natgillin/translations-raw huggingface dataset:
EMEA/ MB/ 040/ 98 EMEA ’ årsberetning for 1998
(5) Carlos Sinogas replaced José BELO as of the 13 January 1998 meeting.
Bilag 4 PARTNERE FRA DE NATIONALE KOMPETENTE MYNDIGHEDER
Annex 4
Adresser, kontaktpunkter og yderligere oplysninger om de nationale kompetente myndigheder kan også indhentes på den nye website, som de nationale myndigheder oprettede i 1998 http: // heads. medagencies. org
Addresses, contact points and further information on the national competent authorities may also be found on the new website launched by the national authorities in 1998 http://heads.medagencies.org
BELGIQUE/ BELGÏE
BELGIQUE/BELGÏE
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:
(32- 2) 227 55 67 Fax:
(32-2) 227 55 67 Fax:
(32- 2) 227 55 55
(32-2) 227 55 55
DANMARK
DANMARK
Direktør Lægemiddelstyrelsen Frederikssundsvej 378 DK- 2700 Brønshøj Tlf:
Ib Bo LUMHOLZ Direktør Lægemiddelstyrelsen Frederikssundsvej 378 DK-2700 Brønshøj Tel:
(45) 44 88 93 41 Fax:
(45) 44 88 93 41 Fax:
(45) 44 91 73 73
(45) 44 91 73 73
DEUTSCHLAND
DEUTSCHLAND
Alfred HILDEBRANDT
Alfred HILDEBRANDT Arzt.
Prof. für Pharmakologie und Toxicologie BfArM Seestraße, 10- 11 D- 13353 Berlin Tel:
Prof. für Pharmakologie und Toxicologie BfArM Seestraße, 10-11 D-13353 Berlin Tel:
(49- 30) 45 48 32 03 Fax:
(49-30) 45 48 32 03 Fax:
(49- 30) 45 48 33 32
(49-30) 45 48 33 32
Direktor BgVV Diedersdorfer Weg, 1 D- 12277 Berlin Tel:
Reinhard KROKER Direktor BgVV Diedersdorfer Weg, 1 D-12277 Berlin Tel:
(49- 30) 84 12 23 64 Fax:
(49-30) 84 12 23 64 Fax:
(49- 30) 84 12 29 65
(49-30) 84 12 29 65
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:
(49- 6103) 770 Fax:
(49-6103) 770 Fax:
(49- 6103) 77 01 23
(49-6103) 77 01 23
EMEA/ MB/ 040/ 98 EMEA ’ årsberetning for 1998
ΕΛΛΑ∆Α/GREECE ΕΛΛΑ∆Α
President National Drug Organisation Mesogion 284 GR- 15562 Holargos Tel:
Gerasimos KAVVADIAS President National Drug Organisation Mesogion 284 GR-15562 Holargos Tel:
(30- 1) 652 55 62 Fax:
(30-1) 652 55 62 Fax:
(30- 1) 654 55 35
(30-1) 654 55 35
ESPAÑA
ESPAÑA
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:
(34- 91) 227 67 00 Fax:
(34-91) 227 67 00 Fax:
(34- 91) 596 15 47
(34-91) 596 15 47
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:
(34- 91) 347 66 06 Fax:
(34-91) 347 66 06 Fax:
(34- 91) 594 35 36
(34-91) 594 35 36
FRANCE
FRANCE
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:
(33- 1) 55 87 30 14 Fax:
(33-1) 55 87 30 14 Fax:
(33- 1) 55 87 30 12
(33-1) 55 87 30 12
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:
(33- 2) 99 94 78 72 Fax:
(33-2) 99 94 78 72 Fax:
(33- 2) 99 94 78 99
(33-2) 99 94 78 99
IRELAND
IRELAND
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:
(353- 1) 676 49 71 Fax:
(353-1) 676 49 71 Fax:
(353- 1) 676 78 36
(353-1) 676 78 36
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:
(353- 1) 607 24 34 Fax:
(353-1) 607 24 34 Fax:
(353- 1) 676 29 89
(353-1) 676 29 89
ITALIA
ITALIA LUXEMBOURG
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:
(39- 65) 994 36 66 Fax:
(39-65) 994 36 66 Fax:
(39- 65) 994 33 65
(39-65) 994 33 65 Mariette BACKES-LIES
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:
(39- 65) 994 39 45 Fax:
(39-65) 994 39 45 Fax:
(39- 65) 994 31 90
(39-65) 994 31 90
Mariette BACKES- LIES Pharmacien- Inspecteur Chef de Division Directeur de la Santé Division Pharmacie et Médicaments 10, rue C. M.
