natgillin/translations-raw huggingface dataset:
Was replaced by Alex NICHOLSON as of the May 2001 meeting and re-appointed as of October 2001.
6 Alex NICHOLSON toimi hänen tilallaan toukokuun 2001 kokouksesta alkaen, mutta hänet nimitettiin uudelleen lokakuun 2001 kokouksesta alkaen.
Replaced Jean-Michel ALEXANDRE as of the March 2001 meeting.
7 Tuli Jean- Michel ALEXANDREn tilalle maaliskuussa 2001 pidetystä kokouksesta alkaen.
EMEA Annual Report 2001
8 Tuli Mary TEELINGin tilalle maaliskuussa 2001 pidetystä kokouksesta alkaen.
Annex 5 National competent authority partners
60 Liite 5 Toimivaltaiset kansalliset viranomaiskumppanit
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
Lisätietoja toimivaltaisista kansallisista viranomaisista on saatavilla kansallisten viranomaisten www - sivustolla: http: // heads. medagencies. org ja 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 Tel.
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 Puh.
(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 Faksi (32- 2) 227 55 54 Sähköposti: andre. pauwels@ afigp. fgov. be Internet: http: // www. afigp. fogv. be
-rückstandskontrolle, Futterzusatzstoffe’ BgVV Diedersdorfer Weg 1 D - 12277 Berlin Tel.
TANSKA
DENMARK Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundvej 378 DK - 2700 Brønshøj
Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundvej 378 DK – 2700 Brønshøj Puh.
(49-6103) 77 20 00 Fax (49-6103) 77 12 52 E-mail: loejo@pei.de Internet: http://www.pei.de
(45) 44 88 93 34 Faksi (45) 44 88 91 09 Sähköposti: 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
Reinhard KROKER Leiter des Fachbereichs
GREECE Marios MARSELOS Preside National Organization for Medicines 284 Mesogion Av.
'Tierarzneimittelzulassung Futterzusatzstoffe'
Holargos
BfArM
GERMANY Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D - 53113 Bonn Tel.
Friedrich- Ebert- Allee 38 D – 53113 Bonn Puh.
(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
(49- 228) 207 32 03 Faksi (49- 228) 207 55 14 Sähköposti: schweim@ bfarm. de Internet: http: // www. bfarm. de
GR - 155 62 Athinai Tel.
Holargos GR – 155 62 Athinai Puh.
(30-1) 06 50 72 10 Fax (30-1) 06 54 95 86 E-mail: mmarselos@eof.gr
(30- 1) 650 72 10 Faksi (30- 1) 654 95 86 Sähköposti: mmarselos@ eof. gr
SPAIN María Victoria de la CUESTA GARCÍA Directora Agencia Española del Medicamento Ministerio de Sanidad y Consumo C/ Huertas, 75 E - 28014 Madrid Tel.
María Victoria de la CUESTA GARCÍA Directora Agencia Española del Medicamento Ministerio de Sanidad y Consumo C / Huertas, 75 E – 28014 Madrid Puh.
(34-91) 596 16 27 Fax (34-91) 596 44 22 E-mail: sdaem@agemed.es
(34- 91) 596 16 27 Faksi (34- 91) 596 44 22 Sähköposti: sdaem@ agemed. es Internet: http: // www. agemed. es
IRELAND Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Tel.
(33- 1) 55 87 30 14 Faksi (33- 1) 55 87 30 12
(353-1) 676 49 71 Fax (353-1) 661 47 64
(33- 1) 49 77 13 99/ 26 54
Internet: http://www.agemed.es
Sähköposti: philippe. duneton@ afssaps. sante. fr Faksi (33- 1) 49 77 26 26
E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
Internet: http: // afssaps. sante. fr
Seamus HEALY Assistant Secretary FRANCE Department of Agriculture, Food and Rural Development
Sähköposti: m. hirsch@ afssa. fr Internet: http: // www. afssa. fr
Philippe DUNETON Directeur Général Agence Française de Sécurité Sanitaire des Produits de Santé 143-147, boulevard Anatole France F - 93285 Saint-Denis CEDEX Tel.
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Puh.
(33-1) 55 87 30 14 Fax (33-1) 55 87 30 12 E-mail: philippe.duneton@afssaps.sante.fr
(353- 1) 676 49 71 Faksi (353- 1) 676 78 36 Sähköposti: frank. hallinan@ imb. ie
Agriculture House Kildare Street Dublin 2 Ireland Tel.
