|
6.11.2014 |
DA |
Den Europæiske Unions Tidende |
C 391/3 |
Lægemidler — liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i første halvdel af 2013
2014/C 391/03
Underudvalg I for frie varebevægelser
Til Det Blandede EØS-udvalgs underretning
Under henvisning til afgørelse truffet af Det Blandede EØS-udvalg nr. 74/1999 af 28. maj 1999 opfordres Det Blandede EØS-udvalg til på sit møde den 4. april 2014 at notere sig følgende lister over markedsføringstilladelser for lægemidler udstedt i perioden 1. januar-30. juni 2013:
|
Bilag I |
Liste over nye markedsføringstilladelser |
|
Bilag II |
Liste over fornyede markedsføringstilladelser |
|
Bilag III |
Liste over udvidede markedsføringstilladelser |
|
Bilag IV |
Liste over tilbagetrukne markedsføringstilladelser |
|
Bilag V |
Liste over suspenderede markedsføringstilladelser |
BILAG I
Liste over nye markedsføringstilladelser
Følgende markedsføringstilladelser er blevet udstedt i EØS-EFTA-staterne i perioden 1. januar-30. juni 2013:
|
EU-nummer |
Vare |
Land |
Godkendelsesdato |
|
EU/1/12/788/001-006 |
Seebri Breezhaler |
Liechtenstein |
30.4.2013 |
|
EU/1/12/789/001-006 |
Enurev Breezhaler |
Liechtenstein |
30.4.2013 |
|
EU/1/12/790/001-006 |
Tovanor Breezhaler |
Liechtenstein |
30.4.2013 |
|
EU/1/12/791/001 |
Glybera |
Liechtenstein |
30.4.2013 |
|
EU/1/12/795/001-010 |
Forxiga |
Liechtenstein |
30.4.2013 |
|
EU/1/12/797/001-002 |
Eylea |
Liechtenstein |
30.4.2013 |
|
EU/1/12/803/001-002 |
NexoBrid |
Liechtenstein |
30.4.2013 |
|
EU/1/12/803/001-002 |
NexoBrid |
Island |
14.1.2013 |
|
EU/1/12/803/001-002 |
NexoBrid |
Norge |
11.1.2013 |
|
EU/1/12/804/001-016 |
BindRen |
Liechtenstein |
30.4.2013 |
|
EU/1/12/804/001-016 |
BindRen |
Island |
8.2.2013 |
|
EU/1/12/804/001-016 |
BindRen |
Norge |
27.2.2013 |
|
EU/1/12/805 |
Amyvid |
Liechtenstein |
28.2.2013 |
|
EU/1/12/805/001-004 |
AMYViD |
Island |
6.2.2013 |
|
EU/1/12/805/001-004 |
AMYViD |
Norge |
4.2.2013 |
|
EU/1/12/806/001-005 |
Ryzodeg |
Liechtenstein |
28.2.2013 |
|
EU/1/12/806/001-005 |
Ryzodeg |
Island |
20.2.2013 |
|
EU/1/12/806/001-005 |
Ryzodeg |
Norge |
12.2.2013 |
|
EU/1/12/807/001-009 |
Tresiba |
Liechtenstein |
28.2.2013 |
|
EU/1/12/807/001-009 |
Tresiba |
Island |
20.2.2013 |
|
EU/1/12/807/001-009 |
Tresiba |
Norge |
12.2.2013 |
|
EU/1/12/808/001-040 |
Imatinib Teva |
Liechtenstein |
28.2.2013 |
|
EU/1/12/808/001-040 |
Imatinib Teva |
Island |
5.2.2013 |
|
EU/1/12/808/001-040 |
Imatinib Teva |
Norge |