Pharmacien-Inspecteur Chef de Division Directeur de la Santé Division Pharmacie et Médicaments 10, rue C.M.
Spoo L – 2546 Luxembourg Tel:
Spoo L-2546 Luxembourg Tel:
(352) 478 55 90 Fax:
(352) 478 55 90 Fax:
(352) 22 44 58
(352) 22 44 58
NEDERLAND
NEDERLAND
Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V. W. S.
André BROEKMANS Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel:
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel:
(31- 70) 356 74 48 Fax:
(31-70) 356 74 48
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:
(31- 31) 747 54 91 Fax:
(31-31) 747 54 91 Fax:
(31- 31) 742 31 93
(31-31) 742 31 93
ÖSTERREICH
ÖSTERREICH
Gunter LIEBESWAR
Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Arbeit,
Alexander JENTZSCH
Alexander JENTZSCH Ministerialrat Leiter der Gruppe fuer
Sektionschef Gesundheitswesen Bundesministerium für Arbeit, Gesundheit und Soziales Stubenring 1 A- 1010 Wien Tel:
Gesundheit und Soziales Stubenring 1 A-1010 Wien Tel:
(43- 1) 711 72 47 17 Fax:
(43-1) 711 72 47 17 Fax:
(43- 1) 713 86 14
(43-1) 713 86 14
Ministerialrat Leiter der Gruppe fuer Pharmazeutische Angelegenheiten 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:
(43- 1) 711 72 46 73 Fax:
(43-1) 711 72 46 73 Fax:
(43- 1) 714 92 22
(43-1) 714 92 22
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:
(351- 1) 798 71 16 Fax:
(351-1) 798 71 16 Fax:
(351- 1) 798 71 20/ 24
(351-1) 798 71 20/24
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:
(351- 1) 323 95 00 Fax:
(351-1) 323 95 00 Fax:
(351- 1) 346 35 18
(351-1) 346 35 18
SUOMI/ FINLAND
SUOMI/FINLAND
Pääjohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P. O.
Hannes WAHLROOS Pääjohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P.O.
Box 55 FIN- 00301 Helsinki Tel:
Box 55 FIN-00301 Helsinki Tel:
(358- 9) 47 33 42 Fax:
(358-9) 47 33 42 Fax:
(358- 9) 47 33 43 45
(358-9) 47 33 43 45
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:
(358- 9) 160 33 38
(358-9) 160 33 38
SVERIGE
SVERIGE
Generaldirektör Läkemedelsverket Husargatan 8, Box 26 S- 751 03 Uppsala Tel:
Kjell STRANDBERG Generaldirektör Läkemedelsverket Husargatan 8, Box 26 S-751 03 Uppsala Tel:
(46- 18) 17 46 00 Fax:
(46-18) 17 46 00 Fax:
(46- 18) 54 85 66
(46-18) 54 85 66
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:
(44- 171) 273 01 00 Fax:
(44-171) 273 01 00 Fax:
(44- 171) 273 05 48
(44-171) 273 05 48 Annex 5
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:
(44- 1932) 33 69 11 Fax:
(44-1932) 33 69 11 Fax:
(44- 1932) 33 66 18
(44-1932) 33 66 18
s
71
Bilag 5 EMEA ’ BUDGETTER FOR 1996 TIL 1998 s
EMEA BUDGETS 1996 TO 1998
De komparative budgetoversigter for 1996 til 1998 er sammenfattet således:
The summarised comparative budget statements for 1996 to 1998 are as follows:
(beløb udtrykt i ECU)
(amounts expressed in ECUs)
19961
Revenues
19971
1996(1)
19982
1997(1)
Indtægter
1998(2)
-
- fees
7 004 333
7 004 333
12 944 666
12 944 666
17 030 000
17 030 000
- -
- EU subsidy - other
