qanastek/EMEA-V3 huggingface dataset:
The summarised comparative budget statements in euro for 1999 to 2001 are given below.
— The Liposome
1999(1)
— L01DB
2000(2)
— Myocet — The Liposome — L01DB — Powder and pre- —
2001(3)
— Myocet — The Liposome — L01DB — Powder and pre- — 30.7.1999 —
(31.12.1999)
17.5.2000
(as at 31.12.2000)
— doxorubicin
(as at 20.12.2000)
Company
Expenditure Staff
— Treatment of
salaries interim and other support persons other staff-related expenditure total title 1
— doxorubicin Company — Treatment of admixtures for —
15 074 905 955 456 1 191 570 17 221 931
— doxorubicin Company — Treatment of admixtures for — 12.4.2000 —
36.61% 2.32% 2.89% 41.82%
13.7.2000
18 493 000 1 058 000 1 350 000 20 901 000
— US
33.45% 1.91% 2.44% 37.80%
metastatic breast
21 772 000 35.15% 1 379 000 2.23% 1 501 000 2.42% 24 652 000 39.80%
—B — US metastatic breast concentrate for, —
Building/ equipment
—B — US metastatic breast concentrate for, — 167 days —
rent/ charges expenditure on data processing other capital expenditure postage and communications other administrative expenditure
26.7.2000
2 136 038 1 034 357 1 824 960 370 754 1 194 962
cancer
5.19% 2.51% 4.43% 0.90% 2.90%
— —
5 212 220 2 423 500 2 353 000 480 000 1 593 000
liposomal dispersion for infusion 50 mg 1 presentation
9.43% 4.38% 4.26% 0.87% 2.88%
—
5 685 000 9.18% 1 400 000 2.26% 824 500 1.33% 537 000 0.87% 1 784 500 2.88%
91 days —
total title 2
2
6 561 071
— Datscan
15.93%
— Nycomed
12 061 720 21.82%
— V09AB03
10 231 000 16.52%
— ioflupane
Operational expenditure
— Diagnosis of Parkinson — 74 MBq/ml
meetings
27.7.2000
3 274 441
—B
7.95%
— UK
3 487 000 6.31%
disease
6 565 000 10.60%
— 1 presentation
evaluations translation studies and consultants publications
—B — UK disease — 1 presentation — 178 days —
13 894 457 93 650 137 130
— 272 days —
33.74% 0.00% 0.23% 0.33%
73 Rapport annuel EMEA 2000
5 000 150 000
Produit — Nom de marque — DCI — Partie A ou B
33.79% 0.00% 0.01% 0.27%
Société — Nom — Origine
19 658 000 31.74% 428 000 0.69% 180 000 0.29% 220 000 0.36%
Présentation — Forme — Dosage — Nombre de présentations
total title 3
— Visudyne — verteporfin —B
17 399 678
— Ciba Vision — CH
42.25%
— —
22 324 500 40.38%
— — —
27 051 000 43.68%
27.8.1999 — 12.4.2000 — 138 days — 63 days —
TOTAL EXPENDITURE
10
41 182 680 100.00%
— NovoMix 30 — insulin aspart —A
55 287 220 100.00%
— Novo Nordisk — DK
61 934 000 100.00%
— A10AD — Diabetes mellitus
Revenue
— — —
fees general EU contribution special EU orphan medicinal
24.9.1999 — 12.4.2000 — 144 days — 55 days —
28 952 500 70.31% 10 481 649 25.45%
10
39 154 000 70.82% 13 200 000 23.88%
— Kogenate Bayer — octocog alfa —A
42 610 000 68.81% 14 700 000 23.73%
— Bayer AG —D
product contribution contribution from EEA contribution from EU
B02BD02 Treatment and prophylaxis of bleeding in haemophilia A
-- 0.00% -- 0.00%
— — —
1 000 000 1.81% 245 220 0.44%
Powder and solvent for solution for injection 250 IU, 500 IU, 1 000 IU 3 presentations
600 000 0.97% 250 000 0.40%
— — — —
programmes (PERF) other
26.2.1999 — 16.3.2000 — 182 days — 201 days —
800 000 1.94% 948 531 2.30%
10
217 000 0.39% 1 471 000 2.66%
— Helixate NexGen — octocog alfa —A
2 440 000 3.94% 1 334 000 2.15%
— Bayer AG —D
TOTAL REVENUE
— —
41 182 680 100.00%
B02BD02 Treatment and prophylaxis of bleeding in haemophilia A
55 287 220 100.00%
— — —
61 934 000 100.00%
26.2.1999 16.3.2000 182 days 201 days
Notes
— —
(2) 2000 budget: final appropriations.
Hepacare triple antigen hepatitis B vaccine
(3) 2001 budget: draft appropriations.
— —
64 EMEA General Report 2000
Medeva Pharma Ltd UK
Annex 3:
— —
Members of the Management Board
J07BC Immunisation against hepatitis B virus in adults
Chairman
— —
André BROEKMANS 1
Suspension for injection Monodose preparation of 1 ml contains
Members
—A
European Parliament
10
Gianmartino BENZI, José-Luis VALVERDE LÓPEZ 2 Alternates:
2 presentations
Dietrich HENSCHLER, Jean-Pierre REYNIER
— Herceptin — trastuzumab —A
European Commission Fabio COLASANTI 3, Bertrand CARSIN 4 Alternates:
Roche Registration Ltd CH
Paul WEISSENBERG Belgique/ België Danmark Deutschland
L01XC03 Treatment of patients with metastatic breast
André PAUWELS, Frans GOSSELINCKX Ib VALSBORG, Jytte LYNGVIG 5 Hermann Josef PABEL, Gerhard Josef KOTHMANN, (Vice-chairman)
Powder for — concentrate for — solution for infusion —
Eλλ δα / Greece España
26.2.1999 — 25.5.2000 — 147 days —
Marios MARSELOS 6, Elias MOSSIALOS 7 María Victoria de la CUESTA GARCIA 8, Ramón PALOP BAIXAULI 9
3.7.2000 28.8.2000 4.9.2000
France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/ Finland Sverige United Kingdom
cancer whose tumour overexpress HER2
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
— 150 mg — — 1 presentation
Observers
305 days —
Ísland
14
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN
— Keppra — levetiracetam —B
Liechtenstein Norge/ Noreg
— UCB SA — US
Brigitte BATLINER, Peter MALIN Andreas DISEN, Gro Ramsten WESENBERG
— —
2 Replaced Dietrich HENSCHLER as of the 22 February 2000 meeting.
N03A Adjunctive therapy in the partial onset seizures in epilepsy
3 Replaced Jörn KECK as of the 22 February 2000 meeting.
— — —
6 Replaced Haralampos MOUTSOPOULOS as of the 20 December 2000 meeting.
Film coated tablet — 250 mg, 500 mg, — 750 mg, 1 000 mg — 26 presentations —
7 Replaced John PSOMAS as of the 20 December 2000 meeting.
26.2.1999 — 29.6.2000 — 187 days — 300 days —
11 Replaced John COSTELLOE as of the 22 February 2000 meeting.
31.7.2000 29.9.2000 11.10.2000 OJ C 308, 27.10.2000, p.
