qanastek/EMEA-V3 huggingface dataset:
Keith Jones Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ United Kingdom Tel.
2000(2)
Beobachter:
2001(3)
Anhang 8:
(31.12.1999)
Arzneimittel - Handelsname - INN - Teil A/B
(as at 31.12.2000)
Unternehmen - Name - Sitz
(as at 20.12.2000)
Anwendungsgebiet - ATC - Indikation
Expenditure Staff
Fertigarzneimittel - Darreichungsform - Dosierung - Anzahl der Packungsgrößen
salaries interim and other support persons other staff-related expenditure total title 1
EMEA/CPMP - Validierung - Gutachten - Bearbeitungszeit - Anhalten der Uhr
15 074 905 955 456 1 191 570 17 221 931
- Orgalutran
36.61% 2.32% 2.89% 41.82%
Organon
18 493 000 1 058 000 1 350 000 20 901 000
- Orgalutran - N.V.
33.45% 1.91% 2.44% 37.80%
Organon - H01CC01 - Solution for injection - 29.01.1999 -
21 772 000 35.15% 1 379 000 2.23% 1 501 000 2.42% 24 652 000 39.80%
22.02.2000
Building/ equipment
- ganirelix
rent/ charges expenditure on data processing other capital expenditure postage and communications other administrative expenditure
- Prevention of
2 136 038 1 034 357 1 824 960 370 754 1 194 962
- ganirelix - NL - Prevention of - 0.5 mg/ml -
5.19% 2.51% 4.43% 0.90% 2.90%
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.01.2000 -
5 212 220 2 423 500 2 353 000 480 000 1 593 000
17.05.2000
9.43% 4.38% 4.26% 0.87% 2.88%
premature luteinising
5 685 000 9.18% 1 400 000 2.26% 824 500 1.33% 537 000 0.87% 1 784 500 2.88%
- B premature luteinising - 2 presentations -
total title 2
- B premature luteinising - 2 presentations - 162 days -
15.93%
22.05.2000
12 061 720 21.82%
hormone surges in conteolled ovarian hyperstimulation
10 231 000 16.52%
-
Operational expenditure
189 days -
meetings
3
3 274 441
- - -
7.95%
Pegintron peginterferon alfa-2b A
3 487 000 6.31%
- SP Europe - US
6 565 000 10.60%
- -
evaluations translation studies and consultants publications
L0 3AB10 Treatment of chronic hepatitis C
13 894 457 93 650 137 130
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
33.74% 0.00% 0.23% 0.33%
26.03.1999 - 17.02.2000 - 189 days - 139 days -
5 000 150 000
27.03.2000 25.05.2000 05.06.2000 OJ C 183, 30.06.2000, p.
19 658 000 31.74% 428 000 0.69% 180 000 0.29% 220 000 0.36%
3
total title 3
25 presentations
17 399 678
- Viraferon PEG
42.25%
- SP Europe
22 324 500 40.38%
- L03AB10
27 051 000 43.68%
- Powder and solvent for -
TOTAL EXPENDITURE
27.03.2000
41 182 680 100.00%
- peginterferon
55 287 220 100.00%
- Treatment of chronic
61 934 000 100.00%
solution for injection -
Revenue
- peginterferon - US - Treatment of chronic solution for injection - 17.02.2000 -
fees general EU contribution special EU orphan medicinal
25.05.2000
28 952 500 70.31% 10 481 649 25.45%
-
39 154 000 70.82% 13 200 000 23.88%
hepatitis C
42 610 000 68.81% 14 700 000 23.73%
50 µg/0.5 ml, 80 - µg/0.5 ml, 100 µg/0.5 - ml 120 µg/0.5 ml, 150µg/0.5 ml
product contribution contribution from EEA contribution from EU
43 days - 0 days -
-- 0.00% -- 0.00%
3
1 000 000 1.81% 245 220 0.44%
25 presentations
600 000 0.97% 250 000 0.40%
- Lantus
programmes (PERF) other
- Aventis Pharma - A10AE
800 000 1.94% 948 531 2.30%
- Lantus - Aventis Pharma - A10AE - Solution for injection -
217 000 0.39% 1 471 000 2.66%
- Lantus - Aventis Pharma - A10AE - Solution for injection - 23.04.1999 -
2 440 000 3.94% 1 334 000 2.15%
23.03.2000
TOTAL REVENUE
- insulin glargine
41 182 680 100.00%
Deutschland
55 287 220 100.00%
- Diabetes mellitus
61 934 000 100.00%
GmbH
Notes
- A GmbH - 7 presentations -
(1) 1999 budget: outturn figures.
