CH01 Short term treatment of insomnia
N05CH01 Indicated for the short term treatment of insomnia
Capsules 5 mg, 10 mg 6 presentations
Capsules 5 mg, 10 mg 6 Presentations
30.1.1998 19.11.1998 182 days 113 days
30. 01. 98 19. 11. 98 182 Days 113 Days
Boehringer Ingelheim International GmbH D
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
L03AA Adjunct to surgery for sarcoma of the limbs
EMEAn vuosikertomus 1998 sarcoma of the limbs Tuote Kauppanimi INN Osa A/ B
Powder and solvent 0.2 mg/ml 1 presentation
Pakkaus Muoto Annos Pakkaustapojen
24.10.1997 19.11.1998 188 days 204 days
EMEA/ CPMP Validointi Lausunto Aktiivinen aika
L04A Prophylaxis of acute rejection in renal transplantation
L04A Prophylaxis of acute organ rejection in patients Receiving renal transplants
Concentrate for solution for infusion 5mg/ml 2 presentations
Concentrate for solution for infusion 5mg/ ml 2 Presentations
26.9.1997 16.11.1998 205 days 214 days
26. 09. 97 16. 11. 98 205 Days 214 Days
Asta Medica D
Asta Medica DE
G03X Prevention of premature ovulation in fertilisation treatment
G03X Prevention of premature ovulation in patients undergoing 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
27.2.1998 17.12.1998 173 days 121 days
27. 02. 98 173 Days 121 Days
Refacto recombin.factor VIII Part A
Refacto recombin. factor VIII Part A
Genetics Institute US
Genetics Institute USA
B02BD02 Control and prevention of haemorrhagic episodes
B02BD02 indicated for the 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
27.2.1998 17.12.1998 146 days 148 days
27. 02. 98 146 Days 148 Days
Regranex becaplermin Part A Annex 7
Regranex becaplermin
Janssen-Cilag International B.V.
Janssen- Cilag International B. V.
B
D03...
D03...
Part A
Healing of full thickness Diabetic ulcers
healing of fullthickness Diabetic ulcers
Gel 100 µg/g 1 presentation
1 Presentation
21.11.1997 17.12.1998 188 days 203 days
188 Days 203 Days
CVMP OPINIONS ON MEDICINAL PRODUCTS FOR VETERINARY USE
EMEA/ MB/ 040/ 98 EMEAn vuosikertomus 1998 Liite 7
Centralised applications
Keskitetyt hakemukset
Product (a) Brand name (b) INN (c) Part A/B
Tuote a) Kauppanimi b) INN c) Osa A/ B
Company (a) Name (b) Origin
Yritys a) Nimi b) Alkuperä
Therapeutic area (a) Target species (b) Indication
Hoitoalue a) Kohdelaji b) Indikaatio
Presentation (a) Form (b) Dosage (c) No of presentations
Pakkaus a) Muoto b) Annostus c) Pakkaustapojen määrä
EMEA/CVMP (a) Validation (b) Opinion (c) Active time (d) Clockstop
EMEA/ CVMP a) Validointi b) Lausunto c) Aktiiv. aika d) Kellon pys.
Commission (a) Opinion (b) Decision (c) Notification (d) Official Journal
Komissio a) Lausunto saatu b) Päätös c) Ilmoitus d) EYVL N: o
(a) Nobi-vac-Porcoli (b) Inactivated vaccine (c) Part A
a) Nobi- vac - Porcoli b) Inactivated vaccine c) Part A
(a) Intervet International (b) NL
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) 1.1.1995 (b) 27.7.1995 (c) 107 days (d) 94 days
a) 01. 01. 95 b) 27. 07. 95 c) 107 days d) 94 days
(a) 24.8.1995 (b) 29.2.1996 (c) 4.3.1996 (d) OJ C 1996, 29.3.1996
a) 24. 08. 95 b) 29. 02. 96 c) 04. 03. 96 d) OJ C 96, 29. 03. 96
(a) Pentofel (b) Vaccine (c) Part A
a) Pentofel b) Vaccine c) Part A
(a) Fort Dodge Laboratories (b) IRL
a) Fort Dodge a) Cats Laboratories b) Rhinotracheitis b) IRL
(a) Solution for injection (b) Monodose (c) 3
a) Solution for injection b) Monodose c) 3
(a) 16.6.1995 (b) 18.9.1996 (c) 208 days (d) 235 days
a) 16. 06. 95 b) 18. 09. 96 c) 208 days d) 235 days
(a) 17.10.1996 (b) 5.2.1997 (c) 6.2.1997 (d) OJ C 63, 28.2.1997
a) 17. 10. 96 b) 05. 02. 97 c) 06. 02. 97 d) OJ C 63, 28. 02. 97
(a) Quadrisol (b) Vedaprofen (c) Part B
a) Quadrisol b) Vedaprofen c) Part B
(a) Horses (b) Control of inflammation