22.1.2013 |
|
EU/1/12/809/001-014 |
Betmiga |
Liechtenstein |
28.2.2013 |
|
EU/1/12/809/001-014 |
Betmiga |
Island |
10.1.2013 |
|
EU/1/12/809/001-014 |
Betmiga |
Norge |
17.1.2013 |
|
EU/1/12/810 |
Krystexxa |
Liechtenstein |
30.4.2013 |
|
EU/1/12/810/001 |
Krystexxa |
Island |
14.1.2013 |
|
EU/1/12/810/001 |
Krystexxa |
Norge |
25.1.2013 |
|
EU/1/12/811/001-005 |
Lyxumia |
Island |
12.2.2013 |
|
EU/1/12/811/001-005 |
Lyxumia |
Norge |
12.2.2013 |
|
EU/1/12/812 |
Bexsero |
Liechtenstein |
28.2.2013 |
|
EU/1/12/812/001-004 |
Bexsero |
Island |
14.2.2013 |
|
EU/1/12/812/001-004 |
Bexsero |
Norge |
4.2.2013 |
|
EU/1/12/814 |
Zaltrap |
Liechtenstein |
28.2.2013 |
|
EU/1/12/814/001-003 |
Zaltrap |
Island |
12.2.2013 |
|
EU/1/12/814/001-003 |
Zaltrap |
Norge |
27.2.2013 |
|
EU/1/12/815/001-005 |
Selincro |
Liechtenstein |
30.4.2013 |
|
EU/1/12/815/001-005 |
Selincro |
Island |
19.3.2013 |
|
EU/1/12/815/001-005 |
Selincro |
Norge |
11.3.2013 |
|
EU/1/13/813/001 |
Perjeta |
Liechtenstein |
30.4.2013 |
|
EU/1/13/813/001 |
Perjeta |
Island |
20.3.2013 |
|
EU/1/13/813/001 |
Perjeta |
Norge |
9.4.2013 |
|
EU/1/13/817/001-041 |
Actelsar HCT |
Island |
21.3.2013 |
|
EU/1/13/817/001-041 |
Actelsar HCT |
Norge |
22.4.2013 |
|
EU/1/13/818/001-004 |
Bosulif |
Island |
15.4.2013 |
|
EU/1/13/818/001-004 |
Bosulif |
Norge |
30.4.2013 |
|
EU/1/13/819/001 |
JETREA |
Liechtenstein |
30.4.2013 |
|
EU/1/13/819/001 |
JETREA |
Island |
11.4.2013 |
|
EU/1/13/819/001 |
JETREA |
Norge |
22.3.2013 |
|
EU/1/13/820/001-026 |
Maruxa |
Liechtenstein |
30.6.2013 |
|
EU/1/13/820/001-026 |
Maruxa |
Norge |
24.5.2013 |
|
EU/1/13/821/001-030 |
Tolucombi |
Liechtenstein |
30.4.2013 |
|
EU/1/13/821/001-030 |
Tolucombi |
Island |
21.3.2013 |
|
EU/1/13/821/001-030 |
Tolucombi |
Norge |
22.3.2013 |
|
EU/1/13/823/001-002 |
Adasuve |
Norge |
12.3.2013 |
|
EU/1/13/823/001-002 |
Adasuve |
Liechtenstein |
30.4.2013 |
|
EU/1/13/823/001-002 |
Adasuve |
Island |
18.3.2013 |
|
EU/1/13/824 |
Nemdatine |
Liechtenstein |
30.4.2013 |
|
EU/1/13/824/001-020 |
Nemdatine |
Island |
21.5.2013 |
|
EU/1/13/824/001-020 |
Nemdatine |
Norge |
3.5.2013 |
|
EU/1/13/825 |
Imatinib Actavis |
Liechtenstein |
30.6.2013 |
|
EU/1/13/825/001-018 |
Imatinib Actavis |
Island |
16.5.2013 |
|
EU/1/13/825/001-018 |
Imatinib Actavis |
Norge |
20.6.2013 |
|
EU/1/13/826 |
Memantine LEK |
Liechtenstein |
30.4.2013 |
|
EU/1/13/826/001-011 |
Memantine LEK |
Island |
21.5.2013 |
|
EU/1/13/826/001-011 |