497 149 372 209
497 149 372 209
546 501 552 087
546 501 552 087
000 000 870 000
000 000 870 000
17 873 692
17
27 043 254
043 254
31 900 000
900 000
Udgifter
Staff costs
Personaleomkostninger - -
- salaries - interim and other supporting persons
029 510 900 432
029 510 900 432
051 341 977 998
051 341 977 998
743 000 620 000
743 000 620 000
andre personalerelaterede udgifter
- other staff related expenditure
1
925 8 16
1
1 140 312
010 000
1 010 000
Bygning og udstyr - - - - -
Building and equipment
husleje/ afgifter udgifter til elektronisk databehandling andre kapitaludgifter porto og telekommunikation andre administrative udgifter
Operational expenditure
641 426 665 993 117 599 326 177 805 561
641 426 665 993 117 599 326 177 805 561
859 982 769 987 439 811 463 346 968 037
859 982 769 987 439 811 463 346 968 037
080 000 954 000 165 000 410 000 922 000
080 000 954 000 165 000 410 000 922 000
Driftsudgifter - - - - -
- meetings - evaluation of medicinal products
401 308 067 500 741 000 224 984 26 379
741 000 224 984 26 379
1 6 1
1
986 442 700 000 200 000 243 782 242 216
200 000 243 782 242 216
487 000 800 000 584 000 105 000 20 000
584 000 105 000 20 000
17 873 692
17 873 692
27 043 254
27 043 254
31 900 000
31 900 000
1996 - og 1997- budgettet: gennemførelse 2.
Notes (1) 1996 and 1997 budgets: outturn.
EMEA/ MB/ 040/ 98 EMEA ’ årsberetning for 1998
(2) 1998 budget: final appropriations.
Side 71
Annex 6
s Bilag 6 CPMP- UDTALELSER I 1998 OM HUMANMEDICINSKE LÆGEMIDLER
CPMP OPINIONS IN 1998 ON MEDICINAL PRODUCTS FOR HUMAN USE
Lægemiddel Handelsnavn INN Del A/ B
Product Brand name INN Part A/B
Firma Navn Oprindelse
Company Name Origin
Behandlingsområde ATC- kode Indikation
Therapeutic area ATC Indication
Præsentation Form Dosis Antal præsentationer
Presentation Form Dose Number of presentations
EMEA/ CPMP Godkendelse Udtalelse Nettotid Urstop
EMEA/CPMP Validation Opinion Active time Clock stop
Kommissionen Udtalelse modtaget den Dato for afgørelsen Dato for meddelelsen EFT. nr.
Commission opinion received on Date of decision Date of notification OJ No.
Mirapexin pramipexole Part B
Mirapexin pramipexole Part B
Pharmacia & Upjohn S
Pharmacia & Upjohn S
N04BC Idiopathic Parkinson disease
N04BC Idiopathic Parkinson disease
Tablets 0. 125 mg, 0. 25 mg, 1 mg, 1. 25 mg, 1. 5 mg 10 Presentations
Tablets 0.125 mg, 0.25 mg, 1 mg, 1.25 mg, 1.5 mg 10 presentations
18. 06. 1996 18. 06. 1997 208 Days 141 Days
18.6.1996 18.6.1997 208 days 141 days
05. 08. 1997 23. 02. 1998 24. 02. 1998 OJ No. C 92/ 2 of 23. 3. 1998
2.
Viracept nelfinavir Part B
Viracept nelf inavir Part B
Agouron Pharmaceuticals US
Agouron Pharmaceuticals US
J05 AX0 Antiviral agent
J05 AX0 Antiviral agent
Tablet, Oral powder 250 mg, 50 mg/ g 3 Presentations
Tablet, Oral powder 250 mg, 50 mg/g 3 presentations
18. 02. 1998 24. 09. 1997 180 Days 34 Days
18.2.1998 2 4.9.1997 180 days 34 days
31. 10. 1997 22. 01. 1998 22. 01. 1998 OJ No. C 63/ 4 of 27. 02. 1998
4.
