qanastek/EMEA-V3 huggingface dataset:
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
André LHOIR Jan RENNEBERG Rembert ELBERS1 George STRATHOPOULOS2 François MEYER Brendan BUCKLEY Domenica TARUSCIO Henri METZ3 Harrie SEEVERENS Hans Georg EICHLER José Manuel Gião TOSCANO RICO Kalle HOPPU Kerstin WESTERMARK Rashmi SHAH4
representatives
Vertegenwoordigers patiënten- organisaties
Moisés ABASCAL ALONSO 5 Yann LE CAM, 5 Vice-chairman Alastair KENT 6
Moisés ABASCAL ALONSO5 Yann LE CAM,5 vice-voorzitter Alastair KENT6
EMEA representatives
EMEA-vertegenwoordigers
Jean-Michel ALEXANDRE 7 Gianmartino BENZI Mary TEELING 8
Jean-Michel ALEXANDRE7 Gianmartino BENZI Mary TEELING8
Ísland Norge/Noreg
Ísland Norge/ Noreg
Replaced Tilman OTT as of the September 2000 meeting.
1 Heeft met ingang van september 2000 Tilman OTT vervangen.
Replaced Thrassyvoulos KEPHALAS as of the October 2000 meeting.
2 Heeft met ingang van oktober 2000 Thrassyvoulos KEPHALAS vervangen.
Replaced Mariette BACKES LIES as of the November 2000 meeting.
3 Heeft met ingang van november 2000 Mariette BACKES LIES vervangen.
Replaced Alexander NICHOLSON as of the June 2000 meeting.
4 Heeft met ingang van juni 2000 Alexander NICHOLSON vervangen.
Representing the European Association for Orphan Diseases (Eurodis).
5 Als vertegenwoordiger van European Association for Orphan Diseases (Eurodis).
Representing the European Alliance of Genetic Support Groups (EAGS).
6 Als vertegenwoordiger van European Alliance of Genetic Support Groups (EAGS).
Resigned as of the December 2000 meeting.
7 Is met ingang van de vergadering van december 2000 afgetreden.
Resigned as of the September 2000 meeting.
8 Is met ingang van de vergadering van september 2000 afgetreden.
68 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Jaarverslag 2000 Bijlage 7 Nationale bevoegde instanties
Annex 7:
Pagina 67/ 88
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
Verdere informatie over de bevoegde nationale instanties is te verkrijgen op de Internet-sites van de nationale autoriteiten http: / /heads. medagencies. org en http: / /www. hevra. org
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.
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 Tél/ Tel.
(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
(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
DANMARK Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundsvej 378 DK – 2700 Brønshøj Tel.
Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundsvej 378 DK – 2700 Brønshøj Tlf.
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-mail: jyl@dkma.dk Internet: http://www.dkma.dk
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-post: jyl@dkma. dk Internet: http: / /www. dkma. dk
DEUTSCHLAND Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D – 53113 Bonn Tel.
Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D – 53113 Bonn Tel.
(49-22) 82 07 32 03 Fax (49-30) 87 07 55 14 E-mail: schweim@bfarm.de Internet: http://www.bfarm.de
(49-22) 82 07 32 03 Fax (49-30) 87 07 55 14 E-Mail: schweim@bfarm. de Internet: http: / /www. bfarm. de
Reinhard KROKER Leiter des Fachbereiches ‘Tierarzneimittelzulassung und -rückstandskontrolle, Futterzusatzstoffe’ BgVV Diedersdorfer Weg, 1 D – 12277 Berlin Tel.
Reinhard KROKER Leiter des Fachbereiches 'Tierarzneimittelzulassung und -rückstandskontrolle, Futterzusatzstoffe 'BgVV Diedersdorfer Weg, 1 D – 12277 Berlin Tel.
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r.kroker@bgvv.de
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r. kroker@bgvv. de Internet: http: / /www. bgvv. de
Johannes LÖW ER Kommissarische Leiter Paul-Ehrlich Institut Paul-Ehrlich Straße 51-59 D – 63225 Langen Tel.
Johannes LÖWER Kommissarische Leiter Paul-Ehrlich Institut Paul-Ehrlich Straße 51-59 D – 63225 Langen Tel.
(49-6103) 77 20 01 Fax (49-6103) 77 12 52 E-mail: loejo@pei.de Internet: http://www.pei.de
(49-6103) 77 20 01 Fax (49-6103) 77 12 52 E-mail: loejo@pei. de Internet: http: / /www. pei. de
Internet: http://www.bgvv.de
αδάλλΕ
69 EMEA General Report 2000
/GREECE
Eλλ δα/GREECE Marios MARSELOS President National Organization for Medicines Mesogion 284 GR – 155 62 Holargos Athens Tel.
Marios MARSELOS President National Organization for Medicines Mesogion 284 GR – 155 62 Holargos Athens Tel.
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
ESPAÑA María Victoria de la CUESTA GARCIA Directora Agencia Española del Medicamento Ministerio de Sanidad y Consumo C/Huertas 75 E – 28014 Madrid Tel.
María Victoria de la CUESTA GARCIA Directora Agencia Española del Medicamento Ministerio de Sanidad y Consumo C/Huertas 75 E – 28014 Madrid Tel.
(34-91) 596 16 27 Fax (34-91) 596 16 15 E-mail: sdaem@agamed.es Internet: http://www.agamed.es
(34-91) 596 16 27 Fax (34-91) 596 16 15 E-mail: sdaem@agamed.es Internet: http://www.agamed.es
Philippe DUNETON Directeur-Général Agence Française de Sécurité Sanitaire des Produits de Santé 143-147, blvd Anatole France F - 93200 Saint-Denis CEDEX Tel.
Philippe DUNETON Directeur-Général Agence française de sécurité sanitaire des produits de santé 143-147, blvd Anatole France F – 93200 Saint-Denis CEDEX Tél.
(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
(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
Martin HIRSCH Directeur-Général Agence Française de Sécurité Sanitaire des aliments 23, avenue du Général de Gaulle B.P.
