natgillin/translations-raw huggingface dataset:
France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/ Finland Sverige United Kingdom
EMEA/ MB/ 050 Vuosikertomus 2000 ESPAÑA
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
(34- 91) 596 16 27 Fax (34- 91) 596 16 15 E- mail: sdaem@ agamed. es Internet: http: // www. agamed. es
Observers
sivu 65/ 85
Ísland
FRANCE
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN
Philippe DUNETON Directeur- Général Agence française de sécurité sanitaire des produits de santé 143- 147, blvd Anatole France F – 93200 Saint- Denis CEDEX Tél.
Liechtenstein Norge/ Noreg
19 F – 94701 Maisons Alfort CEDEX Tél.
Brigitte BATLINER, Peter MALIN Andreas DISEN, Gro Ramsten WESENBERG
IRELAND
2 Replaced Dietrich HENSCHLER as of the 22 February 2000 meeting.
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Tel.
3 Replaced Jörn KECK 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
5 Replaced Ib Bo LUMHOLTZ as of the 23 October 2000 meeting.
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Ireland Tel.
6 Replaced Haralampos MOUTSOPOULOS as of the 20 December 2000 meeting.
(353- 1) 607 24 34 Fax (353- 1) 676 29 89 E- mail: seamus. healy@ daff. irlgov. ie
8 Replaced María Theresa PAGÉS JIMÉNEZ as of the 20 December 2000 meeting.
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e la farmacovigilanza Ministero della Sanità Viale Civilità Romana 7 I – 00144 Roma Tel.
9 Replaced Mariano BITRIÁN CALVO as of the 20 December 2000 meeting.
(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
11 Replaced John COSTELLOE as of the 22 February 2000 meeting.
Romano MARABELLI Direttore Generale del Dipartimento degli alimenti e nutrizione e della sanità pubblica veterinaria Ministero della Sanità Piazzale Marconi 25 I – 00144 Roma Tel.
12 Replaced André BROEKMANS as of the 7 June 2000 meeting.
(39- 6) 59 94 39 45 Fax (39- 6) 59 94 31 90 E- mail: danspv@ izs. it
14 Replaced Maria Armanda MIRANDA as of the 22 February 2000 meeting.
Mariette BACKES- LIES Pharmacien- Inspecteur Chef de Division Directeur de la Santé Division de la pharmacie et des médicaments Villa Louvigny – 1er étage L – 2120 Luxembourg Tél.
15 Replaced Kimmo LEPPO as of the 22 February 2000 meeting.
(352) 478 55 90 Fax (352) 26 20 01 47 E- mail: dpmlux@ pt. lu
65 EMEA General Report 2000
EMEA/ MB/ 050 Vuosikertomus 2000
Annex 4:
sivu 66/ 85
•
NEDERLAND
· Jean-Michel ALEXANDRE (France), Chairman
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel.
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
(31- 70) 356 74 50 Fax (31- 70) 356 75 15 E- mail: aw. broekmans@ cbg. meb. nl Internet: http: // www. cbg- meb. nl
· 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)
(31- 31) 747 54 91 Fax (31- 31) 742 31 93 E- mail: brd@ brd. agro. nl
1 2 3 4 5 6 7 8
ÖSTERREICH
The country of the nominating Member State is given for information purposes only.
Günter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Soziale, Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Tel.
Replaced Gorm JENSEN as of the January 2000 meeting.
(43- 1) 711 00 47 17 Fax (43- 1) 713 86 14 E- Mail: gunter. liebeswar@ bmsg. gv. at
Replaced Mary TEELING as Vice-chairman as of the September 2000 meeting.
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für Soziales, Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Tel.
Replaced Eva ALHAVA as of the March 2000 meeting.
(43- 1) 711 00 46 73 Fax (43- 1) 714 92 22 E- Mail: alexander. jentzsch@ bmsg. gv. at
Replaced David JEFFERYS as of the March 2000 meeting.
Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P – 1749- 004 Lisboa Tel.
Replaced Mary TEELING as of the September 2000 meeting.
(351) 217 98 71 16 Fax (351) 217 98 71 20/ 24 E- mail: miguel. andrade@ infarmed. pt Internet: http: // www. infarmed. pt
66 EMEA General Report 2000
(351) 213 23 95 66 Fax (351) 213 46 35 18 E- mail: rleitao@ dgv. min- agricultura. pt
Annex 5:
SUOMI/ FINLAND
Members of the Committee for Veterinary Medicinal Products1
Hannes WAHLROOS Ylijohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P. O.
•
SVERIGE
Reinhard KROKER (Deutschland), Chairman
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
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
EMEA/ MB/ 050 Vuosikertomus 2000 UNITED KINGDOM Keith JONES
Margarita ARBOIX (España) J.
Michael RUTTER
1 2 3 4
sivu 67/ 85
The country of the nominating Member State is given for information purposes only.
Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ United Kingdom Tel.
Replaced Annika WENNBERG as of the October 2000 meeting.
(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
Replaced Carlos SINOGAS as of the July 2000 meeting.
Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
Replaced Christos HIMONAS as of the April 2000 meeting.
(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
67 EMEA General Report 2000
Tarkkailijat:
Annex 6:
ÍSLAND
Members of the Committee for Orphan Medicinal Products
(354) 520 21 00 Fax (354) 561 21 70 E- mail: rannveig. gunnarsdottir@ lyfjanefnd. is Internet: http: // www. lyfjanefnd. is
Chairman (España)
LIECHTENSTEIN
Josep TORRENT i FARNELL
(423) 236 73 25 Fax (423) 236 73 10 E- mail: brigitte. batliner@ alk. llv. li
Members
NORGE/ NOREG
Belgique/België Danmark Deutschland Eλλ δα/Greece France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/Finland Sverige United Kingdom Patient organisation
(47- 22) 89 77 00 Fax (47- 22) 89 77 99 E- mail: gro. wesenberg@ slk. no Internet: http: // www. slk. no
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
EMEA/ MB/ 050 Vuosikertomus 2000 Liite 8 CPMP: n lausunnot ihmisille tarkoitetuista lääkkeistä vuonna 2000
representatives
68/ 85
Moisés ABASCAL ALONSO 5 Yann LE CAM, 5 Vice-chairman Alastair KENT 6
Tuote Yhtiö Hoitoalue Esittely
EMEA representatives
EMEA/ CPMP
Jean-Michel ALEXANDRE 7 Gianmartino BENZI Mary TEELING 8
Komissio
Observers
- Kauppanimi - INN
Ísland Norge/Noreg
Nimi Alkuperä
Sigurdur THORSTEINSSON Randi NORDAL
- Kohdelaji - Indikaatio
1 2 3 4 5 6 7 8
Muoto Annostus
Replaced Tilman OTT as of the September 2000 meeting.
- Validointi - Lausunto
Replaced Alexander NICHOLSON as of the June 2000 meeting.
- Lausunto saatu - Päätöksen päivämäärä
Representing the European Association for Orphan Diseases (Eurodis).
-
Resigned as of the December 2000 meeting.
Pakkaustapojen määrä
Resigned as of the September 2000 meeting.
- Aktiivinen aika
68 EMEA General Report 2000
- Ilmoituspäivämäärä
National competent authority partners
- Kellon pysäytys
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
- EYVL
BELGIQUE/BELGÏE 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 Bisschoffsheim / Bisschoffsheimlaan, 33 B – 1000 Bruxelles / Brussel Tel.
- Orgalutran - ganirelix
DANMARK Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundsvej 378 DK – 2700 Brønshøj Tel.
-
DEUTSCHLAND Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D – 53113 Bonn Tel.
Organon
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r.kroker@bgvv.de
- H01CC01 - Prevention of
Johannes LÖW ER Kommissarische Leiter Paul-Ehrlich Institut Paul-Ehrlich Straße 51-59 D – 63225 Langen Tel.