Quadramet Samarium [153Sm] Part B
Quadramet Samarium [153Sm] Part B
Cis Bio International F
Cis Bio International F
V10BX02 Therapeutic radiopharmaceutical for pain palliation
V10BX02 Therapeutic radiopharmaceutical for pain palliation
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
26. 11. 1997 05. 02. 1998 10. 02. 1998 OJ No. C 63/ 4 of 27. 02. 1998
4.
Primavax combined vaccines Part A
Primavax combined vaccines Part A
Pasteur Merieux MSD F
Pasteur Merieux MSD F
J07CA Bacterial and viral combined vaccines
J07CA Bacterial and viral combined vaccines
Suspension for injection Diphtheria ≥ 30 IU Tetanus ≥ 40 IU r- HbsAG 5µg 1 Presentation
Suspension for injection Diphtheria > 30 IU Tetanus > 40 IU r-HbsAG 5µg 1 presentation
21. 01. 1997 22. 10. 1997 201 Days 68 Days
21.1.1997 22.10.1997 201 days 68 days
21. 11. 1997 05. 02. 1998 10. 02. 1998 OJ No. C 63/ 4 of 27. 02. 1998
4.
Turvel trovafloxacin Part B
Turvel trovafloxacin Part B
Roerig Farmaceutical I I
Roerig Farmaceutical I
J01M A Antibacterial Agent
J01M A Antibacterial agent
Tablets 100 mg, 200 mg 14 Presentations
Tablets 100 mg, 200 mg 14 presentations
18. 02. 1997 22. 10. 1997 208 Days 34 Days
18. 2.1997 22.10.1997 208 days 34 days
05. 12. 1997 08. 07. 1998 09. 07. 1998 OJ No. C 240/ 2 of 31. 07. 1998
2.
Turvel i. v. alatrofloxacin Part B
Turvel i.v. alatrofloxacin Part B
Roerig Farmaceutical I
Roerig Farmaceutical I
Concentrate for solution 100 mg, 200 mg, 300 mg 3 Presentations
Concentrate for solution 100 mg, 200 mg, 300 mg 3 presentations
05. 12. 1997 03. 07. 1998 20. 07. 1998 OJ No. C 240/ 2 of 31. 07. 1998
2.
Trovan trovafloxacin Part B
Trovan trovafloxacin Part B
Pfizer Ltd UK
Pf izer Ltd UK
05. 12. 1997 03. 07. 1998 06. 07. 1998 OJ No. C 240/ 2 of 31. 07. 1998
2.
Trovan i. v. alatrofloxacin Part B
Trovan i.v. alatrofloxacin Part B
Viramune nevirapine Part B
Viramune nevirapine 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. 06. 1997 22. 10. 1997 125 Days 0 Days
20.6.1997 22.10.1997 125 days 0 days
21. 11. 1997 05. 02. 1998 10. 02. 1998 OJ No. C 63/ 4 of 27. 02. 1998
21.11.1997 5.2.1998 10.2.1998 OJ C 63, 27.2.1998, p.
©
4.
Pylobactell 13
Pylobactell 13
B. S. I. A.
BSIA
V04CX
V04CX
18. 12. 1996
18.12.1996
13. 02. 1998
13.2.1998
C- urea Part B
C-urea Part B
Helicobacter pylori Test
Helicobacter pylori Test
100 mg 1 Presentation
100 mg 1 presentation
19. 11. 1997 163 Days 158 Days
19.11.1997 163 days 158 days
07. 05. 1998 08. 05. 1998 OJ No. C 164/ 2 of 29. 05. 1998
2.
