natgillin/translations-raw huggingface dataset:
Belgien Danmark Tyskland Grækenland Spanien Frankrig Irland Italien Luxembourg Nederlandene Østrig Portugal Finland Sverige Det Forenede Kongerige Repræsentanter for
Portugal
André LHOIR Heidrun BOSCH- TRABERG1 Rembert ELBERS George STRATHOPOULOS José Félix OLLOLA MARAÑÓN François MEYER Brendan BUCKLEY Domenica TARUSCIO Henri METZ Harrie SEEVERENS Hans Georg EICHLER José Manuel GIÃO TOSCANO RICO Kalle HOPPU Kerstin WESTERMARK Rashmi SHAH2
José Manuel GIÃO TOSCANO RICO
patientsammenslutninger
Kerstin WESTERMARK
Moisés ABASCAL ALONSO Yann LE CAM, Næstformand Alastair KENT
Moisés ABASCAL ALONSO, Yann LE CAM, Vice-chairman, Alastair KENT
EMEA- repræsentanter
EMEA representatives
Eric ABADIE3 Gianmartino BENZI David LYONS4
Eric ABADIE 3, Gianmartino BENZI, David LYONS 4
Island Norge
Iceland
Sigurdur THORSTEINSSON Randi NORDAL
Sigurdur THORSTEINSSON
1 Erstattede Jan RENNEBERG fra og med mødet i januar 2001.
Replaced Jan RENNEBERG as of the January 2001 meeting.
2 Blev erstattet af Alex NICHOLSON fra og med mødet i maj 2001 og genudnævnt fra og med oktober 2001.
Was replaced by Alex NICHOLSON as of the May 2001 meeting and re-appointed as of October 2001.
3 Erstattede Jean- Michel ALEXANDRE fra og med mødet i marts 2001.
Replaced Jean-Michel ALEXANDRE as of the March 2001 meeting.
4 Erstattede Mary TEELING fra og med mødet i marts 2001.
Replaced Mary TEELING as of the March 2001 meeting.
Bilag 5 Partnere fra de kompetente nationale myndigheder
Annex 5 National competent authority partners
Yderligere oplysninger om de kompetente nationale myndigheder kan også findes på de nationale myndigheders websteder: http: // heads. medagencies. org og http: // www. hevra. org
Further information on the national competent authorities is also available on the national authorities’ Internet sites: http: //heads.medagencies.org and http:/ /www .hevra.org
André PAUWELS Conseiller Général / Generaal Adviseur Ministère des affaires sociales, de la santé publique et de l’ environnement Inspection Générale de la Pharmacie Ministerie van Sociale Zaken, Volksgezondheid en Leefmilieu Algemeine Farmaceutische Inspektie Boulevard Bischoffsheim / Bischoffsheimlaan, 33 B – 1000 Bruxelles / Brussel Tlf.:
André PAUWELS Conseiller Général/Generaal Adviseur Ministère des affaires sociales, de la santé publique et de l’environnement Inspection Générale de la Pharmacie Ministerie van Sociale Zaken, Volksgezondheid en Leefmilieu Algemeine Farmaceutische Inspektie Boulevard Bischoffsheim / Bischoffsheimlaan, 33 B - 1000 Bruxelles / Brussel Tel.
(32- 2) 227 55 67 Fax (32- 2) 227 55 54 E- mail: andre. pauwels@ afigp. fgov. be Internet: http: // www. afigp. fogv. be
(32-2) 227 55 67 Fax (32-2) 227 55 54 E-mail: andre.pauwels@afigp.fgov.be Internet: http://www.afigp.fogv.be
DANMARK
(49-1888) 412 23 64 Fax (49-1888) 412 29 65 E-mail: r.kroker@bgvv.de Internet: http://www.bgvv.de Johannes LÖWER Kommissarischer Leiter Bundesamt für Sera und Impfstoffe Paul-Ehrlich-Institut Paul-Ehrlich-Straße 51-59 D - 63225 Langen
Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundvej 378 DK – 2700 Brønshøj Tlf.:
DENMARK Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundvej 378 DK - 2700 Brønshøj
(45) 44 88 93 34 Fax (45) 44 88 91 09 E- mail: jyl@ dkma. dk Internet: http: // www. dkma. dk
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-mail: jyl@dkma.dk Internet: http://www.dkma.dk
TYSKLAND
Holargos
Harald SCHWEIM Direktor BfArM Friedrich- Ebert- Allee 38 D – 53113 Bonn Tlf.:
GERMANY Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D - 53113 Bonn Tel.
