natgillin/translations-raw huggingface dataset:
051 000
61 EMEA General Report 2000
43, 68%
A subscription service is available for all EMEA public documents, distributing documents electronically or in paper form.
UDGIFTER I ALT
Further information can be obtained from the above address or from
41
Contact point Iro MAVROPOULOS Direct telephone (44-20) 74 18 85 82 E-mail: subscriptions@emea. eudra. org
182 680
Requests for general information packs should be sent to
100, 00%
Contact point Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eudra. org
55
Requests may be made either in writing to the EMEA or sent to the following e-mail addresses:
287 220 100, 00%
Human medicines’ experts list Veterinary medicines’ experts list Inspectors experts list
61 934 000
human_experts@emea. eudra. org vet_experts@emea. eudra. org inspectors_experts@emea. eudra. org
Indtægter
Media and press contacts
gebyrer bidrag over EU' s almindelige budget specielt EU- bidrag til sjældne
Representatives of the media should contact the following people for information:
28 10
For matters concerning medicinal products for human use
952 500 481 649
Contact point Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
70, 31% 25, 45%
For matters concerning medicinal products for veterinary use
39 13
Contact point Peter JONES Direct telephone (44-20) 74 18 84 13 E-mail: peter. jones@emea. eudra. org
154 000 70, 82% 200 000 23, 88%
For general information on any other matter
42 610 000 14 700 000
Contact points Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eudra. org
68, 81% 23, 73%
Antoine CUVILLIER Direct telephone (44-20) 74 18 84 28 E-mail: antoine. cuvillier@emea. eudra. org
lægemidler bidrag fra EØS bidrag fra EU- programmer
EU official publications
-- --
1)
0, 00% 0, 00%
62 EMEA General Report 2000
000 000 1, 81% 245 220 0, 44%
These publications, along with copies of the Official Journal, are available from:
600 000 250 000
EMEA documents
0, 97% 0, 40%
63 EMEA General Report 2000
(PERF)
Annex 2:
800 000
The summarised comparative budget statements in euro for 1999 to 2001 are given below.
1, 94%
1999(1)
217 000 0, 39%
2000(2)
2 440 000
2001(3)
3, 94%
(31.12.1999)
andre indtægter
(as at 31.12.2000)
948 531
(as at 20.12.2000)
2, 30%
Expenditure Staff
1
salaries interim and other support persons other staff-related expenditure total title 1
471 000 2, 66%
36.61% 2.32% 2.89% 41.82%
1 334 000
18 493 000 1 058 000 1 350 000 20 901 000
2, 15%
33.45% 1.91% 2.44% 37.80%
INDTÆGTER I ALT Noter (1) 1999- budgettet: faktiske beløb.
21 772 000 35.15% 1 379 000 2.23% 1 501 000 2.42% 24 652 000 39.80%
41 182 680
Building/ equipment
100, 00%
2 136 038 1 034 357 1 824 960 370 754 1 194 962
55 287 220 100, 00%
5.19% 2.51% 4.43% 0.90% 2.90%
61 934 000
5 212 220 2 423 500 2 353 000 480 000 1 593 000
100, 00%
9.43% 4.38% 4.26% 0.87% 2.88%
(2) 2000- budgettet: endelige bevillinger.
total title 2
Side 63/ 93
6 561 071
Formand
15.93%
André BROEKMANS1
12 061 720 21.82%
Medlemmer
10 231 000 16.52%
Europa- Parlamentet
Operational expenditure
Europa- Kommissionen
meetings
Paul WEISSENBERG
3 274 441
Belgique/ België Danmark Deutschland αδάλλΕ / Greece España France Ireland Italia Luxembourg Nederland Österreich Portugal Suomi/ Finland Sverige United Kingdom
7.95%
André PAUWELS, Frans GOSSELINCKX Ib VALSBORG, Jytte LYNGVIG5 Hermann Josef PABEL, Gerhard Josef KOTHMANN, Næstformand Marios MARSELOS6, Elias MOSSIALOS7 María Victoria de la CUESTA GARCIA8, Ramón PALOP BAIXAULI9 Philippe DUNETON, Martin HIRSCH10 Tom MOONEY, Colm GAYNOR11 Nello MARTINI, Romano MARABELLI Mariette BACKES- LIES John LISMAN12, Frits PLUIMERS Alexander JENTZSCH, Ernst LUSZCZAK Miguel ANDRADE13, Rógerio GASPAR14 Pekka JÄRVINEN15, Hannes WAHLROOS Birgitta BRATTHALL, Anders BROSTRÖM Keith JONES, Michael RUTTER
3 487 000 6.31%
Observatører
6 565 000 10.60%
Ísland Liechtenstein
evaluations translation studies and consultants publications
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN Brigitte BATLINER, Peter MALIN
13 894 457 93 650 137 130
Trådte tilbage på mødet den 20. december 2000.
