natgillin/translations-raw huggingface dataset:
LIECHTENSTEIN Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel
Martin HIRSCH Directeur Général Agence Française de Sécurité Sanitaire des Aliments 23, avenue du Général de Gaulle B. P.
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Rural Development Agriculture House Kildare Street
IRLAND
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alkvw.llv.li
Pat O’ MAHONY Irish Medicines Board The Earlsfort Centre Earlsfort Terrace IRL - Dublin 2 Tfn (353- 1) 676 49 71 Fax (353 1) 676 78 36 E- post: pat. omahony@ imb. ie Internet: http: // www. imb. ie
Dublin 2 Ireland Tel.
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Rural Development Agriculture House Kildare Street IRL - Dublin 2 Tfn.
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@agriculture.gov.ie
(353- 1) 607 24 34 Fax (353- 1) 676 29 89 E- post: seamus. healy@ agriculture. gov. ie
(354) 520 21 00 Fax (354) 561 21 70 E-mail: rannveig.gunnarsdottir@lyfjastofnun.is Internet: http://www.lyfjastofnun.is
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig ISLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Lyfjastofnun Eidistorg 13- 15 PO Box 180 IS – 172 Seltjarnarnes Tfn (354) 520 21 00 Fax (354) 561 21 70 E- post: rannveig. gunnarsdottir@ lyfjastofnun. is Internet: http: // www. lyfjastofnun. is
Martin HIRSCH ITALY
EMEA 2003 Sida 63/ 88
19 F - 94701 Maisons Alfort CEDEX Tel.
Nello MARTINI
(33-1) 49 77 13 99/26 54
Romano MARABELLI
Nello MARTINI Direttore Generale del Dipartimento della Valutazione dei Medicinali e della Farmacovigilanza Ministero della Salute Viale della Civiltà Romana, 7 I - 00144 Roma
Direttore Generale del Dipartimento della Valutazione dei Medicinali e della Farmacovigilanza Ministero della Salute Viale della Civiltà Romana, 7 I – 00144 Roma Tfn (39- 06) 59 94 36 66 Fax (39- 06) 59 94 34 56 E- post: n. martini@ sanita. it Internet: http: // www. sanita. it/ farmaci
Fax (33-1) 49 77 26 26 E-mail: m.hirsch@afssa.fr Internet: http://www.afssa.fr
(39- 06) 59 94 39 45/ 46 Fax (39- 06) 59 94 32 17 E- post: alimentivet@ sanita. it
Tel.
LUXEMBURG
(39-06) 59 94 36 66 Fax (39-06) 59 94 34 56 E-mail: n.martini@sanita.it Internet: http://www.sanita.it/farmaci
Mariette BACKES- LIES Pharmacien- Inspecteur - Chef de Division Direction de la Santé Division de la Pharmacie et des Médicaments Villa Louvigny – 1er étage Allée Marconi L – 2120 Luxembourg Tfn (352) 478 55 90 Fax (352) 26 20 01 40/ 47/ 49 E- post: mariette. backes- lies@ ms. etat. lu
EMEA Annual Report 2002
NEDERLÄNDERNA
Romano MARABELLI Direttore Generale del Dipartimento della Sanità Pubblica Veterinariadegli Alimenti e della Nutrizione Ministero della Salute Piazzale Marconi 25 I - 00144 Roma Tel.
Huib van de DONK Directeur College ter Beoordeling van Geneesmiddelen Ministerie van V. W. S.
(39-06) 59 94 39 45/46 Fax (39-06) 59 94 32 17 E-mail: alimentivet@sanita.it
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tfn (31- 70) 356 74 48 Fax (31- 70) 356 75 15 E- post: hj. vd. donk@ cbg- meb. nl Internet: http: // www. cbg- meb. nl
Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen Postbus 289 6700 AG Wageningen Nederland Tel.
Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen Postbus 289 6700 AG Wageningen Nederland Tel.
(31-31) 746 57 31 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl
(31- 31) 746 57 31 Fax (31- 31) 742 31 93 E- post: brd@ brd. agro. nl
LUXEMBOURG
NORGE
(47-22) 89 77 00 Fax (47-22) 89 77 99 E-mail: gro.wesenberg@NoMA.no Internet: http://www.legemiddelverket.no http://www.NoMA.no
Gro Ramsten WESENBERG Director General Statens legemiddelverk Sven Oftedals vei 6 N – 0950 Oslo Tfn (47- 22) 89 77 00 Fax (47- 22) 89 77 99 E- post: gro. wesenberg@ NoMA. no Internet: http: // www. legemiddelverket. no http: // www. NoMA. no
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel.
