natgillin/translations-raw huggingface dataset:
André PAUWELS Inspecteur en Chef / Generaal Wnd Ministère des affaires sociales, de la santé publique et de l'environement Inspection Générale de la Pharmacie Ministerie van Sociale Zaken, Volksgezondheid en Leefmilieu Algemeine Farmaceutische Inspektie Boulevard Bisschoffsheim / Bisschoffsheimlaan, 33 B-1000 Bruxelles / Brussel Tel:
André PAUWELS Inspecteur en Chef / Generaal Wnd Ministère des affaires sociales, de la santé publique et de l’ environement Inspection Générale de la Pharmacie Ministerie van Sociale Zaken, Volksgezondheid en Leefmilieu Algemeine Farmaceutische Inspektie Boulevard Bisschoffsheim / Bisschoffsheimlaan, 33 B – 1000 Bruxelles / Brussel Tel:
Ib Bo LUMHOLZ Direktør Lægemiddelstyrelsen Frederikssundsvej 378 DK-2700 Brønshøj Tel:
Ib Bo LUMHOLTZ Directør Lægemiddelstyrelsen Frederikssundsvej 378 DK- 2700 Brønshøj Tel:
Alfred HILDEBRANDT Arzt.
Alfred HILDEBRANDT Arzt.
Reinhard KROKER Direktor BgVV Diedersdorfer Weg, 1 D-12277 Berlin Tel:
Reinhard KROKER Direktor BgVV Diedersdorfer Weg, 1 D- 12277 Berlin Tel:
Reinhard KURTH President Paul-Ehrlich Institut Paul-Erlich Straße 51-59 D-63225 Langen Tel:
Reinhard KURTH President Paul- Ehrlich Institut Paul- Erlich Straße 51- 59 D- 63225 Langen Tel:
Gerasimos KAVVADIAS President National Drug Organisation Mesogion 284 GR-15562 Holargos Tel:
Sida 69 EMEA/ MB/ 040/ 98 © EMEA 1999 Fjärde allmänna rapporten om verksamheten vid EMEA 1998 Å ëëÜ ä á/ GREECE Gerasimos KAVVADIAS President National Drug Organisation Mesogion 284 GR- 15562 Holargos Tel:
Federico PLAZA PIÑOL Directore General de Farmacia y Productos Sanitarios Ministerio de Sanidad y Consumo Paseo del Prado 18-20 E-28014 Madrid Tel:
Federico PLAZA PIÑOL Directore General de Farmacia y Productos Sanitarios Ministerio de Sanidad y Consumo Paseo del Prado 18- 20 E- 28014 Madrid Tel:
Quintiliano PÉREZ BONILLA Director General de Producciones y Mercados Ganaderos Ministerio de Agricultura, Pesca y Alimentación José Abascal, 4 - 7ª planta E-28003 Madrid Tel:
Quintiliano PÉREZ BONILLA Director General de Producciones y Mercados Ganaderos Ministerio de Agricultura, Pesca y Alimentación José Abascal, 4 – 7ª planta E- 28003 Madrid Tel:
Jean-René BRUNETIÈRE Directeur-Général Agence du Médicament 143-147, blvd Anatole France F-93200 Saint-Denis CEDEX Tel:
Jean- René BRUNETIÈRE Directeur- Général Agence du Médicament 143- 147, blvd Anatole France F- 93200 Saint- Denis CEDEX Tel:
Jacques BOISSEAU Directeur Agence Nationale du Médicament Vétérinaire La Haute Marche Javené F-35133 Fougères Tel:
Jacques BOISSEAU Directeur Agence Nationale du Médicament Vétérinaire La Haute Marche Javené F- 35133 Fougères Tel:
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Tel:
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Tel:
Seamus HEALY Assistant Secretary Department of Agriculture/Food/ Forestry Agriculture House Kildare Street Dublin 2 Ireland Tel:
Seamus HEALY Assistant Secretary Department of Agriculture/ Food/ Forestry Agriculture House Kildare Street Dublin 2 Ireland Tel:
Nello MARTINI Direttore-Generale del Servizio Farmaceutico Ministero della Sanità Viale Civilità Romana 7 I-00144 Rome Tel:
Nello MARTINI Direttore- Generale del Servizio Farmaceutico Ministero della Sanità Viale Civilità Romana 7 I- 00144 Rome Tel:
Romano MARABELLI Direttore Generale Servizi Veterinari Ministero della Sanità Viale Civilità Romana 7 I-00144 Rome Tel:
Romano MARABELLI Direttore Generale Servizi Veterinari Ministero della Sanità Viale Civilità Romana 7 I- 00144 Rome Tel:
Pharmacien-Inspecteur Chef de Division Directeur de la Santé Division Pharmacie et Médicaments 10, rue C.M.