33.74% 0.00% 0.23% 0.33%
3 Erstattede Jörn KECK fra og med mødet den 22. februar 2000.
5 000 150 000
EMEA/ MB/ 050/ 00 Årsberetning 2000 Norge/ Noreg
33.79% 0.00% 0.01% 0.27%
Andreas DISEN, Gro Ramsten WESENBERG
19 658 000 31.74% 428 000 0.69% 180 000 0.29% 220 000 0.36%
Side 64/ 93
total title 3
EMEA/ MB/ 050/ 00 Årsberetning 2000 Bilag 4 Medlemmer af Udvalget for Farmaceutiske Specialiteter1
17 399 678
Side 65/ 93
42.25%
· Jean- Michel ALEXANDRE (France), Formand
22 324 500 40.38%
· · · · ·
27 051 000 43.68%
· · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
TOTAL EXPENDITURE
Rolf BASS (Deutschland) Daniel BRASSEUR (Belgique/ België) Hans van BRONSWIJK (Nederland), Næstformand4 Geert DE GREEF (Belgique/ België) Jens ERSBØLL (Danmark) Silvio GARATTINI (Italia) Jacqueline GENOUX- HAMES (Luxembourg) Willem van der GIESEN (Nederland) Lars GRAMSTAD (Norge/ Noreg) Manfred HAASE (Deutschland) Magnús JÓHANNSSON (Ísland) Tove KARLSUD (Norge/ Noreg) Pekka KURKI (Suomi/ Finland) 5 David LYONS (Ireland) Jose Guimarães MORAIS (Portugal) 6 Per NILSSON (Sverige) Jean- Louis ROBERT (Luxembourg) Frances ROTBLAT (United Kingdom) 7 Patrick SALMON (Ireland) 8 Tomas SALMONSON (Sverige) Cristina SAMPAIO (Portugal) Sigurdur THORSTEINSSON (Ísland) Markku TOIVONEN (Suomi/ Finland) Jean- Hugues TROUVIN (France) Guiseppe VICARI (Italia) Patrick WALLER (United Kingdom) Hans WINKLER (Österreich) Christa WIRTHUMER- HOCHE (Österreich) Julia YOTAKI (/ Greece) αδάλλΕ
41 182 680 100.00%
5 Erstattede Eva ALHAVA fra og med mødet i marts 2000.
55 287 220 100.00%
EMEA/ MB/ 050/ 00 Årsberetning 2000 Bilag 5 Medlemmer af Udvalget for Veterinærlægemidler1
61 934 000 100.00%
Side 66/ 93
Revenue
· Reinhard KROKER (Deutschland), Formand
fees general EU contribution special EU orphan medicinal
· · · · · · · · · · · · · · · · · · · · · · · · · · · ·
28 952 500 70.31% 10 481 649 25.45%
Margarita ARBOIX (España) J.
39 154 000 70.82% 13 200 000 23.88%
3 Erstattede Carlos SINOGAS fra og med mødet i juli 2000.
42 610 000 68.81% 14 700 000 23.73%
EMEA/ MB/ 050/ 00 Årsberetning 2000 Bilag 6 Medlemmer af Udvalget for Sjældne Lægemidler
product contribution contribution from EEA contribution from EU
Side 67/ 93
-- 0.00% -- 0.00%
Formand
1 000 000 1.81% 245 220 0.44%
España
600 000 0.97% 250 000 0.40%
Josep TORRENT i FARNELL
programmes (PERF) other
Medlemmer
800 000 1.94% 948 531 2.30%
Belgique/ België Danmark Deutschland αδάλλΕ / Greece France Ireland Italia Luxembourg Nederland Österreich Portugal Suomi/ Finland Sverige United Kingdom
217 000 0.39% 1 471 000 2.66%
Repræsentanter for patient -
2 440 000 3.94% 1 334 000 2.15%
sammenslutninger
TOTAL REVENUE
Moisés ABASCAL ALONSO5 Yann LE CAM, Næstformand Alastair KENT6
41 182 680 100.00%
EMEA- repræsentanter
55 287 220 100.00%
Jean- Michel ALEXANDRE7 Gianmartino BENZI Mary TEELING8
61 934 000 100.00%
Observatører
Notes
1 Erstattede Tilman OTT fra og med mødet i september 2000.
(1) 1999 budget: outturn figures.
