natgillin/translations-raw huggingface dataset:
For matters concerning medicinal products for human use
André LHOIR Jan RENNEBERG Rembert ELBERS (1) George STRATHOPOULOS (2)
Contact point Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
François MEYER Brendan BUCKLEY Domenica TARUSCIO Henri METZ (3)
For matters concerning medicinal products for veterinary use
Nederland Österreich Portugal Suomi/ Finland Sverige United Kingdom
Contact point Peter JONES Direct telephone (44-20) 74 18 84 13 E-mail: peter. jones@emea. eudra. org
Harrie SEEVERENS Hans Georg EICHLER José Manuel Gião TOSCANO RICO Kalle HOPPU Kerstin WESTERMARK Rashmi SHAH (4)
For general information on any other matter
Företrädare för patientorganisationer
Contact points Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eudra. org
Moisés ABASCAL ALONSO (5) Yann LE CAM, 5 Vice ordförande Alastair KENT (6)
Antoine CUVILLIER Direct telephone (44-20) 74 18 84 28 E-mail: antoine. cuvillier@emea. eudra. org
Jean- Michel ALEXANDRE (7) Företrädare för EMEA Gianmartino BENZI Mary TEELING (8)
EU official publications
Observatörer
• Council Regulation (EEC) No 2309/ 93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, as amended (OJ L 214, 24.8.1993, p.
Ísland Norge/ Noreg
62 EMEA General Report 2000
Sigurdur THORSTEINSSON Randi NORDAL
• Council Directive 75/ 319/ EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended (OJ L 147, 9.6.1975, p.
(2) Ersatte Thrassyvoulos KEPHALAS fr. o. m. mötet i oktober 2000.
13) • Council Directive 81/ 851/ EEC of 28 September 1981 on the approximation of the laws of Member States relating to veterinary medicinal products, as amended (OJ L 317, 6.11.1981, p.
(4) Ersatte Alexander NICHOLSON fr. o. m. mötet i juni 2000.
1) • Council Regulation (EC) No 2743/ 98 of 14 December 1998 amending Council Regulation (EC) No 297/ 95 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 345, 19.12.1998, p.
(5) Företräder European Association for Orphan Diseases (Eurodis).
3) • European Parliament and Council Regulation (EC) No 141/ 2000 of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p.
(6) Företräder European Alliance of Genetic Support Groups (EAGS).
1) • EMEA budget statement for the financial year 2000, including final appropriations for 1999 and outturn for 1998 (OJ L 184, 24.7.2000, p.
(8) Avgick vid mötet i september 2000.
1)
Sida 63/ 84
The texts of these and other provisions are available in the series Rules governing medicinal products in the European Community.
Mer information om de behöriga nationella myndigheterna finns på deras webbplatser: http: // heads. medagencies. org och http: // www. hevra. org
These publications, along with copies of the Official Journal, are available from:
(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
Office for Official Publications of the European Communities, 2, rue de Mercier, L - 2985 Luxembourg, and also on the EudraLex Internet site at http: / /pharmacos. eudra. org/ eudralex/ index. htm
(45) 44 88 93 34 Fax (45) 44 88 91 09 E- post: jyl@ dkma. dk Internet: http: // www. dkma. dk
EMEA documents
DEUTSCHLAND
• First General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1995 (ISBN 92-827-7491-0, Office for Official Publications of the EU) • Second General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1996 (ISBN 92-9155-002-7, Office for Official Publications of the EU) • Third General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1997 (ISBN 92-9155-010-8, Office for Official Publications of the EU) • Fourth General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1998 (ISBN 92-9155-018-3, Office for Official Publications of the EU) • Fifth General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1999 (ISBN 92-9155-026-4, EMEA) • Statement of principles governing the partnership between the national competent authorities and the EMEA (EMEA/ MB/ 013/ 97) • Financial Regulation applicable to the budget of the EMEA (EMEA/ MB/ 011/ 97) • Decision of the Executive Director of 3 December 1997 on rules on access to documents of the EMEA (EDIR/ 016/ 1997) • Decision of the Executive Director of 1 June 1999 on cooperation with the European Anti-Fraud Office (OLAF) (EDIR/ 006/ 1999) • Catalogue of EMEA public documents (updated regularly) • EMEA Code of Conduct (EMEA/ D/ 37674/ 99)
(49- 22) 82 07 32 03 Fax (49- 30) 87 07 55 14 E- Mail: schweim@ bfarm. de Internet: http: // www. bfarm. de
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
(49- 30) 84 12 23 64 Fax (49- 30) 84 12 29 65 E- Mail: r. kroker@ bgvv. de Internet: http: // www. bgvv. de
Sector for Document management and publishing European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf London E14 4HB UK
(49- 6103) 77 20 01 Fax (49- 6103) 77 12 52 E- Mail: loejo@ pei. de Internet: http: // www. pei. de
63 EMEA General Report 2000
αδάλλΕ
Annex 2:
/ GREECE
EMEA budgets for 1999 to 2001
EMEA/ MB/ 050/ 00 Allmän rapport 2000 ESPAÑA
The summarised comparative budget statements in euro for 1999 to 2001 are given below.