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig ÖSTERRIKE
(31-70) 356 74 48 Fax (31-70) 356 75 15
EMEA 2003 Sida 64/ 88
(43-1) 711 00 42 26 Fax (43-1) 711 00 48 30 E-mail: hubert.hrabcik@bmsg.gv.at
Hubert HRABCIK Bundesministerium für soziale Sicherheit und Generation Radetzkystraße 2 A – 1030 Wien Tfn (43- 1) 711 00 42 26 Fax (43- 1) 711 00 48 30 E- post: hubert. hrabcik@ bmsg. gv. at
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für soziale Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für soziale Sicherheit und Generationen Radetzkystraße 2 A – 1030 Wien Tfn (43- 1) 711 00 46 73 Fax (43- 1) 714 92 22 E- post: 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
(351-21) 798 71 02 Fax (351-21) 798 71 20 E-mail: rsantos.ivo@infarmed.pt nternet: http://www.infarmed.pt
Rui DOS SANTOS IVO Presidente Conselho de Administraçao INFARMED Parque de Saúde de Lisboa Av. do Brasil, 53 P – 1749- 004 Lisboa Tfn (351- 21) 798 71 02 Fax (351- 21) 798 71 20 E- post: rsantos. ivo@ infarmed. pt Internet: http: // www. infarmed. pt
Dr Francisco CARMO REIS UNITED KINGDOM Chief Veterinary Officer
Dr Francisco CARMO REIS Chief Veterinary Officer Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P – 1294- 105 Lisboa Tfn (351) 213 23 96 55 Fax (351) 213 46 35 18 E- post: freis@ dgv. min- agricultura. pt
(351-21) 323 96 55 Fax (351-21) 346 35 18 E-mail: freis@dgv.min-agricultura.pt FINLAND Hannes WAHLROOS
FINLAND Hannes WAHLROOS Ylijohtaja Lääkelaitos - Läkemedelsverket Mannerheimintie 166 PL 55 FIN – 00301 Helsinki Tfn (358- 9) 47 33 42 00 Fax (358- 9) 47 33 43 45 E- post: hannes. wahlroos@ nam. fi Internet: http: // www. nam. fi
Gordon MUNRO Chief Executive Medicines Control Agency Market Towers, Room 1629 1 Nine Elms Lane London SW8 5NQ United Kingdom Tel.
SVERIGE Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8 Box 26 S – 751 03 Uppsala Tfn (46- 18) 17 46 00 Fax (46- 18) 54 85 66 E- post: gunnar. alvan@ mpa. se Internet: http: // www. mpa. se
(44-20) 72 73 05 00 Fax (44-20) 72 73 05 95 E-mail: gordon.munro@mca.gsi.gov.uk Internet: http://www.open.gov.uk/mca
Gordon MUNRO Chief Executive Medicines Control Agency Market Towers, Room 1629 1 Nine Elms Lane London SW8 5NQ Förenade kungariket Tfn (44- 20) 72 73 05 00 Fax (44- 20) 72 73 05 95 E- post: gordon. munro@ mca. gsi. gov. uk Internet: http: // www. open. gov. uk/ mca
(44-1932) 33 83 01 Fax (44-1932) 33 66 18 E-mail: s.dean@vmd.defra.gsi.gov.uk Internet: http://www.open.gov.uk/vmd
Steve DEAN Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey KT15 3LS Förenade kungariket Tfn (44- 1932) 33 83 01 Fax (44- 1932) 33 66 18 E- post: s. dean@ vmd. defra. gsi. gov. uk Internet: http: // www. open. gov. uk/ vmd
The summarised comparative budget statements for 2001 to 2003 are as follows:
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig Bilaga 6 Budgetsammanfattningar för EMEA 2001- 2003 Nedan redovisas en jämförelse av budgetsammanfattningarna för åren 2001- 2003.