12 Replaced André BROEKMANS as of the 7 June 2000 meeting.
12
65 EMEA General Report 2000
— Panretin — alitretinoin —B
Annex 4:
— —
Members of the Committee for Proprietary Medicinal Products1
Ligand Pharmaceuticals Ltd US
· Jean-Michel ALEXANDRE (France), Chairman
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi’s sarcoma
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
— Gel — — 0,1 %w/w — — 1 presentation — —
· 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)
26.2.1999 — 29.6.2000 — 174 days — 313 days —
1 2 3 4 5 6 7 8
2
Replaced Eva ALHAVA as of the March 2000 meeting.
— Glustin — pioglitazone —B
66 EMEA General Report 2000
— Takeda Europe — JP
Annex 5:
— —
Members of the Committee for Veterinary Medicinal Products1
A10BG03 Combination treatment of Type II Diabetes mellitus
Reinhard KROKER (Deutschland), Chairman
— Tablet — 15 mg, 30 mg — 6 presentations
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
— — — —
Margarita ARBOIX (España) J.
23.4.1999 — 29.6.2000 — 178 days — 251 days —
Replaced Carlos SINOGAS as of the July 2000 meeting.
— Actos — pioglitazone — B
67 EMEA General Report 2000
— Takeda Europe — JP
Annex 6:
— —
Chairman (España)
A10BG03 Combination treatment of Type II Diabetes mellitus
Josep TORRENT i FARNELL
— Tablet — 15 mg, 30 mg — 6 presentations
Members
— — — —
Belgique/België Danmark Deutschland Eλλ δα/Greece France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/Finland Sverige United Kingdom Patient organisation
23.4.1999 — 29.6.2000 — 178 days — 251 days —
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
2
representatives
— Agenerase — amprenavir —B
Moisés ABASCAL ALONSO 5 Yann LE CAM, 5 Vice-chairman Alastair KENT 6
— Glaxo Group — UK
EMEA representatives
— —
Jean-Michel ALEXANDRE 7 Gianmartino BENZI Mary TEELING 8
J05AE05 Treatment of HIV infected adults and children
Observers
— — —
Sigurdur THORSTEINSSON Randi NORDAL
Capsule, soft, Oral solution 50 mg, 150 mg, 15 mg/ml 4 presentations
1 2 3 4 5 6 7 8
— — — —
Replaced Tilman OTT as of the September 2000 meeting.
20.11.1998 — 29.6.2000 — 219 days — 324 days —
Replaced Alexander NICHOLSON as of the June 2000 meeting.
9.8.2000 20.10.2000 25.10.2000 OJ C 337, 28.11.2000, p.
Representing the European Association for Orphan Diseases (Eurodis).
2
68 EMEA General Report 2000
74 Rapport annuel EMEA 2000
National competent authority partners
Produit — Nom de marque — DCI — Partie A ou B
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
Société — Nom — Origine
(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
Domaine thérapeutique — ATC — Indication
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-mail: jyl@dkma.dk Internet: http://www.dkma.dk
Présentation — Forme — Dosage — Nombre de présentations
DEUTSCHLAND Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D – 53113 Bonn Tel.
EMEA-CPMP — Validation — Avis — Temps actif — Temps suspendu
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r.kroker@bgvv.de
Commission — Avis reçu — Date de décision — Notification — Journal officiel
Johannes LÖW ER Kommissarische Leiter Paul-Ehrlich Institut Paul-Ehrlich Straße 51-59 D – 63225 Langen Tel.
— Infanrix hexa
Internet: http://www.bgvv.de
— SmithKline
69 EMEA General Report 2000
— JO7CA
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
— Powder and suspension —
(34-91) 596 16 27 Fax (34-91) 596 16 15 E-mail: sdaem@agamed.es Internet: http://www.agamed.es
— Infanrix hexa — SmithKline — JO7C A — Powder and suspension — 30.7.1999 —
FRANCE
9.8.2000
Philippe DUNETON Directeur-Général Agence Française de Sécurité Sanitaire des Produits de Santé 143-147, blvd Anatole France F - 93200 Saint-Denis CEDEX Tel.
— Hep B-IPV HIB
Martin HIRSCH Directeur-Général Agence Française de Sécurité Sanitaire des aliments 23, avenue du Général de Gaulle B.P.
Beecham
IRELAND
— Immunisation against
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Tel.
— Hep B-IPV HIB Beecham — Immunisation against for suspension for —
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
— Hep B-IPV HIB Beecham — Immunisation against for suspension for — 29.6.2000 —
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Tel.
23.10.2000
ITALIA
vaccine
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e la farmacovigilanza Ministero della Sanità Viale Civilità Romana 7 I -00144 Roma Tel.
Biologicals SA
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.
Haemophilus
70 EMEA General Report 2000
injection
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.
—
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel.
201 days — 26.10.
(31-31) 747 54 91 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl
— 201 days —
ÖSTERREICH Gunter LIEBESWAR Sektionschef Gesundheitswesen Bundesministerium für Soziale, Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
26.10.2000
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für Soziales, Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
—A
PORTUGAL Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
—B
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
influenza, Diphtheria, — Diphtheria toxoid,
71 EMEA General Report 2000
—A —B influenza, Diphtheria, — Diphtheria toxoid, —
(358-9) 47 33 42 00 Fax (358-9) 47 33 43 45 E-mail: hannes.wahlroos@nam.fi Internet: http://www.nam.fi
—A —B influenza, Diphtheria, — Diphtheria toxoid, — 132 days —
SVERIGE Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8, Box 26 S - 751 03 Uppsala Tel.
OJ C 337,
UNITED KINGDOM
adsorbed ≥ 30IU
Keith JONES Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ United Kingdom Tel.
Pertussis, Tetanus, HepB and Poliomyelitis
(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
Tetanus toxoid, adsorbed ≥ 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 Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP) 10 µg and Tetanus toxoid (T), adsorbed (PRP-T) 20-40 µg
Observers:
2
ÍSLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS - 170 Seltjarnarnes Tel.
— 16 presentations
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alk.llv.li
— Infanrix penta
72 EMEA General Report 2000
— SmithKline
Annex 8:
— JO7CA
CPMP opinions in 2000 on medicinal products for human use
— Suspension for injection —
Product - Brandname - INN - Part A/B
— Infanrix penta — SmithKline — JO7CA — Suspension for injection — 30.7.1999 —
Company - Name - Origin
9.8.2000
Therapeutic area - ATC - Indication
— Hep B-IPV
Presentation - Form - Dosage - Number of presentations
— Primary and booster — Diphtheria toxoid, —
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
— Hep B-IPV Beecham — Primary and booster — Diphtheria toxoid, —
Commission - Opinion received - Date of Decision - Notification - Official Journal
— Hep B-IPV Beecham — Primary and booster — Diphtheria toxoid, — 29.6.2000 —
- Orgalutran
23.10.2000
- N.V.
vaccine
Organon - H01CC01
Biologicals SA
- Orgalutran - N.V.
immunisation of
Organon - H01CC01 - Solution for injection -
—
- Orgalutran - N.V.