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Ireland Puh.
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@agriculture.gov.ie
(353- 1) 607 24 34 Faksi (353- 1) 676 29 89
Internet: http://afssaps.sante.fr Martin HIRSCH Directeur Général
Internet: http: // www. imb. ie
ITALY Nello MARTINI Direttore Generale del Dipartimento della Valutazione dei Medicinali e della Farmacovigilanza
Sähköposti: seamus. healy@ daff. irlgov. ie
19 F - 94701 Maisons Alfort CEDEX Tel.
62 ITALIA
Ministero della Salute Viale della Civiltà Romana, 7 I - 00144 Roma Tel.
Nello MARTINI Direttore Generale del Dipartimento della Valutazione dei Medicinale e della Farmacovigilanza Ministero della Salute Viale della Civiltà Romana, 7 I – 00144 Roma Puh.
(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.
Romano MARABELLI Direttore Generale del Dipartimento della Sanità Pubblica Veterinaria, degli Alimenti e della Nutrizione Ministero della Salute Piazzale Marconi 25 I – 00144 Roma Puh.
(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 Faksi (39- 06) 59 94 32 17 Sähköposti: alimentivet@ sanita. it
EMEA Annual Report 2001
LUXEMBURG
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.
Mariette BACKES- LIES Pharmacien- Inspecteur - Chef de Division Direction de la Santé Division de la Pharmacie et des Médicaments Villa Louvigny – 1er étage L – 2120 Luxembourg Puh.
(352) 478 55 90 Fax (352) 26 20 01 40/47/49 E-mail: mariette.backes-lies@ms.etat.lu
(352) 478 55 90 Faksi (352) 26 20 01 40/ 47/ 49 Sähköposti: mariette. backes- lies@ ms. etat. lu
AUSTRIA Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für soziale Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
ALANKOMAAT
NETHERLANDS Huib van de DONK Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
Huib van de DONK Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V. W. S.
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Puh.
Bundesministerium für soziale Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für soziale Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Puh.
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
(43- 1) 711 72 47 17 Faksi (43- 1) 713 86 14 Sähköposti:
(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.
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für soziale Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien
(31-31) 746 57 31 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl 46 EMEA Annual Report 2001
(43- 1) 711 00 46 73 Faksi (43- 1) 714 92 22 Sähköposti: alexander. jentzsch@ bmsg. gv. at
PORTUGAL Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque de Saúde de Lisboa Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque de Saúde de Lisboa Av. do Brasil, 53 P – 1749- 004 Lisboa Puh.
(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.
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P – 1294 Lisboa Puh.
(351-21) 323 95 66 Fax (351-21) 346 35 18 E-mail: rleitao@dgv.min-agricultura.pt
(351) 213 23 95 66 Faksi (351) 213 46 35 18 Sähköposti: rleitao@ dgv. min -
FINLAND Hannes WAHLROOS Ylijohtaja Lääkelaitos - Läkemedelsverket Mannerheimintie 166 PL 55 FIN - 00301 Helsinki Tel.
SUOMI Hannes WAHLROOS Ylijohtaja Lääkelaitos - Läkemedelsverket Mannerheimintie 166 PL 55 FIN – 00301 Helsinki Puh.
(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 Faksi (358- 9) 47 33 43 45 Sähköposti: hannes. wahlroos@ nam. fi Internet: http: // www. nam. fi
UNITED KINGDOM Keith JONES Director and Chief Executive Medicines Control Agency Market Towers, Room 1629 1 Nine Elms Lane London SW8 5NQ United Kingdom Tel.
RUOTSI
SWEDEN Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8 Box 26 S - 751 03 Uppsala Tel.
Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8 Box 26 S – 751 03 Uppsala Puh.
(46-18) 17 46 00 Fax (46-18) 54 85 66 E-mail: gunnar.alvan@mpa.se Internet: http://www.mpa.se
(46- 18) 17 46 00 Faksi (46- 18) 54 85 66 Sähköposti: gunnar. alvan@ mpa. se Internet: http: // www. mpa. se
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey KT15 3LS United Kingdom Tel.
Keith JONES Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey KT15 3NB United Kingdom Puh.
(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 Faksi (44- 1932) 33 66 18/ 35 25 49 Sähköposti:
Observers:
Internet:
ICELAND Rannveig GUNNARSDÓTTIR Chief Executive Director Lyfjastofnun Eidistorg 13-15 PO Box 180 IS - 172 Seltjarnarnes Tel.