20011
EMEA 2003 Sida 65/ 88
2002 2
2001( 1) 2002( 2) (31. 12. 2001) (31. 12. 2002)
2003 3
2003( 3) (19. 12. 2002)
Revenue
Inkomster Avgifter EU: s allmänna bidrag EU: s telematikstrategibidrag EU: s särläkemedelsbidrag
(19.12.2002)
45 14
45 771 000 14 700 000
771 000 700 000 --
69.49% 22.32%
69, 49% 22, 32% --
3 9 17
39 000 17 135
000 000 135 000
000 000 --
63.61% 27.95%
63, 61% 27, 95% --
7 000 000
142 000 500 000 000 000
8.97%
61, 66% 19, 85% 8, 97%
orphan medicinal products Contribution from EEA Contribution from EU programmes
Bidrag från EES Bidrag från EU- program (PERF)
4.49% 0.60%
4, 49% 0, 60%
4.23% 0.71%
4, 23% 0, 71%
0.35%
0, 35%
1 430 000
430 000
1.83%
1, 83%
3.00%
3, 00%
2 151 000
151 000
2.75%
2, 75%
TOTAL REVENUE
SUMMA INKOMSTER
Expenditure Staff Salaries Interim and other support persons Other staff-related expenditure Total title 1 Building/equipment
Övriga personalkostnader Summa avdelning 1 Byggnader och utrustning
2 0 615 000 1 414 000 1 683 640 23 712 640
683 640 712 640
31.30% 2.15% 2.55% 36.00%
2, 55% 36, 00%
337 000 760 000 50 2 000 599 000
2, 45% 45, 02%
37.31% 2.36% 2.83% 42.50%
2, 83% 42, 50%
Rent/charges Expenditure on data processing Other capital expenditure Postage and communications
Hyra och avgifter Databehandling Övriga kapitalkostnader Porto och kommunikationer
5 149 000 4 29 3 000 1 658 000 6 17 000
149 000 293 000 658 000 617 000
7.82% 6.52% 2.52% 0.94%
7, 82% 6, 52% 2, 52% 0, 94%
9.01% 5.03% 0.80% 0.43%
9, 01% 5, 03% 0, 80% 0, 43%
8.04% 8.00% 0.80% 0.54%
8, 04% 8, 00% 0, 80% 0, 54%
Other administrative expenditure Total title 2 Operational expenditure
Övriga administrationskostnader Summa avdelning 2 Driftskostnader
1 829 000 13 546 000
829 000 546 000
2.78% 20.57%
2, 78% 20, 57%
043 000 407 000
3, 33% 18, 60%
2.67% 20.05%
2, 67% 20, 05%
Meetings Evaluations Translation Studies and consultants Publications EU programmes
Möten Utvärderingar Översättning Studier och konsulter Publikationer
4 110 000 21 308 000 428 000 225 000 190 000 2 346 360
110 000 308 000 428 000 225 000 190 000
6.24% 32.35% 0.65% 0.34% 0.29% 3.56%
6, 24% 32, 35% 0, 65% 0, 34% 0, 29%
5.77% 29.13% 0.78% 0.16% 0.19% 0.34%
5, 77% 29, 13% 0, 78% 0, 16% 0, 19%
6.30% 28.10% 0.58% 0.45% 0.19% 1.83%
6, 30% 28, 10% 0, 58% 0, 45% 0, 19%
Total title 3
EU- program Summa avdelning 3
28 607 360
346 360 607 360
43.43%
3, 56% 43, 43%
298 000
0, 34% 36, 38%
36.38%
1 29
29 240 000
430 000 240 000
37.45%
100, 00%
TOTAL EXPENDITURE
SUMMA UTGIFTER
2001 budget.
Noter (1) Slutliga anslag för 2001.
2
(2) Slutliga anslag för 2002.
Final appropriations for the 2002 budget.
(3) Budget för 2003 antagen av styrelsen den 19 december 2002.
3
EMEA 2003 Sida 66/ 88
Budget for 2003 as adopted by the Management Board on 19.12.2002.