Martin HIRSCH Directeur-Général Agence Française de Sécurité Sanitaire des aliments 23, avenue du Général de Gaulle B.P.
(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
(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
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Tel.
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Tel.
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Tel.
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Ireland Tel.
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@daff.irlgov.ie
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@daff.irlgov.ie
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e la farmacovigilanza Ministero della Sanità Viale Civilità Romana 7 I -00144 Roma Tel.
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 36 66 Fax (39-6) 59 94 34 56 E-mail: farmaci.sanita@interbusiness.it Internet: http://www.sanita.it/farmaci
(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
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.
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.
(39-6) 59 94 39 45 Fax (39-6) 59 94 31 90 E-mail: danspv@izs.it
(39-6) 59 94 39 45 Fax (39-6) 59 94 31 90 E-mail: danspv@izs.it
70 EMEA General Report 2000
LUXEMBOURG
LUXEMBOURG 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 Tel.
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.
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
NEDERLAND André BROEKMANS Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
André BROEKMANS Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V.W.S.
(31-70) 356 74 50 Fax (31-70) 356 75 15 E-mail: aw.broekmans@cbg.meb.nl Internet: http://www.cbg-meb.nl
(31-70) 356 74 50 Fax (31-70) 356 75 15 E-mail: aw.broekmans@cbg.meb.nl Internet: http://www.cbg-meb.nl
(31-31) 747 54 91 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl
(31-31) 747 54 91 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl
ÖSTERREICH Gunter LIEBESWAR Sektionschef Gesundheitswesen 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 Tel.
(43-1) 711 00 47 17 Fax (43-1) 713 86 14 E-mail: gunter.liebeswar@bmsg.gv.at
(43-1) 711 00 47 17 Fax (43-1) 713 86 14 E-Mail: gunter.liebeswar@bmsg.gv.at
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für Soziales, Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für Soziales, 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
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
PORTUGAL Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P – 1749-004 Lisboa Tel.
(351) 217 98 71 16 Fax (351) 217 98 71 20/24 E-mail: miguel.andrade@infarmed.pt Internet: http://www.infarmed.pt
(351) 217 98 71 16 Fax (351) 217 98 71 20/24 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 Tel.
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
71 EMEA General Report 2000
SUOMI/FINLAND
SUOMI/FINLAND Hannes WAHLROOS Ylijohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P.O.
Hannes WAHLROOS Ylijohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P.O.
Box 55 FIN - 00301 Helsinki Tel.
Box 55 FIN – 00301 Helsinki Puh.
(358-9) 47 33 42 00 Fax (358-9) 47 33 43 45 E-mail: hannes.wahlroos@nam.fi Internet: http://www.nam.fi
(358-9) 47 33 42 00 Fax (358-9) 47 33 43 45 Sähköposti: hannes.wahlroos@nam.fi Internet: http://www.nam.fi
SVERIGE 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-mail: 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
UNITED KINGDOM
EMEA/MB/050/00 Jaarverslag 2000 UNITED KINGDOM Keith JONES
Keith JONES Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ United Kingdom Tel.
Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ United Kingdom Tel.
(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
(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
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
(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
(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
Observers:
Waarnemers:
ÍSLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS - 170 Seltjarnarnes Tel.
Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS – 170 Seltjarnarnes Tel.
(354) 520 21 00 Fax (354) 561 21 70 E-mail: rannveig.gunnarsdottir@ lyfjanefnd.is Internet: http://www.lyfjanefnd.is
(354) 520 21 00 Fax (354) 561 21 70 E-mail: rannveig.gunnarsdottir@lyfjanefnd.is Internet: http://www.lyfjanefnd.is
NORGE/NOREG Gro Ramsten WESENBERG Director-General Statens legemiddelkontroll Sven Oftedals vei 6 N - 0950 Oslo Tel.
LIECHTENSTEIN
LIECHTENSTEIN Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 FL – 9494 Schaan Tel.
Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 FL – 9494 Schaan Tel.
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alk.llv.li
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alk.llv.li
72 EMEA General Report 2000
NORGE/NOREG
CPMP opinions in 2000 on medicinal products for human use
EMEA/MB/050/00 Jaarverslag 2000 Bijlage 8 CPMP-adviezen over geneesmiddelen voor menselijk gebruik, 2000
Product - Brandname - INN - Part A/B
Product - Merknaam
Company - Name - Origin
Firma - Naam
Therapeutic area - ATC - Indication
Toepassingsgebied - ATC
Presentation - Form - Dosage - Number of presentations
Presentatie - Vorm
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
EMEA/CPMP - Validatie
Commission - Opinion received - Date of Decision - Notification - Official Journal
Commissie - Advies ontvangen op
- Orgalutran
- INN - Doel A/B
- N.V.
- Land
Organon - H01CC01
- Indicatie
- Orgalutran - N.V.
- Dosering - Aantal verpakkingsvormen
Organon - H01CC01 - Solution for injection -
- Advies - Behandelings- tijd - Klokstop
Organon - H01CC01 - Solution for injection - 29.01.1999 -
- Datum besluit - Datum kennisgeving - Publicatieblad
- ganirelix
- Orgalutran - ganirelix - B
- NL
- N.V.
- ganirelix - NL - Prevention of - 0.5 mg/ml -
Organon - NL
premature luteinising
- H01CC01 - Prevention of premature luteinising hormone surges in conteolled ovarian hyperstimulation
-B premature luteinising - 2 presentations -
- Solution for injection - 0.5 mg/ml - 2 presentations
-B premature luteinising - 2 presentations - 162 days -
- 29.01.1999 - 19.01.2000 - 162 days - 189 days
OJ C 183, 30.06.2000, p.
- 22.02.2000 - 17.05.2000 - 22.05.2000 - OJ C 18 3, 30.06.2000, p.