(34- 91) 596 16 27 Fax (34- 91) 596 16 15 E- mail: sdaem@ agamed. es Internet: http: // www. agamed. es
1999(1)
Sida 64/ 84
2000(2)
FRANCE
2001(3)
19 F – 94701 Maisons Alfort CEDEX Tél (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
(31.12.1999)
IRELAND
(as at 31.12.2000)
(353- 1) 676 49 71 Fax (353- 1) 676 78 36 E- mail: frank. hallinan@ imb. ie Internet: http: // www. imb. ie
(as at 20.12.2000)
(353- 1) 607 24 34 Fax (353- 1) 676 29 89 E- mail: seamus. healy@ daff. irlgov. ie
Expenditure Staff
ITALIA
salaries interim and other support persons other staff-related expenditure total title 1
(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
15 074 905 955 456 1 191 570 17 221 931
(39- 6) 59 94 39 45 Fax (39- 6) 59 94 31 90 E- mail: danspv@ izs. it
36.61% 2.32% 2.89% 41.82%
LUXEMBOURG
18 493 000 1 058 000 1 350 000 20 901 000
(352) 478 55 90 Fax (352) 26 20 01 47 E- mail: dpmlux@ pt. lu
33.45% 1.91% 2.44% 37.80%
EMEA/ MB/ 050/ 00 Allmän rapport 2000
21 772 000 35.15% 1 379 000 2.23% 1 501 000 2.42% 24 652 000 39.80%
Sida 65/ 84
Building/ equipment
NEDERLAND
rent/ charges expenditure on data processing other capital expenditure postage and communications other administrative expenditure
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel.
2 136 038 1 034 357 1 824 960 370 754 1 194 962
(31- 31) 747 54 91 Fax (31- 31) 742 31 93 E- mail: brd@ brd. agro. nl
5.19% 2.51% 4.43% 0.90% 2.90%
ÖSTERREICH
5 212 220 2 423 500 2 353 000 480 000 1 593 000
(43- 1) 711 00 47 17 Fax (43- 1) 713 86 14 E- Mail: gunter. liebeswar@ bmsg. gv. at
9.43% 4.38% 4.26% 0.87% 2.88%
(43- 1) 711 00 46 73 Fax (43- 1) 714 92 22 E- Mail: alexander. jentzsch@ bmsg. gv. at
5 685 000 9.18% 1 400 000 2.26% 824 500 1.33% 537 000 0.87% 1 784 500 2.88%
(351) 217 98 71 16 Fax (351) 217 98 71 20/ 24 E- mail: miguel. andrade@ infarmed. pt Internet: http: // www. infarmed. pt
total title 2
SUOMI/ FINLAND
6 561 071
Box 55 FIN – 00301 Helsinki Puh.