Ansökningar enligt det centraliserade förfarandet Produkt
Annex 7 CPMP opinions in 2002 on medicinal products for human use
Innehavare av godkännande för
Product • Brand name • INN • Part A or B
INN Del A eller B
Marketing authorisation holder
Indikation
Therapeutic area • ATC code • Summary of indication
Yttrande Aktiv tid Inaktiv tid
EMEA/CPMP • Validation • Opinion • Active time • Clock stop
Beslutsdatum Kungörelsedatum EGT
• Invanz • ertapenem
Invanz ertapenem
C09DA Treatment of essential hypertension in patients whose blood pressure is not adequately
C09DA Treatment of essential hypertension in patients whose blood
controlled on telmisartan alone
pressure is not adequately controlled on telmisartan alone
• Glaxo Group
Glaxo Grupp
Axura memantine
Axura memantine
N06DX01 Treatment of patients with moderately severe to severe
N06DX01 Treatment of patients with moderately
Alzheimer disease
severe to severe Alzheimer disease
• Tracleer # • bosentan
Tracleer # bosentan
hypertension
pulmonary arterial hypertension
• 167 days
187 days 167 days
conjunctivitis
seasonal allergic conjunctivitis
• 101 days
223 days 101 days
• Tamiflu • oseltamivir
(#) Avser ett läkemedel som klassificerats enligt förordning (EG) nr 121/ 2000.
• Roche
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig
• •
ATC- kod
• 180 days
204 days 180 days
• OJ C 178, 26.7.2002, p.
24. 6. 2002 OJ C 178, 26. 7. 2002, p.
• Pegasys • peginterferon alfa-2a
Pegasys peginterferon alfa- 2a
Neupopeg pegfilgrastim
Neupopeg pegfilgrastim
L03AA13 Reduction in the duration of neutropenia in patients treated
L03AA13 Reduction in the duration of neutropenia in
• 22.5.2001 • 30.5.2002
22. 5. 2001 30. 5. 2002
with cytotoxic chemotherapy
patients treated with cytotoxic chemotherapy
• Amgen Europe
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig
• •
EMEA 2003 Sida 68/ 88
L03AA13 Reduction in the duration of neutropenia in patients treated
Produkt
• 22.5.2001 • 30.5.2002
Innehavare av godkännande för
• 5.7.2002 • 22.8.2002
Terapiområde
• Part A
EMEA/ CPMP
with cytotoxic chemotherapy
Europeiska kommissionen
• 177 days
Namn
• 26.8.2002
försäljning
• 191 days
ATC- kod
5
Validering
52 EMEA Annual Report 2002
Yttrandet inne
• InductOs
Neulasta pegfilgrastim
• M05BC01
L03AA13 Reduction in the duration of neutropenia in
• Adjunct treatment of tibia fractures in adults
patients treated with cytotoxic chemotherapy
GlaxoSmithKline Biologicals
Adjunct treatment of tibia fractures in
• 19.6.2001
9. 10. 2002
• 27.6.2002
adults
virus hepatitis B surface antigen, rDNA
210 days
• 30.5.2002 • 178 days
224 days
•
OJ C 237, 02. 10. 2002, p.
G04BE Treatment of erectile dysfunction
inactivated hepatitis A virus hepatitis B
• 17.7.2001 • 25.7.2002 • 202 days • 166 days
Immunisation against hepatitis A and B infections
• 203 days
30. 5. 2002 178 days
•
30. 8. 2002 5. 9. 2002
primary dysmenorrhoea
surface antigen, rDNA Part A
• 165 days
163 days
•
5
• Pharmacia Europe
Cialis tadalafil
• •
Lilly ICOS
M01AH Symptomatic relief in the treatment of osteoarthritis or
G04BE Treatment of erectile dysfunction
• 29.8.2002 •
26. 8. 2002 12. 11. 2002
• 203 days
202 days 166 days
primary dysmenorrhoea
Pharmacia- Pfizer EEIG
• 165 days
17. 7. 2001 25. 7. 2002
Valdecoxib Pharmacia Europe EEIG valdecoxib
Valdyn valdecoxib
M01AH Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of
M01AH Symptomatic relief in the treatment of
• 17.7.2001 • 25.7.2002 • 203 days
17. 7. 2001 25. 7. 2002
primary dysmenorrhoea
osteoarthritis or rheumatoid arthritis. Treatment of primary dysmenorrhoea.