- -
Internet: http://www.bgvv.de
Solution for injection 0. 5 mg/ ml
69 EMEA General Report 2000
- 29. 01. 1999 - 19. 01. 2000
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
- 22. 02. 2000 - 17. 05. 2000
ESPAÑA María Victoria de la CUESTA GARCIA Directora Agencia Española del Medicamento Ministerio de Sanidad y Consumo C/Huertas 75 E – 28014 Madrid Tel.
- B
FRANCE
-
Philippe DUNETON Directeur-Général Agence Française de Sécurité Sanitaire des Produits de Santé 143-147, blvd Anatole France F - 93200 Saint-Denis CEDEX Tel.
NL
(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
premature luteinising hormone surges in conteolled ovarian hyperstimulation
IRELAND
-
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Tel.
2 presentations
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
3
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@daff.irlgov.ie
- Pegintron - peginterferon
ITALIA
SP Europe
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e la farmacovigilanza Ministero della Sanità Viale Civilità Romana 7 I -00144 Roma Tel.
-
(39-6) 59 94 39 45 Fax (39-6) 59 94 31 90 E-mail: danspv@izs.it
Powder and solvent for solution for injection
70 EMEA General Report 2000
- 26. 03. 1999 - 17. 02. 2000
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
- 27. 03. 2000 - 25. 05. 2000
NEDERLAND André BROEKMANS Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
alfa- 2b - A
Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen Postbus 289 6700 AG Wageningen Nederland Tel.
-
ÖSTERREICH Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Soziale, Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
US
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
chronic hepatitis C
PORTUGAL Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
- -
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
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
71 EMEA General Report 2000
3
Box 55 FIN - 00301 Helsinki Tel.
- Viraferon PEG
(358-9) 47 33 42 00 Fax (358-9) 47 33 43 45 E-mail: hannes.wahlroos@nam.fi Internet: http://www.nam.fi
-
SVERIGE Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8, Box 26 S - 751 03 Uppsala Tel.
SP Europe
UNITED KINGDOM
- L03AB10 - Treatment of
Keith JONES Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ United Kingdom Tel.
-
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
Powder and solvent for solution for injection
Observers:
- 03. 01. 2000 - 17. 02. 2000
ÍSLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS - 170 Seltjarnarnes Tel.
- 27. 03. 2000 - 25. 05. 2000
NORGE/NOREG Gro Ramsten WESENBERG Director-General Statens legemiddelkontroll Sven Oftedals vei 6 N - 0950 Oslo Tel.
- peginterferon 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
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
72 EMEA General Report 2000
- 43 days - 0 days
CPMP opinions in 2000 on medicinal products for human use
3
Product - Brandname - INN - Part A/B
- Lantus - insulin glargine - A
Company - Name - Origin
Aventis Pharma Deutschl and GmbH
Therapeutic area - ATC - Indication
- A10AE - Diabetes mellitus
Presentation - Form - Dosage - Number of presentations
Solution for injection 100 IU/ ml 7 presentations
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- 23. 04. 1999 - 17. 02. 2000 - 215 days - 83 days
Commission - Opinion received - Date of Decision - Notification - Official Journal
3
- Orgalutran
- D -
- N.V.
Optisulin
Organon - H01CC01
- Aventis - A10AE - Solution for injection - 24. 09. 1
- Orgalutran - N.V.
- Optisulin - Aventis -
Organon - H01CC01 - Solution for injection -
A10AE - Solution for injection
- Orgalutran - N.V.