Mariette BACKES- LIES Pharmacien- Inspecteur Chef de Division Directeur de la Santé Division Pharmacie et Médicaments 10, rue C. M.
André BROEKMANS Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
André BROEKMANS Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V. W. S.
Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen (BRD) Postbus 289 6700 AG Wageningen Nederland Tel:
Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen (BRD) Postbus 289 6700 AG Wageningen Nederland Tel:
Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Arbeit,
Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Arbeit, Gesundheit und Soziales Stubenring 1 A- 1010 Wien Tel:
Pharmazeutische Angelegenheiten Bundesministerium für Arbeit, Gesundheit und Soziales Stubenring 1 A-1010 Wien Tel:
Alexander JENTZSCH Ministerialrat Leiter der Gruppe fuer Pharmazeutische Angelegenheiten Bundesministerium für Arbeit, Gesundheit und Soziales Stubenring 1 A- 1010 Wien Tel:
José António ARANDA DA SILVA Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa Av. do Brasil, 53 P-1700 Lisboa Tel:
José António ARANDA DA SILVA Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P- 1700 Lisboa Tel:
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P-1294 Lisboa Tel:
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P- 1294 Lisboa Tel:
SUOMI/FINLAND
Sida 71 EMEA/ MB/ 040/ 98 © EMEA 1999 Fjärde allmänna rapporten om verksamheten vid EMEA 1998 SUOMI/ FINLAND
Hannes WAHLROOS Pääjohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P.O.
Hannes WAHLROOS Pääjohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P. O.
Saara REINIUS Pääjohtaja Maa- ja metsätalousministeriö, eläin- ja elintarvikeosasto Kluuvikatu 4A, 6 krs.
Saara REINIUS Pääjohtaja Maa - ja metsätalousministeriö, eläin - ja elintarvikeosasto Kluuvikatu 4A, 6 krs.
FIN-00170 Helsinki Tel:
FIN- 00170 Helsinki Tel:
(358-9) 160 33 85 Fax:
(358- 9) 160 33 85 Fax:
Kjell STRANDBERG Generaldirektör Läkemedelsverket Husargatan 8, Box 26 S-751 03 Uppsala Tel:
Kjell STRANDBERG Generaldirektör Läkemedelsverket Husargatan 8, Box 26 S- 751 03 Uppsala Tel:
Keith JONES Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London SW8 5NQ United Kingdom Tel:
Keith JONES Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London SW8 5NQ United Kingdom Tel:
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane, New Haw, Addlestone Surrey KT15 3NB United Kingdom Tel:
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane, New Haw, Addlestone Surrey KT15 3NB United Kingdom Tel:
EMEA BUDGETS 1996 TO 1998
Sida 72 EMEA/ MB/ 040/ 98 © EMEA 1999 Fjärde allmänna rapporten om verksamheten vid EMEA 1998 Bilaga 5 EMEA: s BUDGETAR 1996 - 1998
The summarised comparative budget statements for 1996 to 1998 are as follows:
Nedan jämförs sammanställningen av budgetarna för 1996 - 1998:
(amounts expressed in ECUs)
(beloppen är uttryckta i ecu)
Revenues
1996 1
1996(1)
1997 1
1997(1)
1998 2
1998(2)
Intäkter
- fees
avgifter
- EU subsidy - other
EU- stöd övriga
Total revenue
Totalsumma
900 000
31 900 000
Staff costs
Utgifter
- salaries - interim and other supporting persons
Personalkostnader - löner - extrapersonal och andra stödpersoner
- other staff related expenditure
- övriga personalkostnader
1 140 312
1
1 010 000
010 000
Building and equipment
Byggnader och utrustning
Operational expenditure
- hyra/ avgifter - utgifter för databehandling - övriga kapitalutgifter - porto och telekommunikationer - övriga administrativa utgifter
- meetings - evaluation of medicinal products
Driftsutgifter - möten - utvärdering av läkemedel - översättning - studier och konsulter - publikationer
584 000 105 000 20 000
487 000 800 000 584 000 105 000 20 000
Total expenditure
Totalsumma
Notes (1) 1996 and 1997 budgets: outturn.