Rannveig GUNNARSDÓTTIR Chief Executive Director Lyfjastofnun Eidistorg 13- 15 IS – 170 Seltjarnarnes Puh.
(354) 520 21 00 Fax (354) 561 21 70 E-mail: rannveig.gunnarsdottir@ lyfjastofnun.is Internet: http://www.lyfjastofnun.is
(354) 520 21 00 Faksi (354) 561 21 70 Sähköposti: rannveig. gunnarsdottir@ lyfjastofnun. is Internet: http: // www. lyfjastofnun. is
LIECHTENSTEIN Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 Postfach 37 FL - 9494 Schaan Tel.
Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 FL – 9494 Schaan Puh.
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alkvw.llv.li
(423) 236 73 25 Faksi (423) 236 73 10 Sähköposti: brigitte. batliner@ alk. llv. li
NORWAY Gro Ramsten WESENBERG Director General Statens legemiddelverk Sven Oftedals vei 6 N - 0950 Oslo Tel.
NORJA Gro Ramsten WESENBERG Director General Statens legemiddelverk Sven Oftedals vei 6 N – 0950 Oslo Puh.
(47-22) 89 77 00 Fax (47-22) 89 77 99 E-mail: gro.wesenberg@ legemiddelverket.no Internet: http://www.legemiddelverket.no
(47- 22) 89 77 00 Faksi (47- 22) 89 77 99 Sähköposti: gro. wesenberg@ legemiddelverket. no Internet: http: // www. legemiddelverket. no
Annex 6 EMEA budget summaries 2000 - 2002
65 Liite 6 EMEAn vuosien 2000– 2002 talousarvioiden tiivistelmät
The summarised comparative budget statements for 2000 to 2002 are as follows:
Seuraavassa taulukossa esitetään vertaileva tiivistelmä vuosien 2000– 2002 tulo - ja menoarvioista.
(Amounts expressed in euro)
(Summat on esitetty euroina)
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)
Fees
39 13
39 154 000
154 000 200 000
70.82%
70, 82% 23, 88%
45 771 000
45 14
49 000 000
771 000 700 000
13 200 000
69, 49% 22, 32%
14 700 000
49 14
14 000 000
000 000 000 000
1 9.84%
69, 46% 19, 84%
Special EU orphan medicinal product contribution
harvinaislääkkeitä varten ETA: n maksuosuus EU- ohjelmien (PERF)
000 000
000 000 245 220
1.81%
1, 81% 0, 44%
600 000
600 000 287 640
0.91%
0, 91% 0, 44%
300 000
300 000 310 000
287 640
4, 68% 0, 44%
310 000
maksuosuus
0.39%
0, 39%
3.51%
3, 51%
1 632 000
632 000
2.3 1%
2, 31%
2.66%
2, 66%
3.33%
3, 33%
2 305 000
305 000
3.27%
3, 27%
55 287 220 100.00%
220
65 866 000 100.00%
866 000
70 547 000 100.00%
547 000
Expenditure Staff
Menot Henkilöstö
Salaries
Palkat Tilapäinen ja tukipalvelu - henkilöstö
18 493 000
18 1
33.45%
493 058
20 615 000
000 000
24 952 000
33, 45% 1, 91%
1.91%
20 1
1 414 000
615 000 31, 30% 414 000 2, 15%
2.15%
24 1
1 90 5 000
952 000 905 000
2.70%
35, 37% 2, 70%
Other staff-related expenditure
Muut henkilöstömenot Osasto 1 yhteensä Toimitilat ja laitteet
2.44%
1 20
1 683 6 40
350 901
1 776 000
000 000
Total title 1
2, 44% 39, 80%
39.80%
1 23
23 712 640
683 640 2, 56% 712 640 36, 00%
36.00%
1 28
28 633 000
776 000 633 000
Rent/charges
2, 52% 40, 59%
Expenditure on data processing
Vuokrat ja maksut Tietojenkäsittelymenot Muut pääomamenot Postitus ja viestintä
2
5 2 2
353 000
212 423 353 480
170 000
220 500 000 000
Postage and communications
9, 43% 4, 38% 4, 26% 0, 87%
0.87%
5 4 1
617 000
149 000 7, 82% 293 000 6, 52% 658 000 2, 52% 617 000 0, 94%
0.94%
5 2 1
39 4 000
936 000 570 000 170 000 394 000
Other administrative expenditure
8, 41% 3, 64% 1, 66% 0, 56%
Total title 2
Muut hallintomenot Osasto 2 yhteensä Toiminta
12 061 720
1 12
21.82%
593 061
13 546 000
000 720
11 995 000
2, 88% 21, 82%
17.00%
1 13
3 270 000
829 000 2, 78% 546 000 20, 57%
5 .92%
1 11
4 110 000
925 000 995 000
6.24%
2, 73% 17, 00%
4 320 000
Kokoukset Arvioinnit Käännökset
6.12%
3 18
Evaluations
270 682
18 682 500
000 500 p. m
33.79%
5, 92% 33, 79% 0, 00%
308 000
110 000 6, 24% 308 000 32, 35% 428 000 0, 65%
333 000
320 000 333 000 359 000
33.07%
6, 12% 33, 07% 0, 51%
Translation
Tutkimukset ja asiantuntijat Julkaisut
p.m.