Kudeq valdecoxib
Valdecoxib Pharmacia Europe EEIG valdecoxib
• Pfizer
Pharmacia Europe
M01AH Symptomatic relief in the treatment of osteoarthritis or
M01AH Symptomatic relief in the treatment of osteoarthritis or
• 17.7.2001 • 25.7.2002
17. 7. 2001 25. 7. 2002 203 days
rheumatoid arthritis.Treatment of
rheumatoid arthritis. Treatment of primary dysmenorrhoea
• 203 days
165 days
•
Pfizer
primary dysmenorrhoea
M01AH Symptomatic relief in the treatment of
Valdecoxib-Pfizer Europe EEIG valdecoxib
Valdecoxib- Pfizer Europe EEIG valdecoxib
M01AH Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of
M01AH Symptomatic relief in the treatment of osteoarthritis or
primary dysmenorrhoea
rheumatoid arthritis. Treatment of primary dysmenorrhoea.
• •
EMEA 2003 Sida 69/ 88
Zavesca # miglustat
Zavesca # miglustat
A16AX06 Treatment of mild to moderate type 1 Gaucher disease when
A16AX06 Treatment of mild to moderate type 1
enzyme replacement therapy is
Gaucher disease when enzyme replacement therapy is unsuitable
unsuitable
Terapiområde
• 168 days
EMEA/ CPMP
•
Namn
• Somavert # • pegvisomant
Yttrandet inne
• Pharmacia Enterprise
INN Del A eller B
• •
Indikation
H01AX (proposed) Treatment of patients with acromegaly who had an inadequte response to
Yttrande Aktiv tid Inaktiv tid
• 29.3.2001 • 25.7.2002
Beslutsdatum Kungörelsedatum EGT
• 26.8.2002 • 13.11.2002
Somavert # pegvisomant
Pending Radiolabelling of carrier molecules, specifically developed
Pending Radiolabelling of carrier molecules,
and authorised for radiolabelling
specifically developed and authorised for radiolabelling with this radionuclide
• Carbaglu # • carglumic acid
Carbaglu # carglumic acid
A16AA05 Treatment of hyperammonaemia due to N-acetylglutamate
A16AA05 Treatment of hyperammonaemia
synthase deficiency
due to N - acetylglutamate synthase deficiency
• Vivanza • vardenafil • Part B
Levitra vardenafil
V10X Radiolabelling of carrier molecules, specifically developed
V10X Radiolabelling of carrier molecules,
• Hepsera • adefovir dipivoxil
Hepsera adefovir dipivoxil
• Forsteo • teriparatide
Forsteo teriparatide
• •
#) Avser ett läkemedel som klassificerats enligt förordning (EG) nr 121/ 2000.
•
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig Bilaga 8 CVMP: s yttranden under 2002 om veterinärmedicinska läkemedel
women
Produkt
• 207 days
Terapiområde
•
EMEA/ CVMP
• 339 days
Europeiska kommissionen
54 EMEA Annual Report 2002
försäljning
Annex 8 CVMP opinions in 2002 on medicinal products for veterinary use
Validering
Centralised applications
Yttrandet inne
Therapeutic area • Target species • Summary of indication
Yttrande Aktiv tid Inaktiv tid
EMEA/CVMP • Validation • Opinion • Active time • Clock stop
Beslutsdatum Kungörelsedatum EGT
Chickens Immunisation against ornithobacterium rhinotracheale
Chickens Immunisation against ornithobacterium
• 18.1.2000 • 2.10.2002
18. 1. 2000 2. 10. 2002
• 1.11.2002 •
1. 11. 2002
• 206 days • 783 days
206 days 783 days
• Proteqflu • Vaccine • Part A
Proteqflu Vaccine Part A
• Horses • Vaccine against equine influenza
Horses Vaccine against equine influenza
EMEA Annual Report 2002
Proteqflu- Te Vaccine Part A
55
Merial
Product • Brand name • INN • Part A or B
Horses Vaccine against equine influenza and tetanus
Therapeutic area • Target species • Summary of indication
13. 11. 2001 13. 11. 2002
• Proteqflu-Te • Vaccine