1996 och 1997 års budgetar: resultat 2.
(2) 1998 budget: final appropriations.
1998 års budget: slutgiltiga anslag
Annex 6
Sida 73 EMEA/ MB/ 040/ 98 © EMEA 1999 Fjärde allmänna rapporten om verksamheten vid EMEA 1998 Bilaga 6
CPMP OPINIONS IN 1998 ON MEDICINAL PRODUCTS FOR HUMAN USE
CPMP: s YTTRANDEN OM HUMANLÄKEMEDEL UNDER 1998
Product Brand name INN Part A/B
Produkt Namn INN Del A/ B
Company Name Origin
Företag Namn Land
Therapeutic area ATC Indication
Användningsområde ATC Indikation
Presentation Form Dose Number of presentations
Presentation Form Dosering Antal presentationer
EMEA/CPMP Validation Opinion Active time Clock stop
EMEA/ CPMP Validering Yttrande Aktiv tid Inaktiv tid
Commission opinion received on Date of decision Date of notification OJ No.
Kommissionen Yttrandet mottogs den Beslutsdatum Kungörelsedatum EGT nr
N04BC Idiopathic Parkinson disease
Pharmacia & UpjohnN04BC S Idiopathic Parkinson disease
Agouron Pharmaceuticals US
Agouron J05 AX0 Pharmaceuticals Antiviral agent US
Quadramet Samarium [153Sm] Part B
Quadramet
Cis Bio International F
Cis Bio
V10BX02 Therapeutic radiopharmaceutical for pain palliation
International radiopharmaceutical for pain palliation
Solution for injection 1.5 ml, 2.3 ml, 3.1 ml 3 presentations
Therapeutic 3 Presentations
18.12.1996 22.10.1997 198 days 95 days
1. 5 ml, 2. 3 ml, 198 Days 95 Days
4.
3. 1 ml 22. 10. 1997 10. 02. 1998 OJ No. C 63/ 4 of 27. 02. 1998
Primavax combined vaccines Part A
Primavax Pasteur Merieux
Pasteur Merieux MSD F
combined MSD
21.1.1997 22.10.1997 201 days 68 days
05. 02. 1998
Viramune nevirapine Part B
Viramune
Boehringer Ingelheim D
Boehringer Ingelheim
JO5AX04 Treatment of HIV-1 infected adults
Treatment of HIV- 1 infected adults
Tablets 200 mg 2 presentations
200 mg 2 Presentations
20.6.1997 22.10.1997 125 days 0 days
22. 10. 1997 125 Days 0 Days
21.11.1997 5.2.1998 10.2.1998 OJ C 63, 27.2.1998, p.
05. 02. 1998 10. 02. 1998 OJ No. C 63/ 4 of 27. 02. 1998
4.
Kommissionen Yttrandet mottogs den Beslutsdatum Kungörelsedatum EGT nr
2.