Pegintron peginterferon alfa -2b
- Pegintron - peginterferon alfa-2b - A
- SP Europe - US
- SP Europe - US
L03AB10 Treatment of chronic hepatitis C
- L03AB10 - Treatment of chronic hepatitis C
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
- 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
- 26.03.1999 - 17.02.2000 - 189 days
- 26.03.1999 - 17.02.2000 - 189 days - 139 days
OJ C 183, 30.06.2000, p.
- 27.0 3.2000 - 25.05.2000 - 05.06.2000 - OJ C 183, 30.06.2000, p.
- Viraferon PEG - peginterferon alfa -2b -A
- Viraferon PEG - peginterferon alfa-2b - A
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
- 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
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
27.03.2000 25.05.2000 05.06.2000 OJ C 183, 30.06.2000, p.
- 27.0 3.2000 - 25.05.2000 - 05.06.2000 - OJ C 183, 30.06.2000, p.
Lantus insulin glargine
- Lantus - insulin glargine - A
Aventis Pharma Deutschland
- Aventis Pharma Deutschl and GmbH - D
- A10AE - Diabetes mellitus
- A10AE - Diabetes mellitus
- Solution for injection - 100 IU/ml - 7 presentations
- Solution for injection - 100 IU/ml - 7 presentations
- 23.04.1999 - 17.02.2000 - 215 days
- 23.04.1999 - 17.02.2000 - 215 days - 83 days
- 23.03.2000 - 06.06.2000 - 14.06.2000
- 2 3.03.2000 - 06.06.2000 - 14.06.2000 - OJ C 183, 30.06.2000, p.
Optisulin insulin glargine
- Optisulin - insulin glargine - A
- 24.09.1999 - 17.02.2000 - 116 days
- 24.09.1999 - 17.02.2000 - 116 days - 28 days
- 23.03.2000 - 27.06.2000 - 28.06.2000
- 23.03.2000 - 27.06.2000 - 28.06.2000 - OJ C 216, 28.07.2000, p.
- Nyracta - rosiglitazone -B
- Nyracta - rosiglitazone - B
SmithKline Beecham Pharmaceuticals UK
- SmithKli ne Beecham Pharmac euticals - UK
A10BG02 Combination treatment of Type II diabetes mellitus
- A10BG02 - Combination treatment of Type II diabetes mellitus
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
17.04.2000 11.07.2000 26.07.2000 OJ C 244, 25.08.2000, p.
- 17.04. 2000 - 11.07.2000 - 26.07.2000 - OJ C 244, 25.08.2000, p.
- Avandia - rosiglitazone -B
- Avandia - rosiglitazone - B
SmithKline Beecham Pharmaceuticals UK
- SmithKli ne Beecham Phramac euticals - UK
17.04.2000 11.07.2000 28.06.2000 OJ C 216, 28.07.2000, p.
- 17.0 4.2000 - 11.07.2000 - 28.06.2000 - OJ C 216, 28.07.2000, p.
- Venvia - rosiglitazone -B
- Venvia - rosiglitazone - B
A10BG02 Combination treatment of Type II diabetes mellitusus
- A10BG02 - Combination treatment of Type II diabetes mellitusus
- Myocet - doxorubicin -B
- Myocet - doxorubicin - B
The Liposome Company US
- The Liposom e Compan y - US
L01DB Treatment of metastatic breast cancer
- L01DB - Treatment of metastatic breast cancer
- Powder and pre-admixtures for concentrate for, liposomal dispersion for infusion - 50 mg - 1 presentation
- Powder and pre- admixtures for concentrate for, liposomal dispersion for infusion - 50 mg - 1 presentation
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
17.05.2000 13.07.2000 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.
- Datscan - ioflupane -B
- Datscan - ioflupane - B EMEA/MB/050/00
Nycomed Amersham UK
- Nycome d Amersha m - UK
V09AB03 Diagnosis of Parkinson disease
- V09AB03 - Diagnosis of Parkinson disease
- Solution for injection - 74 MBq/ml - 1 presentation
- Solution for injection - 74 MBq/ml - 1 presentation
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
05.05.2000 27.07.2000 02.08.2000 OJ C 244, 25.08.2000, p.
- 05.05.2000 - 27.07.2000 - 02.08.2000 - OJ C 244, 25.08.2000, p.
73 EMEA General Report 2000
Jaarverslag 2000
Company - Name - Origin
Pagina 72/88
- Visudyne - verteporfin -B
- Visudyne - verteporfin - B
- Ciba Vision - CH
- Ciba Vision - CH
L01XX Treatment of age - related macular degeneration
- L01XX - Treatment of age- related macular degeneration
Powder for solution for infusion 15 mg 1 presentation
- Powder for solution for infusion - 15 mg - 1 presentation
- 27.08.1999 - 12.04.2000 - 138 days - 63 days
- 27.08.1999 - 12.04.2000 - 138 days - 63 days
15.05.2000 27.07.2000 31.07.2000 OJ C 244, 25.08.2000, p.
- 15.05.2000 - 27.07.2000 - 31.07.2000 - OJ C 244, 25.08.2000, p.
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
- NovoMix 30 - insulin aspart - A
- A10AD - Diabetes mellitus
- A10AD - Diabetes mellitus
- Suspension for injection - 100 IU/ml - 8 presentations
- Suspension for injection - 100 IU/ml - 8 presentations
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
17.05.2000 01.08.2000 01.08.2000 OJ C 244, 25.08.2000, p.
- 17.05.2000 - 01.08.2000 - 01.08.2000 - OJ C 244, 25.08.2000, p.
