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Document E2006X1130(01)
List of marketing authorisations granted by the EEA EFTA States for the second half of 2005
List of marketing authorisations granted by the EEA EFTA States for the second half of 2005
List of marketing authorisations granted by the EEA EFTA States for the second half of 2005
OJ C 291, 30.11.2006, p. 69–77
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
30.11.2006 |
EN |
Official Journal of the European Union |
C 291/69 |
List of marketing authorisations granted by the EEA EFTA States for the second half of 2005
(2006/C 291/20)
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 2 June 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 June — 31 December 2005:
Annex I |
List of new marketing authorisations |
Annex II |
List of renewed marketing authorisations |
Annex III |
List of extended marketing authorisations |
Annex IV |
List of withdrawn marketing authorisations |
Annex V |
List of suspended marketing authorisations |
ANNEX I
1. New Marketing Authorisations:
The following marketing authorisations have been granted in the EEA EFTA States during the period 1 June — 31 December 2005:
EU-Number |
Product |
Country |
Date of authorisation |
EU/1/00/129/001-003 |
Azopt |
Liechtenstein |
31.7.2005 |
EU/1/00/131/001-030 |
PegIntron |
Liechtenstein |
30.9.2005 |
EU/1/00/134/008-011 |
Lantus |
Liechtenstein |
30.9.2005 |
EU/1/00/135/002 |
DaTSCAN |
Liechtenstein |
30.9.2005 |
EU/1/00/142/009-010 |
NovoMix |
Liechtenstein |
30.9.2005 |
EU/1/00/142/011-016 |
NovoMix |
Liechtenstein |
30.11.2005 |
EU/1/00/142/017-022 |
NovoMix |
Liechtenstein |
30.11.2005 |
EU/1/01/198/007-010 |
Glivec |
Liechtenstein |
31.7.2005 |
EU/1/02/215/001/NO-010/NO |
Pritor Plus |
Norway |
7.9.2005 |
EU/1/02/227/003 |
Neulasta |
Liechtenstein |
30.11.2005 |
EU/1/02/228/003 |
Neupopeg |
Liechtenstein |
30.11.2005 |
EU/1/03/255/001-003 |
Ventavis |
Liechtenstein |
30.11.2005 |
EU/1/03/258/013-014 |
Avandamet |
Liechtenstein |
30.9.2005 |
EU/1/03/263/001-003/IS |
Dukoral, Suspension of vaccine and effervescent granules for oral solution |
Iceland |
6.10.2005 |
EU/1/03/265/003-004 |
Bonviva |
Liechtenstein |
30.9.2005 |
EU/1/03/266/003-004 |
Bondenza |
Liechtenstein |
30.9.2005 |
EU/1/03/269/001 |
Faslodex |
Liechtenstein |
30.11.2005 |
EU/1/03/270/003 |
Kentera |
Liechtenstein |
31.7.2005 |
EU/1/04/276/021-032 |
Abilify |
Liechtenstein |
31.7.2005 |
EU/1/04/276/033-035 |
Abilify |
Liechtenstein |
30.11.2005 |
EU/1/04/279/030-032 |
Lyrica |
Liechtenstein |
30.9.2005 |
EU/1/04/280/007 |
Yentreve |
Liechtenstein |
30.9.2005 |
EU/1/04/283/007 |
Ariclaim |
Liechtenstein |
30.9.2005 |
EU/1/04/289/002 |
Angiox |
Liechtenstein |
31.7.2005 |