2 Erstattede Thrassyvoulos KEPHALAS fra og med mødet i oktober 2000.
(2) 2000 budget: final appropriations.
6 Repræsenterer European Alliance of Genetic Support Groups (EAGS).
(3) 2001 budget: draft appropriations.
EMEA/ MB/ 050/ 00 Årsberetning 2000 Ísland Norge/ Noreg
64 EMEA General Report 2000
Sigurdur THORSTEINSSON Randi NORDAL
Members of the Management Board
Side 68/ 93
Chairman
EMEA/ MB/ 050/ 00 Årsberetning 2000 Bilag 7
André BROEKMANS 1
Side 69/ 93
Members
Partnere fra de kompetente nationale myndigheder
European Parliament
Yderligere oplysninger om de kompetente nationale myndigheder kan også findes på de nationale myndigheders websteder: http: // heads. medagencies. org og http: // www. hevra. org
Dietrich HENSCHLER, Jean-Pierre REYNIER
(32- 2) 227 55 67 Fax (32- 2) 227 55 55/ 56 39 E- mail: andre. pauwels@ afigp. fgov. be Internet: http: // www. afigp. fogv. be
Paul WEISSENBERG Belgique/ België Danmark Deutschland
(45) 44 88 93 34 Fax (45) 44 88 91 09 E- post: jyl@ dkma. dk Internet: http: // www. dkma. dk
André PAUWELS, Frans GOSSELINCKX Ib VALSBORG, Jytte LYNGVIG 5 Hermann Josef PABEL, Gerhard Josef KOTHMANN, (Vice-chairman)
DEUTSCHLAND
Eλλ δα / Greece España
(49- 22) 82 07 32 03 Fax (49- 30) 87 07 55 14 E- Mail: schweim@ bfarm. de Internet: http: // www. bfarm. de
Marios MARSELOS 6, Elias MOSSIALOS 7 María Victoria de la CUESTA GARCIA 8, Ramón PALOP BAIXAULI 9
(49- 30) 84 12 23 64 Fax (49- 30) 84 12 29 65 E- mail: r. kroker@ bgvv. de Internet: http: // www. bgvv. de
France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/ Finland Sverige United Kingdom
(49- 6103) 77 20 01 Fax (49- 6103) 77 12 52 E- mail: loejo@ pei. de Internet: http: // www. pei. de
Philippe DUNETON, Martin HIRSCH 10 Tom MOONEY, Colm GAYNOR 11 Nello MARTINI, Romano MARABELLI Mariette BACKES-LIES John LISMAN 12, Frits PLUIMERS Alexander JENTZSCH, Ernst LUSZCZAK Miguel ANDRADE 13, Rógerio GASPAR 14 Pekka JÄRVINEN 15, Hannes WAHLROOS Birgitta BRATTHALL, Anders BROSTRÖM Keith JONES, Michael RUTTER
αδάλλΕ
Observers
/ GREECE
Ísland
(30- 1) 650 72 10 Fax (30- 1) 654 95 86 E- mail: hmoutsop@ eof. gr
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN
EMEA/ MB/ 050/ 00 Årsberetning 2000 ESPAÑA
Liechtenstein Norge/ Noreg
(34- 91) 596 16 27 Fax (34- 91) 596 16 15 E- mail: sdaem@ agamed. es Internet: http: // www. agamed. es
Brigitte BATLINER, Peter MALIN Andreas DISEN, Gro Ramsten WESENBERG
Philippe DUNETON Directeur- Général Agence française de sécurité sanitaire des produits de santé 143- 147, blvd Anatole France F – 93200 Saint- Denis CEDEX Tél.
