ISSN 1977-0871
Den Europæiske Unions
Tidende
C 391
Dansk udgave
Meddelelser og oplysninger
57. årgang
6. november 2014
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ISSN 1977-0871 |
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Den Europæiske Unions Tidende |
C 391 |
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Dansk udgave |
Meddelelser og oplysninger |
57. årgang |
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Informationsnummer |
Indhold |
Side |
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II Meddelelser |
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MEDDELELSER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
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Europa-Kommissionen |
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2014/C 391/01 |
Beslutning om ikke at gøre indsigelse mod en anmeldt fusion (Sag M.7428 — Iridium/DIF/Concession Businesses) ( 1 ) |
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IV Oplysninger |
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OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
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Europa-Kommissionen |
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2014/C 391/02 |
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OPLYSNINGER VEDRØRENDE DET EUROPÆISKE ØKONOMISKE SAMARBEJDSOMRÅDE |
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Det Stående Udvalg for EFTA-staterne |
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2014/C 391/03 |
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2014/C 391/04 |
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V Øvrige meddelelser |
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ADMINISTRATIVE PROCEDURER |
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Det Europæiske Personaleudvælgelseskontor (EPSO) |
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2014/C 391/05 |
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Berigtigelser |
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2014/C 391/06 |
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(1) EØS-relevant tekst |
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DA |
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II Meddelelser
MEDDELELSER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER
Europa-Kommissionen
|
6.11.2014 |
DA |
Den Europæiske Unions Tidende |
C 391/1 |
Beslutning om ikke at gøre indsigelse mod en anmeldt fusion
(Sag M.7428 — Iridium/DIF/Concession Businesses)
(EØS-relevant tekst)
2014/C 391/01
Den 30. oktober 2014 besluttede Kommissionen ikke at gøre indsigelse mod ovennævnte anmeldte fusion og erklære den forenelig med det indre marked. Beslutningen er truffet efter artikel 6, stk. 1, litra b), i Rådets forordning (EF) nr. 139/2004 (1). Beslutningens fulde ordlyd foreligger kun på engelsk og vil blive offentliggjort, efter at eventuelle forretningshemmeligheder er udeladt. Den vil kunne ses:
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— |
under fusioner på Kommissionens websted for konkurrence (http://ec.europa.eu/competition/mergers/cases/). Dette websted giver forskellige muligheder for at finde de konkrete fusionsbeslutninger, idet de er opstillet efter bl.a. virksomhedens navn, sagsnummer, dato og sektor |
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— |
i elektronisk form på EUR-Lex-webstedet (http://eur-lex.europa.eu/homepage.html?locale=da) under dokument nr. 32014M7428. EUR-Lex giver online-adgang til EU-retten. |
(1) EUT L 24 af 29.1.2004, s. 1.
IV Oplysninger
OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER
Europa-Kommissionen
|
6.11.2014 |
DA |
Den Europæiske Unions Tidende |
C 391/2 |
Euroens vekselkurs (1)
5. november 2014
2014/C 391/02
1 euro =
|
|
Valuta |
Kurs |
|
USD |
amerikanske dollar |
1,2480 |
|
JPY |
japanske yen |
143,21 |
|
DKK |
danske kroner |
7,4426 |
|
GBP |
pund sterling |
0,78430 |
|
SEK |
svenske kroner |
9,2164 |
|
CHF |
schweiziske franc |
1,2043 |
|
ISK |
islandske kroner |
|
|
NOK |
norske kroner |
8,5740 |
|
BGN |
bulgarske lev |
1,9558 |
|
CZK |
tjekkiske koruna |
27,823 |
|
HUF |
ungarske forint |
309,05 |
|
LTL |
litauiske litas |
3,4528 |
|
PLN |
polske zloty |
4,2336 |
|
RON |
rumænske leu |
4,4193 |
|
TRY |
tyrkiske lira |
2,7919 |
|
AUD |
australske dollar |
1,4494 |
|
CAD |
canadiske dollar |
1,4281 |
|
HKD |
hongkongske dollar |
9,6747 |
|
NZD |
newzealandske dollar |
1,6135 |
|
SGD |
singaporeanske dollar |
1,6170 |
|
KRW |
sydkoreanske won |
1 360,83 |
|
ZAR |
sydafrikanske rand |
13,9000 |
|
CNY |
kinesiske renminbi yuan |
7,6310 |
|
HRK |
kroatiske kuna |
7,6628 |
|
IDR |
indonesiske rupiah |
15 223,74 |
|
MYR |
malaysiske ringgit |
4,1798 |
|
PHP |
filippinske pesos |
56,288 |
|
RUB |
russiske rubler |
55,3520 |
|
THB |
thailandske bath |
40,993 |
|
BRL |
brasilianske real |
3,1428 |
|
MXN |
mexicanske pesos |
16,9834 |
|
INR |
indiske rupee |
76,7511 |
(1) Kilde: Referencekurs offentliggjort af Den Europæiske Centralbank.