EU/1/04/296/005-006 |
Cymbalta |
Liechtenstein |
31.7.2005 |
EU/1/04/297/005-006 |
Xeristar |
Liechtenstein |
31.7.2005 |
EU/1/05/310/001/NO-005/NO |
Fosavance |
Norway |
6.9.2005 |
EU/1/05/310/001-005 |
Fosavance |
Liechtenstein |
30.9.2005 |
EU/1/05/310/001-005/IS |
Fosavance tablets |
Iceland |
20.9.2005 |
EU/1/05/311/001/NO-003/NO |
Tarceva |
Norway |
26.9.2005 |
EU/1/05/311/001-003 |
Tarceva |
Liechtenstein |
30.9.2005 |
EU/1/05/311/001-003/IS |
Tarceva |
Iceland |
18.10.2005 |
EU/1/05/312/001/IS |
Xyrem |
Iceland |
18.11.2005 |
EU/1/05/312/001/NO |
Xyrem |
Norway |
18.11.2005 |
EU/1/05/313/001/NO-009/NO |
Vasovist |
Norway |
14.10.2005 |
EU/1/05/313/001-009 |
Vasovist |
Liechtenstein |
30.11.2005 |
EU/1/05/313/001-009/IS |
Vasovist |
Iceland |
2.11.2005 |
EU/1/05/314/001 |
Kepivance |
Liechtenstein |
30.11.2005 |
EU/1/05/314/001/IS |
Kepivance |
Iceland |
24.11.2005 |
EU/1/05/314/001/NO |
Kepivance |
Norway |
22.11.2005 |
EU/1/05/315/001 |
Aptivus |
Liechtenstein |
30.11.2005 |
EU/1/05/315/001/IS |
Aptivus |
Iceland |
25.11.2005 |
EU/1/05/315/001/NO |
Aptivus |
Norway |
2.11.2005 |
EU/1/05/316/001/NO-014/NO |
Procoralan |
Norway |
10.11.2005 |
EU/1/05/316/001-014 |
Procoralan |
Liechtenstein |
30.11.2005 |
EU/1/05/316/001-014/IS |
Procoralan |
Iceland |
24.11.2005 |
EU/1/05/317/001/NO-014/NO |
Corlentor |
Norway |
10.11.2005 |
EU/1/05/317/001-014 |
Corlentor |
Liechtenstein |
30.11.2005 |
EU/1/05/317/001-014/IS |
Corlentor |
Iceland |
24.11.2005 |
EU/1/05/318/001 |
Revatio |
Liechtenstein |
30.11.2005 |
EU/1/05/318/001/IS |
Revatio |
Iceland |
28.11.2005 |
EU/1/05/318/001/NO |
Revatio |
Norway |
11.11.2005 |
EU/1/05/319/001/NO-002/NO |
Xolair |
Norway |
7.11.2005 |
EU/1/05/319/001-002 |
Xolair |
Liechtenstein |
30.11.2005 |
EU/1/05/319/001-002/IS |
Xolair |
Iceland |
25.11.2005 |
EU/1/05/320/001 |
Noxafil |
Liechtenstein |
30.11.2005 |
EU/1/05/320/001/IS |
Noxafil |
Iceland |
20.11.2005 |
EU/1/05/320/001/NO |
Noxafil |
Norway |
23.11.2005 |
EU/1/05/321/001 |
Posaconazole SP |
Liechtenstein |
30.11.2005 |
EU/1/05/321/001/IS |
Posaconazole SP |
Iceland |
24.11.2005 |
EU/1/05/321/001/NO |
Posaconazole SP |
Norway |
23.11.2005 |
EU/2/01/030/003-004 |
Virbagen Omega |
Liechtenstein |
30.9.2005 |
EU/2/04/047/001-002/IS |
Purevax RCPCh Fel V, powder and solv. for susp. for injection |
Iceland |
30.6.2005 |
EU/2/04/048/001-002/IS |
Purevax RCP Fel V, powder and solv. for susp. for injection |
Iceland |
30.6.2005 |
EU/2/04/049/001-002/IS |
Purevax RCCh, powder and solvent for suspension for injection |
Iceland |
30.6.2005 |
EU/2/04/050/001-002/IS |
Purevax RCPCh, powder and solv. for susp. for injection |
Iceland |
30.6.2005 |
EU/2/04/051/001-002/IS |
Purevax RC, powder and solvent for suspension for injection |