Kogenate Bayer octocog alfa
- 26.02.1999 - 16.03.2000 - 182 days - 201 days
- Bayer AG -D
- Helixate NexGen - octocog alfa - A
B02BD02 Treatment and prophylaxis of bleeding
- B02BD02 - Treatment and prophylaxis of bleeding in haemophilia A
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU
- Powder and solvent for solution for infusion - 250 IU, 500 IU, 1000 IU - 3 presentations
- 26.02.1999 - 16.0 3.2000 - 182 days
- 26.02.1999 - 16.03.2000 - 182 days - 201 days
- 05.06.2000 - 04.08.2000 - 07.08.2000
- 05.06.2000 - 04.08.2000 - 07.08.2000 - OJ C 244, 25.08.2000, p.
in haemophilia A
- Hepacare - triple antigen hepatitis B vaccine - A
- 3 presentations
- Medeva Pharma Ltd - UK
- 201 days
- J07BC - Immunisation against hepatitis B virus in adults
-
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
OJ C 244, 25.08.2000, p.
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244, 25.08.2000, p.
- -
- Herceptin - trastuzumab - A
Helixate NexGen octocog alfa
- Roche Registrat ion Ltd - CH
- Bayer AG -D
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
B02BD02 Treatment and prophylaxis of bleeding
- Keppra - levetiracetam - B
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
- N03A - Adjunctive therapy in the partial onset seizures in epilepsy
- 26.02.1999 - 16.0 3.2000 - 182 days
- Film coated tablet - 250 mg, 500 mg, 750 mg, 1000 mg - 26 presentations
- 05.06.2000 - 04.08.2000 - 07.08.2000
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
-A
12
in haemophilia A
- Panretin - alitretinoin - B
- 3 presentations
- Ligand Pharmac euticals Ltd - US
- 201 days
- Gel - 0.1 %w/w - 1 presentation
-
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
OJ C 244, 25.08.2000, p.
- 31.07. 2000 - 11.10.2000 - 18.10.2000 - OJ C 337, 28.11.2000. p.
Hepacare triple antigen hepatitis B vaccine
- A10BG03 - Combination treatment of Type II Diabetes mellitus
- -
- Tablet - 15 mg, 30 mg - 6 presentations
Medeva Pharma Ltd UK
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
J07BC Immunisation against hepatitis B virus in adults
- Actos - pioglitazone - B
Suspension for injection Monodose preparation of 1 ml contains Hepatitis B surface antigen S, pre -S1 and
- A10BG03 - Combination treatment of Type II Diabetes mellitus
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244,
- 31.07. 2000 - 13.10.2000 - 19.10.2000 - OJ C 337, 28.11/00. p.
- Herceptin - trastuzumab -A
- Glaxo Group - UK
- -
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
Roche Registration Ltd CH
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
EMEA/MB/050/00 Jaarverslag 2000
Powder for concentrate for solution for infusion 150 mg 1 presentation
Infanrix hexa - - JO7CA - Powder and suspension for - 30.07.1999 - 09.08.
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
- Infanrix hexa - -
14
- Infanrix hexa - - JO7CA - Powder and suspension for -
- Keppra - levetiracetam -B
- Infanrix hexa - - JO7CA - Powder and suspension for - 30.07.1999 -
- UCB S.A. - US
09.08.2000
N03A Adjunctive therapy in the partial onset seizures in epilepsy
SmithKli - Immunisation suspension for injection - 29.06
- - -
- Hep B-IPV SmithKli -
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
- Hep B-IPV SmithKli - Immunisation suspension for injection -
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
- Hep B-IPV SmithKli - Immunisation suspension for injection - 29.06.2000 -
- - - -
ne ne
- Panretin - alitretinoin -B
Diphtheria toxoid, - 201 days - 26.10
Ligand Pharmaceuticals Ltd US
- Diphtheria toxoid, - 201 days -
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi's sarcoma
Haemophilus
- Gel - 0.1 %w/w - 1 presentation
- A Beecham Haemophilus adsorbed ≥ 30IU -
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
- A Beecham Haemophilus adsorbed ≥ 30IU - 132 days -
- - - -
OJ C 337,
31.07.2000 11.10.2000 18.10.2000 OJ C 337, 28.11.2000. p.
Tetanus toxoid, adsorbed ≥ 40IU
2
28.11.2000. p.
Takeda Europe JP
Pertussis, Tetanus, HepB and Poliomyelitis
- Tablet - 15 mg, 30 mg - 6 presentations
16 presentations
2
Infanrix penta Hep B -IPV vaccine A
- Agenerase - amprenavir -B
-
- Glaxo Group - UK
SmithKli ne Beecham Biologic als S.A.
J05AE05 Treatment of HIV infected adults and children
JO7CA Primary and booster immunisation of infants against Diphtheria,
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
- -
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
Suspension for injection Diphtheria toxoid, adsorbed ≥ 30IU Tetanus toxoid, adsorbed ≥ 40IU Pertussis toxoid, adsorbed
09.08.2000 20.10.2000 25.10.2000 OJ C 337, 28.11.2000. p.
09.08. 2000 23.10.2000 26.10.2000 OJ C 337, 28.11.2000. p.
74 EMEA General Report 2000
B
Product - Brandname - INN - Part A/B
Tetanus, Pertussis, Hepatitis B and Poliomyelitis
Company - Name - Origin
25 µg Filamentous haemagglutinin, adsorbed 25 µg, Pertactin, adsorbed 8 µ g Recombinant Hepatitis B surface antigen (S protein), adsorbed 10 µg Inactivated type 1 Poliovirus 40 DU Inactivated type 2 Poliovirus 8 DU Inactivated type 3 Poliovirus 32 DU
Therapeutic area - ATC - Indication
-
Presentation - Form - Dosage - Number of presentations
8 presentations
Infanrix hexa Hep B-IPV HIB vaccine
Hexavac Comb vaccine
SmithKline Beecham Biologicals
Pasteur Merieux MSD
JO7CA Immunisation against Haemophilus influenza,
JO7CA Immunisation Diphtheria,
Powder and suspension for suspension for injection Diphtheria toxoid, adsorbed ≥.