- Optisulin - Aventis - A10AE -
Organon - H01CC01 - Solution for injection - 29.01.1999 -
- Optisulin - Aventis - A10AE - Solution for injection -
22.02.2000
- Optisulin - Aventis - A10AE - Solution for injection - 24. 09. 1999 -
- ganirelix
23. 03. 2000
- NL
-
- Prevention of
insulin
- ganirelix - NL - Prevention of - 0.5 mg/ml -
Pharma - Diabetes mellitus - 100 IU/ ml - 17. 02
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.01.2000 -
- insulin Pharma -
17.05.2000
Diabetes mellitus - 100 IU/ ml
premature luteinising
- insulin Pharma - Diabetes mellitus -
-B premature luteinising - 2 presentations -
- insulin Pharma - Diabetes mellitus - 100 IU/ ml -
-B premature luteinising - 2 presentations - 162 days -
- insulin Pharma - Diabetes mellitus - 100 IU/ ml - 17. 02. 2000 -
22.05.2000
27. 06. 2000
189 days -
glargine A
3
Deutschl and GmbH
- SP Europe - US
7 presentations - -
- -
116 days - 28 days -
L03AB10 Treatment of chronic hepatitis C
4
- -
- D -
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
Nyracta - - A10BG02 - Film coated tablet - 18. 12. 1998 - 17. 04.
- 26.03.1999 - 17.02.2000 - 189 days
- Nyracta - -
- 27.03.2000 - 25.05.2000 - 05.06.2000
A10BG02 - Film coated tablet
-A
- Nyracta - - A10BG02 -
-
- Nyracta - - A10BG02 - Film coated tablet -
100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
- Nyracta - - A10BG02 - Film coated tablet - 18. 12. 1998 -
- 139 days
17. 04. 2000
3
rosiglitazone
- Viraferon PEG - peginterferon alfa -2b -A
SmithKli - Combination - 1 mg, 2 mg, 4 mg, 8 mg - 21. 10
- SP Europe - US
- rosiglitazone SmithKli -
L03AB10 Treatment of chronic hepatitis C
Combination - 1 mg, 2 mg, 4 mg, 8 mg
- - -
- rosiglitazone SmithKli - Combination -
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
- rosiglitazone SmithKli - Combination - 1 mg, 2 mg, 4 mg, 8 mg -
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
- rosiglitazone SmithKli - Combination - 1 mg, 2 mg, 4 mg, 8 mg - 21. 10. 1999 -
- - - -
11. 07. 2000
Lantus insulin glargine
B
-
ne
Aventis Pharma Deutschland
treatment of Type - 12 presentations
- A10AE - Diabetes mellitus
- B ne treatment of Type -
- Solution for injection - 100 IU/ml - 7 presentations
- B ne treatment of Type - 12 presentations -
- 23.04.1999 - 17.02.2000 - 215 days
- B ne treatment of Type - 12 presentations - 186 days -
- 23.03.2000 - 06.06.2000 - 14.06.2000
Beecham Pharmac euticals
-A
II diabetes mellitus
GmbH
-
- 8 3 days
119 days -
- OJ C 183,
2
-D
-
3
UK
Optisulin insulin glargine
Avandia rosiglitazone B
Aventis Pharma Deutschland
- SmithKli - ne Beecham Phramac euticals
- A10AE - Diabetes mellitus
- - -
- Solution for injection - 100 IU/ml - 7 presentations
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
- 24.09.1999 - 17.02.2000 - 116 days
- - - -
- 23.03.2000 - 27.06.2000 - 28.06.2000
18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days -
-A
-
GmbH
UK
- 28 days
- - -
- OJ C 216,
Venvia rosiglitazone B
28.07.2000, p.
- SmithKli - ne Beecham Pharmac euticals
4
- - -
- Nyracta - rosiglitazone -B
18. 12. 1998 - 21. 10. 1999 - 186 days - 119 days -
SmithKline Beecham Pharmaceuticals UK
Myocet doxorubicin B
A10BG02 Combination treatment of Type II diabetes mellitus
The - Liposom - e Compan y US
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
L01DB Treatment of metastatic breast cancer
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
Powder and pre - admixtures for concentrate for, liposomal dispersion for infusion 50 mg 1 presentation
17.04.2000 11.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
17. 05. 2000 13. 07. 2000 26. 07. 2000 OJ C 244, 25. 08. 2000, p.