Iceland |
30.6.2005 |
EU/2/04/052/001-002/IS |
Purevax RCP, powder and solvent for suspension for injection |
Iceland |
30.6.2005 |
EU/2/05/053/001 |
Naxcel |
Liechtenstein |
31.7.2005 |
EU/2/05/053/001/IS |
Naxcel, suspension for injection |
Iceland |
9.6.2005 |
EU/2/05/053/001/NO |
Naxcel |
Norway |
17.6.2005 |
EU/2/05/054/001/NO-017/NO |
Profender |
Norway |
30.8.2005 |
EU/2/05/054/001-017 |
Profender |
Liechtenstein |
30.9.2005 |
EU/2/05/054/001-017/IS |
Profender Spot-on solution |
Iceland |
26.8.2005 |
EU/2/05/055/001/NO-002/NO |
Equilis Te |
Norway |
12.8.2005 |
EU/2/05/055/001-002 |
Equilis Te |
Liechtenstein |
30.9.2005 |
EU/2/05/055/001-002/IS |
Equilis Te, susp. for injection |
Iceland |
2.8.2005 |
EU/2/05/056/001/NO-002/NO |
Equilis Prequenza |
Norway |
12.8.2005 |
EU/2/05/056/001-002 |
Equilis Prequenza |
Liechtenstein |
30.9.2005 |
EU/2/05/056/001-002/IS |
Equilis Prequenza, susp. for injection |
Iceland |
2.08.2005 |
EU/2/05/057/001/NO-002/NO |
Equilis Prequenza Te |
Norway |
12.8.2005 |
EU/2/05/057/001-002 |
Equilis Prequenza Te |
Liechtenstein |
30.9.2005 |
EU/2/05/057/001-002/IS |
Equilis Prequenza Te, susp. for injection |
Iceland |
2.8.2005 |
EU/2/97/004/011 |
Metacam |
Liechtenstein |
31.7.2005 |
EU/2/97/004/012-013 |
Metacam |
Liechtenstein |
30.9.2005 |
ANNEX II
2. Renewed Marketing Authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 June — 31 December 2005:
EU-Number |
Product |
Country |
Date of renewal |
EU/1/00/129/001/NO-003/NO |
Azopt |
Norway |
30.6.2005 |
EU/1/00/129/001-003/IS |
Azopt, eye drops, suspension, 1% |
Iceland |
30.6.2005 |
EU/1/05/131/001/NO-005/NO |
PegIntron |
Norway |
24.06.2005 |
EU/1/00/131/001-050/IS |
PegIntron |
Iceland |
28.6.2005 |
EU/1/00/131/031-050 |
PegIntron |
Liechtenstein |
30.9.2005 |
EU/1/05/132/001/NO-005/NO |
ViraferonPeg |
Norway |
24.6.2005 |
EU/1/00/132/001-050 |
ViraferonPeg |
Liechtenstein |
31.7.2005 |
EU/1/00/132/001-050/IS |
ViraferonPeg |
Iceland |
28.6.2005 |
EU/1/00/133/001/NO-008/NO |
Optisulin |
Norway |
27.7.2005 |
EU/1/00/133/001-008 |
Optisulin |
Liechtenstein |
30.9.2005 |
EU/1/00/133/001-008/IS |
Optisulin |
Iceland |
29.8.2005 |
EU/1/00/134/001/NO-029/NO |
Lantus |
Norway |
27.7.2005 |
EU/1/00/134/001-007, 012-029 |
Lantus |
Liechtenstein |
30.9.2005 |
EU/1/00/134/001-029/IS |
Lantus |
Iceland |
29.8.2005 |
EU/1/00/135/001 |
DaTSCAN |
Liechtenstein |
30.9.2005 |
EU/1/00/135/001/NO-002/NO |
DaTSCAN |
Norway |
20.9.2005 |
EU/1/00/135/001-002/IS |
DaTSCAN |
Iceland |
11.10.2005 |
EU/1/00/137/001/NO-012/NO |
Avandia |
Norway |
27.7.2005 |
EU/1/00/137/001-012 |
Avandia |
Liechtenstein |
30.9.2005 |
EU/1/00/137/001-012/IS |
Avandia |
Iceland |
16.9.2005 |
EU/1/00/140/001 |
Visudyne |