07. 05. 1998 08. 05. 1998 OJ No. C 164/ 2 of 29. 05. 1998
L03AA11 Multiple sclerosis
L03AA11
Solution for injection 6MIU 3 presentations
Solution for injection
2 2.7.1996 17.12.1997 181 days 285 days
22. 07. 1996
13.2.1998 4.5.1998 5.5.1998 OJ C 164, 29.5.1998, p.
13. 02. 1998
2.
CH
Product Brand name INN Part A/B
Multiple sclerosis 3 Presentations
Company Name Origin
6MIU 181 Days 285 Days
L01 XX Stage III-IV follicular lymphoma
L01 XX Stage III- IV follicular lymphoma
21.3.1997 28.1.1998 179 days 132 days
21. 03. 1997 28. 01. 1998 179 Days 132 Days
17.
09. 03. 1998 02. 06. 1998 03. 06. 1998 OJ No. C 200/ 17 of 26. 06. 1998
Optison octafluoroprop- ane Part B
Optison octafluoropropane Part B
Mallinckrodt Medical D
Mallinckrodt Medical D Agent for use in echocardiography
V08D Ultrasound contrast Agent for use in echocardiography
V08D Ultrasound contrast 2 Presentations
21.3.1997 28.1.1998 192 days 122 days
Suspension for 0. 22 mg/ ml 192 Days 122 Days
17.
injection 28. 01. 1998 19. 05. 1998 OJ No. C 200/ 17 of 26. 06. 1998
Exelon rivastigmine
Exelon rivastigmine Part B
Novartis Europharm
Novartis Europharm NO7 AA CH Alzheimer Disease
Hard capsule 1.5 mg, 3 mg,
Hard capsule 1mg, 1. 5 mg, 3 mg, 4. 5 mg, 6 mg 16 Presentations
4.5 mg, 6 mg 16 presentations
18. 04. 1997 28. 01. 1998 186 days 97 days
186 days 97 days
03. 03. 1998 12. 05. 1998 12. 05. 1998 OJ No.
2.
C 164/ 2 of 29. 05. 1998
20.6.1997
20. 06. 1997
1.4.1998
01. 04. 1998
25.2.1998 194 days 56 days
25. 02. 1998 194 Days 56 Days
17.
15. 06. 1998 16. 06. 1998 OJ No. C 200/ 17 of 26. 06. 1998
Echogen dodecafluoro- pentane Part B
Echogen dodecafluoro - pentane Part B
V08DA Ultrasound contrast Agent for use in echocardiography
V08DA Ultrasound contrast Agent for use in echocardiography
Aqueous emulsion for injection 20 mg/ml 1 presentations
Aqueous emulsion for injection 20 mg/ ml 1 Presentations
18.1 2.1996 25.3.1998 176 days 270 days
18. 12. 1996 25. 03. 1998 176 Days 270 Days
2.
05. 05. 1998 17. 07. 1998 20. 07. 1998 OJ No. C 269/ 2 of 28. 08. 1998
120 mg 6 presentations
Capsule 120 mg 6 Presentations
25.3.1998 183 days 255 days
02. 01. 1997 25. 03. 1998 183 Days 255 Days
2.
05. 05. 1998 29. 07. 1998 30. 07. 1998 OJ No. C 269/ 2 of 28. 08. 1998
Sanof i Pharma Bristol-Myers Squibb SNC F
Sanofi Pharma Bristol- Myers Squibb SNC F
BO1 AC04 Prevention of vascular ischaemia
BO1 AC04 Prevention of vascular ischaemic
Film-coated tablets 75 mg 3 presentations
Film- coated tablets 75 mg 3 Presentations
16.5.1997 25.3.1998 200 days 112 days
16. 05. 1997 25. 03. 1998 200 Days 112 Days
2.
28. 04. 1998 15. 07. 1998 16. 07. 1998 OJNo. C 240/ 2 of 31. 07. 1998
Bristol-Myers Squibb Pharma EEIG F
Bristol- Myers Squibb Pharma EEIG F
BO1 AC04 Prevetnion of vascular ischaemia
BO1 AC04 Prevetnion of vascular ischaemic
2.
