natgillin/translations-raw huggingface dataset:
• Eva FABIANSON-JOHNSSON (Sweden)
Michalis AVGERINOS (Grekland) Rolf BASS (Tyskland) Geert DE GREEF (Belgien) Jens ERSBØLL (Danmark) Silvio GARATTINI (Italien) Fernando GARCIA ALONSO (Spanien) Jacqueline GENOUX- HAMES (Luxemburg) Lars GRAMSTAD (Norge) Manfred HAASE (Tyskland) Else HØIBRAATEN (Norge) Magnús JÓHANNSSON (Island) Pekka KURKI (Finland) Frits LEKKERKERKER (Nederländerna) (2)
• Halldór RUNÓLFSSON (Iceland)
· ·
• Liisa KAARTINEN (Finland)
David LYONS (Irland) Pieter NEELS (Belgien) (3)
• Jean-Claude ROUBY (France)
· · · · · · · · · · · · · · ·
• Reinhard KROKER (Germany)
Per NILSSON (Sverige) Antonia PANTOUVAKI (Grekland) Heribert PITTNER (Österrike) Jean- Louis ROBERT (Luxemburg) Pasqualino ROSSI (Italien) Frances ROTBLAT (Förenade kungariket) Patrick SALMON (Irland) Tomas SALMONSON (Sverige) Cristina SAMPAIO (Portugal) Beatriz SILVIA LIMA (Portugal) Josef SUKO (Österrike) Sigurdur THORSTEINSSON (Island) Markku TOIVONEN (Finland) Jean- Hugues TROUVIN (Frankrike) Barbara VAN ZWIETEN- BOOT (Nederländerna)
• Liisa SIHVONEN (Finland)
(2) Ersatte Hans van BRONSWIJK från och med mötet i september 2001.
• Herman LENSING (Netherlands)
(3) Ersatte Daniel BRASSEUR från och med mötet i februari 2001.
• Marc WIRTOR (Luxembourg)
Steve DEAN (Förenade kungariket), Ordförande
• Jan LUTHMAN (Sweden)
· Margarita ARBOIX (Spanien)
*
· J.
The country of the nominating Member State is given for information purposes only.
· · · · · · · · · · · · · ·
42
· ·
EMEA Annual Report 2001
· · · · · · · · · · · · ·
1
· ·
Replaced Steve DEAN as of the February 2001 meeting.
(1) Ersatte Steve DEAN från och med mötet i februari 2001.
Annex 4 Members of the Committee for Orphan Medicinal Products
Bilaga 4 Ledamöterna av Kommittén för särläkemedel
Belgium
Belgien Danmark
André LHOIR
André LHOIR Heidrun BOSCH- TRABERG1
Denmark
Tyskland Grekland Spanien Frankrike Irland Italien Luxemburg Nederländerna Österrike Portugal Finland Sverige Förenade kungariket
Rashmi SHAH 2
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 SHAH (2)
Moisés ABASCAL ALONSO, Yann LE CAM, Vice-chairman, Alastair KENT
Företrädare för patientorganisationer Moisés ABASCAL ALONSO Yann LE CAM, Vice ordförande Alastair KENT
Eric ABADIE 3, Gianmartino BENZI, David LYONS 4
Eric ABADIE (3) Företrädare för EMEA Gianmartino BENZI David LYONS (4)
Iceland
Island Norge
Replaced Jan RENNEBERG as of the January 2001 meeting.
(1) Ersatte Rogério GASPAR från och med mötet i januari 2001.
Was replaced by Alex NICHOLSON as of the May 2001 meeting and re-appointed as of October 2001.
(2) Ersattes av Alex NICHOLSON från och med mötet i maj 2001 och återutnämndes från och med oktober 2001.
Replaced Jean-Michel ALEXANDRE as of the March 2001 meeting.
(3) Ersatte Jean- Michel ALEXANDRE från och med mötet i mars 2001.
EMEA Annual Report 2001
(4) Ersatte Mary TEELING från och med mötet i mars 2001.