201 days —
22.02.2000
— 201 days —
- ganirelix
26.10.2000
- NL
—B
- Prevention of
infants against
- ganirelix - NL - Prevention of - 0.5 mg/ml -
—A —B infants against Tetanus toxoid, —
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.01.2000 -
—A —B infants against Tetanus toxoid, — 132 days —
17.05.2000
OJ C 337,
-B
adsorbed ≥ 40IU
premature luteinising
Diphtheria, Tetanus, Pertussis, Hepatitis B and Poliomyelitis
-B premature luteinising - 2 presentations -
2
-B premature luteinising - 2 presentations - 162 days -
8 presentations
22.05.2000
— Hexavac
hormone surges in conteolled ovarian hyperstimulation
— Suspension for injection —
-
— Hexavac — Pasteur Merieux — JO7CA — Suspension for injection — 30.7.1999 —
189 days -
10.8.2000
3
— Comb vaccine
- -
MSD
Pegintron peginterferon alfa -2b
— Immunisation
- SP Europe - US
— Purified diphtheria toxoid, —
- -
23.10.2000
L03AB10 Treatment of chronic hepatitis C
adsorbed ≥ 20 IU, —A
- -
—F
Powder and solvent for solution for injection 50 µg/0.5 ml, 80 µg/0.5 ml,
Diphtheria, pertussis,
- 26.03.1999 - 17.02.2000 - 189 days
—A —F Diphtheria, pertussis, —
- 27.03.2000 - 25.05.2000 - 05.06.2000
—A —F Diphtheria, pertussis, — 180 days —
-A
26.10.2000
-
Tetanus, HepB,
100 µg/0.5 ml 120 µg/0.5 ml, 150µg/0.5 ml 25 presentations
Purified tetanus toxoid, adsorbed ≥ 40 IU
- 139 days
153 days —
-
Poliomyelitis,
OJ C 183, 30.06.2000, p.
28.11.2000, p.
- Viraferon PEG - peginterferon alfa -2b -A
— lutropin alfa
- SP Europe - US
(Europe) Ltd
- -
—A
L03AB10 Treatment of chronic hepatitis C
follicular development — 75 IU —
- - -
30.11.2000
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
in women with servere Leng HEng and FSH deficiency
- 03.01.2000 - 17.02.2000 - 43 days - 0 days
— 6 presentations —
- - - -
200 days —
27.03.2000 25.05.2000 05.06.2000 OJ C 183, 30.06.2000, p.
OJ C 2, 5.1.2001, p.
- -
75 Rapport annuel EMEA 2000
Lantus insulin glargine
Produit — Nom de marque — DCI — Partie A ou B
-
Société — Nom — Origine
Aventis Pharma Deutschland
Domaine thérapeutique — ATC — Indication
- A10AE - Diabetes mellitus
Présentation — Forme — Dosage — Nombre de présentations
- Solution for injection - 100 IU/ml - 7 presentations
EMEA-CPMP — Validation — Avis — Temps actif — Temps suspendu
- 23.04.1999 - 17.02.2000 - 215 days
Commission — Avis reçu — Date de décision — Notification — Journal officiel
- 23.03.2000 - 06.06.2000 - 14.06.2000
— NeoSpect — depreotide —B
-A
— —
GmbH
Nycomed Imaging A/S NO
- 8 3 days
— —
- OJ C 183,
— —
-D
20.11.1998 — 27.7.2000 — 204 days — 404 days —
30.06.2000, p.
28.8.2000 29.11.2000 4.12.2000 OJ C 2, 5.1.2001, p.
- -
— —
Optisulin insulin glargine
Trizivir lamivudine zidovudine abacavir
-
— Glaxo Group — UK
Aventis Pharma Deutschland
— —
- A10AE - Diabetes mellitus
J05AF30 Treatment of HIV-1 infected patients
- Solution for injection - 100 IU/ml - 7 presentations
— Film coated tablet — — 1 50/300/300 mg — — 3 presentations —
- 24.09.1999 - 17.02.2000 - 116 days
21.1.2000 29.6.2000 158 days
- 23.03.2000 - 27.06.2000 - 28.06.2000
— 13.10.2000 — 8.12.2000 —
-A
—B —
GmbH
0 day
- 28 days
—
- OJ C 216,
— Nutropin AQ — somatropin
-D
—
4
Schwarz Pharma AG
- Nyracta - rosiglitazone -B
— H01AC01 — Treatment of growth
SmithKline Beecham Pharmaceuticals UK
— Solution for injection — 5 mg/ml
- -
— 21.10.1999 — 21.9.2000
A10BG02 Combination treatment of Type II diabetes mellitus
— 5.12.2000 —
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
—A
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
—D
- - - -
failure
2
— 2 presentations
- Avandia - rosiglitazone -B
Neurobloc botulinum toxin type B
SmithKline Beecham Pharmaceuticals UK
Elan Pharma International Ltd UK
A10BG02 Combination treatment of Type II diabetes mellitus
M03AX01 Treatment of cervical dystonia
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
— Solution for injection — 5 000 IU/ml — 3 presentations
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
— 27.8.1999 — 21.9.2000 — 187 days
- - - -
—B
4
—
- Venvia - rosiglitazone -B
— Tenecteplase
- -
— B01 AD
SmithKline Beecham Pharmaceuticals UK
— Powder and solvent for —
A10BG02 Combination treatment of Type II diabetes mellitusus
— 27.11.2000
- Film coated tablet - 1 mg, 2 mg, 4 mg, 8 mg - 12 presentations
— tenecteplase —A
- 18.12.1998 - 21.10.1999 - 186 days - 119 days
Ingelheim International GmbH
2
Treatment of suspected solution for injection — myocardial infarction — 6 000 IU, 8 000 IU, — 10 000 IU —
- Myocet - doxorubicin -B
21.9.2000 176 days 215 days
The Liposome Company US
— — —
- -
—D
L01DB Treatment of metastatic breast cancer
— 3 presentations
- Powder and pre-admixtures for concentrate for, liposomal dispersion for infusion - 50 mg - 1 presentation
— Metalyse
- 30.07.1999 - 12.04.2000 - 167 days - 91 days
— Boehringer
- - - -
— B01AD
2
— Powder and solvent for —
- Datscan - ioflupane -B
24.9.1999
- -
— 27.11.2000
Nycomed Amersham UK
— tenecteplase —A
- -
Ingelheim International GmbH
V09AB03 Diagnosis of Parkinson disease
—
- Solution for injection - 74 MBq/ml - 1 presentation
Treatment of suspected solution for injection — myocardial infarction — 6 000 IU, 8 000 IU, — 10 000 IU —
- 18.12.1998 - 16.03.2000 - 178 days - 272 days
21.9.2000 176 days 215 days
- - - -
— — —
10
—D
73 EMEA General Report 2000
— 3 presentations
Product - Brandname - INN - Part A/B
— Azomyr — desloratadine —B
Company - Name - Origin
— SP Europe — US
Therapeutic area - ATC - Indication
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Presentation - Form - Dosage - Number of presentations
— Film coated tablet — 5 mg — 13 presentations
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
24.9.1999 21.9.2000 201 days 159 days
Commission - Opinion received - Date of Decision - Notification - Official Journal
— 6.11.2000 — — —
- Visudyne - verteporfin -B
— Opulis — desloratadine —B
- Ciba Vision - CH
— SP Europe — US
L01XX Treatment of age - related macular degeneration