28. 04. 1998 15. 07. 1998 16. 07. 1998 OJ No. C 240/ 2 of 31. 07. 1998
JO5 AX Combined treatment of advanced HIV
JO5 AX Combined treatment of advanced HIV
20.6.1997 22.4.1998 209 days 97 days
20. 06. 1997 22. 04. 1998 209 Days 97 Days
25.5.1998 20.8.1998
25. 05. 1998 20. 08. 1998
ATC not yet available Prevention on post- menopausal osteoporosis
ATC not yet available Prevention on postmenopausal osteoporosis
25.7.1997 2 2.4.1998 188 days 84 days
25. 07. 1997 22. 04. 1998 188 Days 84 Days
2.
25. 05. 1998 05. 08. 1998 07. 08. 1998 OJ No. C 269/ 2 of 28. 08. 1998
Celvista raloxifene Part B
Sida 76 EMEA/ MB/ 040/ 98 © EMEA 1999 Fjärde allmänna rapporten om verksamheten vid EMEA 1998 Produkt Namn INN Del A/ B
NL
Företag Namn Land
ATC not yet available Prevention on post- menopausal osteoporosis
Användningsområde ATC Indikation
Film-coated tablets 60 mg 4 presentations
Presentation Form Dosering Antal presentationer
25.7.1997 2 2.4.1998 188 days 84 days
EMEA/ CPMP Validering Yttrande Aktiv tid Inaktiv tid
2.
Kommissionen Yttrandet mottogs den Beslutsdatum Kungörelsedatum EGT nr
Product Brand name INN Part A/B
Celvista raloxifene Part B
Company Name Origin
NL
Therapeutic area ATC Indication
ATC not yet available Preventionon postmenopausal osteoporosis
Presentation Form Dose Number of presentations
Film- coated tablets 60 mg 4 Presentations
EMEA/CPMP Validation Opinion Active time Clock stop
25. 07. 1997 22. 04. 1998 188 Days 84 Days
Commission opinion received on Date of decision Date of notification OJ No.
25. 05. 1998 05. 08. 1998 06. 08. 1998 OJ No. C 269/ 2 of 28. 08. 1998
A10BX02 Type 2 diabetis
A10BX02 Type 2 diabetis
25.7.1998 2 2.4.1998 199 days 97 days
25. 07. 1998 22. 04. 1998 199 Days 97 Days
2.
05. 06. 1998 17. 08. 1998 18. 08. 1998 OJ No. C 297/ 2 of 25. 09. 1998
V09IX Imaging of carcinoma of colon or rectum
V09IX Imaging of carcinoma of colon or rectum
Powder and solvent for solution for injection 10 mg 1 presentation
Powder and solvent for Solution for injection 10 mg 1 Presentation
22.1 1.1996 27.5.1998 145 days 407 days
22. 11. 1996 27. 05. 1998 145 Days 407 Days
1.
10. 07. 1998 25. 09. 1998 29. 09. 1998 OJ No. C 331/ 1 of 29. 10. 1998
N04BX02 Management of Parkinson disease
N04BX02 Management of Parkinson disease
Film-coated tablet 200 mg 4 presentations
Film- coated tablet 200 mg 4 Presentations
18.4.1997 27.5.1998 214 days 188 days
18. 04. 1997 27. 05. 1998 214 Days 188 Days
1.
03. 07. 1998 16. 09. 1998 18. 09. 1998 OJ No. C 331/ 1 of 29. 10. 1998
1.
03. 07. 1998 22. 09. 1998 23. 09. 1998 OJ No. C 331/ 1 of 29. 10. 1998
Laboratories 3M Sante F
Laboratories 3M Sante F
LO3A A External genital/ perianal warts
LO3A A External genital/ perianal warts
Cream 5%w/w 12.5 mg 1 presentation
Cream 5% w/ w 12. 5 mg 1 Presentation
20.6.1997 27.5.1998 209 days 132 days
20. 06. 1997 27. 05. 1998 209 Days 132 Days
1.
