natgillin/translations-raw huggingface dataset:
(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
Rui DOS SANTOS IVO Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa Av. do Brasil, 53 P – 1749- 004 Lisboa Tlf.
PORTUGAL Rui DOS SANTOS IVO Presidente Conselho de Administraçao INFARMED Parque de Saúde de Lisboa Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
(351- 21) 798 71 02 Fax (351- 21) 798 71 20 E- mail: rsantos. ivo@ infarmed. pt Internet: http: // www. infarmed. pt
(351-21) 798 71 02 Fax (351-21) 798 71 20 E-mail: rsantos.ivo@infarmed.pt nternet: http://www.infarmed.pt
SVERIGE Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8 Box 26 S – 751 03 Uppsala Tlf.
SWEDEN Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8 Box 26 S - 751 03 Uppsala Tel.
(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
DET FORENEDE KONGERIGE
Dr Francisco CARMO REIS UNITED KINGDOM Chief Veterinary Officer
Gordon MUNRO Chief Executive Medicines Control Agency Market Towers, Room 1629 1 Nine Elms Lane London, SW8 5NQ United Kingdom Tlf.
Gordon MUNRO Chief Executive Medicines Control Agency Market Towers, Room 1629 1 Nine Elms Lane London SW8 5NQ United Kingdom Tel.
(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
(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
Steve DEAN Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey KT15 3LS United Kingdom Tlf.
Steve DEAN Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey KT15 3LS United Kingdom Tel.
(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
(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
EMEA’ s årsberetning for 2002
EMEA Annual Report 2002
EMEA 2003
49
EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Annex 6 EMEA budget summaries 2001-2003
Bilag 6 Sammendrag af EMEA' s budgetter for 2001 - 2003 Komparative budgetoversigter for perioden 2001- 2003:
The summarised comparative budget statements for 2001 to 2003 are as follows:
2001( 1)
20011
2002( 2)
2002 2
2003( 3)
2003 3
(31. 12. 2001)
Revenue
(31. 12. 2002)
(31.12.2001)
(19. 12. 2002)
(31.12.2002)
Indtægter Gebyrer Tilskud over EU' s almindelige budget
(19.12.2002)
45 14
Fees General EU contribution Special EU contribution for
771 000 700 000
45 771 000 14 700 000
69, 49% 22, 32%
69.49% 22.32%
39 17
3 9 17
000 000 135 000
000 000 135 000
63, 61% 27, 95%
63.61% 27.95%
142 000 500 000
48 14 2 000 15 500 000
61, 66% 19, 85%
61.66% 19.85%
Særligt EU- tilskud til IT - telematikstrategien Særligt EU- tilskud til lægemidler
IT telematics strategy Special EU contribution for
7
-
000 000
7 000 000
8, 97%
8.97%
til sjældne sygdomme Bidrag fra EØS Bidrag fra EU- programmer
orphan medicinal products Contribution from EEA Contribution from EU programmes
600 000 287 640
600 000 287 640
0, 91% 0, 44%
0.91% 0.44%
750 000 366 000
750 000 366 000
4, 49% 0, 60%
4.49% 0.60%
300 000 558 000
3 300 000 558 000
4, 23% 0, 71%
4.23% 0.71%
(PERF)
(PERF)
2
2 314 360
0, 35%
0.35%
430 000
1 430 000
1, 83%
1.83%
193 000
2 193 000
3, 00%
3.00%
151 000