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
- - -
— Film coated tablet — 5 mg — 13 presentations
Powder for solution for infusion 15 mg 1 presentation
— — — —
- 27.08.1999 - 12.04.2000 - 138 days - 63 days
24.9.1999 21.9.2000 201 days 159 days
- - - -
— 6.11.2000 — — —
10
— Allex — desloratadine —B
- NovoMix 30 - Novo Nordisk - insulin aspart - DK -A
— SP Europe — US
- A10AD - Diabetes mellitus
— —
- Suspension for injection - 100 IU/ml - 8 presentations
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
- 24.09.1999 - 12.04.2000 - 144 days - 55 days
— Film coated tablet — 5 mg — 13 presentations
- - - -
— — — —
10
24.9.1999 21.9.2000 201 days 159 days
- -
— 6.11.2000 — — —
Kogenate Bayer octocog alfa
— Aerius — desloratadine —B
- Bayer AG -D
— SP Europe — US
B02BD02 Treatment and prophylaxis of bleeding
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU
— Film coated tablet — 5 mg — 13 presentations
- 26.02.1999 - 16.0 3.2000 - 182 days
— — — —
- 05.06.2000 - 04.08.2000 - 07.08.2000
24.9.1999 21.9.2000 201 days 159 days
-A
— 6.11.2000 — — —
in haemophilia A
— Neoclarityn — desloratadine —B
- 3 presentations
— SP Europe — US
- 201 days
— —
-
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
10
— Film coated tablet — 5 mg — 13 presentations
- -
— — — —
Helixate NexGen octocog alfa
24.9.1999 21.9.2000 201 days 159 days
- Bayer AG -D
— 6.11.2000 — — —
B02BD02 Treatment and prophylaxis of bleeding
— Xeloda — capecitabine —B
Powder and solvent for solution for infusion 250 IU, 500 IU, 1000 IU
Roche Registration Ltd CH
- 26.02.1999 - 16.0 3.2000 - 182 days
— —
- 05.06.2000 - 04.08.2000 - 07.08.2000
L01BC Treatment of metastatic colorectal cancer
in haemophilia A
— Film coated tablet — 150 mg, 500 mg — 2 presentations
- 3 presentations
— — — —
- 201 days
21.10.1999 21.9.2000 201 days 159 days
10
— 20.11.2000 — — —
Hepacare triple antigen hepatitis B vaccine
Ovidrelle chorio- gonadotropin alfa
Medeva Pharma Ltd UK
Ares Serono (Europe) Ltd CH
J07BC Immunisation against hepatitis B virus in adults
G 03GA01 — Assisted reproductive techniques sus as in —
Suspension for injection Monodose preparation of 1 ml contains Hepatitis B surface antigen S, pre -S1 and
Powder and solvent for — solution for injection — 250 µg —
- 23.10.1998 - 16.03.2000 - 210 days - 293 days
21.10.1999 21.9.2000 174 days
- 16.05.2000 - 04.08.2000 - 07.08.2000 - OJ C 244,
— 23.11.2000 — —
-A
—A
-
vitro fertilisation (IVF) —
pre S2 20 µg 2 presentations
6 presentations —
25.08.2000, p.
186 days
10
—
- Herceptin - trastuzumab -A
76 Rapport annuel EMEA 2000
- -
Produit — Nom de marque — DCI — Partie A ou B
Roche Registration Ltd CH
Société — Nom — Origine
- -
Domaine thérapeutique — ATC — Indication
L01XC03 Treatment of patients with metastatic breast cancer whose tumour overexpress HER2
Présentation — Forme — Dosage — Nombre de présentations
Powder for concentrate for solution for infusion 150 mg 1 presentation
EMEA-CPMP — Validation — Avis — Temps actif — Temps suspendu
- 26.02.1999 - 25.05.2000 - 147 days - 305 days
Commission — Avis reçu — Date de décision — Notification — Journal officiel
- - - -
— —
14
Prevenar pneumococcal conjugate vaccine
- Keppra - levetiracetam -B
— —
- UCB S.A. - US
Wyeth-Lederle Vaccines SA US
N03A Adjunctive therapy in the partial onset seizures in epilepsy
J07AL Active immunisation of infants and children
- - -
— —
Film coated tablet 250 mg, 500 mg, 750 mg, 1000 mg 26 presentations
Suspension for injection — A monodose preparation — of 0,5 ml contains —
- 26.02.1999 - 29.06.2000 - 187 days - 300 days
19.11.1999 21.9.2000 205 days
- Panretin - alitretinoin -B
— 21.11.2000 — —
Ligand Pharmaceuticals Ltd US
against invasive disease, pneumonia
L01XX22 Ttopical treatment of cutaneous lesions in AIDS related Kaposi's sarcoma
Streptococcus pneumoniae: — saccharide suspension of
- 26.02.1999 - 29.06.2000 - 174 days - 313 days
125 days
2
and otitis media caused Serotype 4 2 mg
- Glustin - pioglitazone -B
by Streptococcus pneumoniae
A10BG03 Combination treatment of Type II Diabetes mellitus
Serotype 9V 2 mg Serotype 14 2 mg Serotype 18C 2 mg Serotype 19F 2 mg Serotype 23F 2 mg Serotype 6B 4 mg Conjugated to CRM197 carrier protein ~ 20 mg
- Actos - pioglitazone -B
— Novo Nordisk
- -
30.6.2000
Takeda Europe JP
— 26.10.2000
- -
DK
A10BG03 Combination treatment of Type II Diabetes mellitus
Treatment of Type II diabetes mellitus
- Tablet - 15 mg, 30 mg - 6 presentations
0,5 mg, 1,0 mg, 2,0 mg— 18 presentations — —
- 23.04.1999 - 29.06.2000 - 178 days - 251 days
21.9.2000 91 days 0 day
2
— Rapamune — sirolimus — B
- Agenerase - amprenavir -B
— —
- Glaxo Group - UK
Wyeth Europe Ltd US
J05AE05 Treatment of HIV infected adults and children
L04AA10 Prophylaxis of organ rejection in patient receiving renal transplants
- Capsule, soft, Oral solution - 50 mg, 150 mg, 15 mg/ml - 4 presentations
— Oral solution — 1 mg/ml — 5 presentations
- 20.11.1998 - 29.06.2000 - 219 days - 324 days
29.1.1999 16.11.2000 214 days 393 days
- - - -
— Targretin
2
— Ligand
74 EMEA General Report 2000
— L01XX25
Product - Brandname - INN - Part A/B
— Targretin — Ligand — L01XX25 — Capsule, soft —
Company - Name - Origin
17.12.1999
Therapeutic area - ATC - Indication
— bexarotene
Presentation - Form - Dosage - Number of presentations
Pharmaceuticals — Treatment of skin
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
— bexarotene Pharmaceuticals — Treatment of skin — 75 mg —
Commission - Opinion received - Date of Decision - Notification - Official Journal
16.11.2000
- -
—
Infanrix hexa Hep B-IPV HIB vaccine
—B
SmithKline Beecham Biologicals
manifestations of
JO7CA Immunisation against Haemophilus influenza,
—B Ltd manifestations of — 1 presentation —
- -
197 days
30IU
—
- 30.07.1999 - 29.06.2000 - 201 days
— US
- 09.08.2000 - 23.10.2000 - 26.10.2000
advanced stage of — cutaneous T-cell Lymphoma
-A
159 days
S.A.