a) Intervet a) Horses International b) Control of b) NL inflammation
(a) Oral gel (b) 100mg/ml (c) 1
a) Oral gel b) 100mg/ ml c) 1
(a) 7.5.1996 (b) 16.7.1997 (c) 209 days (d) 235 days
a) 07. 05. 96 b) 16. 07. 97 c) 209 days d) 235 days
(a) 14.8.1997 (b) 4.12.1997 (c) 5.12.1997 (d) OJ C 392, 24.12.1997
a) 14. 08. 97 b) 04. 12. 97 c) 05. 12. 97 d) OJ C 392, 24. 12. 97
(a) Metacam (b) Meloxicam
a) Metacam b) Meloxicam c) Part B
(a) Boehringer Ingelheim
a) Boehringer Ingelheim b) DE
therapy in acute respiratory infection
a) Cattle b) Adjunctive therapy in acute respiratory infection
(b) 5mg/ml (c) 1
a) Solution for injection b) 5mg/ ml c) 1
(c) 208 d ays (d) 180 days
a) 24. 06. 96 b) 16. 07. 97 c) 208 days d) 180 days
(c) 8.1.1998 (d) OJ C 32, 30.1.1998
a) 14. 08. 97 b) 07. 01. 98 c) 08. 01. 98 d) OJ C 32, 30. 01. 98
(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) 6.12.1995 (b) 11.6.1997 (c) 218 days (d) 337 days
a) 06. 12. 95 b) 11. 06. 97 c) 218 days d) 337 days
(a) 11.7.1997 (b) 16.1.1998 (c) 20.1.1998 (d) OJ C 63, 27.2.1998
a) 11. 07. 97 b) 16. 01. 98 c) 20. 01. 98 d) OJ C 63, 27. 02. 98
(a) Clomicalm (b) Clomipramine (c) Part B
a) Clomicalm b) Clomipramine c) Part B
(a) Ciba-Geigy (b) F
a) Ciba- Geigy b) FR
(a) Dogs (b) Treatment of anxieties
a) Dogs b) Treatment of anxieties
(a) Tablets (b) 5, 20 and 80mg (c) 3
a) Tablets b) 5, 20 and 80mg c) 3
(a) 13.11.1996 (b) 12.11.1997 (c) 210 days (d) 156 days
a) 13. 11. 96 b) 12. 11. 97 c) 210 days d) 156 days
(a) 12.12.1997 (b) 1.4.1998 (c) 2.4.1998 (d) OJ C 126, 24.4.1998
a) 12. 12. 97 b) 01. 04. 98 c) 02. 04. 98 d) OJ C 126, 24. 04. 98
Neocolipor Inactivated vaccine Part A
a) Neocolipor b) Inactivated vaccine c) Part A
Rhône Mérieux F
a) Rhône - Mérieux b) FR
Piglets Passive immunisation against neonatal
a) Piglets b) Passive immunisation against neonatal colibacillosis
(a) Suspension (b) 2ml (c) 5
a) Suspension for injection b) 2ml c) 5
(a) 2.10.1996 (b) 10.12.1997 (c) 191 days (d) 245 days
a) 02. 10. 96 b) 10. 12. 97 c) 191 days d) 245 days
(a) 9.1.1998 (b) 14.4.1998 (c) 15.4.1998 (d) OJ C 126, 24.4.1998
a) 09. 01. 98 b) 14. 04. 98 c) 15. 04. 98 d) OJ C 126, 24. 04. 98
(a) (b)
Yritys a) Nimi b) Alkuperä
Nobilis IB4-91 Live vaccine
Hoitoalue a) Kohdelaji b) Indikaatio
(a)
a) Nobilis IB4- 91
Intervet International
a) Intervet International
Poultry, chickens
a) Poultry, chicken b) Live vaccine
(a) Solution (b) 30ml/1000
a) Solution b) 30ml/ 1000 doses
(a) 16.10.1996 (b) 12.11.1997
a) 16. 10. 96 b) 12. 11. 97
(a) 12.12.1997 (b) 9.6.1998
a) 12. 12. 97 b) 09. 06. 98
Part B
b) Live vaccine c) Part B
(b)
b) NL
doses (c) 5
against infectious c) 5 bronchitis
(c) 210 d ays (d) 184 days
c) 210 days d) 184 days
(corrigendum 5.8.1998) (c) 10.6.1998 (d) OJ C 200, 26.6.1998
(corrigendum 05. 08. 98) c) 10. 06. 98 d) OJ C 200, 26. 06. 98
Suvaxyn Aujeszky 783+O/W
a) Suvaxyn Aujeszky
Solvay Duphar
a) Solvay Duphar
Pigs Vaccine against
a) Pigs b) Vaccine against
(a) Solution for injection
a) Solution for injection
(a) 19.10.1996 (b) 8.4.1998
a) 19. 10. 96 b) 08. 04. 98
(b) (c)
a) 08. 05. 98 b) 07. 08. 98
Live vaccine Part A
783+O/ W b) Live vaccine c) Part A
NL
b) NL
(b) 2ml (c) 3
Aujeszky disease b) 2ml c) 3
(c) 208 days (d) 328 days
c) 208 days d) 328 days
(c) 10.8.1998 (d) OJ C 269, 28.8.1998
c) 10. 08. 98 d) OJ C 269, 28. 08. 98
Establishment of maximum residue limits for new substances
© EMEA 1999 EMEAn vuosikertomus 1998 Jäämien enimmäismäärien vahvistaminen uusille aineille
Substance a) INN
Aine a) INN
Therapeutic area a) Target species
Hoitoalue a) Kohdelaji
EMEA/CVMP a) Validation b) Opinion c) Active time d) Clockstop
EMEA/ CVMP a) Validointi b) Lausunto c) Aktiiv. aika d) Kellon pysäytt.