5 150
428 000
000 000
359 000
0, 01% 0, 27%
225 000
225 000 0, 34% 190 000 0, 29%
85 000
85 000 190 000
Publications
0, 12% 0, 27%
190 000
EU- ohjelmat
0.27%
217
217 000
000
0. 39%
0, 39%
346 360
346 360 8, 20%
8.20%
1
2.31%
2, 31%
22 324 500
22
40.38%
40, 38%
28 607 360
28
43.43%
607 360 43, 43%
29 919 000
919 000
42.41%
42, 41%
55 287 220 100.00%
55 287 220
65 866 000 100.00%
100, 00% 65 866 000
70 547 000 100.00%
70 547 000
Notes 1 48
100, 00%
Final appropriations for EMEA Annual Report 2001
66 Liite 7 CPMP: n lausunnot ihmisille tarkoitetuista lääkkeistä vuonna 2001 Tuote Merkin nimi INN Osa A/ B
2
Myyntiluvan haltija
Final appropriations for 2001.
Hoitoalue ATC- koodi Käyttöaihe
3
EMEA/ CPMP Lausunnon validointi Aktiivinen aika Kellon pysäytys
Budget for 2002 as adopted by the Management Board on 18.12.2001.
Euroopan komissio Lausunto saatu Päätöksen päivämäärä Ilmoituspäivä - määrä EYVL
Annex 7 CPMP opinions in 2001 on medicinal products for human use
21. 10. 1999
Product • Brand name • INN • Part A/B
20. 08. 2001
Marketing authorisation holder
temoporfin
Therapeutic area • ATC code • Indication
can
EMEA/CPMP • Validation • Opinion • Active time • Clock stop
Pharmaceuticals
European Commission • Opinion received • Date of decision • Notification • Official Journal
Treatment of squamous cell carcinoma of
• Foscan • temoporfin
25. 01. 2001
• Scotia Pharmaceuticals
24. 10. 2001
• L01XX • Treatment of squamous cell carcinoma of head and neck
Part B
• 21.10.1999 • 25.01.2001
head and neck
• 20.08.2001 • 24.10.2001
215 days
• Part B
26. 10. 2001
• 215 days • 238 days
238 days
• 26.10.2001 • OJ C 336, 30.11.2001, p.
OJ C 336, 30. 11. 2001, p.
• Uprima • apomorphine • Part B
Uprima
•
01. 03. 2001
Abbott Laboratories
Apomorphine Part B
• G04BE • Treatment of erectile dysfunction
Treatment of erectile dysfunction
• 03.01.2000 • 25.01.2001 • 156 days • 227 days
25. 01. 2001 156 days 227 days
• 01.03.2001 • 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.
• Ixense
Ixense
Takeda Europe R & D Centre Ltd
Apomorphine Part B
• G04BE
Treatment of erectile dysfunction
• 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.
HBVAXPRO recombinant Hepatitis B virus small surface
HBVAXPRO
• Aventis Pharma S.A.
Aventis Pharma S. A.
• •
J07BC01
• 68 days
30. 10. 2000
•
05. 03. 2001
Part A
recombinant Hepatitis B virus small surface antigen (HbsAg) Part A
children and adolescents
Active immunisation against hepatitis B virus infection caused by all known subtypes in children and adolescents
• 17 days
25. 01. 2001 68 days 17 days
• OJ C 158, 31.05.2001, p.
27. 04. 2001 04. 05. 2001 OJ C 158, 31. 05. 2001, p.