Memantine LEK |
Norge |
3.5.2013 |
|
EU/1/13/827 |
Memantine Mylan |
Liechtenstein |
30.4.2013 |
|
EU/1/13/827/001-036 |
Memantine Mylan |
Island |
21.5.2013 |
|
EU/1/13/827/001-036 |
Memantine Mylan |
Norge |
3.5.2013 |
|
EU/1/13/828 |
Hexacima |
Liechtenstein |
30.4.2013 |
|
EU/1/13/828/001-007 |
Hexacima |
Island |
17.5.2013 |
|
EU/1/13/828/001-007 |
Hexacima |
Norge |
15.5.2013 |
|
EU/1/13/829 |
Hexyon |
Liechtenstein |
30.4.2013 |
|
EU/1/13/829/001-007 |
Hexyon |
Island |
17.5.2013 |
|
EU/1/13/829/001-007 |
Hexyon |
Norge |
15.5.2013 |
|
EU/1/13/830/001-002 |
Stribild |
Island |
19.6.2013 |
|
EU/1/13/830/001-002 |
Stribild |
Norge |
24.5.2013 |
|
EU/1/13/835/001-018 |
Voriconazole Accord |
Island |
31.5.2013 |
|
EU/1/13/835/001-018 |
Voriconazole Accord |
Norge |
31.5.2013 |
|
EU/1/13/836 |
Memantine ratiopharm |
Liechtenstein |
30.6.2013 |
|
EU/1/13/836/001-023 |
Memantine ratiopharm |
Norge |
25.6.2013 |
|
EU/1/13/840/001-005 |
HyQvia |
Island |
27.5.2013 |
|
EU/1/13/840/001-005 |
HyQvia |
Norge |
3.6.2013 |
|
EU/2/12/142/001-006 |
Cardalis |
Norge |
20.6.2013 |
|
EU/2/12/144/001-004 |
Contacera |
Liechtenstein |
28.2.2013 |
|
EU/2/12/144/001-004 |
Contacera |
Island |
3.1.2013 |
|
EU/2/12/144/001-004 |
Contacera |
Norge |
17.1.2013 |
|
EU/2/12/145/001-003 |
Kexxtone |
Liechtenstein |
30.4.2013 |
|
EU/2/12/145/001-003 |
Kexxtone |
Island |
27.2.2013 |
|
EU/2/12/145/001-003 |
Kexxtone |
Norge |
8.3.2013 |
|
EU/2/12/146/001 |
Semintra |
Liechtenstein |
30.4.2013 |
|
EU/2/12/146/001 |
Semintra |
Island |
12.3.2013 |
|
EU/2/12/146/001 |
Semintra |
Norge |
5.4.2013 |
|
EU/2/12/147/001-004 |
Pexion |
Liechtenstein |
30.4.2013 |
|
EU/2/12/147/001-004 |
Pexion |
Island |
19.3.2013 |
|
EU/2/12/147/001-004 |
Pexion |
Norge |
8.3.2013 |
|
EU/2/13/148 |
Meloxidolor |
Liechtenstein |
30.6.2013 |
|
EU/2/13/148/001-007 |
Meloxidolor |
Island |
21.5.2013 |
|
EU/2/13/148/001-007 |
Meloxidolor |
Norge |
22.4.2013 |
|
EU/2/13/149 |
ECOPORC SHIGA |
Liechtenstein |
30.4.2013 |
|
EU/2/13/149/001-002 |
ECOPORC SHIGA |
Island |
15.5.2013 |
|
EU/2/13/149/001-002 |
ECOPORC SHIGA |
Norge |
13.5.2013 |
|
EU/2/13/150 |
Oncept IL-2 |
Liechtenstein |
30.6.2013 |
|
EU/2/13/151/001-003 |
Equilis West Nile |
Island |
27.6.2013 |
BILAG II
Liste over fornyede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet fornyet i EØS-EFTA-staterne i perioden 1. januar-30. juni 2013:
|
EU-nummer |
Vare |
Land |
Godkendelsesdato |
|
EU/1/03/247 |
Forsteo |