2 151 000
2, 75%
2.75%
65 866 000
65 866 000 100.00%
61 304 000 100, 00%
61 304 000 100.00%
78 081 000
78 08 1 000 100.00%
Udgifter Personaleomkostninger Vederlag Vikarer og andre hjælpeansatte Andre personalerelaterede udgifter
Expenditure Staff Salaries Interim and other support persons Other staff-related expenditure Total title 1 Building/equipment
615 000 414 000 683 640
2 0 615 000 1 414 000 1 683 640 23 712 640
31, 30% 2, 15% 2, 55%
31.30% 2.15% 2.55% 36.00%
24 337 000 1 760 000 1 502 000
24 1 1 27
39, 70% 2, 87% 2, 45%
337 000 760 000 50 2 000 599 000
29 1 2
39.70% 2.87% 2.45% 45.02%
130 000 845 000 213 000
29 130 000 1 845 000 2 213 000 33 188 000
37, 31% 2, 36% 2, 83%
37.31% 2.36% 2.83% 42.50%
Afsnit 1 i alt Bygninger og udstyr
5 149 000 4 29 3 000 1 658 000 6 17 000
23
5 3
712 640
526 000 083 000 491 000 264 000
36, 00%
9.01% 5.03% 0.80% 0.43%
27 599 000
6 275 000 6 250 000 627 000 418 000
45, 02%
8.04% 8.00% 0.80% 0.54%
33
Other administrative expenditure Total title 2 Operational expenditure
188 000
1 829 000 13 546 000
42, 50%
2.78% 20.57%
5 4 1
2 11
149 000 293 000 658 000 617 000
043 000 407 000
7, 82% 6, 52% 2, 52% 0, 94%
3.33% 18.60%
5 526000 3 083 000 491 000 264 000
2 083 000 15 653 000
9, 01% 5, 03% 0, 80% 0, 43%
2.67% 20.05%
6 6
Meetings Evaluations Translation Studies and consultants Publications EU programmes
275 000 250 000 627 000 418 000
4 110 000 21 308 000 428 000 225 000 190 000 2 346 360
8, 04% 8, 00% 0, 80% 0, 54%
6.24% 32.35% 0.65% 0.34% 0.29% 3.56%
Andre administrative udgifter Afsnit 2 i alt Driftsudgifter
535 000 855 500 477 000 98 500 119 000 213 000
1 13
5.77% 29.13% 0.78% 0.16% 0.19% 0.34%
829 000 546 000
4 9 20 000 21 941 000 451 000 350 000 148 000 1 430 000
2, 78% 20, 57%
Total title 3
2 043 000 11 407 000
28 607 360
3, 33% 18, 60%
43.43%
2 15
22
083 000 653 000
298 000
2, 67% 20, 05%
29 240 000
Møder Vurderinger Oversættelse Undersøgelser og konsulenter Publikationer
37.45%
4 21
TOTAL EXPENDITURE
110 000 308 000 428 000 225 000 190 000
65 866 000 100.00%
6, 24% 32, 35% 0, 65% 0, 34% 0, 29%
61 304 000 100.00%
3 535 000 17 855 500 477 000 98 500 119 000
78 081 000 100.00%
5, 77% 29, 13% 0, 78% 0, 16% 0, 19%
1 50
4 21
Final appropriations for the EMEA Annual Report 2002
920 000 941 000 451 000 350 000 148 000
2
6, 30% 28, 10% 0, 58% 0, 45% 0, 19%
Final appropriations for the 2002 budget.
EU- programmer Afsnit 3 i alt
3
2 28
Annex 7 CPMP opinions in 2002 on medicinal products for human use
346 360 607 360
Centralised applications
3, 56% 43, 43%
Marketing authorisation holder
213 000 22 298 000
• Invanz • ertapenem
0, 34% 36, 38%
• Merck Sharp & Dohme
1 29
• J01DHXX • Parenteral treatment of moderate to severe infections caused by
430 000 240 000
• 26.12.2000 • 17.1.2002
1, 83% 37, 45%
• 17.2.2002 • 18.4.2002
UDGIFTER I ALT
• Part B
65 866 000
susceptible bacteria
100, 00%
• 212 days
61 304 000 100, 00%
• 22.4.2002
78 081 000
• 169 days
100, 00%
8
Bemærkninger
• •
(1) Endelige bevillinger opført på budgettet for 2001.