(49- 228) 207 32 03 Fax (49- 228) 207 55 14 E- mail: schweim@ bfarm. de Internet: http: // www. bfarm. de
(49-228) 207 32 03 Fax (49-228) 207 55 14 E-mail: schweim@bfarm.de Internet: http://www.bfarm.de 44 EMEA Annual Report 2001
Holargos GR – 155 62 Athinai Tlf.:
GR - 155 62 Athinai Tel.
(30- 1) 650 72 10 Fax (30- 1) 654 95 86 E- mail: mmarselos@ eof. gr
(30-1) 06 50 72 10 Fax (30-1) 06 54 95 86 E-mail: mmarselos@eof.gr
María Victoria de la CUESTA GARCIA Directora Agencia Española del Medicamento Ministerio de Sanidad y Consumo C/ Huertas 75 E – 28014 Madrid Tlf.:
SPAIN María Victoria de la CUESTA GARCÍA Directora Agencia Española del Medicamento Ministerio de Sanidad y Consumo C/ Huertas, 75 E - 28014 Madrid Tel.
(34- 91) 596 16 27 Fax (34- 91) 596 44 22 E- mail: sdaem@ agemed. es Internet: http: // www. agamed. es
(34-91) 596 16 27 Fax (34-91) 596 44 22 E-mail: sdaem@agemed.es
Philippe DUNETON Directeur- Général Agence Française de Sécurité Sanitaire des Produits de Santé 143- 147, blvd Anatole France F - 93285 Saint- Denis CEDEX Tlf.:
IRELAND Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Tel.
(33- 1) 55 87 30 14 Fax (33- 1) 55 87 30 12 E- mail: philippe. duneton@ afssaps. sante. fr Internet: http: // afssaps. sante. fr
(353-1) 676 49 71 Fax (353-1) 661 47 64
19 F – 94701 Maisons Alfort CEDEX Tlf.:
Internet: http://www.agemed.es
(33- 1) 49 77 13 99/ 26 54 Fax (33- 1) 49 77 26 26 E- mail: m. hirsch@ afssa. fr Internet: http: // www. afssa. fr
E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
IRLAND
Seamus HEALY Assistant Secretary FRANCE Department of Agriculture, Food and Rural Development
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Tlf.:
Philippe DUNETON Directeur Général Agence Française de Sécurité Sanitaire des Produits de Santé 143-147, boulevard Anatole France F - 93285 Saint-Denis CEDEX Tel.
(353- 1) 676 49 71 Fax (353- 1) 676 78 36 E- mail: frank. hallinan@ imb. ie Internet: http: // www. imb. ie
(33-1) 55 87 30 14 Fax (33-1) 55 87 30 12 E-mail: philippe.duneton@afssaps.sante.fr
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Ireland Tlf.:
Agriculture House Kildare Street Dublin 2 Ireland Tel.