SmithKline Beecham Pharmaceuticals UK
Datscan ioflupane B
A10BG02 Combination treatment of Type II diabetes mellitus
V09AB03 Diagnosis of Parkinson disease
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- - -
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
Solution for injection 74 MBq/ ml 1 presentation
17.04.2000 11.07.2000 28.06.2000 OJ C 216, 28.07.2000, p.
05. 05. 2000 27. 07. 2000 02. 08. 2000 OJ C 244, 25. 08. 2000, p.
4
10
- Venvia - rosiglitazone -B
Tuote - Kauppanimi - INN
- -
Yhtiö - Nimi - Alkuperä
SmithKline Beecham Pharmaceuticals UK
Hoitoalue - Kohdelaji - Indikaatio
- -
Esittely - Muoto - Annostus
A10BG02 Combination treatment of Type II diabetes mellitusus
EMEA/ CPMP - Validointi - Lausunto
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
Komissio - Lausunto saatu - Päätöksen päivämäärä
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
- Pakkaustapojen määrä
- - - -
- Aktiivinen aika
17.04.2000 11.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
- Ilmoituspäivämäärä
2
- UK
- Myocet - doxorubicin -B
- Kellon pysäytys
- -
- EYVL
The Liposome Company US
- Visudyne - verteporfin - B
- -
- Ciba Vision - CH
L01DB Treatment of metastatic breast cancer
- L01XX - Treatment of age - related macular degeneration
- Powder and pre-admixtures for concentrate for, liposomal dispersion for infusion - 50 mg - 1 presentation
- Powder for solution for infusion - 15 mg - 1 presentation
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
- 27. 08. 1999 - 12. 04. 2000 - 138 days - 63 days
- - - -
- Novo Nordisk - DK
2
- Suspension for injection - 100 IU/ ml - 8 presentations
- Datscan - ioflupane -B
- 24. 09. 1999 - 12. 04. 2000 - 144 days - 55 days
Nycomed Amersham UK
- Kogenate Bayer - octocog alfa - A
- -
- Bayer AG - D
V09AB03 Diagnosis of Parkinson disease
- B02BD02 - Treatment and prophylaxis of bleeding in haemophilia A
- Solution for injection - 74 MBq/ml - 1 presentation
- Powder and solvent for solution for injection - 250 IU, 500 IU, 1000 IU - 3 presentations
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
- 26. 02. 1999 - 16. 03. 2000 - 182 days - 201 days
05.05.2000 27.07.2000 02.08.2000 OJ C 244, 25.08.2000, p.
- 05. 06. 2000 - 04. 08. 2000 - 07. 08. 2000 - OJ C 244, 25. 08. 2000, p.
Product - Brandname - INN - Part A/B
- Helixate NexGen - octocog alfa - A
Company - Name - Origin
- Bayer AG - D
Therapeutic area - ATC - Indication
- B02BD02 - Treatment and prophylaxis of bleeding in haemophilia A
Presentation - Form - Dosage - Number of presentations
- Powder and solvent for solution for infusion - 250 IU, 500 IU, 1000 IU - 3 presentations
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- 26. 02. 1999 - 16. 03. 2000 - 182 days - 201 days
Commission - Opinion received - Date of Decision - Notification - Official Journal
10
- Visudyne - verteporfin -B
- Hepacare - triple antigen hepatitis B vaccine - A
- Ciba Vision - CH
- Medeva Pharma Ltd - UK
L01XX Treatment of age - related macular degeneration
- J07BC - Immunisation against hepatitis B virus in adults
Powder for solution for infusion 15 mg 1 presentation
- Suspension for injection - Monodose preparation of 1 ml contains Hepatitis B surface antigen S, pre- S1 and pre S2 20 µg - 2 presentations
- 27.08.1999 - 12.04.2000 - 138 days - 63 days
- 23. 10. 1998 - 16. 03. 2000 - 210 days - 293 days
15.05.2000 27.07.2000 31.07.2000 OJ C 244, 25.08.2000, p.