MicardisPlus telmisartan - hydrochlorothiazide
(2) Endelige bevillinger opført på budgettet for 2002.
• Boehringer Ingelheim
(3) Budgettet for 2003 som vedtaget af bestyrelsen den 19. 12. 2002.
C09DA Treatment of essential hypertension in patients whose blood pressure is not adequately
EMEA 2003 Side 65/ 88
• 24.4.2001 • 17.1.2002 • 148 days
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
• 25.2.2002 • 22.4.2002 • 23.4.2002
Bilag 7 CPMP- udtalelser i 2002 om humanmedicinske lægemidler
controlled on telmisartan alone
EMEA 2003 Side 66/ 88
• 115 days
Centraliserede ansøgninger
8
Indehaver af
• •
Behandlingsområde
• Glaxo Group
EMEA/ CPMP
• •
Europa- Kommissionen
• 24.4.2001 • 17.1.2002 • 148 days
Handelsnavn INN Del A eller B
Part B
markedsføringstilladelse
controlled on telmisartan alone
ATC- kode Resumé af indikation
• 115 days
Godkendelse Udtalelse Nettotid Urstop
8
Udtalelse modtaget Dato for afgørelsen Meddelelse EFT
BolusacPlus telmisartan - hydrochlorothiazide
Invanz ertapenem Part B
• Boehringer Ingelheim
Merck Sharp & Dohme
• •
J01DHXX Parenteral treatment of moderate to severe infections caused by susceptible bacteria
C09DA Treatment of essential hypertension in patients whose blood pressure is not adequately
26. 12. 2000 17. 1. 2002 212 days 169 days
• 24.4.2001 • 17.1.2002 • 148 days
8
• 25.2.2002 • 19.4.2002 • 23.4.2002
MicardisPlus telmisartan - hydrochlorothiazide Part B
•
Boehringer Ingelheim
Part B
C09DA Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone
controlled on telmisartan alone
24. 4. 2001 17. 1. 2002 148 days 115 days
• 115 days
25. 2. 2002 22. 4. 2002 23. 4. 2002 OJ C 129, 31. 5. 2002, p.
• OJ C 129, 31.5.2002, p.
PritorPlus telmisartan - hydrochlorothiazide Part B
• Merz Pharmaceuticals
Glaxo Group
• •
C09DA Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone
N06DX01 Treatment of patients with moderately severe to severe
24. 4. 2001 17. 1. 2002 148 days 115 days
• 26.9.2000 • 21.2.2002
25. 2. 2002 22. 4. 2002 24. 4. 2002 OJ C 129, 31. 5. 2002, p.
• 25.3.2002 • 17.5.2002
8
•
BolusacPlus telmisartan - hydrochlorothiazide Part B
Part B
Boehringer Ingelheim
Alzheimer disease
C09DA Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone
• 22.5.2002
24. 4. 2001 17. 1. 2002 148 days 115 days
• 295 days
25. 2. 2002 19. 4. 2002 23. 4. 2002 OJ C 129, 31. 5. 2002, p.
• OJ C 157, 2.7.2002, p.
Axura memantine Part B
• Tracleer # • bosentan
Merz Pharmaceuticals
• Actelion
N06DX01 Treatment of patients with moderately severe to severe Alzheimer disease
C02KX01 Symptomatic treatment of patients with pulmonary arterial
26. 9. 2000 21. 2. 2002 210 days 295 days
2.2002
2
• 25.3.2002 • 15.5.2002
Tracleer # bosentan Part B
• Part B
Actelion
hypertension
C02KX01 Symptomatic treatment of patients with pulmonary arterial hypertension
• 187 days
27. 2. 2001 21.
• 17.5.2002
2. 2002 187 days 167 days
• 167 days
25. 3. 2002 15. 5. 2002 17. 5. 2002 OJ C 129, 31. 5. 2002, p.