Liechtenstein |
30.4.2013 |
|
EU/1/03/247/001-002 |
Forsteo |
Island |
19.2.2013 |
|
EU/1/03/247/001-002 |
Forsteo |
Norge |
6.3.2013 |
|
EU/1/07/423 |
Vectibix |
Liechtenstein |
30.4.2013 |
|
EU/1/07/423/001-003 |
Vectibix |
Island |
5.2.2013 |
|
EU/1/07/423/001-003 |
Vectibix |
Norge |
12.2.2013 |
|
EU/1/07/428/001 |
Abraxane |
Liechtenstein |
30.4.2013 |
|
EU/1/07/428/001 |
Abraxane |
Island |
5.2.2013 |
|
EU/1/07/428/001 |
Abraxane |
Norge |
11.2.2013 |
|
EU/1/07/430/001-002 |
Atripla |
Liechtenstein |
30.4.2013 |
|
EU/1/07/433/001 |
Nevanac |
Island |
9.1.2013 |
|
EU/1/07/434 |
Avamys |
Liechtenstein |
28.2.2013 |
|
EU/1/07/434/001-003 |
Avamys |
Island |
11.1.2013 |
|
EU/1/07/434/001-003 |
Avamys |
Norge |
14.1.2013 |
|
EU/1/07/435/001-018 |
Tesavel |
Liechtenstein |
30.4.2013 |
|
EU/1/07/438/001-006 |
Myfenax |
Liechtenstein |
30.4.2013 |
|
EU/1/07/439/001-006 |
Mycophenolate mofetil Teva |
Liechtenstein |
30.4.2013 |
|
EU/1/07/440 |
Tyverb |
Liechtenstein |
30.4.2013 |
|
EU/1/07/440/001-007 |
Tyverb |
Norge |
15.5.2013 |
|
EU/1/08/441 |
Effentora |
Liechtenstein |
30.4.2013 |
|
EU/1/08/441/001-010 |
Effentora |
Island |
20.3.2013 |
|
EU/1/08/441/001-010 |
Effentora |
Norge |
12.3.2013 |
|
EU/1/08/442/001-019 |
Pradaxa |
Norge |
26.2.2013 |
|
EU/1/08/442/001-019 |
Pradaxa |
Liechtenstein |
30.4.2013 |
|
EU/1/08/442/001-019 |
Pradaxa |
Island |
15.2.2013 |
|
EU/1/08/443/001 |
Thalidomide Celgene |
Island |
14.1.2013 |
|
EU/1/08/443/001 |
Thalidomide Celgene |
Norge |
16.1.2013 |
|
EU/1/08/446/001-006 |
Privigen |
Island |
22.3.2013 |
|
EU/1/08/446/001-006 |
Privigen |
Norge |
21.3.2013 |
|
EU/1/08/447/001-012 |
Adenuric |
Norge |
15.1.2013 |
|
EU/1/08/447/001-012 |
Adenuric |
Liechtenstein |
30.4.2013 |
|
EU/1/08/447/001-012 |
Adenuric |
Island |
14.1.2013 |
|
EU/1/08/448/001-002 |
Mycamine |
Liechtenstein |
30.4.2013 |
|
EU/1/08/448/001-002 |
Mycamine |
Island |
24.1.2013 |
|
EU/1/08/448/001-002 |
Mycamine |
Norge |
12.2.2013 |
|
EU/1/08/451 |
Volibris |
Liechtenstein |
30.4.2013 |
|
EU/1/08/451/001-004 |
Volibris |
Island |
5.2.2013 |
|
EU/1/08/451/001-004 |
Volibris |
Norge |
12.2.2013 |
|
EU/1/08/453 |
Prepandrix |
Liechtenstein |
30.4.2013 |
|
EU/1/08/453/002 |
Prepandrix |
Island |
6.2.2013 |
|
EU/1/08/453/002 |
Prepandrix |
Norge |
4.2.2013 |
|
EU/1/08/454/001-002, 005-007 |
Extavia |
Island |
9.1.2013 |
|
EU/1/08/454/001-002, 005-007 |
Extavia |
Liechtenstein |
30.4.2013 |
|
EU/1/08/454/001-002, 005-007 |