2 Replaced Dietrich HENSCHLER as of the 22 February 2000 meeting.
(33- 1) 55 87 30 14 Fax (33- 1) 55 87 30 12 E- mail: philippe. duneton@ afssaps. sante. fr Internet: http: // agmed. sante. gouv. fr
4 Replaced Joachim HEINE as of the 22 February 2000 meeting.
Martin HIRSCH Directeur- Général Agence Française de Sécurité Sanitaire des aliments 23, avenue du Général de Gaulle B. P.
6 Replaced Haralampos MOUTSOPOULOS as of the 20 December 2000 meeting.
19 F – 94701 Maisons Alfort CEDEX Tél.
7 Replaced John PSOMAS as of the 20 December 2000 meeting.
(33- 1) 49 77 13 99/ 26 54 Fax (33- 1) 49 77 26 26 E- mail: m. hirsch@ dg. afssa. fr Internet: http: // www. afssa. fr
8 Replaced María Theresa PAGÉS JIMÉNEZ as of the 20 December 2000 meeting.
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Tel.
10 Replaced Jacques BOISSEAU as of the 22 February 2000 meeting.
(353- 1) 676 49 71 Fax (353- 1) 676 78 36 E- mail: frank. hallinan@ imb. ie Internet: http: // www. imb. ie
12 Replaced André BROEKMANS as of the 7 June 2000 meeting.
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Ireland Tel.
14 Replaced Maria Armanda MIRANDA as of the 22 February 2000 meeting.
(353- 1) 607 24 34 Fax (353- 1) 676 29 89 E- mail: seamus. healy@ daff. irlgov. ie
15 Replaced Kimmo LEPPO as of the 22 February 2000 meeting.
ITALIA
65 EMEA General Report 2000
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e la farmacovigilanza Ministero della Sanità Viale Civilità Romana 7 I – 00144 Roma Tel.
Annex 4:
(39- 6) 59 94 39 45 Fax (39- 6) 59 94 31 90 E- mail: danspv@ izs. it
Members of the Committee for Proprietary Medicinal Products1
LUXEMBOURG
•
(352) 478 55 90 Fax (352) 26 20 01 47 E- mail: dpmlux@ pt. lu
· Jean-Michel ALEXANDRE (France), Chairman
EMEA/ MB/ 050/ 00 Årsberetning 2000
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
Side 71/ 93
· Eric ABADIE (France) · Mark AINSWORTH (Danmark) 2 · Fernando de ANDRES-TRELLES (España) · Cristina AVENDAÑO (España) · Michalis AVGERINOS (Eλλ δα/Greece) · Rolf BASS (Deutschland) 3 · Daniel BRASSEUR (Belgique/België) · Hans van BRONSWIJK (Nederlands), Vice-chairman 4 · Geert DE GREEF (Belgique/België) · Jens ERSBØLL (Danmark) · Silvio GARATTINI (Italia) · Jacqueline GENOUX-HAMES (Luxembourg) · Willem van der GIESEN (Nederlands) · Lars GRAMSTAD (Norge/Noreg) · Manfred HAASE (Deutschland) · Magnús JÓHANNSSON (Ísland) · Tove KARLSUD (Norge/Noreg) · Pekka KURKI (Suomi/Finland) 5 · David LYONS (Ireland) · Jose Guimarães MORAIS (Portugal) 6 · Per NILSSON (Sverige) · Jean-Louis ROBERT (Luxembourg) · Frances ROTBLAT (United Kingdom) 7 · Patrick SALMON (Ireland) 8 · Tomas SALMONSON (Sverige) · Cristina SAMPAIO (Portugal) · Sigurdur THORSTEINSSON (Ísland) · Markku TOIVONEN (Suomi/Finland) · Jean-Hugues TROUVIN (France) · Guiseppe VICARI (Italia) · Patrick WALLER (United Kingdom) · Hans WINKLER (Österreich) · Christa WIRTHUMER-HOCHE (Österreich) · Julia YOTAKI (Eλλ δα/Greece)
NEDERLAND
1 2 3 4 5 6 7 8
André BROEKMANS Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V. W. S.
Replaced Gorm JENSEN as of the January 2000 meeting.
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel.
Replaced Alfred HILDEBRANDT as of the September 2000 meeting.