Annex 5 National competent authority partners
Bilaga 5 Behöriga nationella myndigheter
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
Mer information om de behöriga nationella myndigheterna finns på deras webbplatser: http: // heads. medagencies. org och http: // www. hevra. org
(32-2) 227 55 67 Fax (32-2) 227 55 54 E-mail: andre.pauwels@afigp.fgov.be Internet: http://www.afigp.fogv.be
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 Tfn (32- 2) 227 55 67 Fax (32- 2) 227 55 54 E- post: andre. pauwels@ afigp. fgov. be Internet: http: // www. afigp. fogv. be
-rückstandskontrolle, Futterzusatzstoffe’ BgVV Diedersdorfer Weg 1 D - 12277 Berlin Tel.
DANMARK
DENMARK Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundvej 378 DK - 2700 Brønshøj
Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundvej 378 DK – 2700 Brønshøj Tfn (45) 44 88 93 34 Fax (45) 44 88 91 09 E- post: jyl@ dkma. dk Internet: http: // www. dkma. dk
(49-6103) 77 20 00 Fax (49-6103) 77 12 52 E-mail: loejo@pei.de Internet: http://www.pei.de
Johannes LÖWER Kommissarische Leiter Bundesamt für Sera und Impfstoffe Paul- Ehrlich Institut Paul- Ehrlich Straße 51- 59 D – 63225 Langen Tfn (49- 6103) 77 20 00 Fax (49- 6103) 77 12 52 E- post: loejo@ pei. de Internet: http: // www. pei. de
Tel.
GREKLAND
Holargos
Marios MARSELOS President National Organization for Medicines 284 Mesogion Av.
(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 Tfn (30- 1) 650 72 10 Fax (30- 1) 654 95 86 E- post: mmarselos@ eof. gr
GR - 155 62 Athinai Tel.
SPANIEN
(34-91) 596 16 27 Fax (34-91) 596 44 22 E-mail: sdaem@agemed.es
María Victoria de la CUESTA GARCIA Directora Agencia Española del Medicamento Ministerio de Sanidad y Consumo C/ Huertas, 75 E- 28014 Madrid Tfn (34- 91) 596 16 27 Fax (34- 91) 596 44 22 E- post: sdaem@ agemed. es Internet: http: // www. agemed. es
Internet: http://www.agemed.es
FRANKRIKE
E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
Philippe DUNETON Directeur Général Agence Française de Sécurité Sanitaire des Produits de santé 143- 147, boulevard Anatole France F - 93285 Saint- Denis CEDEX Tfn (33- 1) 55 87 30 14 Fax (33- 1) 55 87 30 12 E- post: philippe. duneton@ afssaps. sante. fr Internet: http: // afssaps. sante. 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.
Martin HIRSCH Directeur Général Agence Française de Sécurité Sanitaire des Aliments 23, avenue du Général de Gaulle B. P.
(33-1) 55 87 30 14 Fax (33-1) 55 87 30 12 E-mail: philippe.duneton@afssaps.sante.fr
19 F – 94701 Maisons Alfort CEDEX Tfn (33- 1) 49 77 13 99/ 26 54 Fax (33- 1) 49 77 26 26 E- post: m. hirsch@ afssa. fr Internet: http: // www. afssa. fr
Agriculture House Kildare Street Dublin 2 Ireland Tel.