(353- 1) 607 24 34 Fax (353- 1) 676 29 89 E- mail: seamus. healy@ daff. irlgov. ie
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@agriculture.gov.ie
ITALIEN
Internet: http://afssaps.sante.fr Martin HIRSCH Directeur Général
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e della Farmacovigilanza Ministero della Salute Viale della Civiltà Romana, 7 I – 00144 Roma Tlf.:
ITALY Nello MARTINI Direttore Generale del Dipartimento della Valutazione dei Medicinali e della Farmacovigilanza
(39- 06) 59 94 36 66 Fax (39- 06) 59 94 34 56 E- mail: n. martini@ sanita. it Internet: http: // www. sanita. it/ farmaci
(33-1) 49 77 13 99/26 54 Fax (33-1) 49 77 26 26 E-mail: m.hirsch@afssa.fr Internet: http://www.afssa.fr
Romano MARABELLI Direttore Generale del Dipartimento della sanità pubblica veterinaria degli Alimenti e della Nutrizione Ministero della Salute Piazzale Marconi 25 I – 00144 Roma Tlf.:
(39-06) 59 94 36 66 Fax (39-06) 59 94 34 56 E-mail: n.martini@sanita.it Internet: http://www.sanita.it/farmaci Romano MARABELLI Direttore Generale del Dipartimento della Sanità Pubblica Veterinaria, degli Alimenti e della Nutrizione Ministero della Salute Piazzale Marconi 25 I - 00144 Roma Tel.
(39- 06) 59 94 39 45/ 46 Fax (39- 06) 59 94 32 17 E- mail: alimentivet@ sanita. it
(39-06) 59 94 39 45/46 Fax (39-06) 59 94 32 17 E-mail: alimentivet@sanita.it
LUXEMBOURG
EMEA Annual Report 2001
Mariette BACKES- LIES Pharmacien- Inspecteur Chef de Division Directeur de la Santé Division de la pharmacie et des médicaments Villa Louvigny – 1er étage L – 2120 Luxembourg Tlf.:
LUXEMBOURG Mariette BACKES-LIES Pharmacien-Inspecteur - Chef de Division Direction de la Santé Division de la Pharmacie et des Médicaments Villa Louvigny - 1er étage Allée Marconi L - 2120 Luxembourg Tel.
(352) 478 55 90 Fax (352) 26 20 01 40/ 47/ 49 E- mail: mariette. backes- lies@ ms. etat. lu
(352) 478 55 90 Fax (352) 26 20 01 40/47/49 E-mail: mariette.backes-lies@ms.etat.lu
NEDERLANDENE
(43-1) 711 72 47 17 Fax (43-1) 713 86 14 E-mail: gunter.liebeswar@bmsg.gv.at Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten
Huib van de DONK Kees KUIPER Directeur Hoofd van het Agentschap voor College ter Beoordeling van de registratie van diergeneesmiddelen Geneesmiddelen Bureau Registratie Ministerie van V. W. S.
NETHERLANDS Huib van de DONK Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
(31- 31) 747 54 91 Tlf.:
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland
Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Soziales, Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Tlf.:
Bundesministerium für soziale Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
(43- 1) 711 72 47 17 Fax (43- 1) 713 86 14 E- mail: gunter. liebeswar@ bmsg. gv. at
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für Soziales, Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Tlf.:
(31-70) 356 74 48 Fax (31-70) 356 75 15 E-mail: hj.vd.donk@cbg-meb.nl Internet: http://www.cbg-meb.nl Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen Postbus 289 6700 AG Wageningen Nederland Tel.
(43- 1) 711 00 46 73 Fax (43- 1) 714 92 22 E- mail: alexander. jentzsch@ bmsg. gv. at
(31-31) 746 57 31 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl 46 EMEA Annual Report 2001
Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P – 1749- 004 Lisboa Tlf.:
PORTUGAL Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque de Saúde de Lisboa Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P – 1294 Lisboa Tlf.:
(351-21) 798 71 16 Fax (351-21) 798 71 24 E-mail: miguel.andrade@infarmed.pt Internet: http://www.infarmed.pt Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P - 1294 Lisboa Tel.