30. 06. 1998 18. 09. 1998 22. 09. 1998 OJ No. C 331/ 1 of 29. 10. 1998
imiquinod Part B
Zartra imiquinod Part B
Sante F
Laboratories 3M Sante F
External genital/ perianal warts
LO3A A External genital/ perianal warts
12.5 mg 1 presentation
Cream 5% w/ w 12. 5 mg 1 Presentation
27.5.1998 209 days 132 days
20. 06. 1997 27. 05. 1998 209 Days 132 Days
G04B E Erectile dysfunction
G04B E Erectile dysfunction
Film-coated tablet 25 mg, 50 mg, 100 mg 12 presentations
Film- coated tablet 25 mg, 50 mg, 100 mg 12 Presentations
24.10.1997 27.5.1998 188 days 28 days
24. 10. 1997 27. 05. 1998 188 Days 28 Days
2.
26. 06. 1998 14. 09. 1998 15. 09. 1998 OJ No. C 269/ 2 of 28. 08. 1998
I
Roerig Pharmaceutici Italiana S. p. A.
G04B E Erectile dysfunction
Erectile dysfunction I
Film-coated tablet 25 mg, 50 mg, 100 mg 12 presentations
G04B E 25 mg, 50 mg, 100 mg 12 Presentations
24.10.1997 27.5.1998 188 days 28 days
Film- coated tablet 27. 05. 1998 14. 09. 1998 188 Days 16. 09. 1998 28 Days OJ No. C 269/ 2 of 28. 08. 1998
L04 AA02 Prophylaxis of acute rejection in renal transplantation
L04 A1 Prophylaxis of acute rejection in renal transplantation
Powder and Solvent for solution for infusion 20 mg 1 presentation
Powder and Solvent for solution for infusion 20 mg 1 Presentation
24.10.1997 24.6.1998 153 days 91 days
24. 10. 1997 24. 06. 1998 153 Days 91 Days
1.
08. 10. 1998
Triacellucax bacterial vaccine Part A
bacterial vaccine
JO7AJ Pediatric vaccine for diphteria, tetanus and pertussi
Pediatric
Suspension for injection diphtheria > 30 IU Tetanus > 40 IU Pertactin 2.5µ 1 presentation
Tetanus ≥ 40 IU
20.6.1997 23.7.1998 188 days 209 days
23. 07. 1998
8.10.1998
Part A
Infergen
Pertactin 2. 5 µ
Yamanouchi
188 Days
Solution for injection
tetanus and pertussi
25.7.1997
209 Days
JO5AX Chronic hepatitis C
JO5AX Chronic hepatitis C
9 µg 3 presentations
Solution for injection 9 µg 3 Presentations
23.7.1998 182 days 181 days
25. 07. 1997 23. 07. 1998 182 Days 181 Days
3.12.1998
03. 12. 1998
Company Name Origin
Micardis
Therapeutic area ATC Indication
Boehringer Ingelheim
Presentation Form Dose Number of presentations
C09CA0
EMEA/CPMP Validation Opinion Active time Clock stop
Tablets
Commission opinion received on Date of decision Date of notification OJ No.