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Irland Tfn (353- 1) 676 49 71 Fax (353- 1) 676 78 36 E- post: frank. hallinan@ imb. ie Internet: http: // www. imb. ie
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@agriculture.gov.ie
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Irland Tfn (353- 1) 607 24 34 Fax (353- 1) 676 29 89 E- post: seamus. healy@ daff. irlgov. ie
Internet: http://afssaps.sante.fr Martin HIRSCH Directeur Général
ITALIEN
ITALY Nello MARTINI Direttore Generale del Dipartimento della Valutazione dei Medicinali e della Farmacovigilanza
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e della Farmacovigilanza Ministero della Salute Viale della Civiltà Romana, 7 I – 00144 Roma Tfn (39- 06) 59 94 36 66 Fax (39- 06) 59 94 34 56 E- post: n. martini@ sanita. it Internet: http: // www. sanita. it/ farmaci
(39-06) 59 94 39 45/46 Fax (39-06) 59 94 32 17 E-mail: alimentivet@sanita.it
Romano MARABELLI Direttore Generale del Dipartimento della Sanità Pubblica Veterinaria degli Alimenti e della Nutrizione Ministero della Salute Piazzale Marconi 25 I – 00144 Roma Tfn (39- 06) 59 94 39 45/ 46 Fax (39- 06) 59 94 32 17 E- post: alimentivet@ sanita. it
(352) 478 55 90 Fax (352) 26 20 01 40/47/49 E-mail: mariette.backes-lies@ms.etat.lu
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 Luxemburg Tfn (352) 478 55 90 Fax (352) 26 20 01 40/ 47/ 49 E- post: mariette. backes- lies@ ms. etat. lu
NETHERLANDS Huib van de DONK Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
NEDERLÄNDERNA 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 Tfn (31- 70) 356 74 50 Fax (31- 70) 356 75 15 Internet: http: // www. cbg- meb. nl
Bundesministerium für soziale Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
Günter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für soziale, Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Tfn (43- 1) 711 72 47 17 Fax (43- 1) 713 86 14 E- post: 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 soziale, Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Tfn (43- 1) 711 00 46 73 Fax (43- 1) 714 92 22 E- post: alexander. jentzsch@ bmsg. gv. at
Tel.
PORTUGAL
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 Tfn (351- 21) 798 71 16 Fax (351- 21) 798 71 24 E- post: miguel. andrade@ infarmed. pt Internet: http: // www. infarmed. pt
(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 Tfn (351) 213 23 95 66 Fax (351) 213 46 35 18 E- post: rleitao@ dgv. min- agricultura. pt
(351-21) 323 95 66 Fax (351-21) 346 35 18 E-mail: rleitao@dgv.min-agricultura.pt
FINLAND
(358-9) 47 33 42 00 Fax (358-9) 47 33 43 45 E-mail: hannes.wahlroos@nam.fi Internet: http://www.nam.fi
Hannes WAHLROOS Ylijohtaja Lääkelaitos - Läkemedelsverket Mannerheimintie 166 PL 55 FIN – 00301 Helsinki Tfn (358- 9) 47 33 42 00 Fax (358- 9) 47 33 43 45 E- post: 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.
SVERIGE
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 Tfn (46- 18) 17 46 00 Fax (46- 18) 54 85 66 E- post: 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
Michael RUTTER
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey KT15 3LS United Kingdom Tel.
Director and Chief Executive Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ Förenade kungariket Tfn (44- 20) 72 73 01 00 Fax (44- 20) 72 73 05 48 E- post: khj@ mca. gov. uk Internet: http: // www. open. gov. uk/ mca
(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
Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB Förenade kungariket Tfn (44- 1932) 33 83 02/ 33 69 11 Fax (44- 1932) 33 66 18/ 35 25 49 E- post: m. rutter@ vmd. defra. gsi. gov. uk Internet: http: // www. open. gov. uk/ vmd
Observers:
Observatörer:
(354) 520 21 00 Fax (354) 561 21 70 E-mail: rannveig.gunnarsdottir@ lyfjastofnun.is Internet: http://www.lyfjastofnun.is
Rannveig GUNNARSDÓTTIR Chief Executive Director Lyfjastofnun Eidistorg 13 - 15 IS – 170 Seltjarnarnes Tfn (354) 520 21 00 Fax (354) 561 21 70 E- post: rannveig. gunnarsdottir@ lyfjastofnun. is Internet: http: // www. lyfjanefnd. is
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alkvw.llv.li
Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 FL – 9494 Schaan Tfn (423) 236 73 25 Fax (423) 236 73 10 E- post: brigitte. batliner@ alk. llv. li
(47-22) 89 77 00 Fax (47-22) 89 77 99 E-mail: gro.wesenberg@ legemiddelverket.no Internet: http://www.legemiddelverket.no
NORGE Gro Ramsten WESENBERG Director General Statens legemiddelverk Sven Oftedals vei 6 N – 0950 Oslo Tfn (47- 22) 89 77 00 Fax (47- 22) 89 77 99 E- post: gro. wesenberg@ legemiddelverket. no Internet: http: // www. legemiddelverket. no Bilaga 6 Budgetsammanfattningar för EMEA 2000– 2002
The summarised comparative budget statements for 2000 to 2002 are as follows:
Nedan redovisas en jämförelse av budgetsammanfattningar för åren 2000- 2002.