—
Diphtheria, Pertussis,
— Fasturtec — rasburicase —A
Tetanus toxoid, adsorbed ≥
— Sanofi —F
- 132 days
— —
- OJ C 337,
V03AF07 Treatment of tumor induced hpreuricemia
-B
— — —
Tetanus, HepB and Poliomyelitis
Powder and solvent for — solution for infusion — 1,5 mg/ml — 1 presentation —
40IUPertussis 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 Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP) 10 µg and Tetanus toxoid (T), adsorbed (PRP-T) 20-40 µg
21.1.2000 16.11.2000 177 days 118 days
2
— — — —
-
— Trazec
16 presentations
— Novartis
- -
— A10B03
Infanrix penta - Hep B-IPV vaccine
— Trazec — Novartis — A10B03 — Film coated tablet —
SmithKline Beecham Biologicals
31.10.2000
JO7CA Primary and booster immunisation of infants
Europharm Ltd — Combination
- Suspension for injection - Diphtheria toxoid, adsorbed ≥ 30IU
— nateglinide Europharm Ltd — Combination — 60 mg, 120 mg, —
- 30.07.1999 - 29.06.2000 - 201 days
14.12.2000
- 09.08.2000 - 23.10.2000 - 26.10.2000
—
-A
—B
S.A.
— CH
against Diphtheria,
treatment of diabetes
Tetanus toxoid, adsorbed ≥
— B — CH treatment of diabetes 180 mg —
- 132 days
58 days
- OJ C 337,
mellitus Type II
-B
—
Tetanus, Pertussis, Hepatitis B and Poliomyelitis
— Vaniqa — eflornithine —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
— —
2
Bristol Myers — Squibb Pharma — EEIG US
-
D11AX Treatment of facial hirsutism
8 presentations
— Cream — — 11,5% — — 3 presentations — —
- Hexavac
— — — —
-
— Starlix
Pasteur
— Novartis
- JO7CA
— A10BX03
- Suspension for injection
— Starlix — Novartis — A10BX03 — Film coated tablet —
- 30.07.1999
21.1.2000
- 10.08.2000
—
- Comb vaccine -A
— nateglinide
Merieux MSD - -F
Europharm Ltd — Combination
Immunisation Diphtheria, pertussis, Tetanus, HepB, Poliomyelitis, Haemophilus influenza
— nateglinide Europharm Ltd — Combination — 60 mg, 120 mg, —
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)
treatment of diabetes
- 26.06.2000 - 180 days - 153 days
—B — CH treatment of diabetes 180 mg —
- - -
179 days
-
mellitus Type II
8 presentations
— 21 presentations —
- Luveris - lutropin alfa -A
— Zometa — zoledronic acid
Ares Serono (Europe) Ltd CH
Novartis Europharm Ltd
G03G Stimulation of follicular development in women - 75 with servere Leng HEng and FSH deficiency
M05BA08 Treatment of tumour
- Powder and solvent for solution for injection IU - 6 presentations
Powder and solvent for — solution for infusion —
- 25.06.1999 - 27.07.2000 - 192 days - 200 days
21.1.2000 14.12.2000
07.09.2000 29.11.2000 30.11.2000 OJ C 2, 05.01.2001, p.
induced hypercalcaemia
3
4 mg — 3 presentations —
75 EMEA General Report 2000
177 days 146 days
Product - Brandname - INN - Part A/B
— —
Company - Name - Origin
— Kaletra
Therapeutic area - ATC - Indication
— Abbott
Presentation - Form - Dosage - Number of presentations
— J05A
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
— Kaletra — Abbott — J05A — Capsule, soft, Oral —
- NeoSpect - depreotide
18.7.2000
Nycomed Imaging A/S
— lopinavir/
- -
Laboratories
V09IA05 Scintigraphic imaging
— Combination
Kit for radiopaharmaceutical preparation
— lopinavir/ Laboratories — Combination solution —
- 20.11.1998 - 27.07.2000
14.12.2000
28.08.2000 29.11.2000
ritonavir
NO
— US
of suspected malignant tumours in the lung
treatment in
- -
— 133,3
47 µg 2 presentations
— US treatment in — 133,3/33,3 mg, —
- 204 days - 404 days
145 days
3
—B
- Trizivir - lamivudine zidovudine abacavir -B
combination of HIV-1
- -
—B combination of HIV-1 80/20 mg/ml —
Glaxo Group UK
0 day
J05AF30 Treatment of HIV -1 infected patients
infected patients
- - -
—
Film coated tablet 150/300/300 mg 3 presentations
3 presentations
13.10.2000 08.12.2000
SonoVue sulphur hexafluoride
- Nutropin AQ - - somatropin
— Bracco SpA —I
Schwarz Pharma AG
— —
- Solution for injection - 5 mg/ml
V08DA Ultrasound agent to enhance the
- 05.1 2.2000 -
— Powder for injection — — 8 µl/ml — — 2 presentations —
-A
— — —
- D
— B
failure
echogenicity of the
- 2 presentations
— B echogenicity of the —
- 174 days - 186 days
276 days
- Neurobloc - botulinum
— Osteogenis
Elan Pharma International
Protein 1 Howmedia International Osteogenic Protein-1 BMP-7
M03AX01 Treatment of cervical
Treatment of non- union of tibia of at least 9 month duration
- Solution for injection - 5000 IU/ml
for implantation — 3,5 mg — 1 presentation —
- 27.08.1999 - 21.09.2000
14.12.2000 201 days 297 days
- 21.11.2000 -
— — —
toxin type B
—A
Ltd
77 Rapport annuel EMEA 2000
cancer
Annexe 9 — Avis du CVMP en 2000 sur les médicaments à usage vétérinaire Demandes centralisées
- 3 presentations
Produit — Nom de marque — DCI — Partie A ou B
- 187 days
Société — Nom — Origine
-
EMEA-CPMP — Validation — Avis — Temps actif — Temps suspendu
-B
Commission — Avis reçu — Date de décision — Notification — Journal officiel
- UK
— Ibraxion — Inactivated vaccine —A
- 229 days
— Merial — F
-
— —
- Tenecteplase - tenecteplase -A
Cattle Vaccine against IBR (QJ57DA)
-
— 17.11.1998 — — 10.11.1999 — — 210 days — — 176 days —
Boehringer Ingelheim International GmbH
10.12.1999 9.3.2000 10.3.2000 OJ C 95, 4.4.2000
- -
— Metacam
B01AD Treatment of suspected myocardial infarction
— Boehringer
- - -
— Dogs
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