Extavia |
Norge |
10.1.2013 |
|
EU/1/08/455 |
Janumet |
Liechtenstein |
30.4.2013 |
|
EU/1/08/455/001-006 |
Janumet |
Norge |
10.4.2013 |
|
EU/1/08/455/001-016 |
Janumet |
Island |
25.3.2013 |
|
EU/1/08/456 |
Velmetia |
Liechtenstein |
30.4.2013 |
|
EU/1/08/456/001-016 |
Velmetia |
Island |
26.3.2013 |
|
EU/1/08/457 |
Efficib |
Liechtenstein |
30.4.2013 |
|
EU/1/08/457/001-016 |
Efficib |
Island |
26.3.2013 |
|
EU/1/08/461 |
Firazyr |
Liechtenstein |
30.4.2013 |
|
EU/1/08/461/001-002 |
Firazyr |
Island |
11.4.2013 |
|
EU/1/08/461/001-002 |
Firazyr |
Norge |
10.4.2013 |
|
EU/1/08/462 |
Ranexa |
Liechtenstein |
30.4.2013 |
|
EU/1/08/462/001-002 |
Ranexa |
Norge |
9.4.2013 |
|
EU/1/08/462/001-012 |
Ranexa |
Island |
20.3.2013 |
|
EU/1/08/463 |
Relistor |
Liechtenstein |
30.6.2013 |
|
EU/1/08/463/001-011 |
Relistor |
Island |
21.6.2013 |
|
EU/1/08/463/001-011 |
Relistor |
Norge |
26.6.2013 |
|
EU/1/08/465 |
Clopidogrel Zentiva |
Liechtenstein |
28.2.2013 |
|
EU/1/08/465/001-021 |
Clopidogrel Zentiva |
Island |
3.1.2013 |
|
EU/1/08/465/001-021 |
Clopidogrel Zentiva |
Norge |
5.2.2013 |
|
EU/1/08/467 |
Doribax |
Liechtenstein |
30.6.2013 |
|
EU/1/08/467/001-002 |
Doribax |
Island |
17.5.2013 |
|
EU/1/08/469 |
Oprymea |
Liechtenstein |
30.4.2013 |
|
EU/1/08/469/001-025 |
Oprymea |
Island |
14.5.2013 |
|
EU/1/08/469/001-025 |
Oprymea |
Norge |
24.5.2013 |
|
EU/1/08/472 |
Xarelto |
Liechtenstein |
30.6.2013 |
|
EU/1/08/472/001-033 |
Xarelto |
Norge |
13.6.2013 |
|
EU/1/08/472/001-033 |
Xarelto |
Island |
20.6.2013 |
|
EU/1/08/475 |
Olanzapine Mylan |
Liechtenstein |
30.6.2013 |
|
EU/1/08/475/001-060 |
Olanzapine Mylan |
Island |
20.6.2013 |
|
EU/1/08/475/001-060 |
Olanzapine Mylan |
Norge |
7.6.2013 |
|
EU/1/08/476 |
Adcirca |
Liechtenstein |
30.6.2013 |
|
EU/1/08/476/005-006 |
Adcirca |
Island |
31.5.2013 |
|
EU/1/08/476/005-006 |
Adcirca |
Norge |
4.6.2013 |
|
EU/1/10/625 |
Arzerra |
Liechtenstein |
30.4.2013 |
|
EU/1/10/625/001, 003 |
Arzerra |
Island |
15.3.2013 |
|
EU/1/10/625/001, 003 |
Arzerra |
Norge |
9.4.2013 |
|
EU/1/11/749 |
Caprelsa |
Liechtenstein |
30.4.2013 |
|
EU/1/11/749/001-002 |
Caprelsa |
Island |
12.3.2013 |
|
EU/1/11/749/001-002 |
Caprelsa |
Norge |
9.4.2013 |
|
EU/1/12/764 |
Pixuvri |
Liechtenstein |
30.4.2013 |
|
EU/1/12/764/001 |
Pixuvri |
Island |
12.4.2013 |
|
EU/1/12/764/001 |
Pixuvri |
Norge |
9.4.2013 |
|
EU/1/97/055/001-009 |
Viramune |
Liechtenstein |
30.4.2013 |
|
EU/1/97/055/001-009 |
Viramune |