(Amounts expressed in euro)
(Belopp i euro)
Fees
Avgifter EU: s allmänna bidrag EU: s särläkemedelsbidrag
39 154 000
39 13
13 200 000
154 000 200 000
14 700 000
70. 82% 23. 88%
14 000 000
45 771 000 14 700 000
1 9.84%
49 14
Special EU orphan medicinal product contribution
Bidrag från EES Bidrag från EU- program (PERF)
1.81%
1. 81% 0. 44%
0.91%
0. 91% 0. 44%
310 000
4. 68% 0. 44%
0.39%
0. 39%
2.3 1%
2. 31%
2.66%
2. 66%
3.27%
3. 27%
55 287 220 100.00%
287 220
Expenditure Staff
Kostnader Personal
Salaries
Löner Extern personal och andra stödpersoner
20 615 000
493 000 058 000
24 952 000
33. 45% 1. 91%
1 414 000
615 000 31. 30% 414 000 2. 15%
2.70%
35. 37% 2. 70%
Other staff-related expenditure
Övriga personalkostnader Summa avdelning 1 Byggnader och utrustning
2.56%
1 20
1 776 000
350 000 901 000
Total title 1
2. 44% 39. 80%
23 712 640
683 640 2. 56% 712 640 36. 00%
Rent/charges
2. 52% 40. 59%
Expenditure on data processing
Hyra och avgifter Databehandling Övriga kapitalkostnader Porto och kommunikationer
4.26%
9. 43% 4. 38% 4. 26% 0. 87%
1
5 4 1
658 000
149 000 7. 82% 293 000 6. 52% 658 000 2. 52% 617 000 0. 94%
2.52%
5 2 1
170 000
936 000 570 000 170 000 394 000
Postage and communications
8. 41% 3. 64% 1. 66% 0. 56%
Total title 2
Övriga administrationskostnader Summa avdelning 2 Driftskostnader
12 061 720
593 000 061 720
21.82%
2. 88% 21. 82%
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
Möten Utvärderingar Översättning Studier och konsulter Publikationer
4 110 000
270 000 682 500 p. m.
Evaluations
5. 92% 33. 79% 0. 00% 0. 01% 0. 27%
308 000
110 000 6. 24% 308 000 32. 35% 428 000 0. 65% 225 000 0. 34% 190 000 0. 29%
359 000
320 000 333 000 359 000 85 000 190 000
Studies and consultants
6. 12% 33. 07% 0. 51% 0. 12% 0. 27%
EU programmes
EU- program
0. 39%
0. 39%
346 360
346 360 8. 20%
2.31%
2. 31%
Total title 3
Summa avdelning 3
40.38%
40. 38%
43.43%
607 360 43. 43%
42.41%
42. 41%
65 866 000 100.00%
100. 00% 65 866 000
Notes 1 48
100. 00%
Final appropriations for EMEA Annual Report 2001
Noter (1) Slutliga anslag för 2000.
2
(2) Slutliga anslag för 2001.
Budget for 2002 as adopted by the Management Board on 18.12.2001.
(3) Budgeten för 2002 (godkänd av styrelsen den 18. 12. 2001).