Liechtenstein |
31.7.2005 |
EU/1/00/140/001/IS |
Visudyne 15 mg Powder for solution for injection |
Iceland |
14.7.2005 |
EU/1/00/140/001/NO |
Visudyne |
Norway |
27.7.2005 |
EU/1/00/141/001 |
Myocet |
Liechtenstein |
30.9.2005 |
EU/1/00/141/001/IS |
Myocet |
Iceland |
13.10.2005 |
EU/1/00/141/001/NO |
Myocet |
Norway |
28.9.2005 |
EU/1/00/142/004/NO-005/NO |
NovoMix Penfill |
Norway |
13.10.2005 |
EU/1/00/142/004-005 |
NovoMix |
Liechtenstein |
30.9.2005 |
EU/1/00/142/004-005/IS |
NovoMix 30 Penfill |
Iceland |
21.10.2005 |
EU/1/00/142/009/NO-010/NO |
NovoMix Flexpen |
Norway |
13.10.2005 |
EU/1/00/142/009-010/IS |
NovoMix 30 FlexPen |
Iceland |
21.10.2005 |
EU/1/00/143/001/NO-006/NO |
Kogenate Bayer |
Norway |
7.9.2005 |
EU/1/00/143/001-006 |
Kogenate |
Liechtenstein |
30.9.2005 |
EU/1/00/143/001-006/IS |
Kogenate Bayer |
Iceland |
7.10.2005 |
EU/1/00/144/001/NO-003/NO |
Helixate NexGen |
Norway |
7.9.2005 |
EU/1/00/144/001-003 |
Helixate |
Liechtenstein |
30.9.2005 |
EU/1/00/144/001-003/IS |
Helixate NexGen |
Iceland |
7.10.2005 |
EU/1/00/145/001 |
Herceptin |
Liechtenstein |
30.9.2005 |
EU/1/00/145/001/IS |
Herceptin |
Iceland |
28.11.2005 |
EU/1/00/145/001/NO |
Herceptin |
Norway |
23.9.2005 |
EU/1/00/146/001/NO-029/NO |
Keppra |
Norway |
08.8.2005 |
EU/1/00/146/001-029 |
Keppra |
Liechtenstein |
30.9.2005 |
EU/1/00/146/001-029/IS |
Keppra |
Iceland |
12.9.2005 |
EU/1/00/148/001/NO-004/NO |
Agenerase |
Norway |
12.12.2005 |
EU/1/00/148/001-004 |
Agenerase |
Liechtenstein |
30.11.2005 |
EU/1/00/148/001-004/IS |
Agenerase |
Iceland |
16.12.2005 |
EU/1/00/149/001 |
Panretin |
Liechtenstein |
30.11.2005 |
EU/1/00/149/001/IS |
Panretin |
Iceland |
16.12.2005 |
EU/1/00/149/001/NO |
Panretin |
Norway |
9.12.2005 |
EU/1/00/150/001/NO-015/NO |
Actos |
Norway |
2.11.2005 |
EU/1/00/150/001-015 |
Actos |
Liechtenstein |
30.11.2005 |
EU/1/00/150/001-015/IS |
Actos |
Iceland |
11.11.2005 |
EU/1/00/151/001/NO-013/NO |
Glustin |
Norway |
2.11.2005 |
EU/1/00/151/001-013 |
Glustin |
Liechtenstein |
30.11.2005 |
EU/1/00/151/001-013/IS |
Glustin |
Iceland |
11.11.2005 |
EU/1/00/152/001-018 |
Infanrix hexa |
Liechtenstein |
30.11.2005 |
EU/1/00/153/001-010 |
Infanrix penta |
Liechtenstein |
30.11.2005 |
EU/1/00/153/001-010/IS |
Infanrix penta |
Iceland |
16.12.2005 |
EU/1/00/153/001-010/NO |
Infanrix penta |
Norway |
7.12.2005 |
EU/1/00152/001-018/NO |
Infanrix hexa |
Norway |
7.12.2005 |
EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035/IS |
Gonal-F |
Iceland |
15.11.2005 |
EU/1/95/001/001/NO |
Gonal-F |
Norway |
11.11.2005 |
EU/1/95/001/003/NO-006/NO |
Gonal-F |
Norway |
11.11.2005 |
EU/1/95/001/009/NO |
Gonal-F |
Norway |
11.11.2005 |
EU/1/95/001/012/NO |
Gonal-F |
Norway |
11.11.2005 |