13. 12. 2002
• Merial
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig
• Horses • Vaccine against equine influenza and tetanus
EMEA 2003 Sida 72/ 88
• 13.11.2001 • 13.11.2002
Innehavare av godkännande för
• 13.12.2002 •
Terapiområde
• Part A
EMEA/ CVMP
• •
Europeiska kommissionen
• •
Namn
Advocate Imidacloprid/ Moxidectin
Djurslag
• Bayer
Validering
• Dogs and cats • Antiparasitic
Yttrandet inne
• 18.12.2001 • 11.12.2002
INN Del A eller B
•
Yttrande Aktiv tid Inaktiv tid
Part B
Beslutsdatum Kungörelsedatum EGT
• 210 days • 149 days
Advocate Imidacloprid / Moxidectin Part B
• •
Bayer
• • •
18. 12. 2001 11. 12. 2002 210 days 149 days
Establishment of maximum residue limits for new substances
Fastställande av maximalt tillåtna restmängder för nya substanser Substansens INN
Substance INN
Terapiområde Djurslag
Therapeutic area • Target species
EMEA/ CVMP Validering Yttrande Aktiv tid Inaktiv tid
•
13. 5. 2002 1. 10. 2002 OJ L 264, 2. 10. 2002
• 6.9.2001
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig
EMEA Annual Report 2002
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig Bilaga 9 COMP: s yttranden under 2002 om klassificering av särläkemedel
Annex 9 COMP opinions in 2002 on designation of orphan medicinal products
EMEA 2003 Sida 74/ 88
Positive COMP designation opinions
Positiva yttranden
Summary of indication
Indikation
EMEA/COMP • Submission • Start Date • Opinion • Active Time
EMEA/ COMP Inlämnande Startdatum Yttrande Aktiv tid
European Commission • Opinion received • Date of decision
Europeiska kommissionen Yttrandet inne Beslutsdatum
• 4-(3,5-Bis(hdroxy-phenyl) -1,2,4) triazol-1-yl) benzoic acid (ICL670)
4 - (3, 5- Bis( hdroxy- phenyl) - 1, 2, 4)
• Treatment of chronic iron overload requiring chelation therapy
Treatment of
• 31.1.2002 • 13.3.2002
10. 10. 2001
•
31. 1. 2002
Beclomethasone 17, 21- dipropionate
triazol- 1- yl) benzoic acid (ICL670)
•
13. 3. 2002
Treatment of juvenile myelomonocytic leukaemia
Treatment of juvenile myelomonocyti c leukaemia
• 31.1.2002 • 22.3.2002
31. 1. 2002 22. 3. 2002
• Pseudomonas exotoxin (domains II/III)-
Pseudomonas exotoxin (domains
• PPD Global Ltd
PPD Global Ltd.
• 31.1.2002
16. 1. 2002
• 30.4.2002
28. 3. 2002
protein
II/ III) - Interleukin 13 chimeric protein
•
31. 1. 2002 26. 3. 2002 54 days
•
30. 4. 2002
• 11.1.2002
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig
• 28.3.2002
Indikation
• 31.1.2002 • 26.3.2002 • 54 days
EMEA/ COMP Inlämnande Startdatum Yttrande Aktiv tid
Treatment of visceral leishmaniasis
Treatment of adrenal cortical carcinoma
• 15.11.2001
14. 1. 2002 31. 2. 2002 30. 4. 2002 89 days
Mitotane (Lysodren)
Treatment of cystic fibrosis
•
07. 2. 2002
Treatment of adrenal cortical carcinoma
hydroxyphenyl) - 1- methyl - ethyl] phenoxy] methyl] phenyl] m ethoxy] - phenyl] iminomethyl] -, ethyl ester (Amelubant)
• 14.1.2002
25. 2. 2002 22. 5. 2002 86 days
•
26. 6. 2002
• 30.5.2002
Antisense NF -? Bp65
• 25.2.2002 • 22.5.2002
InDex Pharmaceuticals AB
• 26.6.2002
Treatment of
•
12. 3. 2002
SciClone Pharmaceuticals Italy S.r.l.
Oligonucletide (Kappaproct)
Antisense NF-KBp65 Oligonucletide (Kappaproct)
Treatment of ovarian cancer
Treatment of active ulcerative colitis
Myristolated- peptidyl - recombinant SCR1- 3 of human complement receptor type I
• 12.3.2002 • 25.3.2002 • 27.6.2002 • 94 days
Adprotech Ltd.