(351) 213 23 95 66 Fax (351) 213 46 35 18 E- mail: rleitao@ dgv. min- agricultura. pt
(351-21) 323 95 66 Fax (351-21) 346 35 18 E-mail: rleitao@dgv.min-agricultura.pt
Hannes WAHLROOS Ylijohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 PL 55 FIN – 00301 Helsinki Tlf.:
FINLAND Hannes WAHLROOS Ylijohtaja Lääkelaitos - Läkemedelsverket Mannerheimintie 166 PL 55 FIN - 00301 Helsinki Tel.
(358- 9) 47 33 42 00 Fax (358- 9) 47 33 43 45 E- mail: hannes. wahlroos@ nam. fi Internet: http: // www. nam. fi
(358-9) 47 33 42 00 Fax (358-9) 47 33 43 45 E-mail: hannes.wahlroos@nam.fi Internet: http://www.nam.fi
SVERIGE
(44-20) 72 73 01 00 Fax (44-20) 72 73 05 48 E-mail: khj@mca.gov.uk Internet: http://www.open.gov.uk/mca
Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8 Box 26 S – 751 03 Uppsala Tlf.:
SWEDEN Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8 Box 26 S - 751 03 Uppsala Tel.
(46- 18) 17 46 00 Fax (46- 18) 54 66 18 E- mail: gunnar. alvan@ mpa. se Internet: http: // www. mpa. se
(46-18) 17 46 00 Fax (46-18) 54 85 66 E-mail: gunnar.alvan@mpa.se Internet: http://www.mpa.se
Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB UK Tlf.:
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey KT15 3LS United Kingdom Tel.
(44- 1932) 33 83 02/ 33 69 11 Fax (44- 1932) 33 66 18/ 35 25 49 E- mail: m. rutter@ vmd. defra. gsi. gov. uk Internet: http: // www. open. gov. uk/ vmd
(44-1932) 33 83 02/33 69 11 Fax (44-1932) 33 66 18/35 25 49 E-mail: m.rutter@vmd.defra.gsi.gov.uk Internet: http://www.open.gov.uk/vmd
Rannveig GUNNARSDÓTTIR Chief Executive Director Lyfjastofnun Eidistorg 13 - 15 IS – 170 Seltjarnarnes Tlf.:
ICELAND Rannveig GUNNARSDÓTTIR Chief Executive Director Lyfjastofnun Eidistorg 13-15 PO Box 180 IS - 172 Seltjarnarnes Tel.
(354) 520 21 00 Fax (354) 561 21 70 E- mail: rannveig. gunnarsdottir@ lyfjastofnun. is Internet: http: // www. lyfjanefnd. is
(354) 520 21 00 Fax (354) 561 21 70 E-mail: rannveig.gunnarsdottir@ lyfjastofnun.is Internet: http://www.lyfjastofnun.is
Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 FL – 9494 Schaan Tlf.:
LIECHTENSTEIN Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 Postfach 37 FL - 9494 Schaan Tel.
(423) 236 73 25 Fax (423) 236 73 10 E- mail: brigitte. batliner@ alk. llv. li
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alkvw.llv.li
NORGE Gro Ramsten WESENBERG Director- General Statens legemiddelkontroll Sven Oftedals vei 6 N – 0950 Oslo Tlf.:
NORWAY Gro Ramsten WESENBERG Director General Statens legemiddelverk Sven Oftedals vei 6 N - 0950 Oslo Tel.