(31- 70) 356 74 50 Fax (31- 70) 356 75 15 E- mail: aw. broekmans@ cbg. meb. nl Internet: http: // www. cbg- meb. nl
Replaced Eva ALHAVA as of the March 2000 meeting.
Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen Postbus 289 6700 AG Wageningen Nederland Tel.
Replaced David JEFFERYS as of the March 2000 meeting.
(31- 31) 747 54 91 Fax (31- 31) 742 31 93 E- mail: brd@ brd. agro. nl
Replaced Mary TEELING as of the September 2000 meeting.
ÖSTERREICH
66 EMEA General Report 2000
(43- 1) 711 00 47 17 Fax (43- 1) 713 86 14 E- Mail: gunter. liebeswar@ bmsg. gv. at
Members of the Committee for Veterinary Medicinal Products1
PORTUGAL
•
(351) 217 98 71 16 Fax (351) 217 98 71 20/ 24 E- mail: miguel. andrade@ infarmed. pt Internet: http: // www. infarmed. pt
Reinhard KROKER (Deutschland), Chairman
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P – 1294 Lisboa Tel.
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
Box 55 FIN – 00301 Helsinki Puh.
Margarita ARBOIX (España) J.
(358- 9) 47 33 42 00 Fax (358- 9) 47 33 43 45 Sähköposti: hannes. wahlroos@ nam. fi Internet: http: // www. nam. fi
Gabriel BEECHINOR (Ireland), Vice-chairman Hanne BERGENDAHL (Norge/Noreg) Rory BREATHNACH (Ireland) Gabriella CONTI (Italia) Luis CORBALAN (España) Steve DEAN (United Kingdom) Johannes DICHTL (Österreich) Sabine EGLIT (Deutschland) Françoise FALIZE (Belgique/België) Christian FRIIS (Danmark) Helle HARTMANN FRIES (Danmark) Johannes HOOGLAND (Nederlands) Tonje HØY (Norge/Noreg) Albert HUBERTY (Luxembourg) Eva FABIANSON-JOHNSSON (Sverige) 2 Liisa KAARTINEN (Suomi/Finland) Herman LENSING (Nederlands) Jan LUTHMAN (Sverige) Agostino MACRI (Italia) Ioannis MALEMIS (Eλλ δα/Greece) Maria Leonor MEISEL (Portugal) 3 Manfred MOOS (Deutschland) Gérard MOULIN (France) John O’BRIEN (United Kingdom) Eugen OBERMAYR (Österreich) Sigurdur ÖRN HANSSON (Ísland) Orestis PAPADOPOULOS (Eλλ δα/Greece) 4 Paul-Pierre PASTORET (Belgique/België) Margarida PRATAS (Portugal) Halldór RUNÓLFSSON (Ísland) Jean-Claude ROUBY (France) Liisa SIHVONEN (Suomi/Finland) Marc WIRTOR (Luxembourg)
SVERIGE
1 2 3 4
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
Replaced Carlos SINOGAS as of the July 2000 meeting.
EMEA/ MB/ 050/ 00 Årsberetning 2000 UNITED KINGDOM Keith JONES
Replaced Christos HIMONAS as of the April 2000 meeting.
Michael RUTTER
67 EMEA General Report 2000
Side 72/ 93
Annex 6:
(44- 20) 72 73 01 00 Fax (44- 20) 72 73 05 48 E- mail: keith. jones@ mca. gov. uk Internet: http: // www. open. gov. uk/ mca
Members of the Committee for Orphan Medicinal Products
Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
Chairman (España)
Observatører:
Josep TORRENT i FARNELL
ÍSLAND
Members
Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS – 170 Seltjarnarnes Tel.