Suspension for injection Purified diphtheria toxoid, adsorbed ≥ 20 IU,
30IU
- - -
- 30.07.1999 - 29.06.2000 - 201 days
30.07.1999 - 26.06.2000 - 180 days -
- 09.08.2000 - 23.10.2000 - 26.10.2000
10.08.2000 23.10.2000 26.10.2000
Diphtheria, Pertussis,
F
Tetanus toxoid, adsorbed ≥
pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
- OJ C 337,
153 days -
28.11.2000. p.
OJ C 337, 28.11.2000. p.
16 presentations
Pagina 74/88
Infanrix penta - Hep B-IPV vaccine
Ares - G03G - Powder and solvent for - 25.0
SmithKline Beecham Biologicals
G03G - Powder and solvent
JO7CA Primary and booster immunisation of infants
Stimulation of
- Suspension for injection - Diphtheria toxoid, adsorbed ≥ 30IU
- lutropin alfa Serono - Stimulation of solution for injection -
- 30.07.1999 - 29.06.2000 - 201 days
- A (Europe) follicular - 75 IU -
- 09.08.2000 - 23.10.2000 - 26.10.2000
- A (Europe) follicular - 75 IU - 192 days -
against Diphtheria,
development in women with servere Leng HEng and FSH deficiency
Tetanus toxoid, adsorbed ≥
6 presentations
- 132 days
200 days
- OJ C 337,
3
-B
- - -
Tetanus, Pertussis, Hepatitis B and Poliomyelitis
NeoSpect depreotide B
40IU Pertussis toxoid, adsorbed 25 µg Filamentous haemagglutinin, adsorbed 25 µg, Pertactin, adsorbed 8 µg Recombinant Hepatitis B surface antigen (S protein), adsorbed 10 µg Inactivated type 1 Poliovirus 40 DU Inactivated type 2 Poliovirus 8 DU Inactivated type 3 Poliovirus 32 DU
- -
28.11.2000. p.
- Nycome - d Imaging A/S NO
2
Kit for radiopaharmaceutical preparation 47 µg 2 presentations
8 presentations
20.11.1998 27.07.2000 204 days 404 days
- Hexavac
- - - -
Pasteur
- -
- JO7CA
Glaxo - Group - UK
- Suspension for injection
J05AF30 Treatment of HIV -1 infected patients
- 30.07.1999
- - -
- 10.08.2000
- - - -
- Comb vaccine -A
21.01.2000 29.06.2000 158 days 0 days
Merieux MSD - -F
- - - -
Immunisation Diphtheria, pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
13.10.2000 08.12.2000
Purified diphtheria toxoid, adsorbed ≥ 20 IU, Purified tetanus toxoid, adsorbed ≥ 40 IU Purified pertussis toxoid, adsorbed 25 µg Purified pertussis filamentous haemagglutinin adsorbed 25 µg Recombinant hepatitis B surface antigen 5.0 µg Inactivated poliomyelitis virus: type 1 40 D units type 2 8 D units type 3 32 D units Haemophilus influenzae polysaccharide type b 12 µg conjugated to tetanus toxoid (24 µg)
- -
- 26.06.2000 - 180 days - 153 days
Schwarz - Pharma - AG D
2
Solution for injection 5 mg/ml 2 presentations
8 presentations
21.10.1999 21.09.2000 174 days 186 days
- Luveris - lutropin alfa -A
- - - -
Ares Serono (Europe) Ltd CH
Neurobloc botulinum toxin type B B
- Powder and solvent for solution for injection IU - 6 presentations
Elan - Pharma - Internati onal Ltd UK
3
Solution for injection 5000 IU/ml 3 presentations
75 EMEA General Report 2000
27.08.1999 21.09.2000 187 days 229 days
Therapeutic area - ATC - Indication
Tenecteplase tenecteplase
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
- Boehring -
Commission - Opinion received - Date of Decision - Notification - Official Journal