(47- 22) 89 77 00 Fax (47- 22) 89 77 99 E- mail: gro. wesenberg@ legemiddelverket. no Internet: http: // www. legemiddelverket. no Bilag 6 Sammendrag af EMEA' s budgetter for 2000 – 2002
(47-22) 89 77 00 Fax (47-22) 89 77 99 E-mail: gro.wesenberg@ legemiddelverket.no Internet: http://www.legemiddelverket.no
Komparative budgetoversigter for perioden 2000- 2002:
The summarised comparative budget statements for 2000 to 2002 are as follows:
(Alle beløb er angivet i euro)
(Amounts expressed in euro)
2000( 1)
2000 1
2001( 2)
2001 2
2002( 3)
2002 3
(31. 12. 2000)
(31.12.2000)
(31. 12. 2001)
(31.12.2001)
(18. 12. 2001)
(18.12.2001)
Gebyrer Tilskud over EU' s almindelige budget Særligt EU- bidrag til sjældne
Fees
39 13
39 154 000
154 000 200 000
45 771 000
70, 82% 23, 88%
49 000 000
45 771 000 14 700 000
General EU contribution
69, 49% 22, 32%
13 200 000
49 14
14 700 000
000 000 000 000
14 000 000
69, 46% 19, 84%
1 9.84%
lægemidler Bidrag fra EØS Bidrag fra EU- programmer
Special EU orphan medicinal product contribution
000 000 245 220
000 000
1, 81% 0, 44%
1.81%
600 000 287 640
600 000
0, 91% 0, 44%
0.91%
300 000 310 000
300 000
4, 68% 0, 44%
287 640
(PERF)
310 000
0, 39%
0.39%
2 314 360
2 314 360
3, 51%
3.51%
1
2.3 1%
471 000
471 000
2, 66%
2.66%
2 193 000
2 193 000
3, 33%
3.33%
305 000
2 305 000
3, 27%
3.27%
287 220
55 287 220 100.00%
100, 00%
20 615 000
65
31.30%
866 000 100, 00%
24 952 000
70
1.91%
547 000
1 414 000
100, 00%
1 90 5 000
Udgifter Personaleomkostninger
Other staff-related expenditure
Lønninger Vikarer og andre hjælpeansatte Andre personalerelaterede udgifter Afsnit 1 i alt Bygninger og udstyr
Total title 1
18 1 1 20
40.59%
493 000 058 000 350 000 901 000
Building/equipment
33, 45% 1, 91% 2, 44% 39, 80%
Rent/charges
20 1 1 23
5 936 000
615 000 31, 30% 414 000 2, 15% 683 640 2, 56% 712 640 36, 00%
Expenditure on data processing
24 1 1 28
2 423 500
952 000 905 000 776 000 633 000
4 293 000
35, 37% 2, 70% 2, 52% 40, 59%
2 570 000
Husleje/ afgifter Udgifter til databehandling Andre kapitaludgifter Porto og telekommunikation
Other capital expenditure
5 2 2
2
212 220 423 500 353 000 480 000
353 000
9, 43% 4, 38% 4, 26% 0, 87%
4.26%
5 4 1
1
149 000 7, 82% 293 000 6, 52% 658 000 2, 52% 617 000 0, 94%
658 000
5 2 1
1
936 000 570 000 170 000 394 000
170 000
8, 41% 3, 64% 1, 66% 0, 56%
Postage and communications
Andre administrative udgifter Afsnit 2 i alt Driftsudgifter
Total title 2
593 000 061 720
12 061 720
2, 88% 21, 82%
21.82%
1 13
13 546 000
829 000 2, 78% 546 000 20, 57%
20.57%
1 11
11 995 000
925 000 995 000
17.00%
2, 73% 17, 00%
Operational expenditure
Møder Vurderinger Oversættelse Undersøgelser og konsulenter Publikationer
Meetings
3 18
3 270 000
270 000 682 500 p. m.
18 682 500
5, 92% 33, 79% 0, 00% 0, 01% 0, 27%
33.79%
4 21
21
110 000 6, 24% 308 000 32, 35% 428 000 0, 65% 225 000 0, 34% 190 000 0, 29%
32.35%
4 23
23
320 000 333 000 359 000 85 000 190 000
359 000
6, 12% 33, 07% 0, 51% 0, 12% 0, 27%
Studies and consultants
EU- programmer
EU programmes
0, 39%
0. 39%
346 360 8, 20%
346 360
1
8.20%
632 000
1 632 000
2, 31%
2.31%
22
22 324 500
40, 38%
40.38%
28
28 607 360
607 360 43, 43%
43.43%
919 000
29 919 000
42, 41%
42.41%
55 287 220
55 287 220 100.00%
65 866 000 100, 00%
65 866 000 100.00%
70 547 000
70 547 000 100.00%
100, 00%
Notes 1 48
Bemærkninger (1) Endelige bevillinger for 2000.