Belgique/België Danmark Deutschland Eλλ δα/Greece France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/Finland Sverige United Kingdom Patient organisation
(354) 520 21 00 Fax (354) 561 21 70 E- mail: rannveig. gunnarsdottir@ lyfjanefnd. is Internet: http: // www. lyfjanefnd. is
André LHOIR Jan RENNEBERG Rembert ELBERS 1 George STRATHOPOULOS 2 François MEYER Brendan BUCKLEY Domenica TARUSCIO Henri METZ 3 Harrie SEEVERENS Hans Georg EICHLER José Manuel Gião TOSCANO RICO Kalle HOPPU Kerstin WESTERMARK Rashmi SHAH
LIECHTENSTEIN
representatives
(423) 236 73 25 Fax (423) 236 73 10 E- mail: brigitte. batliner@ alk. llv. li
Moisés ABASCAL ALONSO 5 Yann LE CAM, 5 Vice-chairman Alastair KENT 6
NORGE/ NOREG
EMEA representatives
EMEA/ MB/ 050/ 00 Årsberetning 2000 Bilag 8 CPMP- udtalelser i 2000 om humanmedicinske lægemidler
Jean-Michel ALEXANDRE 7 Gianmartino BENZI Mary TEELING 8
Side 73/ 93
Observers
Lægemiddel Firma Behandlingsområde
Ísland Norge/Noreg
Præsentation
Sigurdur THORSTEINSSON Randi NORDAL
EMEA/ CPMP
1 2 3 4 5 6 7 8
Kommissionen
Resigned as of the December 2000 meeting.
- Handelsnavn
68 EMEA General Report 2000
- Navn
Annex 7:
- ATC- kode
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
- Form
(32-2) 227 55 67 Fax (32-2) 227 55 55/56 39 E-mail: andre.pauwels@afigp.fgov.be Internet: http://www.afigp.fogv.be
- Handelsnavn - Navn - ATC- kode - Form - Godkendelse -
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-mail: jyl@dkma.dk Internet: http://www.dkma.dk
Udtalelse
(49-22) 82 07 32 03 Fax (49-30) 87 07 55 14 E-mail: schweim@bfarm.de Internet: http://www.bfarm.de
-
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r.kroker@bgvv.de
modtaget den
(49-6103) 77 20 01 Fax (49-6103) 77 12 52 E-mail: loejo@pei.de Internet: http://www.pei.de
- INN
Internet: http://www.bgvv.de
- Oprindelse
69 EMEA General Report 2000
- Indikation
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
- Dosis
(34-91) 596 16 27 Fax (34-91) 596 16 15 E-mail: sdaem@agamed.es Internet: http://www.agamed.es
- Udtalelse
FRANCE
-
(33-1) 55 87 30 14 Fax (33-1) 55 87 30 12 E-mail: philippe.duneton@afssaps.sante.fr Internet: http://agmed.sante.gouv.fr
Dato for afgørelsen
19 F – 94701 Maisons Alfort CEDEX Tel.
- Del A/ B
IRELAND
-
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
Antal præsentationer
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@daff.irlgov.ie
- Nettotid
ITALIA
- Dato for meddelelsen
(39-6) 59 94 36 66 Fax (39-6) 59 94 34 56 E-mail: farmaci.sanita@interbusiness.it Internet: http://www.sanita.it/farmaci
- Urstop
(39-6) 59 94 39 45 Fax (39-6) 59 94 31 90 E-mail: danspv@izs.it
- EFT nr.
70 EMEA General Report 2000
- Orgalutran - ganirelix - B
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
- -
(31-70) 356 74 50 Fax (31-70) 356 75 15 E-mail: aw.broekmans@cbg.meb.nl Internet: http://www.cbg-meb.nl
Organon NL
(31-31) 747 54 91 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl
- -
(43-1) 711 00 47 17 Fax (43-1) 713 86 14 E-mail: gunter.liebeswar@bmsg.gv.at
H01CC01 Prevention of premature luteinising hormone surges in conteolled ovarian hyperstimulation
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
- - -
(351) 217 98 71 16 Fax (351) 217 98 71 20/24 E-mail: miguel.andrade@infarmed.pt Internet: http://www.infarmed.pt
Solution for injection 0. 5 mg/ ml 2 presentations
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P - 1294 Lisboa Tel.
- 29. 01. 1999 - 19. 01. 2000 - 162 days - 189 days
71 EMEA General Report 2000
3
SUOMI/FINLAND Hannes WAHLROOS Ylijohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P.O.
- Pegintron - peginterferon
Box 55 FIN - 00301 Helsinki Tel.