• OJ C 129, 31.5.2002, p.
Opatanol olopatadine Part B
• Opatanol • olopatadine
Alcon Laboratories
• Alcon Laboratories
S01GX09 Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis
S01GX09 Treatment of ocular signs and symptoms of seasonal allergic
27. 3. 2001 21. 2. 2002 223 days 101 days
• 101 days
23. 3. 2002 17. 5. 2002 22. 5. 2002 OJ C 157, 2. 7. 2002, p.
• OJ C 157, 2.7.2002, p.
EVRA norelgestromin - ethinylestradiol Part B
EVRA norelgestromin - ethinylestradiol
Janssen- Cilag
• Janssen-Cilag
G03AA Female Contraception
G03AA Female Contraception
27. 3. 2001 21. 2. 2002 177 days 147 days
• 177 days • 147 days
1. 7. 2002 22. 8. 2002 26. 8. 2002 OJ C 237, 2. 10. 2002, p.
• 26.8.2002 • OJ C 237, 2.10.2002, p.
Ebixa memantine Part B
Ebixa memantine
H.
• H.
Lundbeck
Lundbeck
N06DX01 Treatment of patients with moderately severe to severe Alzheimer disease
N06DX01 Treatment of patients with moderately severe to severe
22. 10. 2001 21. 2. 2002 55 days 64 days
• 64 days
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
• Tamiflu • oseltamivir
EMEA 2003 Side 67/ 88
• Roche
Lægemiddel Handelsnavn INN Del A eller B
• •
Indehaver af markedsføringstilladelse
J05AH02 Treatment of influenza and post- exposure prophylaxis of
Behandlingsområde ATC- kode Resumé af indikation
• 27.2.2001 • 21.3.2002
EMEA/ CPMP Godkendelse Udtalelse Nettotid Urstop
• 23.4.2002 • 20.6.2002
Tamiflu oseltamivir Part B
• Part B
J05AH02 Treatment of influenza and post- exposure prophylaxis of influenza
influenza
27. 2. 2001 21. 3. 2002 204 days
• 204 days
23. 4. 2002 20. 6. 2002 24. 6. 2002
• 24.6.2002
180 days
• 180 days
OJ C 178, 26. 7. 2002, p.
• OJ C 178, 26.7.2002, p.
Pegasys peginterferon alfa- 2a Part A
• Pegasys • peginterferon alfa-2a
Roche
• Roche
L03AB11 Treatment of chronic hepatitis C in adults
• L03AB11 • Treatment of chronic hepatitis C in adults
30. 1. 2001 21. 3. 2002 205 days 216 days
• 205 days • 216 days
19. 4. 2002 20. 6. 2002 24. 6. 2002 OJ C 178, 26. 7. 2002, p.
• 24.6.2002 • OJ C 178, 26.7.2002, p.
Velosulin insulin human, rDNA Part A
• Velosulin • insulin human, rDNA • Part A
Novo Nordisk
• Novo Nordisk
A10AB01 Treatment of diabetes mellitus
• A10AB01 • Treatment of diabetes mellitus
22. 5. 2001 25. 4. 2002 200 days 133 days
• 22.5.2001 • 25.4.2002 • 200 days • 133 days
1. 8. 2002 7. 10. 2002 9. 10. 2002 OJ C 258, 25. 10. 2002, p.
• 1.8.2002 • 7.10.2002 • 9.10.2002 • OJ C 258, 25.10.2002, p.
Monotard insulin human, rDNA Part A
• Monotard • insulin human, rDNA • Part A
A10AC01 Treatment of diabetes mellitus
• A10AC01 • Treatment of diabetes mellitus
17. 7. 2001 25. 4. 2002 200 days 78 days
• 17.7.2001 • 25.4.2002 • 200 days • 78 days
Ultratard insulin human, rDNA Part A
• Ultratard • insulin human, rDNA • Part A
A10AE01 Treatment of diabetes mellitus
• A10AE01 • Treatment of diabetes mellitus
Protaphane insulin human, rDNA Part A
• Protaphane • insulin human, rDNA • Part A
1. 8. 2002 7. 10. 2002 10. 10. 2002 OJ C 258, 25. 10. 2002, p.