15.93%
SVERIGE
12 061 720 21.82%
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
10 231 000 16.52%
EMEA/ MB/ 050/ 00 Allmän rapport 2000 UNITED KINGDOM Keith JONES
Operational expenditure
Michael RUTTER
meetings
Sida 66/ 84
3 274 441
(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
7.95%
(44- 1932) 33 69 11 Fax (44- 1932) 33 66 18 E- mail: m. rutter@ vmd. maff. gov. uk Internet: http: // www. open. gov. uk/ vmd
3 487 000 6.31%
Observatörer:
6 565 000 10.60%
ÍSLAND
evaluations translation studies and consultants publications
(354) 520 21 00 Fax (354) 561 21 70 E- mail: rannveig. gunnarsdottir@ lyfjanefnd. is Internet: http: // www. lyfjanefnd. is
13 894 457 93 650 137 130
LIECHTENSTEIN
-
(423) 236 73 25 Fax (423) 236 73 10 E- mail: brigitte. batliner@ alk. llv. li
33.74% 0.00% 0.23% 0.33%
NORGE/ NOREG
5 000 150 000
(47- 22) 89 77 00 Fax (47- 22) 89 77 99 E- mail: gro. wesenberg@ slk. no Internet: http: // www. slk. no
33.79% 0.00% 0.01% 0.27%
Sida 67/ 84
19 658 000 31.74% 428 000 0.69% 180 000 0.29% 220 000 0.36%
Läkemedel Företag Användningsom - råde
total title 3
Presentation
17 399 678
EMEA/ CPMP
42.25%
Kommissionen
22 324 500 40.38%
- Namn - Namn
27 051 000 43.68%
- ATC
TOTAL EXPENDITURE
- Form
41 182 680 100.00%
- Giltigförklaring
55 287 220 100.00%
- Yttrandet inne
61 934 000 100.00%
- INN - Del A/ B
Revenue
-
fees general EU contribution special EU orphan medicinal
Land
28 952 500 70.31% 10 481 649 25.45%
- Indikation
39 154 000 70.82% 13 200 000 23.88%
- -
42 610 000 68.81% 14 700 000 23.73%
Dosering Antal presentationer
product contribution contribution from EEA contribution from EU
- Yttrande - Aktiv tid - Inaktiv tid
-- 0.00% -- 0.00%
- Beslutsdatum - Kungörelsedatum - EGT
1 000 000 1.81% 245 220 0.44%
- Orgalutran - ganirelix
600 000 0.97% 250 000 0.40%
-
programmes (PERF) other
Organon
800 000 1.94% 948 531 2.30%
- H01CC01 - Prevention of
217 000 0.39% 1 471 000 2.66%
- -
2 440 000 3.94% 1 334 000 2.15%
Solution for injection 0. 5 mg/ ml
TOTAL REVENUE
- 29. 01. 1999 - 19. 01. 2000
41 182 680 100.00%
- 22. 02. 2000 - 17. 05. 2000
55 287 220 100.00%
- B
61 934 000 100.00%
-
Notes
NL
(2) 2000 budget: final appropriations.
premature luteinising hormone surges in conteolled ovarian hyperstimulatio n
(3) 2001 budget: draft appropriations.
2 presentations
64 EMEA General Report 2000
- 162 days - 189 days
Annex 3:
3
Members of the Management Board
- Pegintron - peginterferon alfa- 2b - A
Chairman
SP Europe US
André BROEKMANS 1
- L03AB10 - Treatment of chronic hepatitis C
Members
- - -
European Parliament
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
Dietrich HENSCHLER, Jean-Pierre REYNIER
- 26. 03. 1999 - 17. 02. 2000 - 189 days - 139 days
European Commission Fabio COLASANTI 3, Bertrand CARSIN 4 Alternates:
3
Eλλ δα / Greece España
- Viraferon PEG - peginterferon alfa- 2b - A
Observers
- -
Ísland
SP Europe US
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN
- L03AB10 - Treatment of chronic hepatitis C
Liechtenstein Norge/ Noreg
- - -
8 Replaced María Theresa PAGÉS JIMÉNEZ as of the 20 December 2000 meeting.
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
65 EMEA General Report 2000
- 03. 01. 2000 - 17. 02. 2000 - 43 days - 0 days
Members of the Committee for Proprietary Medicinal Products1
- 27. 03. 2000 - 25. 05. 2000 - 05. 06. 2000 - OJ C 183, 30. 06. 2000, p.