EU/1/95/001/021/NO-022/NO |
Gonal-F |
Norway |
11.11.2005 |
EU/1/95/001/025/NO-028/NO |
Gonal-F |
Norway |
11.11.2005 |
EU/1/95/001/031/NO-035/NO |
Gonal-F |
Norway |
11.11.2005 |
EU/1/98/093/002 |
Forcaltonin |
Liechtenstein |
31.7.2005 |
EU/1/99/127/001/NO-044/NO |
IntronA |
Norway |
20.6.2005 |
EU/1/99/127/001-044 |
IntronA |
Liechtenstein |
31.7.2005 |
EU/1/99/127/001-044/IS |
IntronA |
Iceland |
27.6.2005 |
EU/1/99/128/001/NO-037/NO |
Viraferon |
Norway |
20.6.2005 |
EU/1/99/128/001-037 |
Viraferon |
Liechtenstein |
31.7.2005 |
EU/1/99/128/001-037/IS |
Viraferon |
Iceland |
27.6.2005 |
EU/2/00/018/001 |
Incurin |
Liechtenstein |
31.7.2005 |
EU/2/00/018/001/NO |
Incurin |
Norway |
16.6.2005 |
EU/2/00/022//002b-03a |
Ibaflin |
Liechtenstein |
30.9.2005 |
EU/2/00/022/001/NO-017/NO |
Ibaflin |
Norway |
31.8.2005 |
EU/2/00/022/001-017/IS |
Ibaflin |
Iceland |
15.07.2005 |
EU/2/00/022/001a |
Ibaflin |
Liechtenstein |
30.9.2005 |
EU/2/00/022/001b-02a |
Ibaflin |
Liechtenstein |
30.9.2005 |
EU/2/00/022/003b-04a |
Ibaflin |
Liechtenstein |
30.9.2005 |
EU/2/00/022/004b |
Ibaflin |
Liechtenstein |
30.9.2005 |
EU/2/00/022/005-017 |
Ibaflin |
Liechtenstein |
30.9.2005 |
EU/2/00/024/001/IS |
Pruban |
Iceland |
16.12.2005 |
EU/2/99/016/001/NO-006/NO |
Porcilis Pesti |
Norway |
18.7.2005 |
EU/2/99/016/001-006 |
Porcilis Pesti |
Liechtenstein |
31.7.2005 |
EU/2/99/016/001-006/IS |
Porcilis Pesti |
Iceland |
13.7.2005 |
EU/2/99/017/001/NO-006/NO |
Ibraxion |
Norway |
2.6.2005 |
ANNEX III
3. Extended Marketing Authorisations
The following marketing authorisations have been extended in the EEA EFTA States during the period 1 June — 31 December 2005:
EU-Number |
Product |
Country |
Date of extention |
EU/1/00/142/011/NO-013/NO |
NovoMix Penfill 50 |
Norway |
1.11.2005 |
EU/1/00/142/001-013/IS |
NovoMix 50 Penfill suspension for injection |
Iceland |
5.10.2005 |
EU/1/00/142/014/NO-016/NO |
NovoMix Flexpen 50 |
Norway |
1.11.2005 |
EU/1/00/142/014-016/IS |
NovoMix 50 FlexPen suspension for injection |
Iceland |
5.10.2005 |
EU/1/00/142/017/NO-019/NO |
NovoMix Penfill 70 |
Norway |
1.11.2005 |
EU/1/00/142/017-019/IS |
NovoMix 70 Penfill suspension for injection |
Iceland |
5.10.2005 |
EU/1/00/142/020/NO-022/NO |
NovoMix Flexpen 70 |
Norway |
1.11.2005 |
EU/1/00/142/020-022/IS |
NovoMix 70 FlexPen suspension for injection |
Iceland |
5.10.2005 |
EU/1/03/265/003/NO-004/NO |
Bonviva, film-coated tablets |
Norway |
28.9.2005 |
EU/1/03/265/003-004/IS |
Bonviva, film-coated tablets |
Iceland |
25.10.2005 |
EU/1/03/266/003/NO-004/NO |
Bondenza, film-coated tablets |
Norway |
28.9.2005 |
EU/1/03/266/003-004/IS |
Bondenza, film-coated tablets |
Iceland |
21.10.2005 |
EU/1/04/276/021/NO-023/NO |
Abilify, orodispersible tablet 5 mg |