— Metacam — Boehringer — Dogs —Solution for injection —
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
— Metacam — Boehringer — Dogs —Solution for injection — 12.1.1999 —
- 27.11.2000 - - -
— Meloxicam
-D
Ingelheim
- Metalyse - tenecteplase -A
— Initiation therapy for —5 mg/ml
-
— Meloxicam Ingelheim — Initiation therapy for —5 mg/ml —
Boehringer Ingelheim International GmbH
— Meloxicam Ingelheim — Initiation therapy for —5 mg/ml — 10.11.1999 —
- -
24.3.2000
B01AD Treatment of suspected myocardial infarction
— B (extension)
- - -
—D
Powder and solvent for solution for injection 6000 IU, 8000 IU, 10000 IU 3 presentations
alleviation of pain and —1 presentation inflammation (QM01AC06)
- 24.09.1999 - 21.09.2000 - 176 days - 215 days
210 days — 92 days —
- 27.11.2000 - - -
27.3.2000 OJ C 120, 28.4.2000
-D
— Incurin — Oestriol —B
- Azomyr - desloratadine -B
— —
- SP Europe - US
Intervet International NL
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Dogs Hormone-dependent urinary incontinence (QG03C A04)
- Film coated tablet - 5 mg - 13 presentations
— Scored tablets — 1 mg — 1 presentation
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
14.7.1998 — 8.12.1999 — 210 days — 302 days —
- 06.11.2000 - - -
— —
- Opulis - desloratadine -B
Rabigen SAG2 Live vaccine
- SP Europe - US
— Virbac —F
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Foxes Vaccine against rabies (QJ57HA)
- Film coated tablet - 5 mg - 13 presentations
—
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
Liquid within a blister pack embedded in a bait
- 06.11.2000 - - -
— — —
- Allex - desloratadine -B
23.3.1998 — 8.12.1999 — 196 days —
- SP Europe - US
7.1.2000 6.4.2000 10.4.2000
- -
— A
- Film coated tablet - 5 mg - 13 presentations
— 8 log 10 CCID50 — — 2 presentations
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
428 days —
- 06.11.2000 - - -
OJ C 120, 28.4.2000
- Aerius - desloratadine -B
— Eurifel FeLV — Live vaccine —A
- SP Europe - US
— Merial —F
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
Cats Vaccine against feline leukaemis (QJ57BA04)
- Film coated tablet - 5 mg - 13 presentations
— Pellet plus diluent — 1 ml — 3 presentations
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
12.1.1999 — 8.12.1999 — 183 days — 120 days —
- 06.11.2000 - - -
7.1.2000 13.4.2000 18.4.2000 OJ C 120, 28.4.2000
- Neoclarityn - desloratadine -B
— Porcilis Pesti
- SP Europe - US
— Intervet
- -
— Pigs
R06AX27 Relief of symptoms associated with seasonal allergic rhinitis
— Porcilis Pesti — Intervet — Pigs — Water in oil emulsion —
- Film coated tablet - 5 mg - 13 presentations
— Porcilis Pesti — Intervet — Pigs — Water in oil emulsion — 14.7.1998 —
- 24.09.1999 - 21.09.2000 - 201 days - 159 days
— Inactivated vaccine International —A — NL
- 06.11.2000 - - -
—
- Xeloda - capecitabine -B
Marker vaccine against CSF (QJ57EA)
- Roche Registration Ltd - CH
— 120 Elisa Units/2ml — 3 presentations
- -
— — —
L01BC treatment of metastatic colorectal cancer
13.10.1999 — 210 days — 246 days —
- Film coated tablet - 150 mg, 500 mg - 2 presentations
9.6.2000 14.6.2000 OJ C 183, 30.6.2000
- 21.10.1999 - 21.09.2000 - 201 days - 159 days
— Ibaflin — Ibafloxacin —B
- 20.11.2000 - - -
Intervet International NL
Ovidrelle chorio- gonadotropin alfa
Dogs Pyoderma (QG51AC)
- -
— Tablet — 150 et 300 mg — 1 presentation
Ares Serono (Europe) Ltd CH
— — — —
- -
12.1.1999 — 9.2.2000 — 210 days — 184 days —
G03GA01 Assisted reproductive techniques sus as in vitro fertilisation (IVF)
10.3.2000 13.6.2000 15.6.2000 OJ C 183, 30.6.2000
Powder and solvent for solution for injection 250 µg 6 presentations
— Solution for injection — 5 mg/ml
- 21.10.1999 - 21.09.2000 - 174 days - 186 days
— 2.1.2000 — — 19.4.2000 —
- 23.11.2000 - - -
— B (extension)
-A
—D
76 EMEA General Report 2000
— 1 presentation
Product - Brandname - INN - Part A/B
— 101 days — — 7 days —
Company - Name - Origin
18.9.2000 OJ C 277, 29.9.2000
Therapeutic area - ATC - Indication
— Econor — Valnemulin — B (extension)
Presentation - Form - Dosage - Number of presentations
Pigs Prevention & treatment of dysentery (QJ01XX94)
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
— 0,5% premix — various — 2 presentations
Commission - Opinion received - Date of Decision - Notification - Official Journal
10.8.1999 — 19.4.2000 — 210 days — 43 days —
- Prevenar - Prevenarp- neumococcal conjugate vaccine -A
19.5.2000 15.9.2000 20.9.2000 OJ C 308, 27.10.2000
- Wyeth- Lederle Vaccines S.A. - US
— Econor — Valnemulin — B (extension)
- J07AL - Active immunisation of infants and children against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae
Pigs Prevention/treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
- 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
— — — —
- 19.11.1999 - 21.09.2000 - 205 days - 125 days
12.10.1999 — 8.3.2000 — 148 days — 0 day —
- 21.11.2000 - - -
7.4.2000 15.9.2000 20.9.2000 OJ C 308, 27.10.2000
- Prandin - replaglinide -B
78 Rapport annuel EMEA 2000
Novo Nordisk DK
Société — Nom — Origine
- -
Domaine thérapeutique — Espèces visées — Indication
A10BX02 Treatment of Type II diabetes mellitus
Présentation — Forme — Dosage — Nombre de présentations
- Tablet - 0.5 mg, 1.0 mg, 2.0 mg, - 18 presentations
EMEA-CPMP — Validation — Avis — Temps actif — Temps suspendu