Annex 7 CPMP opinions in 2001 on medicinal products for human use
Bilaga 7 CPMP: s yttranden under 2001 om humanläkemedel Produkt Namn INN Del A/ B
Therapeutic area • ATC code • Indication
Terapiområde ATC- kod Indikation
EMEA/CPMP • Validation • Opinion • Active time • Clock stop
EMEA/ CPMP Validering Yttrande Aktiv tid Inaktiv tid
European Commission • Opinion received • Date of decision • Notification • Official Journal
Europeiska kommissionen Yttrandet inne Beslutsdatum Kungörelsedatu m EGT
• L01XX • Treatment of squamous cell carcinoma of head and neck
L01XX Treatment of squamous cell carcinoma of head and neck
• 215 days • 238 days
21. 10. 1999 25. 01. 2001 215 days 238 days
• 26.10.2001 • OJ C 336, 30.11.2001, p.
20. 08. 2001 24. 10. 2001 26. 10. 2001 OJ C 336, 30. 11. 2001, p.
Abbott Laboratories
apomorphine Part B
Takeda Europe R & D Centre Ltd
apomorphine Part B
Nonafact human coagulation factor IX
Nonafact human coagulation factor IX Part A
• 18.02.2000 • 01.03.2001 • 202 days
18. 02. 2000 01. 03. 2001 202 days 171 days
•
03. 04. 2001 03. 07. 2001 05. 07. 2001 OJ C 209, 27. 07. 2001, p.
B01AX Indicated in purpura fulminans and coumarin induced skin
B01AX Indicated in purpura fulminans and coumarin induced skin necrosis in
• 21.01.2000 • 29.03.2001
21. 01. 2000 29. 03. 2001
• 03.05.2001 • 16.07.2001
03. 05. 2001 16. 07. 2001
necrosis in patients with severe
patients with severe congenital protein C
# Denotes an orphan medicinal product designated under Regulation (EC) No 121/2000
MabCampath
EMEA Annual Report 2001
Millenium & Ilex UK Ltd
49
L01XC
• MabCampath • alemtuzumab
14. 04. 2000
• Millenium & Ilex UK Ltd
30. 04. 2001
• L01XC • Second-line treatment of chronic lymphocytic leukaemia
Second- line treatment of chronic lymphocytic leukaemia
• 14.04.2000 • 29.03.2001
29. 03. 2001
• Caspofungin MSD • caspofungin
Caspofungin MSD
• •
20. 08. 2001
J02AX04 Secondline treatment of invasive aspergillosis
Secondline treatment of invasive aspergillosis
• 31.10.2000 • 26.07.2001
26. 07. 2001 207 days
• 20.08.2001 • 24.10.2001
24. 10. 2001 25. 10. 2001
•
8
Treatment of elevated intraocular pressure (second-line)
Produkt Namn
• 26.07.2001
27. 03. 2001
• 27.11.2001
23. 08. 2001
• Part B
imatinib
8
Treatment of patients with chronic myeloid leukemia (CML)
• •
07. 11. 2001
• Part B
mesilate Part B
• 119 days • 0 days
119 days 0 days
• 12.11.2001 • OJ C 336, 30.11.2001, p.
12. 11. 2001 OJ C 336, 30. 112001, p.