Norway |
18.7.2005 |
EU/1/04/276/021-023/IS |
Abilify, orodispersible tablet 5 mg |
Iceland |
14.7.2005 |
EU/1/04/276/024/NO-026/NO |
Abilify, orodispersible tablet 10 mg |
Norway |
18.7.2005 |
EU/1/04/276/024-026/IS |
Abilify, orodispersible tablet 10 mg |
Iceland |
14.7.2005 |
EU/1/04/276/027/NO-029/NO |
Abilify, orodispersible tablet 15 mg |
Norway |
18.7.2005 |
EU/1/04/276/027-029/IS |
Abilify, orodispersible tablet 15 mg |
Iceland |
14.7.2005 |
EU/1/04/276/030/NO-032/NO |
Abilify, orodispersible tablet 30 mg |
Norway |
18.7.2005 |
EU/1/04/276/030-032/IS |
Abilify, orodispersible tablet 30 mg |
Iceland |
14.7.2005 |
EU/1/04/276/033/NO-035/NO |
Abilify 1mg/ml, oral solution |
Norway |
9.11.2005 |
EU/1/04/276/033-035/IS |
Abilify 1 mg/ml, oral solution |
Iceland |
1.12.2005 |
EU/1/96/026/002/IS |
Invirase, filmcoated tablet 500 mg |
Iceland |
19.7.2005 |
EU/1/96/026/002/NO |
Invirase |
Norway |
9.6.2005 |
EU/2/97/004/012/NO-013/NO |
Metacam, 0,5 mg/ml oral suspension for dogs |
Norway |
5.9.2005 |
EU/2/97/004/012-013/IS |
Metacam, 0,5 mg/ml oral suspension for dogs |
Iceland |
2.9.2005 |
ANNEX IV
4. Withdrawn Marketing Authorisations
The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 June — 31 December 2005:
EU-Number |
Product |
Country |
Date of withdrawal |
EU/1/00/158/001-034/IS |
Opulis |
Iceland |
9.9.2005 |
EU/1/00/168/001/NO-006/NO |
Tenecteplase |
Norway |
9.8.2005 |
EU/1/00/168/001-006 |
Tenecteplase |
Liechtenstein |
30.9.2005 |
EU/1/02/208/001-008/IS |
Xapit |
Iceland |
9.9.2005 |
EU/1/02/210/001/NO-008/NO |
Rayzon |
Norway |
22.7.2005 |
EU/1/02/210/001-008 |
Rayzon |
Liechtenstein |
31.7.2005 |
EU/1/02/210/001-008/IS |
Rayzon |
Iceland |
5.7.2005 |
EU/1/02/242/001-024 |
Valdyn |
Liechtenstein |
30.9.2005 |
EU/1/02/242/001-024/IS |
Valdyn, filmcoated tablets |
Iceland |
5.07.2005 |
EU/1/02/244/001/NO-024/NO |
Valdyn |
Norway |
22.7.2005 |
EU/1/02/244/001-024/IS |
Valdyn |
Liechtenstein |
31.7.2005 |
EU/1/96/009/010/NO-017/NO |
Zerit |
Norway |
30.9.2005 |
EU/1/96/009/010-017/IS |
Zerit prolonged-release capsules |
Iceland |
29.11.2005 |
EU/1/96/023/001 |
Cea-Scan |
Liechtenstein |
30.11.2005 |
EU/1/96/023/001/IS |
CEA-Scan |
Iceland |
9.11.2005 |
EU/1/97/048/001-014/IS |
Infanrix HepB, suspension for injection |
Iceland |
15.6.2005 |
EU/2/00/023/001-003 |
Pulsaflox |
Liechtenstein |
30.11.2005 |
ANNEX V
5. Suspended Marketing Authorisations
The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 June — 31 December 2005:
EU-Number |
Product |
Country |
Date of suspension |
EU/1/00/147/001/NO-012/NO |
Hexavac |
Norway |
17.11.2005 |
EU/1/00/147/001-008 |
Hexavac |
Liechtenstein |
30.11.2005 |
EU/1/00/147/001-008/IS |
Hexavac |
Iceland |
17.11.2005 |