- 30.06.2000 - 21.09.2000 - 91 days - 0 days
Commission — Avis reçu — Date de décision — Notification — Journal officiel
- 26.10.2000 - - -
— Econor
- Rapamune - sirolimus -B
— Novartis
Wyeth Europe Ltd US
— Valnemulin
L04AA10 rophylaxis of organ rejection in patient receiving renal transplants
— Prevention/treatment — various
- Oral solution - 1 mg/ml - 5 presentations
— Valnemulin —A — Prevention/treatment — various —
- 29.01.1999 - 16.11.2000 - 214 days - 393 days
— Valnemulin —A — Prevention/treatment — various — 8.3.2000 —
- 08.01.2001 - - -
15.9.2000
- Targretin - bexarotene -B
— B (extension)
Ligand Pharmaceuticals Ltd US
of dysentery and
L01XX25 Treatment of skin manifestations of advanced stage of cutaneous T -cell Lymphoma
— B (extension) of dysentery and — 2 presentations —
- Capsule, soft - 75 mg - 1 presentation
— B (extension) of dysentery and — 2 presentations — 148 days —
- 17.12.1999 - 16.11.2000 - 197 days - 159 days
treatment/control of enzootic pneumonia (QJ01XX94)
- Fasturtec
0 day —
-
OJ C 308, 27.10.2000
Sanofi
— Dicural
-
— Dicural — Fort Dodge — Cattle & pigs — Solution for injection — 16.12.1998 —
V03AF07
21.7.2000
- Powder and solvent for
Animal Health — Antibacterial for
- 21.01.2000
— 50 mg/ml
-
— Difloxacin Animal Health — Antibacterial for — 50 mg/ml — 21.6.2000 —
- rasburicase -A
24.10.2000
-F
— B (extension)
-
— NL
Treatment of tumor induced hpreuricemia
systemic use
- -
— 3 presentations
solution for infusion 1.5 mg/ml 1 presentation
— B (extension) — NL systemic use — 3 presentations — 203 days —
- 16.11.2000 - 177 days - 118 days
25.10.2000
- - -
(QJ01MA)
- Trazec - nateglinide -B
OJ C 337, 28.11.2000
- -
— Poulflox
Novartis Europharm Ltd CH
— Virbac SA
- -
— Poultry
A10B03 Combination treatment of diabetes mellitus Type II
— Poulflox — Virbac SA — Poultry — Oral solution —
- Film coated tablet - 60 mg, 120 mg, 180 mg - 21 presentations
— 21.7.2000
- 31.10.2000 - 14.12.2000 - 58 days - 0 days
— Difloxacin
- - - -
—F
- Vaniqa - eflornithine -B
— Antibacterial for
- -
21.6.2000
Bristol Myers Squibb Pharma EEIG US
— 16.11.2000
- -
—B
D11AX Treatment of facial hirsutism
systemic use
- Cream - 11.5% - 3 presentations
—B systemic use — 3 presentations —
- 03.01.2000 - 14.12.2000 - 182 days - 157 days
152 days
- - - -
— OJ C 2,
- Starlix - nateglinide -B
(QJ01MA94)
Novartis Europharm Ltd CH
— Bayovac CSF
- -
— Bayer
A10BX03 Combination treatment of diabetes mellitus Type II
— Pigs — Emulsion for inj
- Film coated tablet - 60 mg, 120 mg, 180 mg - 21 presentations
— Bayovac CSF — Bayer — Pigs —
- 21.01.2000 - 14.12.2000 - 179 days - 144 days
— Bayovac CSF — Bayer — Pigs — Emulsion for injection —
- - - -
16.12.1998
- Zometa - zoledronic
— 7.8.2000
Novartis Europharm
Marker Live vaccine
M05BA08 Treatment of tumour
Marker vaccine against — Classical Swine Fever
- Powder and solvent for solution for infusion
E2 glycoprotein of — Classical Swine Fever —
- 21.01.2000 - 14.12.2000
19.7.2000 210 days
acid
309 days
Ltd
—
induced hypercalcaemia - 4 mg
4 presentations
- 177 days
— Pigs
-
— Porcilis AR-T-DF — Intervet — Pigs — Suspension for —
- B
12.1.1999
- CH
— 18.8.2000
- 3 presentations
— Inactivated vaccine International
- 146 days
— Vaccine against
-
— Inactivated vaccine International — Vaccine against injection —
- Kaletra
19.7.2000
- Abbott
—A
- J05A
— NL
- Capsule, soft, Oral solution
—A — NL atrophic rhinitis — 2 ml —
- 18.07.2000
204 days
-
— OJ C 2,
-
(QJ57EA)
lopinavir/ ritonavir
— 2 presentations —
-
— Pruban
Laboratories US
— Intervet
-
— Dogs
Combination treatment - 133.3/33.3 mg, 80/20 mg/ml in combination of HIV- - 3 presentations
— Pruban — Intervet — Dogs — Cream —
- 14.12.2 000 - 145 days
— 18.8.2000
- -
Rescortol
1 infected patients
Anti-inflammatory for — 1 mg/g —
- 0 days
19.7.2000
- Bracco S.P.A. -I - V08DA
— 16.11.2000
Ultrasound agent to enhance the echogenicity of the blood
butyrate
- -
NL
Osteogenis Protein 1 Howmedia International Osteogenic Protein-1 BMP-7
cutaneous — 1 presentation —
- -
196 days
Stryker - Biotech US
— OJ C 2, 5.1.2001
M09AX Treatment of non-union of tibia of at least 9 month duration
inflammatory disorders
- Powder for suspension for implantation - 3.5 mg - 1 presentation
—B inflammatory disorders —
- 30.07.1999 - 14.12.2000 - 201 days - 297 days
477 days
- - - -
(QD07AC90)
-A
— Pirsue
77 EMEA General Report 2000
— Pharmacia
Annex 9:
— Dairy cattle
CVMP opinions in 2000 on medicinal products for veterinary use Centralised applications
— Pirsue — Pharmacia — Dairy cattle — Sterile solution for —
Product - Brandname - INN - Part A/B
12.1.1999
Company - Name - Origin
— 10.11.2000
Therapeutic area - Target species - Indication
— Pirlimycin
Presentation - Form - Dosage - Number of presentations
Upjohn
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
— Clinical & sub-clinical
Commission - Opinion received - Date of Decision - Notification - Official Journal
— Pirlimycin Upjohn — Clinical & sub-clinical intramammary use —
Ibraxion Inactivated vaccine Part A
11.10.2000
Merial F
—B —B
Cattle Vaccine against IBR (QJ57DA)
mastitis
Emulsion for injection 2 ml 1
—B —B mastitis — 5 mg/ml —
- 17.11.1998 - 10.11.1999 - 210 days - 176 days
210 days
- - - -
(QJ51FF90)
10.12.1999 09.03.