1 2 3 4 5 6 7 8
3
Replaced Eva ALHAVA as of the March 2000 meeting.
- Lantus - insulin glargine - A
Replaced Rogério GASPAR as of the January 2000 meeting.
-
66 EMEA General Report 2000
Aventis Pharma Deutschlan d GmbH
Members of the Committee for Veterinary Medicinal Products1
- A10AE - Diabetes mellitus
Reinhard KROKER (Deutschland), Chairman
Solution for injection 100 IU/ ml 7 presentations
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
- 23. 04. 1999 - 17. 02. 2000 - 215 days - 83 days
Margarita ARBOIX (España) J.
- 23. 03. 2000 - 06. 06. 2000 - 14. 06. 2000 - OJ C 183,
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)
- D
1 2 3 4
3
The country of the nominating Member State is given for information purposes only.
- - -
67 EMEA General Report 2000
Optisulin insulin glargine A
Members of the Committee for Orphan Medicinal Products
- Aventis - Pharma - Deutschlan d GmbH - D
Chairman (España)
A10AE Diabetes mellitus
Josep TORRENT i FARNELL
Solution for injection 100 IU/ ml 7 presentations
Members
- - - -
Belgique/België Danmark Deutschland Eλλ δα/Greece France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/Finland Sverige United Kingdom Patient organisation
4
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
- - -
representatives
Nyracta rosiglitazone B
Moisés ABASCAL ALONSO 5 Yann LE CAM, 5 Vice-chairman Alastair KENT 6
- - SmithKlin - e Beecham Pharmaceu ticals - UK
EMEA representatives
A10BG02 Combination treatment of Type II diabetes mellitus
Jean-Michel ALEXANDRE 7 Gianmartino BENZI Mary TEELING 8
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
Observers
- - - -
Ísland Norge/Noreg
18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days -
Sigurdur THORSTEINSSON Randi NORDAL
2
1 2 3 4 5 6 7 8
- - -
Resigned as of the December 2000 meeting.
Avandia rosiglitazone B
68 EMEA General Report 2000
- - SmithKlin - e Beecham Phramaceu ticals - UK
National competent authority partners
A10BG02 Combination treatment of Type II diabetes mellitus
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
- - -
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-mail: jyl@dkma.dk Internet: http://www.dkma.dk
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
DEUTSCHLAND Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D – 53113 Bonn Tel.
- - - -
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r.kroker@bgvv.de
18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days -
(49-6103) 77 20 01 Fax (49-6103) 77 12 52 E-mail: loejo@pei.de Internet: http://www.pei.de
4
Internet: http://www.bgvv.de
- - -
69 EMEA General Report 2000
Venvia rosiglitazone B
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
- - SmithKlin - e Beecham Pharmaceu ticals - UK
(34-91) 596 16 27 Fax (34-91) 596 16 15 E-mail: sdaem@agamed.es Internet: http://www.agamed.es
A10BG02 Combination treatment of Type II diabetes mellitusus
FRANCE
- - -
19 F – 94701 Maisons Alfort CEDEX Tel.
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
IRELAND
- - - -
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days -
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@daff.irlgov.ie
2
ITALIA
- - -
(39-6) 59 94 39 45 Fax (39-6) 59 94 31 90 E-mail: danspv@izs.it
Myocet doxorubicin B
70 EMEA General Report 2000
- The - Liposome - Company - US
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
L01DB Treatment of metastatic breast cancer
NEDERLAND André BROEKMANS Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
- - -
Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen Postbus 289 6700 AG Wageningen Nederland Tel.
Powder and pre - admixtures for concentrate for, liposomal dispersion for infusion 50 mg 1 presentation
ÖSTERREICH Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Soziale, Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
- - - -
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
30. 07. 1999 - 12. 04. 2000 - 167 days - 91 days -
PORTUGAL Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
17. 05. 2000 13. 07. 2000 26. 07. 2000 OJ C 244, 25. 08. 2000, p.