Taluvian apomorphine Part B
Taluvian Apomorphine Part B
• Abbott S.p.A
Abbott S. p. A
• 31.10.2000 • 25.01.2001 • 60 days • 26 days
31. 10. 2000 25. 01. 2001 60 days 26 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.
• Nespo • darbepoetin alfa
Nespo
• Amgen Europe B.V.
Amgen Europe B. V.
B03XA02 (temporary) Treatment of anaemia associated with chronic renal
B03XA02 (temporary)
• 21.03.2001 • 08.06.2001
21. 01. 2000
• Part A
21. 03. 2001
failure
Treatment of anaemia associated with chronic renal failure
• 202 days
01. 03. 2001
• 11.06.2001
08. 06. 2001
• 199 days
202 days 199 days
• OJ C 183, 26.06.2001, p.
11. 06. 2001 OJ C 183, 26. 06. 2001, p.
• Aranesp • darbepoetin alfa
Aranesp
Nonafact human coagulation factor IX
Nonafact human coagulation factor IX
• Sanquin
Sanquin
• 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
Part A
Part A
• 171 days
171 days
• OJ C 209, 27.07.2001, p.
OJ C 209, 27. 07. 2001, p.
• •
02. 05. 2001
Fabrazyme # agalsidase beta
agalsidase beta
• Genzyme B.V.
29. 03. 2001
•
03. 08. 2001
diagnosis of Fabry disease
patients with a confirmed diagnosis of Fabry disease
• 187 days
187 days 64 days
• 07.08.2001
07. 08. 2001 OJ C 243, 31. 08. 2001, p.
• Ceprotin • protein C
Ceprotin protein C
• Baxter AG
Baxter AG
• •
03. 05. 2001
B01AX Indicated in purpura fulminans and coumarin induced skin
Indicated in purpura fulminans and
• 21.01.2000 • 29.03.2001
29. 03. 2001
• 03.05.2001 • 16.07.2001
16. 07. 2001
• Part A
Part A
necrosis in patients with severe
coumarin induced skin necrosis in patients with severe congenital protein C
• 185 days
185 days
• 17.07.2001
17. 07. 2001
congenital protein C deficiency
deficiency
• 243 days
243 days
• INOmax • nitric oxide
INOmax nitric oxide
• AGA AB
AGA AB
• 18.02.2000 • 29.03.2001
18. 02. 2000 29. 03. 2001
• 11.05.2001 • 01.08.2001
11. 05. 2001 01. 08. 2001
• Part B
Part B
• 199 days • 202 days
199 days 202 days
• 06.08.2001 • OJ C 243, 31.08.2001, p.
06. 08. 2001 OJ C 243, 31. 08. 2001, p.
# Denotes an orphan medicinal product designated under Regulation (EC) No 121/2000
Millenium & Ilex UK Ltd
EMEA Annual Report 2001
30. 04. 2001
Marketing authorisation holder
alemtuzumab
EMEA/CPMP • Validation • Opinion • Active time • Clock stop
Second- line treatment of chronic lymphocytic leukaemia
• Millenium & Ilex UK Ltd
29. 03. 2001
• 30.04.2001 • 06.07.2001
06. 07. 2001
• 203 days • 142 days
203 days 142 days
• 10.07.2001 • OJ C 209, 27.07.2001, p.
10. 07. 2001 OJ C 209, 27. 07. 2001, p.
• Ketek • telithromycin
Ketek telithromycin
• •
02. 05. 2001 09. 07. 2001
J01 Treatment of community-acquired pneumonia, acute exacerbation
Part B
• 14.04.2000 • 29.03.2001
chronic bronchitis, acute sinusitis and
• 02.05.2001 • 09.07.2001
164 days
• Part B
10. 07. 2001
of chronic bronchitis, acute sinusitis and tonsillitis/pharyngitis
tonsillitis/ pharyngitis
• 164 days • 181 days
181 days
• 10.07.2001 • OJ C 209, 27.07.2001, p.
OJ C 209, 27. 07. 2001, p.
• Levviax • telithromycin
Levviax telithromycin
• Depocyte • cytarabine
Depocyte cytarabine
• SkyePharma PLC
SkyePharma PLC
• 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 # • agalsidase alfa
(♦) Replagal
• TKT Europe-5S AB
TKT Europe- 5S AB
A16AB03 (temporary) Long-term replacement therapy in patients with a confirmed
Long- term replacement therapy in
• 18.07.2000 • 29.03.2001
29. 03. 2001
• 02.05.2001 • 03.08.2001
03. 08. 2001
• 200 days
200 days 49 days
• Liprolog • insulin lispro • Part A
Liprolog
• Eli Lilly Nederland B.V.