• 1.8.2002 • 7.10.2002 • 10.10.2002 • OJ C 258, 25.10.2002, p.
Actraphane insulin human, rDNA Part A
• Actraphane • insulin human, rDNA • Part A
A10AD01 Treatment of diabetes mellitus
• A10AD01 • Treatment of diabetes mellitus
19. 6. 2001 25. 4. 2002 201 days 105 days
• 19.6.2001 • 25.4.2002 • 201 days • 105 days
Mixtard insulin human, rDNA Part A
• Mixtard • insulin human, rDNA • Part A
1. 8. 2002 7. 10. 2002 11. 10. 2002 OJ C 258, 25. 10. 2002, p.
• 1.8.2002 • 7.10.2002 • 11.10.2002 • OJ C 258, 25.10.2002, p.
Insulatard insulin human, rDNA Part A
• Insulatard • insulin human, rDNA • Part A
A10AC01 Treatment of Diabetes mellitus
• A10AC01 • Treatment of Diabetes mellitus
Actrapid insulin human, rDNA Part A
• Actrapid • insulin human, rDNA • Part A
Neupopeg pegfilgrastim Part A
Neupopeg pegfilgrastim
L03AA13 Reduction in the duration of neutropenia in patients treated with cytotoxic chemotherapy
L03AA13 Reduction in the duration of neutropenia in patients treated
22. 5. 2001 30. 5. 2002 177 days 191 days
• 191 days
5. 7. 2002 22. 8. 2002 26. 8. 2002 OJ C 237, 02. 10. 2002, p.
• OJ C 237, 02.10.2002, p.
Xigris drotrecogin alfa (activated) Part A
Xigris drotrecogin alfa (activated)
Eli Lilly Nederland
• Eli Lilly Nederland
B01AD10 Treatment of adult patients with severe sepsis with multiple organ failure, when added to best standard care
B01AD10 Treatment of adult patients with severe sepsis with multiple organ failure, when added to best
30. 1. 2001 30. 5. 2002 211 days 270 days
• 270 days
2. 7. 2002 22. 8. 2002 26. 8. 2002 OJ C 237, 02. 10. 2002, p.
• OJ C 237, 02.10.2002, p.
Lægemiddel Indehaver af
• Neulasta • pegfilgrastim
Behandlingsområde
• Amgen Europe
Europa- Kommissionen
L03AA13 Reduction in the duration of neutropenia in patients treated
Handelsnavn INN Del A eller B
• 22.5.2001 • 30.5.2002
markedsføringstilladelse
• 5.7.2002 • 22.8.2002
ATC- kode Resumé af indikation
• Part A
Godkendelse Udtalelse Nettotid Urstop
with cytotoxic chemotherapy
Neulasta pegfilgrastim Part A
• 177 days
Amgen Europe
• 26.8.2002
InductOs dibotermin alfa Part A
Product • Brand name • INN • Part A or B
Genetics Institute of Europe
• Genetics Institute of Europe
M05BC01 Adjunct treatment of tibia fractures in adults
• Adjunct treatment of tibia fractures in adults
27. 3. 2001 30. 5. 2002 210 days 224 days
• 210 days • 224 days
2. 7. 2002 9. 10. 2002 11. 9. 2002 OJ C 237, 02. 10. 2002, p.
• 11.9.2002 • OJ C 237, 02.10.2002, p.