(351) 217 98 71 16 Fax (351) 217 98 71 20/24 E-mail: miguel.andrade@infarmed.pt Internet: http://www.infarmed.pt
2
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P - 1294 Lisboa Tel.
- - -
71 EMEA General Report 2000
Datscan ioflupane B
Box 55 FIN - 00301 Helsinki Tel.
- Nycomed - Amersham - - UK
(46-18) 17 46 00 Fax (46-18) 54 85 66 E-mail: gunnar.alvan@mpa.se Internet: http://www.mpa.se
V09AB03 Diagnosis of Parkinson disease
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
Solution for injection 74 MBq/ ml 1 presentation
Observers:
- - - -
ÍSLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS - 170 Seltjarnarnes Tel.
18. 12. 1998 - 16. 03. 2000 - 178 days - 272 days -
NORGE/NOREG Gro Ramsten WESENBERG Director-General Statens legemiddelkontroll Sven Oftedals vei 6 N - 0950 Oslo Tel.
05. 05. 2000 27. 07. 2000 02. 08. 2000 OJ C 244, 25. 08. 2000, p.
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alk.llv.li
10
72 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Allmän rapport 2000
Annex 8:
Visudyne
Product - Brandname - INN - Part A/B
- Ciba - L01XX - Powder for solution for - 27. 08.
Company - Name - Origin
- Visudyne - Ciba -
Therapeutic area - ATC - Indication
L01XX - Powder for solution for
Presentation - Form - Dosage - Number of presentations
- Visudyne - Ciba - L01XX -
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Visudyne - Ciba - L01XX - Powder for solution for -
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Visudyne - Ciba - L01XX - Powder for solution for - 27. 08. 1999 -
- Orgalutran
15. 05. 2000
- N.V.
-
Organon - H01CC01
verteporfin
Organon - H01CC01 - Solution for injection -
Vision - Treatment of age - infusion - 12. 0
- Orgalutran - N.V.
- verteporfin Vision -
22.02.2000
Treatment of age -
- ganirelix
- verteporfin Vision - Treatment of age - infusion - 12. 04. 2000 -
- NL
27. 07. 2000
- Prevention of
31. 07. 2000
17.05.2000
degeneration
-B
- 1
premature luteinising
presentation
-B premature luteinising - 2 presentations -
-
22.05.2000
63 days -
-
10
189 days -
- - -
OJ C 183, 30.06.2000, p.
NovoMix 30 insulin aspart A
3
- -
Pegintron peginterferon alfa -2b
Suspension for injection 100 IU/ ml 8 presentations
- SP Europe - US
24. 09. 1999 - 12. 04. 2000 - 144 days - 55 days -
L03AB10 Treatment of chronic hepatitis C
- Bayer - B02BD02 - Powder and solvent for - 26. 02.
- -
05. 06. 2000
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
Treatment and
- 26.03.1999 - 17.02.2000 - 189 days
solution for injection - 1
- 27.03.2000 - 25.05.2000 - 05.06.2000
- Treatment and solution for injection -
-A
- Treatment and solution for injection - 16. 03. 2000 -
-
04. 08. 2000
100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
- octocog alfa - D prophylaxis of - 250 IU, 500 IU, 1000 IU -
- 139 days
- octocog alfa - D prophylaxis of - 250 IU, 500 IU, 1000 IU - 182 days -
-
07. 08. 2000
OJ C 183, 30.06.2000, p.
bleeding in
3
- 3 p
3
- A bleeding in - 3 presentations -
- -
OJ C 244,
Lantus insulin glargine
haemophilia A
-
25. 08. 2000, p.