30. 01. 2001
• •
07. 06. 2001
A10AB04 Diabetes mellitus
Diabetes mellitus
• 30.01.2001 • 25.04.2001 • 86 days • 0 days
25. 04. 2001 86 days 0 days
• 07.06.2001 • 01.08.2001 • 03.08.2001 • OJ C 243, 31.08.2001, p.
01. 08. 2001 03. 08. 2001 OJ C 243, 31. 08. 2001, p.
• Caspofungin MSD • caspofungin
Caspofungin MSD caspofungin Part B
• Merck Sharp & Dohme
Merck Sharp & Dohme
• •
20. 08. 2001 24. 10. 2001 25. 10. 2001
• 207 days • 59 days
59 days
• 25.10.2001 • OJ C 336, 30.11.2001, p.
OJ C 336, 30. 112001, p.
• Travatan
Travatan
•
22. 08. 2001
Alcon Laboratories (UK) Ltd
Treatment of elevated intraocular pressure (second- line)
•
26. 07. 2001
• 26.12.2000
27. 11. 2001
• 22.08.2001
Part B
• travoprost
152 days 58 days
•
29. 11. 2001 OJ C 371, 28. 12. 2001, p.
• Glivec # • imatinib mesilate
Glivec
•
27. 03. 2001
Novartis Europharm Ltd
23. 08. 2001
• •
imatinib mesilate Part B
L01XX28 (temporary) Treatment of patients with chronic myeloid leukemia (CML)
Treatment of patients with chronic myeloid leukemia (CML)
• 27.03.2001 • 26.07.2001
26. 07. 2001 119 days
• 23.08.2001 • 07.11.2001
07. 11. 2001 12. 11. 2001
• 119 days • 0 days
0 days
• 12.11.2001 • OJ C 336, 30.11.2001, p.
OJ C 336, 30. 112001, p.
• Viread • tenofovir
Viread
•
22. 05. 2001
• •
tenofovir
J05A Treatment of HIV infected patients with early virological
Ttreatment of HIV infected patients with early virological failure in combination
• •
18. 10. 2001
failure in combination with other anti HIV products
with other anti HIV products
• 83 days • 63 days
83 days 63 days
• Protopy • tacrolimus
Protopy tacrolimus
• 16.08.2000 • 18.10.2001
16. 08. 2000 18. 10. 2001
• 204 days • 218 days
204 days 218 days
• •
(♦) Trisenox
• Trisenox # • arsenic trioxide
Cell Therapeutics (UK)
•
27. 02. 2001
Cell Therapeutics (UK) Ltd
arsenic trioxide
• •
Ltd
L01XX27 (temporary) Induction for induction of remission and consolidation in adult patients
Induction for induction of remission and
with relapsed/ refractory acute promyelocytic leukaemia (APL)
consolidation in adult patients with relapsed/ refractory acute promyelocytic leukaemia (APL),
• 180 days • 51 days
180 days 51 days
• Protopic • tacrolimus
Protopic tacrolimus
• Fujisawa GmbH
Fujisawa GmbH
• D11AX14 (temporary) • Treatment of moderate to severe atopic dermatitis
D11AX14 (temporary) Treatment of moderate to severe atopic dermatitis
• Kineret • anakinra
Kineret anakinra
• Amgen Europe
Amgen Europe
L04AA14 Treatment of the signs and symptoms of rheumatoid
L04AA14 Treatment of the signs and symptoms of rheumatoid arthritis
• 18.07.2000 • 15.11.2001
18. 07. 2000 15. 11. 2001
• 204 days
204 days 273 days
• Xapit • parecoxib
Xapit parecoxib
• G D Searle & Co Ltd
G D Searle & Co Ltd
M01AH For the short-term treatment of postoperative pain
M01AH For the short- term treatment of postoperative pain
• 31.10.2000 • 15.11.2001
31. 10. 2000 15. 11. 2001
• 204 days • 171 days
204 days 171 days
• Dynastat • parecoxib
Dynastat parecoxib
• Rayzon • parecoxib
Rayzon parecoxib
• 31.10. 2000 • 15.11.2001
31. 10. 2000 15. 11. 2001
• Lumigan • bimatoprost
Lumigan bimatoprost
• Allergan Sales Ltd
Allergan Sales Ltd