Combivir lamivudine / zidovudine Part B
Combivir lamivudine/ zidovudine Part B
Glaxo- Wellcome UK
Glaxo-Wellcome UK
J05AB20 HIV infected adults and children
J05AB20 HIV infected adults and children
Film- coated tablets 150 mg/ 300 mg 2 Presentations
Film-coated tablets 150 mg/300 mg 2 presentations
25. 07. 1997 19. 11. 1997 119 Days 0 Days
25.7.1997 19.11.1997 119 days 0 days
05. 01. 1998 18. 03. 1998 19. 03. 1998 OJ No. C 126 of 24. 04. 1998
5.1.1998 18.3.1998 19.3.1998 OJ C 126, 24.4.1998.
Rebif
Rebif Interferon beta-1a Part A
Serono
Serono CH
L03AA11
L03AA11 Multiple sclerosis
Solution for injection
Solution for injection 6MIU 3 presentations
22. 07. 1996
2 2.7.1996 17.12.1997 181 days 285 days
13. 02. 1998
2.
Interferon beta- 1a CH Part A
Product Brand name INN Part A/B
Multiple sclerosis 29. 05. 1998
Company Name Origin
6MIU 3 Presentations
Therapeutic area ATC Indication
17. 12. 1997 181 Days 285 Days
Presentation Form Dose Number of presentations
04. 05. 1998 05. 05. 1998 OJ No. C 164/ 2 of
Commission opinion received on Date of decision Date of notification OJ No.
MabThera Hoffmann La Roche rituximab CH Part A
MabThera rituximab Part A
L01 XX Antineoplastic Agent
L01 XX Stage III-IV follicular lymphoma
Concentration for solution for infusion 100 mg, 500 mg 2 Presentations
Concentration for solution for infusion 100 mg, 500 mg 2 presentations
21. 03. 97 28. 01. 98 179 Days 132 Days
21.3.1997 28.1.1998 179 days 132 days
09. 03. 98 02. 06. 98 03. 06. 98 OJ No. C 200/ 17 of 26. 06. 98
17.
Optison perfluoropropane Part B
Optison octafluoroprop- ane Part B
Mallinckrodt DE
Mallinckrodt Medical D
V08D Ultrasound contrast Agent
V08D Ultrasound contrast Agent for use in echocardiography
Suspension for injection 5- 8 x 108 2 Presentations
Suspension for injection 0.22 mg/ml 2 presentations
21. 03. 97 28. 01. 98 192 Days 122 Days
21.3.1997 28.1.1998 192 days 122 days
04. 03. 98 18. 05. 98 19. 05. 98 OJ No. C 200/ 17 of 26. 06. 98
17.
Exelon carbamoylatine Part B
Exelon rivastigmine
Novartis Europharm CH
Novartis Europharm
NO7 AA treatment of Alzheimer Disease
NO7 AA
Hard capsule 1mg, 1. 5 mg, 3 mg, 4. 5 mg, 6 mg 20 Presentations
Hard capsule 1.5 mg, 3 mg,
18. 04. 97 28. 01. 98 186 days 97 days
186 days 97 days
03. 03. 98 12. 05. 98 12. 05. 98 OJ No.
12.5.1998 OJ C 164, 29.5.1998, p.
C 164/ 2 of 29. 05. 98
2.
Pylori- chek 13
Pylori-chek 13
Alimenterics BV
Alimenterics BV
Powder for oral solution
Powder for oral solution
20. 06. 97
20.6.1997
01. 04. 98
1.4.1998
C Urea Part B
C Urea Part B
25. 02. 98 194 Days 56 Days
25.2.1998 194 days 56 days
15. 06. 98 16. 06. 98 OJ No. C 200/ 17 of 26. 06. 98
17.
Echogen dodecafluoro - Pentane Part B
Echogen dodecafluoro- pentane Part B
Sonus Pharmaceuticals UK
Sonus Pharmaceuticals UK
V08DA Ultrasound contrast Agent
V08DA Ultrasound contrast Agent for use in echocardiography
Aqueous emulsion for injection 20 mg/ ml 2 Presentations
Aqueous emulsion for injection 20 mg/ml 1 presentations
18. 12. 96 25. 03. 98 176 Days 270 Days
18.1 2.1996 25.3.1998 176 days 270 days
05. 05. 98 17. 07. 98 20. 07. 98 OJ No. C 269/ 2 of 28. 08. 98
2.