• •
Protopy
• Protopy • tacrolimus
Fujisawa GmbH
•
D11AX14 (temporary)
Fujisawa GmbH
16. 08. 2000
• •
tacrolimus
D11AX14 (temporary) Treatment of moderate to severe atopic dermatitis
Treatment of moderate to severe atopic dermatitis
• •
(♦)
Cell Therapeutics (UK) Ltd
Ltd
• •
INN Del A/ B
• Quixidar • fondaparinux
Quixidar fondaparinux
• 205 Days • 78 Days
205 Days 78 Days
• Dynepo
Dynepo
• 26.09.2000
26. 09. 2000
• •
Pfizer Ltd
• Vfend • Voriconazole • Part B
28. 11. 2000 13. 12. 2001 203 days 169 days
• Pfizer Ltd
CVMP: s yttranden under 2001 om veterinärmedicinska läkemedel
• 28.11.2000 • 13.12.2001 • 203 days • 1 69 days
Ansökningar enligt det centraliserade förfarandet
• • • •
Produkt Namn
EMEA Annual Report 2001
Innehavare av godkännande för
51
Terapiområde Djurslag
Annex 8 CVMP opinions in 2001 on medicinal products for veterinary use
EMEA/ CPMP
Centralised applications
Europeiska kommissionen
Product • Brand name • INN • Part A/B
INN Del A/ B
Marketing authorisation holder
försäljning
Therapeutic area • Target species • Indication
Indikation
EMEA/CVMP • Validation • Opinion • Active time • Clock stop
Validering Yttrande Aktiv tid Inaktiv tid
European Commission • Opinion received • Date of decision • Notification • Official Journal
Yttrandet inne Beslutsdatum Kungörelsedatu m EGT
• Poulflox • difloxacin • Part B
Poulflox difloxacin Part B
• Porcilis AR-T DF • inactivated vaccine • Part A
Porcilis AR- T DF inactivated
• Pruban • rescortol butyrate
Pruban rescortol butyrate
• 15.09.98 • 19.07.00
15. 09. 98 19. 07. 00
• 18.08.00 • 16.11.00
18. 08. 00 16. 11. 00
• 196 days • 477 days
196 days 477 days
• 20.11.00 • OJ C 2, 05.01.2001, p.
20. 11. 00 OJ C 2, 05. 01. 2001, p.
• Pirsue • pirlimycin • Part B
Pirsue pirlimycin Part B
• Zubrin • tepoxalin • Part B
Zubrin tepoxalin Part B
• Eurican Herpes 205 • inactivated vaccine • Part B
Eurican Herpes 205 inactivated
• Metacam • meloxicam • Part B extension
Metacam meloxicam Part B extension
• Eurifel RCP-FelV • vaccine
Innehavare av godkännande för
• Merial
Terapiområde Djurslag
Cats Vaccine against feline rhinotracheitis, calcivirus,
Europeiska kommissionen
• 19.12.00 • 05.12.01
INN Del A/ B
• •
försäljning
• Part A
Indikation
panleucopenia and leukaemiac
Validering Yttranden Aktiv tid Inaktiv tid
• 210 days
Eurifel RCP - FelV
•
Cats
• 141 days
19. 12. 00
•
vaccine Part A
52 EMEA Annual Report 2001
05. 12. 01 210 days 141 days
Establishment of maximum residue limits for new substances
Fastställande av högsta tillåtna restmängder för nya substanser
Therapeutic area • Target species
Terapiområde Djurslag
EMEA/CVMP • Validation • Opinion • Active time • Clock stop
EMEA/ CVMP Validering Yttrande Aktiv tid Inaktiv tid
European Commission • Opinion received • Date of regulation • Official Journal
Europeiska kommissionen Yttrandet inne Förordningens datum EGT
• 19.07.00 • 195 days • 321 days
22. 01. 99 19. 07. 00 195 days 321 days
• 25.04.01 • OJ L118, 27.04.2001, p.
18. 08. 00 25. 04. 01 OJ L118, 27. 04. 2001, p.
• 09.10.00 • 14.02.01 • 90 days •0
09. 10. 00 14. 02. 01 90 days 0
•
Substansens INN
• 14.03.01 • 120 days • 298 days
20. 01. 00 14. 03. 01 120 days 298 days
• 22.08.01 • OJ L227, 23.08.2001, p.
06. 04. 01 22. 08. 01 OJ L227, 23. 08. 2001, p.