B01AD Treatment of
- NeoSpect - depreotide
Powder and solvent for solution for injection
Nycomed Imaging A/S
24.09.1999 21.09.2000
V09IA05 Scintigraphic imaging
27.11.2000
Kit for radiopaharmaceutical preparation
er Ingelhei m Internati onal GmbH
- 20.11.1998 - 27.07.2000
suspected myocardial infarction
28.08.2000 29.11.2000
6000 IU, 8000 IU, 10000 IU 3 presentations
-B
- -
NO
-
of suspected malignant tumours in the lung
D
47 µg 2 presentations
Metalyse tenecteplase
- 204 days - 404 days
- Boehring -
04.12.2000 OJ C 2, 05.01.2001, p.
Powder and solvent for solution for injection
- Trizivir - lamivudine zidovudine abacavir -B
24.09.1999 21.09.2000
Glaxo Group UK
27.11.2000
J05AF30 Treatment of HIV -1 infected patients
suspected myocardial infarction
Film coated tablet 150/300/300 mg 3 presentations
6000 IU, 8000 IU, 10000 IU 3 presentations
- 21.01.2000 - 29.06.2000 - 158 days - 0 days
176 days 215 days
13.10.2000 08.12.2000
Azomyr desloratadine
- Nutropin AQ - - somatropin
SP - Europe -
Schwarz Pharma AG
R06AX27 Relief of
- H01AC01 - Treatment of growth
- -
- Solution for injection - 5 mg/ml
Film coated tablet 5 mg
- 21.10.1999 - 21.09.2000
24.09.1999 21.09.2000
- 05.1 2.2000 -
- -
failure
US
- 2 presentations
13 presentations
- 174 days - 186 days
201 days 159 days
Elan Pharma International
Opulis desloratadine
- Solution for injection - 5000 IU/ml
SP - Europe -
- 27.08.1999 - 21.09.2000
R06AX27 Relief of
- 21.11.2000 -
- -
cancer
24.09.1999 21.09.2000
- 187 days
06.11.2000
- 229 days
US
- Tenecteplase - tenecteplase -A
13 presentations
Boehringer Ingelheim International GmbH
201 days 159 days
- 27.11.2000 - - -
Allex desloratadine
- Metalyse - tenecteplase -A
SP - Europe -
Boehringer Ingelheim International GmbH
R06AX27 Relief of
B01AD Treatment of suspected myocardial infarction
Film coated tablet 5 mg
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
24.09.1999 21.09.2000
- Azomyr - desloratadine -B
B
- SP Europe - US
-
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
symptoms associated with seasonal allergic rhinitis
- Opulis - desloratadine -B
Aerius desloratadine
- -
SP - Europe -
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
R06AX27 Relief of
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
24.09.1999 21.09.2000
- Allex - desloratadine -B
06.11.2000
- Aerius - desloratadine -B
- Neoclarityn - desloratadine
- Neoclarityn - desloratadine -B
06.11.2000
- SP Europe - US
- B
- Xeloda - capecitabine -B
- Xeloda - capecitabine - B
- Roche Registration Ltd - CH
Roche - Registrat - ion Ltd CH
-A
- -
Product - Brandname - INN - Part A/B
Prevenar Prevenarpneu mococcal conjugate vaccine A
- Wyeth- Lederle Vaccines S.A. - US
US
- J07AL - Active immunisation of infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
J07AL Active immunisation of infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
- Suspension for injection - A monodose preparation of 0.5 ml contains Streptococcus pneumoniae: saccharide suspension of Serotype 4 2 (gSerotype 9V 2 µg Serotype 14 2 µg Serotype 18C 2 µg Serotype 19F 2 µg Serotype 23F 2 µg Serotype 6B 4 µg Conjugated to CRM197 carrier protein - 20 µg - 2 presentations
Suspension for injection A monodose preparation of 0.5 ml contains Streptococcus pneumoniae: saccharide suspension of Serotype 4 2 µg Serotype 9V 2 µg Serotype 14 2 µg Serotype 18C 2 µg Serotype 19F 2 µg Serotype 23F 2 µg Serotype 6B 4 µg Conjugated to CRM197 carrier protein ∼ 20 µg
- 19.11.1999 - 21.09.2000 - 205 days - 125 days
19.11.1999 21.09.2000 205 days 125 days
- 21.11.2000 - - -
- - - -
- Oral solution - 1 mg/ml - 5 presentations
Oral solution 1 mg/ml 5 presentations
L01XX25 Treatment of skin manifestations of advanced stage of cutaneous T -cell Lymphoma
L01XX25 Treatment of skin manifestations of advanced stage of cutaneous T -cell Lymphoma
solution for infusion 1.5 mg/ml 1 presentation
Powder and solvent for solution for infusion 1.5 mg/ml 1 presentation
Combination treatment - 133.3/33.3 mg, 80/20 mg/ml in combination of HIV- - 3 presentations
133.3/33.3 mg, -
1 infected patients
combination of HIV -1 infected patients
- SonoVue - sulphur hexafluoride -B
SonoVue sulphur hexafluoride B
- Bracco S.P.A. -I - V08DA
I
Ultrasound agent to enhance the echogenicity of the blood
V08DA Ultrasound agent to enhance the echogenicity of the blood
- Powder for injection - 8 µl/ml - 2 presentations
Powder for injection - 8 µl/ml - 2 presentations - -
- 27.08.1999 - 14.12.2000 - 194 days - 276 days
27.08.1999 14.12.2000 194 days 276 days
Osteogenis Protein 1 Howmedia International Osteogenic Protein-1 BMP-7
Osteogenis Protein 1
Stryker - Biotech US
Stryker - Biotech
M09AX Treatment of non-union of tibia of at least 9 month duration
non -union of tibia of at least 9 month duration
77 EMEA General Report 2000
Gecentraliseerde aanvragen
Annex 9:
Firma - Naam
CVMP opinions in 2000 on medicinal products for veterinary use Centralised applications
Toepassingsgebied - Doelgroep- diersoort
Product - Brandname - INN - Part A/B
- INN - Deel A/B
Company - Name - Origin
- Land
Therapeutic area - Target species - Indication
- Indicatie
Presentation - Form - Dosage - Number of presentations
- Dosering - Aantal verpakkingsvormen
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
- Advies - Behandelings- tijd - Klokstop
Commission - Opinion received - Date of Decision - Notification - Official Journal
- Datum besluit - Datum kennisgeving - Publicatieblad
Solution for injection 5 mg/ml 1
Solution for injection 5 mg/ml 1
Solution for injection 5mg/ml 1
Solution for injection 5mg/ml 1
Econor Valnemulin Part B extension
Econor Valnemulin Part B extension EMEA/MB/050/00
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
10%/50% premix various 2
10%/50% premix various 2
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
- 07.04.2000 - 15.09.2000 - 22.09.2000 - OJ C 308, 27.10.2000
Solution for injection 50 mg/ml 3
Solution for injection 50 mg/ml 3
Virbac S.A.
Virbac S.A.