24. 10. 1997
Micardis telmisartan Part B
telmisartan Part B
Boehringer Ingelheim International GmbH D
International GmbH Hypertension D
Tablets 40 mg, 80 mg 8 presentations
40 mg, 80 mg 8Presentations
24.10.1997 23.7.1998 188 days 84 days
23. 07. 1998 188 Days 84 Days
5.10.1998 16.12.1998
16. 12. 1998
C09CA0 Hypertension
Glaxo Group Ltd C09CA0 UK Hypertension
Tablets 40 mg, 80 mg 10 presentations
Tablets 40 mg, 80 mg 10 Presentations
24.10.1997 23.7.1998 188 days 84 days
24. 10. 1997 23. 07. 1998 188 Days 84 Days
20.9.1998 11.12.1998
20. 09. 1998 11. 12. 1998
Boehringer Ingelheim International GmbH D
Boehringer Ingelheim International GmbH Hypertension D
Tablets 40 mg, 80 mg 8 presentations
C09CA0 40 mg, 80 mg 8 Presentations
24.10.1997 23.7.1998 188 days 84 days
Tablets 23. 07. 1998 188 Days 84 Days
5.10.1998 16.12.1998
24. 10. 1997 16. 12. 1998
Karvezide irbesartan/ hydrochlorotiazide Part B
Karvezide irbesartan /
C09DA Essential hypertension
C09DA Bristol- Myers Essential hypertension
Tablet 150/12.5 mg, 300/12.5 mg 6 presentations
Tablet 150/ 12. 5 mg, 300/ 12. 5 mg
19.12.1997 23.7.1998 153 days 63 days
19. 12. 1997 23. 07. 1998
21.8.1998 17.10.1998
21. 08. 1998 17. 10. 1998
CoAprovel irbesartan/ hydrochlorotiazide Part B
hydrochlorotiazide Part B EEIG F
Sanof i Pharma Bristol-Myers Squibb SNC F
Squibb Pharma
C09DA Essential hypertension
C09DA Essential hypertension Squibb SNC
19.12.1997 23.7.1998 153 days 63 days
19. 12. 1997 23. 07. 1998 6 Presentations 63 Days
21.8.1998 15.10.1998
21. 08. 1998 15. 10. 1998 153 Days
H05B A01 Hypercalcaemia of malignancy and Paget's Disease
H05B A01 Hypercalcaemia of malignacy and osteoporosis
26.9.1997 17.9.1998 210 days 147 days
26. 09. 1997 17. 09. 1998 210 Days 147 Days
20.10.1998
20. 10. 1998
NO7 AA Alzheimer disease
NO7 AA Alzheimer Disease
24.7.1998 17.9.1998 53 days
24. 07. 1998 17. 09. 1998 53 Days
1.10.1998 4.12.1998
01. 10. 1998 04. 12. 1998
........
........
................
................
NO7 Mild or moderate dementia of Alzheimer's type
NO7 Mild or moderate dementia of Alzheimer ’ type s
Filmtablet 300 mg 5 presentations
Filmtablet 300 mg 5 Presentations
19.11.1996 22.10.1998 182 days 519 days
19. 11. 1996 22. 10. 1998 182 Days 519 Days
NO7 Mild or moderate dementia of Alzheimer's type
moderate dementia of Alzheimer ’ type s
19.11.1996 22.10.1998 182 days 519 days
182 Days 519 Days
Gruenenthal GmbH D
Gruenenthal GmbH D
25.07.1997 22.10.1998 212 days 243 days
25. 07. 1997 22. 10. 1998 212 Days 243 Days
S01GX Allergic conjuctivitis
S01GX Allergic conjuctivitis
Solution 0.05% 2 presentations
Solution 0. 05% 2 Presentations 127 Days
19.12.1997 22.10.1998 182 days 127 days
19. 12. 1997 22. 10. 1998 182 Days
2.12.1998
02. 12. 1998
Medica Ireland zaleplon Part B
Zaleplon Wyeth Wyeth Medica Ireland US zaleplon Part B
Short term treatment of insomnia
N05CH01 Short term treatment of insomnia
19.11.1998 182 days 113 days
30. 01. 1998 19. 11. 1998 182 Days 113 Days
Sonata zaleplon Part B
Sonata Wyeth zaleplon US Part B
N05CH01 Short term treatment of insomnia
N05CH01 Short term treatment of insomnia
30.1.1998 19.11.1998 182 days 113 days
30. 01. 1998 19. 11. 1998 182 Days 113 Days
Boehringer Ingelheim International GmbH D
Boehringer Ingelheim International GmbH Adjunct to surgery D for sarcoma of the limbs
Powder and solvent 0.2 mg/ml 1 presentation
L03AA 0. 2 mg/ ml 1 Presentation
24.10.1997 19.11.1998 188 days 204 days
Powder and solvent 19. 11. 1998 188 Days 204 Days
Roche Registration Ltd CH
Roche L04A Registration Ltd Prophylaxis of acute CH rejection in renal transplants
26.9.1997 16.11.1998 205 days 214 days
26. 09. 1997 16. 11. 1998 205 Days 214 Days
Asta Medica D
Asta Medica D
G03X Prevention of premature ovulation in fertilisation treatment
G03X Prevention of premature ovulation in fertilisation treatment
27.2.1998 17.12.1998 173 days 121 days
27. 02. 1998 17. 12. 1998 173 Days 121 Days
Genetics Institute US
Genetics Institute US
B02BD02 Control and prevention of haemorrhagic episodes
B02BD02 Control and prevention of haemorrhagic episodes
27.2.1998 17.12.1998 146 days 148 days
27. 02. 1998 17. 12. 1998 146 Days 148 Days
Regranex becaplermin Part A Annex 7
Regranex becaplermin Part A
B
BE
D03...