Xenical orlistat Part B
orlistat Part B
Hoffmann - La Roche CH
Roche CH
A08 A Antiobesity
Antiobesity
Capsule 120 mg 3 Presentations
120 mg 6 presentations
02. 01. 97 25. 03. 98 183 Days 255 Days
25.3.1998 183 days 255 days
05. 05. 98 29. 07. 98 30. 07. 98 OJ No. C 269/ 2 of 28. 08. 98
2.
Plavix clopidogrel Part B
Plavix clopidogrel Part B
Sanofi Pharma Bristol- Myers Squibb SNC FR
Sanof i Pharma Bristol-Myers Squibb SNC F
BO1 AC04 Prevention of vascular ischaemic events
BO1 AC04 Prevention of vascular ischaemia
Film- coated tablets 75 mg 6 Presentations
Film-coated tablets 75 mg 3 presentations
16. 05. 97 25. 03. 98 200 Days 112 Days
16.5.1997 25.3.1998 200 days 112 days
28. 04. 98 15. 07. 98 16. 07. 98 OJNo. C 240/ 2 of 31. 07. 98
2.
Iscover clopidogrel Part B
Iscover clopidogrel Part B
Bristol- Myers Squibb Pharma EEIG FR
Bristol-Myers Squibb Pharma EEIG F
BO1 AC04 Prevetnion of vascular ischaemic events
BO1 AC04 Prevetnion of vascular ischaemia
28. 04. 98 15. 07. 98 16. 07. 98 OJ No. C 240/ 2 of 31. 07. 98
28.4.1998 15.7.1998 16.7.1998 OJ C 240, 31.7.1998, p.
©
2.
Fortovase saquinavir Part B
Fortovase saquinavir Part B
Hoffmann - La Roche CH
Hoffmann La Roche CH
JO5 AX Treatment of Zidovudine - Exp.
JO5 AX Combined treatment of advanced HIV
Capsule 200 mg 1 Presentation
Capsule 200 mg 1 presentation
20. 06. 97 22. 04. 98 209 Days 97 Days
20.6.1997 22.4.1998 209 days 97 days
25. 05. 98 20. 08. 98
25.5.1998 20.8.1998
Evista raloxifene Part B
Evista raloxifene Part B
Eli Lilly Nederlands B. V.
Eli Lilly Nederlands B.V.
Not yet available Prevention of Osteoporosis in postmeno- pausal women
ATC not yet available Prevention on post- menopausal osteoporosis
Film- coated tablets 60 mg 4 Presentations
Film-coated tablets 60 mg 4 presentations
25. 07. 97 22. 04. 98 188 Days 84 Days
25.7.1997 2 2.4.1998 188 days 84 days
25. 05. 98 05. 08. 98 07. 08. 98 OJ No. C 269/ 2 of 28. 08. 98
2.
Celvista raloxifene Part B
Celvista raloxifene Part B
25. 05. 98 05. 08. 98 06. 08. 98 OJ No. C 269/ 2 of 28. 08. 98
2.
NovoNorm repaglinide Part B
NovoNorm repaglinide Part B
A10BX02 Treatment of type 2 diabetis or NIDDM
A10BX02 Type 2 diabetis
Tablets 0. 5 mg, 1 mg, 2 mg 7 Presentations
Tablets 0.5 mg, 1 mg, 2 mg 7 presentations
25. 07. 98 22. 04. 98 199 Days 97 Days
25.7.1998 2 2.4.1998 199 days 97 days
05. 06. 98 17. 08. 98 18. 08. 98 OJ No. C 297/ 2 of 25. 09. 98
2.