Oral solution 100 mg/ml 3
Oral solution 100 mg/ml 3
Cream 1 mg/g 1
Cream 1 mg/g 1
Sterile solution for intramammary use 5 mg/ml 4
Sterile solution for intramammary use 5 mg/ml 4
Oral lyophilisate 30,50,100 & 200 mg/ml 39
Oral lyophilisate 30,50,100 & 200 mg/ml 39
79 EMEA General Report 2000
EMEA/MB/050/00 Jaarverslag 2000 Vaststelling van veilige maximumwaarden voor
Establishment of maximum residue limits for new substances
residuen voor nieuwe stoffen
Substance - INN
Pagina 79/88
Therapeutic area - Target species
Stof Toepassingsgebied - INN - Doelgroep-diersoort
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
EMEA/CVMP Commissie - Validatie - Aan Commissie gezonden op - Advies - Datum verordening - Behandelings- - Publicatieblad tijd - Klokstop
Bismuth subnitrate (extension)
Bismuth subnitrate Bovine (extension)
- 18.06.1999 - 13.10.1999 - 113 days -0
- 18.06.1999 - 12.11.1999 - 13.10.1999 - 19.06.2000 - 113 days - OJ L 145, 20.06.2000 - 0
Acetyl isovaleryl tylosin tartrate
Acetyl isovaleryl Porcine tylosin tartrate
- 18.10.1995 - 13.10.1999 - 195 days - 1260 days
- 18.10.1995 - 12.11.1999 - 13.10.1999 - 19.06.2000 - 195 days - OJ L 145, 20.06.2000 - 1260 days
Methylprednisolone
Methylprednisolone Bovine
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
- 13.07.1999 - 12.11.1999 - 13.10.1999 - 19.06.2000 - 92 days - OJ L 145, 20.06.2000 - 0
Deltamethrin (extension)
Deltamethrin Fin fish (extension)
- 09.12.1999 - 08.03.2000 - 90 days -0
- 09.12.1999 - 07.04.2000 - 08.03.2000 - 15.09.2000 - 90 days - OJ L 234, 16.09.2000 - 0
Tylosin (extension)
Tylosin Eggs (extension)
- 09.11.1999 - 08.03.2000 - 90 days -0
- 09.11.1999 - 07.04.2000 - 08.03.2000 - 15.09.2000 - 90 days - OJ L 234, 16.09.2000 - 0
Dicyclanil
Dicyclanil Ovine
25.02.1997 - 08.03.2000 - 281 days - 825 days
- 25.02.1997 - 07.04.2000 - 08.03.2000 - 15.09.2000 - 281 days - OJ L 234, 16.09.2000 - 825 days
Tilmicosin (extension)
Tilmicosin Rabbit (extension)
- 12.11.1999 - 20.10.2000 - OJ L 269, 21.10.2000
- 16.07.1999 - 12.11.1999 - 13.10.1999 - 20.10.2000 - 86 days - OJ L 269, 21.10.2000 - 0
Bovine milk & turkey
Flumequine Bovine milk & turkey (extension)
- 09.12.1999 - 20.10.2000 - OJ L 269, 21.10.2000
- 27.07.1999 - 09.12.1999 - 10.11.1999 - 20.10.2000 - 89 days - OJ L 269, 21.10.2000 - 0
Tiamulin (extension)
Tiamulin Rabbit (extension)
- 11.02.2000 - 20.10.2000 - OJ L 269, 21.10.2000
- 14.10.1999 - 11.02.2000 - 12.01.2000 - 20.10.2000 - 90 days - OJ L 269, 21.10.2000 - 0
Dicyclanil (modification)
Dicyclanil Sheep fat (modification)
- 16.06.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 23.02.2000 - 16.06.2000 - 17.05.2000 - 27.10.2000 - 84 days - OJ L 276, 28.10.2000 - 0
Butafosfan (extension)
Butafosfan Dairy cattle (extension)
- 19.01.2000 - 19.04.2000 - 90 days -0
- 19.01.2000 - 19.05.2000 - 19.04.2000 - 27.10.2000 - 90 days - OJ L 276, 28.10.2000 - 0
Tilmicosin (extension)
Tilmicosin Bovine milk (extension)
- 22.02.1999 - 19.04.2000 - 203 days - 210 days
- 22.02.1999 - 19.05.2000 - 19.04.2000 - 27.10.2000 - 203 days - OJ L 276, 28.10.2000 - 210 days
Phoxim (extension)
Phoxim Ovine (extension)
- 19.01.2000 - 19.04.2000 - 90 -0
- 19.01.2000 - 19.05.2000 - 19.04.2000 - 27.10.2000 - 90 - OJ L 276, 28.10.2000 - 0
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
- 19.01.2000 - 19.05.2000 - 19.04.2000 - 27.10.2000 - 90 days - OJ L 276, 28.10.2000 - 0
80 EMEA General Report 2000
Flunixin Equine (extension)
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
- 23.03.2000 - 21.07.2000 - 21.06.2000 - 29.12.2000 - 90 days - OJ L 336, 30.12.2000 - 0
Commission - Sent to Commission - Date of Regulation - Official Journal
EMEA/MB/050/00 Jaarverslag 2000
Flumethrin (extension)
Pagina 80/88
Ovine
Stof
- 19.01.2000 - 19.04.2000 - 90 days -0
Toepassingsgebied
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
EMEA/CVMP
Flunixin (extension)
Commissie
- 23.03.2000 - 21.06.2000 - 90 days -0
- Doelgroep-diersoort
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
- Validatie - Advies - Behandelings- tijd - Klokstop
- 19.01.2000 - 19.07.2000 - 120 days -0
- 19.01.2000 - 19.07.2000 - 120 days - o
81 EMEA General Report 2000
EMEA/MB/050/00 Jaarverslag 2000 Bijlage 10 COMP-adviezen over weesgeneesmiddelen, 2000
Annex 10:
Pagina 81/88
EMEA/COMP - Submission - Validation - Opinion - Active time
EMEA/COMP - Indiening - Validatie - Advies - Behandelingstijd
Commission - Opinion received - Date of Designation
Commissie - Advies ontvangen op - Datum aanwijzing
AIDS-wasting
AIDS -wasting
Ethypharm S.A.
Ethypharm S.A.
Treatment of N-acetylglutamate synthetase (NAGS) deficiency
Treatment of N -acetylglutamate synthetase (NAGS) deficiency
- 09.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
- 09.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
Treatment of Huntington's disease
Treatment of Huntington’s disease
Treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug -induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease and chronic thromboembolic pulmonary hypertension
Treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug -induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease and chronic thromboembolic pulmonary hypertension
- -
Sponsor
Treatment of acute promyelocytic leukaemia
Indicatie
- 08.08.2000
EMEA/COMP
-
Commissie
- 22.09.2000
- Indiening - Validatie - Advies - Behandelingstijd
- 21.11.2000
- Advies ontvangen op - Datum aanwijzing
- 21.08.2000
......
- -
......
- 19.10.2000
......