Island |
14.1.2013 |
|
EU/1/97/055/001-009 |
Viramune |
Norge |
22.1.2013 |
|
EU/2/02/032/001-002 |
Vaxxitec HVT+IBD |
Norge |
11.6.2013 |
|
EU/2/03/037 |
ProteqFlu |
Liechtenstein |
30.4.2013 |
|
EU/2/03/037/005 |
ProteqFlu |
Island |
21.3.2013 |
|
EU/2/03/037/005 |
ProteqFlu |
Norge |
20.6.2013 |
|
EU/2/03/038 |
ProteqFlu-Te |
Liechtenstein |
30.4.2013 |
|
EU/2/03/038/005 |
ProteqFlu-Te |
Island |
21.3.2013 |
|
EU/2/03/038/005 |
ProteqFlu-Te |
Norge |
20.6.2013 |
|
EU/2/03/039 |
Advocate |
Liechtenstein |
28.2.2013 |
|
EU/2/03/039/001-054 |
Advocate |
Island |
19.2.2013 |
|
EU/2/03/039/001-054 |
Advocate |
Norge |
5.3.2013 |
|
EU/2/07/074/001-006 |
Prilactone |
Norge |
11.6.2013 |
|
EU/2/07/077/001-005 |
Meloxivet |
Norge |
5.4.2013 |
|
EU/2/07/078 |
Rheumocam |
Liechtenstein |
28.2.2013 |
|
EU/2/07/078/001-020 |
Rheumocam |
Island |
11.1.2013 |
|
EU/2/07/078/001-020 |
Rheumocam |
Norge |
21.1.2013 |
|
EU/2/07/079 |
Ingelvac CircoFLEX |
Liechtenstein |
30.4.2013 |
|
EU/2/07/079/001-008 |
Ingelvac CircoFLEX |
Island |
7.2.2013 |
|
EU/2/07/079/001-008 |
Ingelvac CircoFLEX |
Norge |
5.3.2013 |
|
EU/2/08/081/001-003 |
Posatex |
Island |
14.6.2013 |
|
EU/2/08/081/001-003 |
Posatex |
Norge |
11.6.2013 |
|
EU/2/08/083/001-005 |
Equioxx |
Island |
28.6.2013 |
|
EU/2/08/083/001-005 |
Equioxx |
Norge |
20.6.2013 |
BILAG III
Liste over udvidede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet udvidet i EØS-EFTA-staterne i perioden 1. januar-30. juni 2013:
|
EU-nummer |
Vare |
Land |
Godkendelsesdato |
|
EU/1/01/200/003-009 |
Viread |
Norge |
11.1.2013 |
|
EU/1/02/221/017 |
Pegasys |
Island |
26.3.2013 |
|
EU/1/02/221/017 |
Pegasys |
Norge |
26.3.2013 |
|
EU/1/06/380/006-007 |
Prezista |
Liechtenstein |
28.2.2013 |
|
EU/1/06/380/007 |
Prezista |
Island |
6.2.2013 |
|
EU/1/06/380/007 |
Prezista |
Norge |
11.2.2013 |
|
EU/1/07/433/002 |
Nevanac |
Norge |
24.5.2013 |
|
EU/1/07/436/003-004 |
Isentress |
Island |
19.3.2013 |
|
EU/1/07/436/003-004 |
Isentress |
Norge |
25.2.2013 |
|
EU/1/08/468/003 |
Intelence |
Norge |
17.4.2013 |
|
EU/1/09/538/009-010 |
Afinitor |
Island |
5.2.2013 |
|
EU/1/09/538/009-010 |
Afinitor |
Norge |
16.1.2013 |
|
EU/1/09/576/041-042 |
Irbesartan Teva |
Liechtenstein |
28.2.2013 |
|
EU/1/11/690/003-004 |
Zoely |
Liechtenstein |
28.2.2013 |
|
EU/1/11/693/017-024 |
Rivastigmine Actavis |
Island |
17.5.2013 |
|
EU/1/11/693/017-024 |
Rivastigmine Actavis |
Norge |
25.6.2013 |
|
EU/1/12/750/002 |
Esmya |