• 3.7.2002 • 30.7.2002
Prevention of post transplantation graft dysfunction
Treatment of ovarian cancer
Purified bromelain (Debrase Gel Dressing)
• 5.4.2002 • 22.4.2002 • 27.6.2002 • 66 days
Keith Judkins
• 3.7.2002 • 30.7.2002
Treatment of partial deep dermal and full thickness burns
• 3.7.2002 • 30.7.2002
Benzoic acid, sodium salt (Benzoate)
receptor type I
Ethicare GmbH
• 27.6.2002 • 94 days
Treatment of non - ketotic hyperglycinaem ia
EMEA Annual Report 2002
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig
59
EMEA 2003 Sida 76/ 88
• 19.8.2002 • 15.11.2002 • 89 days
Treatment of post - transplantation lymphoproliferati ve disorders
Treatment of inborn errors of primary bile acid synthesis
EMEA/ COMP Inlämnande Startdatum Yttrande Aktiv tid
• 27.6.2002 • 19.8.2002
Europeiska kommissionen Yttrandet inne Beslutsdatum
• 15.11.2002 • 89 days
Treatment of angioedema
AGEPS-EPHP Agence Générale des Équipements et Produits
plasma kallikrein (DX- 88)
• 29.8.2002 • 16.9.2002
18. 12. 2002
• 20.11.2002 • 18.12.2002
Cholic Acid
de Santé
AGEPS- EPHP Agence Générale des Équipements et Produits de Santé
• 15.11.2002 • 67 days
Treatment of inborn errors of primary bile acid synthesis
IDIS Ltd
3, 4 diaminopyridine phosphate
• Treatment of narcolepsy
AGEPS- EPHP Agence Générale des Équipements et Produits de Santé
• 28.8.2002
Treatment of Lambert- Eaton myasthenic syndrome
•
29. 8. 2002 16. 9. 2002 15. 11. 2002 67 days
G17(9) gastrin- Diphtheria Toxoid Conjugate
G17( 9) gastrin- Diphtheria Toxoid Conjugate
• Treatment of gastric cancer
Treatment of gastric cancer
Negative COMP designation opinions
Negativa yttranden
Annex 10 Guidelines and working documents in 2002
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig Bilaga 10 Riktlinjer och arbetsdokument 2002
Reference number
EMEA 2003 Sida 78/ 88
CPMP/BWP/2490/00
CPMP: s arbetsgrupp för bioteknik
Note for guidance on Cell Culture Inactivated Influenza Vaccines Annex to NfG on Harmonisation of requirements for Influenza Vaccines (CPMP/BWP/214/96)
Referensnummer Dokumenttitel CPMP/ BWP/ 2490/ 00 Note for guidance on Cell Culture Inactivated Influenza Vaccines Annex to NfG on Harmonisation of requirements for Influenza Vaccines (CPMP/ BWP/ 214/ 96)
Adopted January 2002
Status Antogs i januari 2002
Public Statement on Lactose prepared using Calf Rennet:
EMEA/ CPMP/ 571/ 02 Public Statement on Lactose prepared using Calf Rennet:
Adopted February 2002
Antogs i februari 2002
CPMP/BWP/6622/02
CPMP/ BWP/ 1793/ 01
Concept Paper on the Development of a CPMP Note for Guidance on requirements for the Evaluation of New Adjuvants in Vaccines
Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products
Adopted April 2002
Sändes ut på remiss i april 2002
CPMP/BWP/1412/02
CPMP/ BWP/ 6622/ 02
Testing for SV40 in Polio Virus Vaccines
Concept Paper on the Development of a CPMP Note for Guidance on requirements for the Evaluation of New Adjuvants in Vaccines
Adopted April 2002
Antaget i april 2002
CPMP/BWP/1571/02
CPMP/ BWP/ 1412/ 02 CPMP/ BWP/ 1571/ 02
CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use
Testing for SV40 in Polio Virus Vaccines CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use
Adopted April 2002
Utsänt på remiss i maj 2002
Adopted May 2002
Antogs i maj 2002
Adopted October 2002
Antaget i oktober 2002
CPMP ad hoc Working Group on Blood Products
CPMP: s ad hoc- arbetsgrupp för blodprodukter Referensnummer CPMP/ BPWG/ 2220/ 99
Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products
Dokumenttitel Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products
CPMP/BPWG/3226/99
CPMP/ BPWG/ 3226/ 99 CPMP/ BPWG/ 283/ 00
Core SPC for Human Plasma derived Antithrombin
Core SPC for Human Plasma derived Antithrombin Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use