-
(46-18) 17 46 00 Fax (46-18) 54 85 66 E-mail: gunnar.alvan@mpa.se Internet: http://www.mpa.se
L03AB10 Treatment of
UNITED KINGDOM
-
(44-20) 72 73 01 00 Fax (44-20) 72 73 05 48 E-mail: keith.jones@mca.gov.uk Internet: http://www.open.gov.uk/mca
Powder and solvent for solution for injection
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
- 26. 03. 1999 - 17. 02. 2000
Observers:
- 27. 03. 2000 - 25. 05. 2000
ÍSLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS - 170 Seltjarnarnes Tel.
alfa- 2b - A
(47-22) 89 77 00 Fax (47-22) 89 77 99 E-mail: gro.wesenberg@slk.no Internet: http://www.slk.no
-
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alk.llv.li
chronic hepatitis C
72 EMEA General Report 2000
- -
Annex 8:
50 µg/ 0. 5 ml, 80 µg/ 0. 5 ml, 100 µg/ 0. 5 ml 120 µg/ 0. 5 ml, 150µg/ 0. 5 ml 25 presentations
CPMP opinions in 2000 on medicinal products for human use
- 189 days - 139 days
Product - Brandname - INN - Part A/B
3
Company - Name - Origin
- Viraferon PEG
Therapeutic area - ATC - Indication
-
Presentation - Form - Dosage - Number of presentations
SP Europe
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- -
Commission - Opinion received - Date of Decision - Notification - Official Journal
L03AB10 Treatment of
- Orgalutran
-
- N.V.
Powder and solvent for solution for injection
Organon - H01CC01
- 03. 01. 2000 - 17. 02. 2000
- Orgalutran - N.V.
- 27. 03. 2000 - 25. 05. 2000
- Orgalutran - N.V.
- peginterferon alfa- 2b - A
Organon - H01CC01 - Solution for injection - 29.01.1999 -
US
22.02.2000
chronic hepatitis C
- ganirelix
- -
- NL
- 43 days - 0 days
- Prevention of
3
- ganirelix - NL - Prevention of - 0.5 mg/ml -
- Lantus - insulin glargine - A
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.01.2000 -
- -
-B
Aventis Pharma Deutschl and GmbH D
premature luteinising
- -
-B premature luteinising - 2 presentations -
A10AE Diabetes mellitus
-B premature luteinising - 2 presentations - 162 days -
- - -
22.05.2000
Solution for injection 100 IU/ ml 7 presentations
hormone surges in conteolled ovarian hyperstimulation
- 23. 04. 1999 - 17. 02. 2000 - 215 days - 83 days
189 days -
- 23. 03. 2000 - 06. 06. 2000 - 14. 06. 2000 - OJ C 183, 30. 06. 2000, p.
OJ C 183, 30.06.2000, p.
Aventis Pharma Deutschl and GmbH D
Pegintron peginterferon alfa -2b
- -
- SP Europe - US
Solution for injection 100 IU/ ml 7 presentations
L03AB10 Treatment of chronic hepatitis C
- 24. 09. 1999 - 17. 02. 2000 - 116 days - 28 days
- -
4
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
- Nyracta - rosiglitazone - B
- 26.03.1999 - 17.02.2000 - 189 days
SmithKli ne Beecham Pharmac euticals
- 27.03.2000 - 25.05.2000 - 05.06.2000
- -
-A
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
- 18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days
- 139 days
UK
3
- Avandia - rosiglitazone - B
- Viraferon PEG - peginterferon alfa -2b -A
-
- SP Europe - US
A10BG02 Combination treatment of Type II diabetes mellitus
L03AB10 Treatment of chronic hepatitis C
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml, 100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
- 18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
SmithKli ne Beecham Pharmac euticals
Lantus insulin glargine
A10BG02 Combination treatment of Type II diabetes mellitusus
Aventis Pharma Deutschland
- - -
- A10AE - Diabetes mellitus
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
- Solution for injection - 100 IU/ml - 7 presentations
- 18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days
- 23.04.1999 - 17.02.2000 - 215 days
2
- 23.03.2000 - 06.06.2000 - 14.06.2000
-
-A
UK
GmbH
- Myocet - doxorubicin - B
- 8 3 days
- -
- OJ C 183,
The Liposom e Company US
3
L01DB Treatment of metastatic breast cancer
Optisulin insulin glargine
Powder and pre- admixtures for concentrate for, liposomal dispersion for infusion 50 mg 1 presentation
Aventis Pharma Deutschland
- 30. 07. 1999 - 12. 04. 2000 - 167 days - 91 days
- A10AE - Diabetes mellitus