Commission a) Sent to Commission b) Date of regulation c) Official Journal
Komissio a) Lähetetty komissioon b) Asetuksen päivämäärä c) EYVL N: o
a) 16.5.1995 b) 15.12.1995 c) 134 days d) 49 days
a) 16. 05. 95 b) 15. 12. 95 c) 134 days d) 49 days
a) 13.2.1996 b) 8.7.1996 c) OJ L 170, 9.7.1996
a) 13. 02. 96 b) 08. 07. 96 c) OJ L 170, 09. 07. 96
a) 15.5.1995 b) 22.3.1996 c) 85 days d) 217 days
a) 15. 05. 95 b) 22. 03. 96 c) 85 days d) 217 days
a) 25.4.1996 b) 6.9.1996 c) OJ L 226, 7.9.1996
a) 25. 04. 96 b) 06. 09. 96 c) OJ L 226, 07. 09. 96
a) 12.12.1995 b) 24.4.1996 c) 104 days d) 0
a) 12. 12. 95 b) 24. 04. 96 c) 104 days d) 0
a) 24.5.1996 b) 21.10.1996 c) OJ L 269, 22.10.1996
a) 24. 05. 96 b) 21. 10. 96 c) OJ L 269, 22. 10. 96
a) 22.2.1996 b) 25.6.1996 c) 108 days d) 0
a) 22. 02. 96 b) 25. 06. 96 c) 108 days d) 0
a) 26.7.1996 b) 8.1.1997 c) OJ L 5, 09.1.1997
a) 26. 07. 96 b) 08. 01. 97 c) OJ L 5, 09. 01. 97
a) Doramectin (modif ication)
a) Doramectin (modification)
a) 14.5.1996 b) 24.7.1996 c) 70 days d) 0
a) 14. 05. 96 b) 24. 07. 96 c) 70 days d) 0
a) 23.8.1996 b) 14.2.1997 c) OJ L 45, 15.2.1997
a) 23. 08. 96 b) 14. 02. 97 c) OJ L 45, 15. 02. 97
b) 18.9.1996 c) 187 d ays d) 152 days
a) 03. 08. 95 b) 18. 09. 96 c) 187 days d) 152 days
b) 25.4.1997 c) OJ L 110, 26.4.1997
a) 16. 10. 96 b) 25. 04. 97 c) OJ L 110, 26. 04. 97
a) Moxidectin (modif ication)
a) Moxidectin (modification)
a) Bovine, ovine
a) Bovine, Ovine
a) 12.6.1996 b) 18.9.1996 c) 97 days d) 0
a) 12. 06. 96 b) 18. 09. 96 c) 97 days d) 0
a) 16.10.1996 b) 25.4.1997 c) OJ L 110, 26.4.1997
a) 16. 10. 96 b) 25. 04. 97 c) OJ L 110, 26. 04. 97
a) Difloxacin (modif ication)
a) Difloxacin (modification)
a) Chicken, turkeys
a) Chicken, Turkeys
a) 10.7.1996 b) 23.10.1996 c) 104 days d) 0
a) 10. 07. 96 b) 23. 10. 96 c) 104 days d) 0
a) 19.11.1996 b) 25.4.1997 c) OJ L 110, 26.4.1997
a) 19. 11. 96 b) 25. 04. 97 c) OJ L 110, 26. 04. 97
a) 20.8.1996 b) 11.12.1996 c) 86 days d) 0
a) 20. 08. 96 b) 11. 12. 96 c) 86 days d) 0