Mucopolysaccharidosis type VI (Maroteaux -Lamy
EMEA/MB/050/00 Jaarverslag 2000 Bijlage 11 EMEA-richtsnoeren, 2000
- 04.10.2000
Pagina 83/88
-
Richtsnoeren Final EU recommendations for the
Syndrome)
Status
- 19.10.2000 - 19.12.2000 - 62 days
EMEA/CPMP/BWP/840/00
83 EMEA General Report 2000
Influenza vaccine composition for the season 2000/2001 Report of the EMEA Expert Workshop on
EMEA guidelines in 2000
Aangenomen in april 2000
CPMP Biotechnology Working Party
EMEA/CPMP/BWP/1244/00
Reference number
Aangenomen in juli 2000
Guidelines/Status
EMEA/CPMP/BWP/3326/99
EMEA/ CPMP/ BWP/840/00
Points to consider on xenogeneic cell therapy Note for Guidance on the production and
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
Aangenomen in november 2000
EMEA/ CPMP/ BWP/1244/00
EMEA/CPMP/BWP/3354/99
Report of the EMEA Expert Workshop on human TSEs and plasma-derived medicinal products, 15-16 May 2000 Adopted July 2000
2000
EMEA/ CPMP/ BWP/3326/99
EMEA/CPMP/BWP/3207/00
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
2000
EMEA/ CPMP/ BWP/3354/99 Draft
EMEA/CPMP/BWP/1143/00
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
tumorigenic cells of human origin for the
EMEA/ CPMP/ BWP/3207/00
Ter discussie vrijgegeven in juli
Note for Guidance on Comparability of medicinal products containing biotechnology-derived proteins as active substances Released for consultation May 2000
production of biological and biotechnological medicinal products Revision of section 3.2.5 of CPMP Note
Position statement on the Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products Released for consultation July 2000
2000
EMEA/CPMP/BWP/269/95rev.
EMEA/CPMP/BWP/269/95
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
2000 Ter discussie vrijgegeven in
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
november 2000
CPMP Blood and Plasma Working Group
CPMP-werkgroep Bloed en Plasma
Reference number
Referentienummer
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Aangenomen in juni 2000
EMEA/CPMP/BPWG/388/95 rev.
EMEA/CPMP/BPWG/388/95
EMEA/CPMP/BPWG/574/99
EMEA/CPMP/BPWG/574/99 EMEA/CPMP/BPWG/859/95
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Aangenomen in juni 2000
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Aangenomen in juni 2000
EMEA/ CPMP/ BPWG/1619/99
EMEA/CPMP/BPWG/1619/99
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
Aangenomen in juni 2000
EMEA/ CPMP/ BPWG/1625/99
EMEA/CPMP/BPWG/1625/99
Core SPC for Human plasma derived and recombinant coagulation factor IX products Adopted June 2000
Aangenomen in juni 2000
EMEA/CPMP/BPWG/198/95 rev.1
EMEA/CPMP/BPWG/198/95 rev.1
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adopted October 2000
EMEA/MB/050/00 Jaarverslag 2000
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
2000 Ter discussie vrijgegeven in juni
84 EMEA General Report 2000
2000
EMEA/CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/198/95 rev.
EMEA/CPMP/PhvWP/BPWG/
1
2231/99
Core SPC for Human albumin Adopted October 2000 Note for guidance on the Clinical investigation of human plasma derived factor VIII and IX products Released for consultation June 2000
Note for Guidance on the Clinical
EMEA/ CPMP/ BPWG/1561/99
EMEA/CPMP/BPWG/2220/99
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
december 2000
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
EMEA/CPMP/BPWG/3226/99
Core SPC for Human albumin Released for consultation June 2000 Note for Guidance on the Clinical investigation of plasma derived antithrombin products Released for consultation December 2000
Core SPC for Human plasma derived
EMEA/ CPMP/BPWG/3226/99
Ter discussie vrijgegeven in
Core SPC for Human plasma derived antithrombin Released for consultation December 2000
december 2000
CPMP Efficacy Working Party Reference number
CPMP-werkgroep Werkzaamheid
Guidelines/Status
Referentienummer
EMEA/ CPMP/ EWP/519/98
EMEA/CPMP/EWP/519/98
Note for Guidance on clinical investigation of steroid contraceptives in woman Adopted February 2000
Aangenomen in februari 2000
EMEA/ CPMP/ EWP/197/99
EMEA/CPMP/EWP/197/99
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
Aangenomen in februari 2000
EMEA/ CPMP/ EWP/570/98
EMEA/CPMP/EWP/570/98
Points to consider on the clinical investigation of new medicinal products for treatment of acute coronary syndrome (ACS) without persistent ST-segment elevation Adopted February 2000
Aangenomen in februari 2000
EMEA/ CPMP/ EWP/2922/99
EMEA/CPMP/EWP/2922/99
Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Adopted February 2000
Aangenomen in februari 2000
EMEA/ CPMP/ EWP/2863/99
EMEA/CPMP/EWP/2863/99
Concept paper on the development of a CPMP Points to Consider on biostatistical/methodological issues arising from CPMP discussions on licensing applications: adjustment for baseline covariates Adopted February 2000
Aangenomen in februari 2000
EMEA/ CPMP/ EWP/707/98
EMEA/CPMP/EWP/707/98
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
Aangenomen in juni 2000
EMEA/ CPMP/ EWP/612/00
EMEA/CPMP/EWP/612/00
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adopted June 2000
Aangenomen in juni 2000
EMEA/ CPMP/ EWP/2655/99
EMEA/CPMP/EWP/2655/99
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adopted July 2000
Aangenomen in juli 2000
EMEA/ CPMP/ EWP/482/99
EMEA/CPMP/EWP/482/99
Points to consider on switching between superiority and non-inferiority Adopted July 2000
Aangenomen in juli 2000
EMEA/ CPMP/ EWP/1080/00
EMEA/CPMP/EWP/1080/00
Concept paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products in the treatment of diabetes mellitus Adopted July 2000
Aangenomen in juli 2000