- 16. 05. 2000 - 04. 08. 2000 - 07. 08. 2000 - OJ C 244, 25. 08. 2000, p.
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
- Herceptin - trastuzumab - A
- A10AD - Diabetes mellitus
- Roche Registrat ion Ltd - CH
- Suspension for injection - 100 IU/ml - 8 presentations
- Powder for concentrate for solution for infusion - 150 mg - 1 presentation
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
- 26. 02. 1999 - 25. 05. 2000 - 147 days - 305 days
- - - -
- UCB S. A. - US
17.05.2000 01.08.2000 01.08.2000 OJ C 244, 25.08.2000, p.
- 31. 07. 2000 - 29. 09. 2000 - 11. 10. 2000 - OJ C 308, 27. 10. 2000, p.
- -
- Panretin - alitretinoin - B
Kogenate Bayer octocog alfa
- Ligand Pharmac euticals Ltd - US
- Bayer AG -D
- Gel - 0. 1% w/ w - 1 presentation
- -
2
B02BD02 Treatment and prophylaxis of bleeding
- Glustin - pioglitazone - B
- -
- Takeda Europe - JP
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU
- A10BG03 - Combination treatment of Type II Diabetes mellitus
- 26.02.1999 - 16.0 3.2000 - 182 days
- Tablet - 15 mg, 30 mg - 6 presentations
- 05.06.2000 - 04.08.2000 - 07.08.2000
- 23. 04. 1999 - 29. 06. 2000 - 178 days - 251 days
-A
2
in haemophilia A
- Takeda Europe - JP
- 3 presentations
- Tablet - 15 mg, 30 mg - 6 presentations
- 201 days
- 23. 04. 1999 - 29. 06. 2000 - 178 days - 251 days
10
- Agenerase - amprenavir - B
- -
- Glaxo Group - UK
Helixate NexGen octocog alfa
EMEA/ MB/ 050 Vuosikertomus 2000
- Bayer AG -D
sivu 70/ 85
B02BD02 Treatment and prophylaxis of bleeding
Infanrix hexa - - JO7CA - Powder and suspension for - 30. 07. 1999 - 09. 08.
- -
- Infanrix hexa - -
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
JO7CA - Powder and suspension for
- 26.02.1999 - 16.0 3.2000 - 182 days
- Infanrix hexa - - JO7CA -
- 05.06.2000 - 04.08.2000 - 07.08.2000
- Infanrix hexa - - JO7CA - Powder and suspension for -
in haemophilia A
Hep B- IPV
- 3 presentations
- Hep B- IPV SmithKli -
- 201 days
HIB vacci
10
Diphtheria toxoid, - 201 days - 26. 10
- -
- Diphtheria toxoid, -
Hepacare triple antigen hepatitis B vaccine
- Diphtheria toxoid, - 201 days -
- -
26. 10. 2000
Medeva Pharma Ltd UK
adsorbed ≥ 30IU -
- -
A
J07BC Immunisation against hepatitis B virus in adults
Beecham
- -
Haemophilus
Suspension for injection Monodose preparation of 1 ml contains Hepatitis B surface antigen S, pre -S1 and
- A Beecham Haemophilus -
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
- A Beecham Haemophilus - 132 days -
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244,
OJ C 337,
-A
influenza, Diphtheria,
-
40IU
pre S2 20 µg 2 presentations
2
10
- B
- Herceptin - trastuzumab -A
Pertussis, Tetanus, HepB and Poliomyelitis
Roche Registration Ltd CH
16 presentations
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
- SmithKli
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
JO7CA Primary and
03.07.2000 28.08.2000 04.09.2000 OJ C 277, 29.09.2000, p.
Suspension for injection Diphtheria toxoid, adsorbed ≥ 30IU
14
- -