- A GmbH - 7 presentations - 215 days -
(2) 2000 budget: final appropriations.
14.06.2000
(3) 2001 budget: draft appropriations.
83 days -
64 EMEA General Report 2000
3
Annex 3:
- Optisulin - insulin glargine - A
Members of the Management Board
- -
Chairman
- A10AE - Diabetes mellitus
André BROEKMANS 1
- Nyracta
Members
- SmithKline
European Parliament
- A10BG02 - Film coated tablet
Gianmartino BENZI, José-Luis VALVERDE LÓPEZ 2 Alternates:
- Nyracta - SmithKline - A10BG02 -
Dietrich HENSCHLER, Jean-Pierre REYNIER
- Nyracta - SmithKline - A10BG02 - Film coated tablet -
European Commission Fabio COLASANTI 3, Bertrand CARSIN 4 Alternates:
- Nyracta - SmithKline - A10BG02 - Film coated tablet - 18.12.1998 -
Paul WEISSENBERG Belgique/ België Danmark Deutschland
17.04.2000
André PAUWELS, Frans GOSSELINCKX Ib VALSBORG, Jytte LYNGVIG 5 Hermann Josef PABEL, Gerhard Josef KOTHMANN, (Vice-chairman)
- Combination treatment -
Eλλ δα / Greece España
- rosiglitazone Beecham - Combination treatment - 1 mg, 2 mg, 4 mg, -
Marios MARSELOS 6, Elias MOSSIALOS 7 María Victoria de la CUESTA GARCIA 8, Ramón PALOP BAIXAULI 9
- rosiglitazone Beecham - Combination treatment - 1 mg, 2 mg, 4 mg, - 21.10.1999 -
France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/ Finland Sverige United Kingdom
11.07.2000
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
Pharmaceuticals
Observers
of Type II diabetes
Ísland
- B Pharmaceuticals of Type II diabetes 8 mg -
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN
- B Pharmaceuticals of Type II diabetes 8 mg - 186 days -
Liechtenstein Norge/ Noreg
12 presentations -
Brigitte BATLINER, Peter MALIN Andreas DISEN, Gro Ramsten WESENBERG
OJ C 244, 25.08.2000, p.
1 Resigned at the 20 December 2000 meeting.
2
2 Replaced Dietrich HENSCHLER as of the 22 February 2000 meeting.
- Avandia - rosiglitazone - B
3 Replaced Jörn KECK as of the 22 February 2000 meeting.
SmithKline Beecham Phramaceuticals UK
7 Replaced John PSOMAS as of the 20 December 2000 meeting.
A10BG02 - Combination treatment - of Type II diabetes mellitus -
10 Replaced Jacques BOISSEAU as of the 22 February 2000 meeting.
Film coated tablet - 1 mg, 2 mg, 4 mg, - 8 mg - 12 presentations -
12 Replaced André BROEKMANS as of the 7 June 2000 meeting.
18.12.1998 - 21.10.1999 - 186 days - 119 days -
65 EMEA General Report 2000
- Venvia
•
- SmithKline
· Jean-Michel ALEXANDRE (France), Chairman
- A10BG02 - Film coated tablet
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
- Venvia - SmithKline - A10BG02 -
· 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)
- Venvia - SmithKline - A10BG02 - Film coated tablet -
1 2 3 4 5 6 7 8
- Venvia - SmithKline - A10BG02 - Film coated tablet - 18.12.1998 -
Replaced Alfred HILDEBRANDT as of the September 2000 meeting.
17.04.2000
66 EMEA General Report 2000
- rosiglitazone
Annex 5:
Beecham
•
- rosiglitazone Beecham - Combination treatment - 1 mg, 2 mg, 4 mg, -
Reinhard KROKER (Deutschland), Chairman
- rosiglitazone Beecham - Combination treatment - 1 mg, 2 mg, 4 mg, - 21.10.1999 -
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
11.07.2000
Margarita ARBOIX (España) J.
- B
1 2 3 4
Pharmaceuticals
The country of the nominating Member State is given for information purposes only.
of Type II diabetes
Replaced Annika WENNBERG as of the October 2000 meeting.
- B Pharmaceuticals of Type II diabetes 8 mg -
Replaced Carlos SINOGAS as of the July 2000 meeting.
- B Pharmaceuticals of Type II diabetes 8 mg - 186 days -
Replaced Christos HIMONAS as of the April 2000 meeting.
26.07.2000
67 EMEA General Report 2000