— 4 presentations —
00 10.03.
428 days
00 OJ C 95, 04.04.2000
— Zubrin
Metacam Meloxicam Part B extension
— Schering-Plough — Dogs
Boehringer Ingelheim D
— Treatment of pain &
Dogs Initiation therapy for alleviation of pain and inflammation (QM01AC06)
— Tepoxalin — UK — Treatment of pain & — 30, 50, 100 et 200 —
Solution for injection 5 mg/ml 1
—B inflammation mg/ml —
- - - -
330 days
10.12.1999 24.03.2000 27.03.2000 OJ C 120, 28.04.2000
— Eurican herpes
Incurin Oestriol Part B
— Merial
Intervet International NL
— Dogs
Dogs Hormone-dependent urinary incontinence (QG03CA04)
— Eurican herpes — Merial — Dogs — Powder plus solvent for —
Scored tablets 1 mg 1
13.7.1999
- 14.07.1998 - 08.12.1999 - 210 days - 302 days
— 8.12.2000
07.01.2000 24.03.2000 29.03.2000 OJ C 120, 28.04.2000
205 Inactivated vaccine
Rabigen SAG2 Virbac Live vaccine F Part A
—
Foxes Vaccine against rabies (QJ57HA)
Vaccine against canine herpes
Liquid within a blister pack embedded in a bait 8 log 10 CCID50 2
emulsion for injection — 1 ml —
- 23.03.1998 - 08.12.1999 - 196 days - 428 days
8.11.2000 209 days
07.01.2000 06.04.2000 10.04.2000 OJ C 120, 28.04.2000
—B — 2 presentations —
Eurifel FeLV Live vaccine Part A
274 days
Merial F
79 Rapport annuel EMEA 2000
Cats Vaccine against feline leukaemis (QJ57BA04)
Établissement de limites maximales de résidus pour les nouvelles substances
Pellet plus diluent 1 ml 3
Substance — DCI
- 12.01.1999 - 08.12.1999 - 183 days - 120 days
Domaine thérapeutique — Espèces visées
- - - -
EMEA-CVMP — Validation — Avis — Temps actif — Temps suspendu
12.11.1999 09.06.2000 14.06.2000 OJ C 183, 30.06.2000
Commission — Envoi à la Commission — Date du règlement — Journal officiel
Ibaflin Ibafloxacin Part B
Bismuth subnitrate (extension)
Intervet International NL
— Bovine
Dogs Pyoderma (QG51AC)
— — — —
Tablet 150 & 300mg 1
18.6.1999 13.10.1999 113 days 0 day
- 12.01.1999 - 09.02.2000 - 210 days - 184 days
— 12.11.1999 — 19.6.2000 — JO L 145, 20.6.2000
10.03.2000 13.06.2000 15.06.2000 OJ C 183, 30.06.2000
Acetyl isovaleryl tylosin tartrate
Metacam Meloxicam Part B (extension)
— Porcine
Boehringer Ingelheim D
— — — —
Dogs Post-operative pain (QM01AC06)
18.10.1995 13.10.1999 195 days 1 260 days
Solution for injection 5mg/ml 1
— 12.11.1999 — 19.6.2000 — JO L 145, 20.6.2000
- 02.01.2000 - 19.04.2000 - 101 days - 7 days
— Methylprednisolone
- - - -
— Bovine
28.04.2000 15.09.2000 18.09.2000 OJ C 277, 29.09.2000
— 12.11.1999 — 19.6.2000 — JO L 145, 20.6.2000
Econor Valnemulin Part B (extension)
Deltamethrin (extension)
Novartis A
— Fin fish
Pigs Prevention & treatment of dysentery (QJ01XX94)
— — — —
0.5% premix various 2
9.12.1999 8.3.2000 90 days 0 day
- 10.08.1999 - 19.04.2000 - 210 days - 43 days
— 7.4.2000 — 15.9.2000 — JO L 234, 16.9.2000
19.05.2000 15.09.2000 20.09.2000 OJ C 308, 27.10.2000
9.11.1999 8.3.2000 90 days 0 day
Econor Valnemulin Part B extension
— 7.4.2000 — 15.9.2000 — JO L 234, 16.9.2000
Novartis A
— Dicyclanil
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
— Ovine
10%/50% premix various 2
— — — —
- 12.10.1999 - 08.03.2000 - 148 days -0
25.2.1997 8.3.2000 281 days 825 days
07.04.2000 15.09.2000 20.09.2000 OJ No.
Tilmicosin (extension)
308, 27.10.2000
— — — —
Econor Valnemulin Part B (extension)
Flumequine (extension)
Novartis A
— Bovine milk & turkey
Pigs Prevention /treatment of dysentery and treatment/control of enzootic pneumonia (QJ01XX94)
— — — —
10%/50% premix various 2
27.7.1999 10.11.1999 89 days 0 day
- 12.10.1999 - 08.03.2000 - 148 days -0
— 9.12.1999 — 20.10.2000 — JO L 269, 21.10.2000
07.04.2000 15.09.2000 22.09.2000 OJ C 308, 27.10.2000
Tiamulin (extension)
78 EMEA General Report 2000
— Rabbit
Product - Brandname - INN - Part A/B
— — — —
Company - Name - Origin
14.10.1999 12.1.2000 90 days 0 day
Therapeutic area - Target species - Indication
— 11.2.2000 — 20.10.2000 — JO L 269, 21.10.2000
Presentation - Form - Dosage - Number of presentations
Dicyclanil (modification)
EMEA/CVMP - Validation - Opinion - Active time - Clock stop
23.2.2000 17.5.2000 84 days 0 day
Commission - Opinion received - Date of Decision - Notification - Official Journal
— 16.6.2000 — 27.10.2000 — JO L 276, 28.10.2000
Dicural Difloxacin Part B (extension)
Butafosfan (extension)
Fort Dodge Animal Health NL
— Dairy cattle
Cattle & pigs Antibacterial for systemic use (QJ01MA)
— — — —
Solution for injection 50 mg/ml 3
19.1.2000 19.4.2000 90 days 0 day
- 16.12.1998 - 21.06.2000 - 203 days - 351 days
— 19.5.2000 — 27.10.2000 — JO L 276, 28.10.2000
21.07.2000 24.10.2000 25.10.2000 OJ C 337, 28.11.2000
Tilmicosin (extension)
Poulflox Difloxacin Part B
— Bovine milk
F
— — — —