• Bronopol (extension)
Bronopol (extension) Bilaga 9
Annex 9 COMP opinions in 2001 on designation of orphan medicinal products
COMP: s yttranden under 2001 om klassificering av särläkemedel Produkt INN
EMEA/COMP • Validation • Opinion • Active time • Clock stop
EMEA/ COMP Validering Yttrande Aktiv tid Inaktiv tid
European Commission • Opinion received • Date of decision
Europeiska kommissionen Yttrandet inne Beslutsdatu m
• 19.10.2000 • 19.12.2000 • 62 days
11. 08. 2000
• Bosentan
03. 01. 2001
• Actelion Registration Ltd
19. 10. 2000 19. 12. 2000 62 days
•
14. 02. 2001
• 21.08.2000
Bosentan
• 03.01.2001
Actelion Registration Ltd
thromboembolic pulmonary
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Product INN
Produkt INN
Therapeutic area • ATC code • Indication
Indikation
EMEA/COMP • Validation • Opinion • Active time • Clock stop
EMEA/ COMP Validering Yttrande Aktiv tid
European Commission • Opinion received • Date of decision
Europeiska kommissionen Yttrandet inne
of less than 34 weeks of
Prevention of patent ductus arteriosus in premature neonates of less than 34
• 19.10.2000
02. 05. 2000
• 05.03.2001
19. 01. 2001
gestational age
weeks of gestational age
• 15.01.2001 • 89 days
19. 10. 2000 15. 01. 2001 89 days
• 11.04.2001 • 30.05.2001
15. 12. 2000 11. 01. 2001 10. 04. 2001 90 days
• 11.04.2001 • 30.05.2001
18. 12. 2000 11. 01. 2001 10. 04. 2001 90 days
• 23.02.2001
10. 08. 2000 23. 02. 2001 23. 05. 2001 90 days
• 18.06.2001 • 31.07.2001
18. 06. 2001 31. 07. 2001
• Seocalcitol
Seocalcitol
Treatment of hepatocellular carcinoma
Treatment of Wilson’ s disease
• 05.01.2001 • 20.04.2001 • 12.06.2001 • 54 days
02. 05. 2000 20. 04. 2001 12. 06. 2001 54 days
• Zinc acetate dihydrate
Discovery Laboratories, Inc
Treatment of Wilson’s disease
erol and palmitic acid (Surfaxin)
• 02.05.2000 • 20.04.2001 • 12.06.2001 • 54 days
Beraprost sodium
• 18.06.2001 • 31.07.2001
Aventis Pharma SA
•
21. 05. 2001 11. 06. 2001 18. 07. 2001 38 days
Discovery Laboratories, Inc
Treatment of indolent non- Hodgkin lymphoma
•
01. 03. 2001 20. 04. 2001 18. 07. 2001 90 days
Beraprost sodium
Genzyme BV
• 21.05.2001
Repertaxin L- lysine salt
• 25.07.2001
Dompé s. p. a.
thromboembolic pulmonary
Prevention of delayed graft function in organ transplant
• 11.06.2001
05. 04. 2001 20. 04. 2001 18. 07. 2001 90 days
• 18.09.2001
25. 07. 2001 19. 09. 2001
hypertension
Porcine lung surfactant
• 18.07.2001 • 38 days
Leo Pharmaceutical Products
•
23. 05. 2001
• Lipomed GmbH
25. 07. 2001
•
11. 06. 2001 18. 07. 2001 38 days
• 25.07.2001
19. 09. 2001
• 20.04.2001 • 18.07.2001 • 90 days
Dexrazoxane
• 18.09.2001
TopoTarget A/ S
Treatment of Niemann-Pick disease, type B
Pemetrexed disodium
• 25.07.2001 • 19.09.2001
Eli Lilly Nederland B. V.
• Repertaxin L-lysine salt
Treatment of malignant mesothelioma
•
25. 05. 2001
• 05.04.2001
11. 06. 2001 18. 07. 2001 54 days
• 25.07.2001
17. 09. 2001
• 20.04.2001 • 18.07.2001 • 90 days
* Inklusive tid för överklagande Produkt INN
• 19.09.2001
Indikation
• Porcine lung surfactant
Voisin Consulting SARL
• 23.05.2001
Idebenone
• 25.07.2001
Laboratoires Takeda
• 11.06.2001 • 18.07.2001 • 38 days
Treatment of Friedreich’ s ataxia
• 19.09.2001
12. 07. 2001 30. 07. 2001 07. 09. 2001 40 days
• 24.05.2001
Imatinib mesilate
• 25.07.2001
Novartis Europharm Ltd
• 11.06.2001 • 18.07.2001 • 38 days
Treatment of malignant gastrointestinal stromal tumours