Final appropriations for EMEA Annual Report 2001
(2) Endelige bevillinger for 2001.
2
(3) Budget for 2002 som vedtaget af bestyrelsen den 18. 12. 2001.
Budget for 2002 as adopted by the Management Board on 18.12.2001.
Bilag 7 CPMP- udtalelser i 2001 om humanmedicinske lægemidler Lægemiddel Handelsnavn INN Del A/ B
Annex 7 CPMP opinions in 2001 on medicinal products for human use
Indehaver af markedsføringstill adelse
Product • Brand name • INN • Part A/B
Behandlingsområde ATC- kode Indikation
Therapeutic area • ATC code • Indication
EMEA/ CPMP Godkendelse Udtalelse Nettotid Urstop
EMEA/CPMP • Validation • Opinion • Active time • Clock stop
Europa - Kommissionen Udtalelse modtaget Dato for afgørelsen Meddelelse EFT nr.
European Commission • Opinion received • Date of decision • Notification • Official Journal
20. 08. 2001
• Foscan • temoporfin
Pharmaceuticals
• Scotia Pharmaceuticals
Treatment of squamous cell carcinoma of head and neck
• L01XX • Treatment of squamous cell carcinoma of head and neck
25. 01. 2001 215 days
• 21.10.1999 • 25.01.2001
24. 10. 2001 26. 10. 2001
• 20.08.2001 • 24.10.2001
Part B
• Part B
238 days
• 215 days • 238 days
OJ C 336, 30. 11. 2001, p.
• 26.10.2001 • OJ C 336, 30.11.2001, p.
Uprima apomorphine Part B
• Uprima • apomorphine • Part B
Abbott Laboratories
Abbott Laboratories
G04BE Treatment of erectile dysfunction
• G04BE • Treatment of erectile dysfunction
03. 01. 2000 25. 01. 2001 156 days 227 days
• 03.01.2000 • 25.01.2001 • 156 days • 227 days
01. 03. 2001 28. 05. 2001 30. 05. 2001 OJ C 183, 26. 06. 2001, p.
• 01.03.2001 • 28.05.2001 • 30.05.2001 • OJ C 183, 26.06.2001, p.
Ixense
• Ixense
Takeda Europe R & D Centre Ltd
Takeda Europe R & D Centre Ltd
G04BE
• G04BE
03. 01. 2000
• 03.01.2000
01. 03. 2001
• 01.03.2001
apomorphine Part B
• apomorphine • Part B
Treatment of erectile dysfunction
• Treatment of erectile dysfunction
25. 01. 2001 156 days 227 days
• 25.01.2001 • 156 days • 227 days
28. 05. 2001 30. 05. 2001 OJ C 183, 26. 06. 2001, p.
• 28.05.2001 • 30.05.2001 • OJ C 183, 26.06.2001, p.
HBVAXPRO
HBVAXPRO recombinant Hepatitis B virus small surface
Aventis Pharma S. A.
• Aventis Pharma S.A.
J07BC01
• •
30. 10. 2000
• 30.10.2000 • 25.01.2001
05. 03. 2001
• 05.03.2001 • 27.04.2001
recombinant Hepatitis B virus small surface antigen (HbsAg) Part A
antigen (HbsAg)
Active immunisation against hepatitis B virus infection caused by all known subtypes in children and adolescents
caused by all known subtypes in
25. 01. 2001 68 days 17 days
• 17 days
27. 04. 2001 04. 05. 2001 OJ C 158, 31. 05. 2001, p.
• OJ C 158, 31.05.2001, p.