Ambirix inactivated hepatitis A virus hepatitis B surface antigen, rDNA Part A
Ambirix inactivated hepatitis A
GlaxoSmithKline Biologicals
GlaxoSmithKline Biologicals
J07BC Immunisation against hepatitis A and B infections
Immunisation against hepatitis A and B infections
19. 6. 2001 30. 5. 2002 178 days 163 days
• 163 days
27. 6. 2002 30. 8. 2002 5. 9. 2002 OJ C 237, 02. 10. 2002, p.
• OJ C 237, 02.10.2002, p.
Cialis tadalafil Part B
Cialis tadalafil Part B
Lilly ICOS
Lilly ICOS
17. 7. 2001 25. 7. 2002 202 days 166 days
• 17.7.2001 • 25.7.2002 • 202 days • 166 days
26. 8. 2002 12. 11. 2002 14. 11. 2002
• 26.8.2002 • 12.11.2002 • 14.11.2002 •
Bextra valdecoxib Part B
• Bextra • valdecoxib
M01AH Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis. Treatment of primary dysmenorrhoea
M01AH Symptomatic relief in the treatment of osteoarthritis or
17. 7. 2001 25. 7. 2002 203 days 165 days
• 203 days
29. 8. 2002
• 165 days
Valdyn valdecoxib Part B
• Valdyn • valdecoxib
Pharmacia Europe
• Pharmacia Europe
M01AH Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis. Treatment of primary dysmenorrhoea.
M01AH Symptomatic relief in the treatment of osteoarthritis or
Valdecoxib Pharmacia Europe EEIG valdecoxib Part B
Valdecoxib Pharmacia Europe EEIG valdecoxib
M01AH Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis. Treatment of primary dysmenorrhoea
M01AH Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of
17. 7. 2001 25. 7. 2002 203 days 165 days
• 165 days
29. 8. 2002
• •
Kudeq valdecoxib Part B
Kudeq valdecoxib
Pfizer
• Pfizer
Valdecoxib- Pfizer Europe EEIG valdecoxib Part B
Valdecoxib-Pfizer Europe EEIG valdecoxib
M01AH Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis. Treatment of primary dysmenorrhoea.
M01AH Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of
Zavesca # miglustat Part B
Zavesca # miglustat
Oxford GlycoScience
• Oxford GlycoScience
A16AX06 Ttreatment of mild to moderate type 1 Gaucher disease when enzyme replacement therapy is unsuitable
A16AX06 Treatment of mild to moderate type 1 Gaucher disease when
17. 7. 2001 25. 7. 2002 200 days 168 days
• 17.7.2001 • 25.7.2002
26. 8. 2002 20. 11. 2002
• 26.8.2002 • 20.11.2002
121/ 2000.
•
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Part B
EMEA 2003 Side 69/ 88
enzyme replacement therapy is
Lægemiddel Handelsnavn INN Del A eller B
• 200 days
Behandlingsområde ATC- kode Resumé af indikation
unsuitable
EMEA/ CPMP Godkendelse Udtalelse Nettotid Urstop
• 168 days
Europa- Kommissionen Udtalelse modtaget Dato for afgørelsen Meddelelse EFT
•
Somavert # pegvisomant Part A
• Somavert # • pegvisomant
Pharmacia Enterprise
• Pharmacia Enterprise
H01AX (proposed) Treatment of patients with acromegaly who had an inadequte response to surgery and/ or radiation therapy and who did not respond to treatment with somatostatin analogues
H01AX (proposed) Treatment of patients with acromegaly who had an inadequte response to
29. 3. 2001 25. 7. 2002 177 days 299 days
• 177 days
26. 8. 2002 13. 11. 2002 15. 11. 2002
somatostatin analogues
Theryttrex yttrium( Y- 90) chloride Part B
• Theryttrex • yttrium(Y-90) chloride
MDS Nordion
• MDS Nordion