HumaSPECT CR Kit votumumab Part A
HumaSPECT CR Kit votumumab Part A
Organon Teknika NL
Organon Teknika NL
Not yet available Radiopharmaceutical imaging agent
V09IX Imaging of carcinoma of colon or rectum
Solution for injection 12 mg 1 Presentation
Powder and solvent for solution for injection 10 mg 1 presentation
22. 11. 96 27. 05. 98 145 Days 407 Days
22.1 1.1996 27.5.1998 145 days 407 days
10. 07. 98 25. 09. 98 29. 09. 98 OJ No. C 331/ 1 of 29. 10. 98
1.
Comtess entacapone Part B
Comtess entacapone Part B
Orion FIN `
Orion FIN
Not yet available Management of Parkinson disease
N04BX02 Management of Parkinson disease
Film- coated tablet 200 mg 5 Presentations
Film-coated tablet 200 mg 4 presentations
18. 04. 97 27. 05. 98 214 Days 188 Days
18.4.1997 27.5.1998 214 days 188 days
03. 07. 98 16. 09. 98 18. 09. 98 OJ No. C 331/ 1 of 29. 10. 98
1.
Comtan entacapone Part B
Comtan entacapone Part B
Novartis Europharm CH
Novartis Europharm CH
03. 07. 98 22. 09. 98 23. 09. 98 OJ No. C 331/ 1 of 29. 10. 98
1.
Aldara imiquinod Part B
Aldara imiquinod Part B
Laboratories 3M Sante FR
Laboratories 3M Sante F
LO3A A Topical treatment of external genital/ perianal warts
LO3A A External genital/ perianal warts
Cream 12. 5 mg 1 Presentation
Cream 5%w/w 12.5 mg 1 presentation
20. 06. 97 27. 05. 98 209 Days 132 Days
20.6.1997 27.5.1998 209 days 132 days
30. 06. 98 18. 09. 98 22. 09. 98 OJ No. C 331/ 1 of 29. 10. 98
1.
Zartra imiquinod Part B
Zartra
Laboratories 3M Sante FR
Laboratories 3M
LO3A A Topical treatment of external genital/ perianal warts
LO3A A
Cream 12. 5 mg 1 Presentation
Cream 5%w/w
20. 06. 97 27. 05. 98 209 Days 132 Days
20.6.1997
Side 74
30.6.1998
s
imiquinod Part B
©
Sante F
Lægemiddel Handelsnavn INN Del A/ B
External genital/ perianal warts
Firma Navn Oprindelse
12.5 mg 1 presentation
Behandlingsområde ATC- kode Indikation
27.5.1998 209 days 132 days
Præsentation Form Dosis Antal præsentationer
1.
EMEA/ CPMP Godkendelse Udtalelse Nettotid Urstop
75
Viagra sildenafil Part B
Viagra sildenaf il Part B
Pfizer Limited UK
Pf izer Limited UK
G04B E Treatment of erectile dysfunction
G04B E Erectile dysfunction
Film- coated tablet 50 mg 7 Presentations
Film-coated tablet 25 mg, 50 mg, 100 mg 12 presentations
24. 10. 97 27. 05. 98 188 Days 28 Days
24.10.1997 27.5.1998 188 days 28 days
26. 06. 98 14. 09. 98 15. 09. 98 OJ No. C 269/ 2 of 28. 08. 98
2.
Patrex sildenafil Part B
Patrex sildenaf il Part B
Roerig Pharmaceutici Italiana S. p. A.
Roerig Pharmaceutici Italiana S.p.A.
IT
I
26. 06. 98 14. 09. 98 16. 09. 98 OJ No. C 269/ 2 of 28. 08. 98
2.
Simulect basiliximab Part A
Simulect basiliximab Part A
Novartis Europharm Ltd.
Novartis Europharm Ltd.
L04 A1 Prophylaxis of acute organ rejection in the novorenal transplantation
L04 AA02 Prophylaxis of acute rejection in renal transplantation
Powder and Solvent 20 mg 1 Presentation
Powder and Solvent for solution for infusion 20 mg 1 presentation
24. 10. 97 24. 06. 98 153 Days 91 Days
24.10.1997 24.6.1998 153 days 91 days
03. 08. 98 09. 10. 98 14. 10. 98 OJ No. C 331/ 1 of 29. 10. 98
1.