Liechtenstein |
28.2.2013 |
|
EU/1/12/770/005 |
Docetaxel Kabi |
Liechtenstein |
28.2.2013 |
|
EU/1/98/066/027-030 |
Exelon |
Island |
7.2.2013 |
|
EU/1/98/066/027-030 |
Exelon |
Norge |
12.2.2013 |
|
EU/1/98/077/020-023 |
Viagra |
Island |
17.5.2013 |
|
EU/1/98/077/020-023 |
Viagra |
Norge |
15.5.2013 |
|
EU/100/146/033/-037 |
Keppra |
Liechtenstein |
28.2.2013 |
|
EU/2/08/090/029-031 |
Loxicom |
Island |
21.3.2013 |
|
EU/2/08/090/029-031 |
Loxicom |
Norge |
6.3.2013 |
|
EU/2/10/115/016-019 |
Comfortis |
Island |
8.2.2013 |
|
EU/2/10/115/016-019 |
Comfortis |
Norge |
14.1.2013 |
|
EU/2/11/134/018-020 |
Inflacam |
Norge |
17.1.2013 |
BILAG IV
Liste over tilbagetrukne markedsføringstilladelser
Følgende markedsføringstilladelser er blevet trukket tilbage i EØS-EFTA-staterne i perioden 1. januar-30. juni 2013:
|
EU-nummer |
Vare |
Land |
Tilbagetrækningsdato |
|
EU/1/03/266 |
Bondenza |
Liechtenstein |
30.4.2013 |
|
EU/1/03/266/001-006 |
Bondenza |
Norge |
12.6.2013 |
|
EU/1/07/409 |
Riprazo |
Liechtenstein |
30.4.2013 |
|
EU/1/07/409/001-040 |
Riprazo |
Island |
27.5.2013 |
|
EU/1/07/409/001-040 |
Riprazo |
Norge |
14.3.2013 |
|
EU/1/08/458/001-014 |
Trevaclyn |
Island |
15.5.2013 |
|
EU/1/08/458/001-014 |
Trevaclyn |
Norge |
23.4.2013 |
|
EU/1/08/459/001-014 |
Tredaptive |
Island |
15.5.2013 |
|
EU/1/08/459/001-014 |
Tredaptive |
Norge |
23.4.2013 |
|
EU/1/08/460/001-014 |
Pelzont |
Island |
15.5.2013 |
|
EU/1/08/460/001-014 |
Pelzont |
Norge |
23.4.2013 |
|
EU/1/08/474/001-003 |
Alisade |
Island |
27.6.2013 |
|
EU/1/09/582/001 |
Rilonacept Regeneron |
Liechtenstein |
28.2.2013 |
|
EU/1/09/582/001 |
Rilonacept Regeneron |
Norge |
8.2.2013 |
|
EU/1/10/656/001-006 |
Possia |
Island |
15.4.2013 |
|
EU/1/10/656/001-006 |
Possia |
Norge |
12.6.2013 |
|
EU/1/11/683/001-080 |
Sprimeo HCT |
Norge |
21.3.2013 |
|
EU/1/12/754/001-021 |
Sepioglin |
Norge |
20.6.2013 |
|
EU/1/97/040/001-002 |
Teslascan |
Liechtenstein |
28.2.2013 |
|
EU/2/04/046 |
Nobivac Piro |
Liechtenstein |
30.6.2013 |
|
EU/2/04/046/001-003 |
Nobivac Piro |
Island |
3.6.2013 |
|
EU/2/04/046/001-003 |
Nobivac Piro |
Norge |
22.5.2013 |
BILAG V
Liste over suspenderede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet suspenderet i EØS-EFTA-staterne i perioden 1. januar-30. juni 2013:
|
EU-nummer |
Vare |
Land |
Suspensionsdato |
|
EU/1/09/509/001-004 |
Ribavirin Teva |
Norge |
3.1.2013 |
|
EU/1/09/527/001-006 |
Ribavirin Teva Pharma BV |
Norge |
3.1.2013 |