Taluvian apomorphine Part B
Taluvian apomorphine Part B
Abbott S. p. A
• Abbott S.p.A
G04BE Treatment of erectile dysfunction
G04BE Treatment of erectile dysfunction
31. 10. 2000 25. 01. 2001 60 days 26 days
• 31.10.2000 • 25.01.2001 • 60 days • 26 days
Nespo darbepoetin alfa Part A
• Nespo • darbepoetin alfa
Amgen Europe B. V.
• Amgen Europe B.V.
B03XA02 (temporary) Treatment of anaemia associated with chronic renal failure
B03XA02 (temporary) Treatment of anaemia associated with chronic renal
21. 01. 2000 01. 03. 2001 202 days 199 days
• 199 days
21. 03. 2001 08. 06. 2001 11. 06. 2001 OJ C 183, 26. 06. 2001, p.
• OJ C 183, 26.06.2001, p.
Aranesp darbepoetin alfa Part A
• Aranesp • darbepoetin alfa
Nonafact human coagulation factor IX Part A
Nonafact human coagulation factor IX
Sanquin
• Sanquin
B02BD04 Treatment and prophylaxis of bleeding in patients with haemophilia B
B02BD04 Treatment and prophylaxis of bleeding in patients with haemophilia B
18. 02. 2000 01. 03. 2001 202 days
• 18.02.2000 • 01.03.2001 • 202 days
03. 04. 2001 03. 07. 2001 05. 07. 2001
• 03.04.2001 • 03.07.2001 • 05.07.2001
171 days
• 171 days
OJ C 209, 27. 07. 2001, p.
• OJ C 209, 27.07.2001, p.
(♦) Fabrazyme
Fabrazyme # agalsidase beta
Genzyme B. V.
• Genzyme B.V.
A16AB04 (temporary)
A16AB04 (temporary) Long-term replacement therapy in patients with a confirmed
18. 07. 2000
• 02.05.2001 • 03.08.2001
02. 05. 2001
•
agalsidase beta Part A
Part A
Long- term replacement therapy in patients with a confirmed diagnosis of Fabry disease
diagnosis of Fabry disease
29. 03. 2001 187 days 64 days
• 187 days
03. 08. 2001 07. 08. 2001 OJ C 243, 31. 08. 2001, p.
• OJ C 243, 31.08.2001, p.
Ceprotin protein C
• Ceprotin • protein C
Baxter AG
• Baxter AG
B01AX
• •
21. 01. 2000
• 21.01.2000 • 29.03.2001
03. 05. 2001
• 03.05.2001 • 16.07.2001
Part A
• Part A
Indicated in purpura fulminans and coumarin induced skin necrosis in patients with severe congenital protein
necrosis in patients with severe
29. 03. 2001 185 days
• 185 days
16. 07. 2001 17. 07. 2001
• 17.07.2001
C deficiency
congenital protein C deficiency
243 days
• 243 days
INOmax nitric oxide Part B
• INOmax • nitric oxide
AGA AB
• AGA AB
R07AX Treatment of newborns with hypoxic respiratory failure
R07AX Treatment of newborns with hypoxic respiratory failure
18. 02. 2000 29. 03. 2001 199 days 202 days
• 199 days • 202 days
11. 05. 2001 01. 08. 2001 06. 08. 2001 OJ C 243, 31. 08. 2001, p.
• 06.08.2001 • OJ C 243, 31.08.2001, p.
MabCampath alemtuzumab Part A
• MabCampath • alemtuzumab
Millenium & Ilex UK Ltd
• Millenium & Ilex UK Ltd
L01XC Second- line treatment of chronic lymphocytic leukaemia
• L01XC • Second-line treatment of chronic lymphocytic leukaemia
14. 04. 2000 29. 03. 2001 203 days 142 days
• 203 days • 142 days
30. 04. 2001 06. 07. 2001 10. 07. 2001 OJ C 209, 27. 07. 2001, p.