Pending Radiolabelling of carrier molecules, specifically developed and authorised for radiolabelling with this radionuclide
Pending Radiolabelling of carrier molecules, specifically developed
17. 9. 2001 19. 9. 2002 212 days 150 days
• 150 days
Carbaglu # carglumic acid Part B
• Carbaglu # • carglumic acid
Orphan Europe
• Orphan Europe
A16AA05 Treatment of hyperammonaemia due to N- acetylglutamate synthase deficiency
A16AA05 Treatment of hyperammonaemia due to N-acetylglutamate
22. 10. 2001 17. 10. 2002 191 days 164 days
• 164 days
Vivanza vardenafil Part B
• Vivanza • vardenafil • Part B
G04B E09 Treatment of erectile dysfunction
• G04B E09 • Treatment of erectile dysfunction
22. 4. 2002 21. 11. 2002 96 days 115 days
• 22.4.2002 • 21.11.2002 • 96 days • 11 5 days
Levitra vardenafil Part B
• Levitra • vardenafil • Part B
G04B E09 Treatment of erectile dysfunction
G04B E09 Treatment of erectile dysfunction
28. 1. 2002 21. 11. 2002 180 days 115 days
• 28.1.2002 • 21.11.2002 • 180 days • 115 days
Ytracis yttrium( Y- 90) Part B
• Ytracis • yttrium(Y-90)
CIS bio International
• CIS bio International
V10X Radiolabelling of carrier molecules, specifically developed and authorised for radiolabelling with this radionuclide
V10X Radiolabelling of carrier molecules, specifically developed
22. 10. 2001 21. 11. 2002 176 days 209 days
• 209 days
Hepsera adefovir dipivoxil Part B
• Hepsera • adefovir dipivoxil
Gilead Science
• Gilead Science
J05 (pending) Treatment of chronic hepatitis B in adults
J05 (pending) Treatment of chronic hepatitis B in adults
22. 4. 2002 21. 11. 2002 152 days 59 days
• 152 days • 59 days
Forsteo teriparatide
• Forsteo • teriparatide
Eli Lilly
• Eli Lilly
Treatment of established osteoporosis in postmenopausal women
Treatment of established osteoporosis in postmenopausal
19. 6. 2001 18. 12. 2002 207 days 339 days
• 207 days
121/ 2000.
• 339 days
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
54 EMEA Annual Report 2002
Bilag 8 CVMP- udtalelser i 2002 om veterinærlægemidler
Annex 8 CVMP opinions in 2002 on medicinal products for veterinary use
Lægemiddel Handelsnavn INN Del A eller B
Product • Brand name • INN • Part A or B
Behandlingsområde Tilsigtede dyrearter Resumé af indikation
Therapeutic area • Target species • Summary of indication
Europa- Kommissionen Udtalelse modtaget Dato for afgørelsen Meddelelse EFT
European Commission • Opinion received • Date of decision • Notification • Official Journal
Eurifel RCP FeLV Vaccine Part A
• Eurifel RCP-FelV • Vaccine
Mérial
• Mérial
Cats Vaccine against feline rhinotracheitis, calcivirus, panleucopenia and leukaemiac
panleucopenia and leukaemiac
19. 12. 2000 5. 12. 2001 210 days 141 days
• 141 days
4. 1. 2002 8. 3. 2002 12. 3. 2002 OJ C 77, 28. 3. 2002, p.
• OJ C 77, 28.3.2002, p.
Porcilis Porcoli Diluvac Forte Vaccine Part A extension
Porcilis Porcoli Diluvac Forte
Pigs (sows & gilts) Vaccine against neonatal diarrhoea
Vaccine against neonatal diarrhoea
16. 1. 2001 13. 2. 2002 210 days 183 days
• 13.2.2002 • 210 days • 183 days
15. 3. 2002 22. 5. 2002 24. 5. 2002 OJ C 157, 2. 7. 2002, p.
• 22.5.2002 • 24.5.2002 • OJ C 157, 2.7.2002, p.