D03...
Healing of full thickness Diabetic ulcers
Healing of fullthickness Diabetic ulcers
Gel 100 µg/g 1 presentation
Gel 100 µg/ g 1 Presentation
21.11.1997 17.12.1998 188 days 203 days
21. 11. 1997 17. 12. 1998 188 Days 203 Days
CVMP OPINIONS ON MEDICINAL PRODUCTS FOR VETERINARY USE
Sida 79 EMEA/ MB/ 040/ 98 © EMEA 1999 Fjärde allmänna rapporten om verksamheten vid EMEA 1998 Bilaga 7
Centralised applications
YTTRANDEN OM VETERINÄRMEDICINSKA LÄKEMEDEL
Product (a) Brand name (b) INN (c) Part A/B
Centraliserade ansökningar
Company (a) Name (b) Origin
Produkt a) Namn b) INN c) Del A/ B
Therapeutic area (a) Target species (b) Indication
Företag a) Namn b) Land
Presentation (a) Form (b) Dosage (c) No of presentations
Användn. område a) Måldjurart b) Indikation
EMEA/CVMP (a) Validation (b) Opinion (c) Active time (d) Clockstop
Presentation a) Form b) Dosering c) Antal presentationer
Commission (a) Opinion (b) Decision (c) Notification (d) Official Journal
EMEA/ CVMP a) Validering b) Yttrande c) Aktiv tid d) Inaktiv tid
(a) Nobi-vac-Porcoli (b) Inactivated vaccine (c) Part A
Kommissionen a) Yttrandet mottogs den b) Beslut c) Kungörelsedatum d) EGT nr
(a) Intervet International (b) NL
a) Nobi- vac - a) Intervet Porcoli International b) Inactivated b) NL vaccine c) Part A
(a) 1.1.1995 (b) 27.7.1995 (c) 107 days (d) 94 days
a) 01. 01. 1995 b) 27. 07. 1995 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. 1995 b) 29. 02. 1996 c) 04. 03. 1996 d) OJ C 96, 29. 03. 1996
(a) 16.6.1995 (b) 18.9.1996 (c) 208 days (d) 235 days
a) 16. 06. 1995 b) 18. 09. 1996 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. 1996 b) 05. 02. 1997 c) 06. 02. 1997 d) OJ C 63, 28. 02. 1997
(a) Quadrisol (b) Vedaprofen (c) Part B
b) Vedaprofen c) Part B
(a) Intervet International (b) NL
International b) NL
(a) Horses (b) Control of inflammation
b) Control of inflammation
(a) Oral gel (b) 100mg/ml (c) 1
b) 100mg/ ml c) 1
(a) 7.5.1996 (b) 16.7.1997 (c) 209 days (d) 235 days
b) 16. 07. 1997 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
b) 04. 12. 1997 c) 05. 12. 1997 d) OJ C 392, 24. 12. 1997