-A
10
- 8 3 days
Helixate
- OJ C 183,
- Bayer -
-D
B02BD02 -
3
Powder and solvent for -
Optisulin insulin glargine
26. 02. 1999 -
-
05. 06. 2000
Aventis Pharma Deutschland
NexGen
- A10AE - Diabetes mellitus
AG
- Solution for injection - 100 IU/ml - 7 presentations
-
- 24.09.1999 - 17.02.2000 - 116 days
Treatment and
- 23.03.2000 - 27.06.2000 - 28.06.2000
solution for infusion - 1
-A
- Treatment and solution for infusion -
- 28 days
- Treatment and solution for infusion - 16. 03. 2000 -
-D
04. 08. 2000
- Nyracta - rosiglitazone -B
octocog alfa
- -
- D
SmithKline Beecham Pharmaceuticals UK
prophylaxis of
- -
- 250
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- octocog alfa - D prophylaxis of - 250 IU, 500 IU, 1000 IU -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
- octocog alfa - D prophylaxis of - 250 IU, 500 IU, 1000 IU - 182 days -
- - - -
07. 08. 2000
SmithKline Beecham Pharmaceuticals UK
bleeding in
- -
- 3 p
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- A bleeding in - 3 presentations -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
- A bleeding in - 3 presentations - 201 days -
- - - -
OJ C 244,
4
haemophilia A
- Venvia - rosiglitazone -B
10
SmithKline Beecham Pharmaceuticals UK
Hepacare triple antigen
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
Medeva - Pharma -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
J07BC - Immunisation -
2
Suspension for injection - Monodose preparation of 1 -
- Myocet - doxorubicin -B
23. 10. 1998 - 16. 03. 2000 -
- -
16. 05. 2000 04. 08. 2000
The Liposome Company US
hepatitis B
L01DB Treatment of metastatic breast cancer
against hepatitis
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
ml contains Hepatitis B
- Datscan - ioflupane -B
210 days -
- -
07. 08. 2000
Nycomed Amersham UK
vaccine A
- -
UK
V09AB03 Diagnosis of Parkinson disease
B virus in adults
- Solution for injection - 74 MBq/ml - 1 presentation
surface antigen S, pre- S1 and pre S2 20 µg 2 presentations
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
-
- - - -
293 days -
05.05.2000 27.07.2000 02.08.2000 OJ C 244, 25.08.2000, p.
OJ C 244, 25. 08. 2000, p.
73 EMEA General Report 2000
- -
Product - Brandname - INN - Part A/B
Herceptin trastuzumab
Company - Name - Origin
-
Therapeutic area - ATC - Indication
Roche - Registrat -
Presentation - Form - Dosage - Number of presentations
L01XC03 Treatment of
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
-
Commission - Opinion received - Date of Decision - Notification - Official Journal
Powder for concentrate for solution for infusion
- Visudyne - verteporfin -B
- -
- Ciba Vision - CH
26. 02. 1999 - 25. 05. 2000 -
- -
03. 07. 2000 28. 08. 2000
L01XX Treatment of age - related macular degeneration
-
- - -
A
Powder for solution for infusion 15 mg 1 presentation
-
- - - -
ion Ltd CH
10
patients with metastatic breast cancer whose tumour overexpress HER2
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
- -
- A10AD - Diabetes mellitus
150 mg 1 presentation
- Suspension for injection - 100 IU/ml - 8 presentations
- -
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
147 days - 305 days -
- -
14
Kogenate Bayer octocog alfa
- UCB - N03A - Film coated tablet - 26. 02.
- Bayer AG -D
31. 07. 2000
B02BD02 Treatment and prophylaxis of bleeding
levetiracetam
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU
S. A. - Adjunctive - 250 mg, 500 mg, 750 mg, - 29. 0
- 26.02.1999 - 16.0 3.2000 - 182 days
- levetiracetam S. A. -
- 05.06.2000 - 04.08.2000 - 07.08.2000
Adjunctive
-A
- 250
in haemophilia A
- levetiracetam S. A. - Adjunctive - 250 mg, 500 mg, 750 mg, -
- 3 presentations
- levetiracetam S. A. - Adjunctive - 250 mg, 500 mg, 750 mg, - 29. 06. 2000 -
-
29. 09. 2000
OJ C 244, 25.08.2000, p.
therapy in the
- -
11. 10. 2000
Helixate NexGen octocog alfa
partial onset seizures in epilepsy
- Bayer AG -D
- 26 presentations -
- -
300 days -
B02BD02 Treatment and prophylaxis of bleeding
12
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
Ligand -