Quadrisol Vedaprofen Part B extension
Quadrisol Vedaprofen
Dogs Control of inflammation and relief of pain
Dogs Control of inflammation and relief of pain
13. 2. 2001 13. 3. 2002 210 days 183 days
• 210 days • 183 days
12. 4. 2002 10. 7. 2002 15. 7. 2002 OJ C 178, 26. 7. 2002, p.
• 15.7.2002 • OJ C 178, 26.7.2002, p.
Metacam Meloxicam Part B extension
• Metacam • Meloxicam
Cats Alleviation of pain and inflammation
Cats Alleviation of pain and inflammation
13. 6. 2001 17. 4. 2002 210 days 99 days
• 210 days • 99 days
17. 5. 2002 9. 8. 2002 13. 8. 2002 OJ C 206, 30. 8. 2002, p.
• 13.8.2002 • OJ C 206, 30.8.2002, p.
Gallivac HVT IBD Live vaccine Part A
• Gallivac HVT IBD • Live vaccine
Chickens Infectious Bursal disease/ Marek’ s disease
Chickens Infectious Bursal disease/ Marek's disease
12. 7. 2000 17. 4. 2002 210 days 436 days
• 210 days • 436 days
Dexdomitor Dexmedetonidine Part B
• Dexdomitor • Dexmedetonidine • Part B
Orion Pharma
• Orion Pharma
Dogs and cats Restraint, sedation and analgesia
Dogs and cats Restraint, sedation and analgesia
15. 5. 2001 15. 5. 2002 210 days 155 days
• 15.5.2001 • 15.5.2002 • 210 days • 155 days
14. 6. 2002 30. 8. 2002 05. 9. 2002 OJ C 237, 2. 10. 2002, p.
• 14.6.2002 • 30.8.2002 • 5.9.2002 • OJ C 237, 2.10.2002, p.
Nobivac Bb Vaccine Part B
• Nobivac Bb • Vaccine
Cats Vaccine against Bordetella bronchiseptica
Cats Vaccine against Bordetella bronchiseptica
13. 2. 2001 12. 6. 2002 210 days 274 days
• 210 days • 274 days
12. 7. 2002 10. 9. 2002 12. 9. 2002 OJ C 237, 2. 10. 2002 p.
• 12.9.2002 • OJ C 237, 2.10.2002 p.
Sevoflo Sevoflurane Part B
• Sevoflo • Sevoflurane • Part B
Cyton Biosciences
• Cyton Biosciences
Dogs Inhalation anaesthetic
Dogs Inhalation anaesthetic
11. 7. 2001 4. 9. 2002 210 days 211 days
• 11.7.2001 • 4.9.2002 • 210 days • 211 days
5. 10. 2002 11. 12. 2002 13. 12. 2002 OJ C 2, 7. 1. 2003, p.
• 5.10.2002 • 11.12.2002 • 13.12.2002 • OJ C 2, 7.1.2003, p.
Nobilis OR inac Vaccine Part B
• Nobilis OR inac • Vaccine
Chickens Immunisation against ornithobacterium rhinotracheale
Chickens Immunisation against ornithobacterium rhinotracheale
18. 1. 2000 2. 10. 2002 206 days 783 days
• 206 days • 783 days
1. 11. 2002
• •
Proteqflu Vaccine Part A
• Proteqflu • Vaccine • Part A
Horses Vaccine against equine influenza
• Horses • Vaccine against equine influenza
13. 11. 2001 13. 11. 2002
• 13.12.2002 • • •
13. 12. 2002
EMEA Annual Report 2002
Proteqflu- Te Vaccine Part A
Product • Brand name • INN • Part A or B
Horses Vaccine against equine influenza and tetanus
• Horses • Vaccine against equine influenza and tetanus
13. 11. 2001 13. 11. 2002
• 13.11.2001 • 13.11.2002
13. 12. 2002
• 13.12.2002 •
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
• Part A
EMEA 2003 Side 71/ 88
• •