• 10.07.2001 • OJ C 209, 27.07.2001, p.
Ketek telithromycin Part B
• Ketek • telithromycin
J01 Treatment of community- acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis and
J01 Treatment of community-acquired pneumonia, acute exacerbation
14. 04. 2000 29. 03. 2001 164 days
• 14.04.2000 • 29.03.2001
02. 05. 2001 09. 07. 2001 10. 07. 2001
• 02.05.2001 • 09.07.2001
tonsillitis/ pharyngitis
of chronic bronchitis, acute sinusitis and tonsillitis/pharyngitis
181 days
• 164 days • 181 days
OJ C 209, 27. 07. 2001, p.
• 10.07.2001 • OJ C 209, 27.07.2001, p.
Levviax telithromycin
• Levviax • telithromycin
J01 Treatment of community- acquired pneumonia, acute exacerbation of
J01 Treatment of community-acquired pneumonia, acute exacerbation
14. 04. 2000 29. 03. 2001
• 14.04.2000 • 29.03.2001
02. 05. 2001 09. 07. 2001
• 02.05.2001 • 09.07.2001
chronic bronchitis, acute sinusitis and
of chronic bronchitis, acute sinusitis and tonsillitis/pharyngitis
Depocyte cytarabine
• Depocyte • cytarabine
SkyePharma PLC
• SkyePharma PLC
L01BC01 Intrathecal treatment of lymphomatous meningitis
L01BC01 Intrathecal treatment of lymphomatous meningitis
21. 10. 1999 29. 03. 2001
• 21.10.1999 • 29.03.2001
02. 05. 2001 11. 07. 2001
• 02.05.2001 • 11.07.2001
176 days 313 days
• 176 days • 313 days
12. 07. 2001 OJ C 209, 27. 07. 2001, p.
• 12.07.2001 • OJ C 209, 27.07.2001, p.
(♦) Replagal
• Replagal # • agalsidase alfa
TKT Europe- 5S AB
• TKT Europe-5S AB
A16AB03 (temporary)
A16AB03 (temporary) Long-term replacement therapy in patients with a confirmed
18. 07. 2000
• 18.07.2000 • 29.03.2001
02. 05. 2001
• 02.05.2001 • 03.08.2001
agalsidase alfa Part A
• Part A
29. 03. 2001 200 days 49 days
• 200 days
Liprolog insulin lispro Part A
• Liprolog • insulin lispro • Part A
Eli Lilly Nederland B. V.
• Eli Lilly Nederland B.V.
A10AB04 Diabetes mellitus
A10AB04 Diabetes mellitus
30. 01. 2001 25. 04. 2001 86 days 0 days
• 30.01.2001 • 25.04.2001 • 86 days • 0 days
07. 06. 2001 01. 08. 2001 03. 08. 2001 OJ C 243, 31. 08. 2001, p.
• 07.06.2001 • 01.08.2001 • 03.08.2001 • OJ C 243, 31.08.2001, p.
Caspofungin MSD caspofungin Part B
• Caspofungin MSD • caspofungin
Merck Sharp & Dohme
• Merck Sharp & Dohme
J02AX04 Secondline treatment of invasive aspergillosis
J02AX04 Secondline treatment of invasive aspergillosis
31. 10. 2000 26. 07. 2001 207 days
• 31.10.2000 • 26.07.2001
20. 08. 2001 24. 10. 2001 25. 10. 2001
• 20.08.2001 • 24.10.2001
59 days
• 207 days • 59 days
OJ C 336, 30. 112001, p.
• 25.10.2001 • OJ C 336, 30.11.2001, p.
Travatan
• Travatan
Alcon Laboratories (UK) Ltd
Alcon Laboratories (UK) Ltd
S01EX
S01EX
26. 12. 2000
• 26.12.2000
22. 08. 2001
• 22.08.2001
travoprost
• travoprost