OPLYSNINGER VEDRØRENDE DET EUROPÆISKE ØKONOMISKE SAMARBEJDSOMRÅDE
Det Stående Udvalg for EFTA-staterne
|
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 |
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Bilag II |
Liste over fornyede markedsføringstilladelser |
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Bilag III |
Liste over udvidede markedsføringstilladelser |
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Bilag IV |
Liste over tilbagetrukne markedsføringstilladelser |
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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 |
|
6.11.2014 |
DA |
Den Europæiske Unions Tidende |
C 391/15 |
Lægemidler — liste over markedsføringstilladelser udstedt af EØS-EFTA-staterne i anden halvdel af 2013
2014/C 391/04
Underudvalg I for frie varebevægelser
Til Det Blandede EØS-udvalgs underretning
Under henvisning til Det Blandede EØS-udvalg afgørelse nr. 74/1999 af 28. maj 1999 opfordres Det Blandede EØS-udvalg til på sit møde den 16. maj 2014 at notere sig følgende lister over markedsføringstilladelser for lægemidler for perioden 1. juli-31. december 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. juli-31. december 2013:
|
EU-nummer |
Vare |
Land |
Godkendelsesdato |
|
EU/1/13/818/001-004 |
Bosulif |
Liechtenstein |
31.8.2013 |
|
EU/1/13/820 |
Marixino |
Island |
22.8.2013 |
|
EU/1/13/822 |
PHEBURANE |
Island |
21.8.2013 |
|
EU/1/13/822 |
PHEBURANE |
Norge |
29.8.2013 |
|
EU/1/13/830 |
Stribild |
Norge |
1.7.2013 |
|
EU/1/13/831 |
Capecitabin SUN |
Liechtenstein |
31.8.2013 |
|
EU/1/13/831 |
Capecitabine SUN |
Island |
19.7.2013 |
|
EU/1/13/831 |
Capecitabine SUN |
Norge |
26.7.2013 |
|
EU/1/13/832 |
Stayveer |
Liechtenstein |
31.8.2013 |
|
EU/1/13/832 |
Stayveer |
Island |
19.7.2013 |
|
EU/1/13/832 |
Stayveer |
Norge |
24.7.2013 |
|
EU/1/13/833 |
Nuedexta |
Liechtenstein |
31.8.2013 |
|
EU/1/13/833 |
NUEDEXTA |
Island |
24.7.2013 |
|
EU/1/13/833 |
Nuedexta |
Norge |
3.7.2013 |
|
EU/1/13/836 |
Memantine Ratiopharm |
Island |
9.8.2013 |
|
EU/1/13/838 |
AUBAGIO |
Liechtenstein |
31.10.2013 |
|
EU/1/13/838 |
AUBAGIO |
Island |
9.9.2013 |
|
EU/1/13/838 |
AUBAGIO |
Norge |
18.9.2013 |
|
EU/1/13/839 |
Iclusig |
Liechtenstein |
31.10.2013 |
|
EU/1/13/839 |
Iclusig |
Island |
19.7.2013 |
|
EU/1/13/839 |
Iclusig |
Norge |
23.7.2013 |
|
EU/1/13/840 |
HyQvia |
Liechtenstein |
31.10.2013 |
|
EU/1/13/841 |
Spedra |
Liechtenstein |
31.8.2013 |
|
EU/1/13/841 |
Spedra |
Island |
19.7.2013 |
|
EU/1/13/841 |
Spedra |
Norge |
19.7.2013 |
|
EU/1/13/842 |
Incresync |
Liechtenstein |
31.10.2013 |
|
EU/1/13/842 |
Incresync |
Island |
14.10.2013 |
|
EU/1/13/842 |
Incresync |
Norge |
10.10.2013 |
|
EU/1/13/843 |
Vipdomet |
Liechtenstein |
31.10.2013 |
|
EU/1/13/843 |
Vipdomet |
Island |
15.10.2013 |
|
EU/1/13/843 |
Vipdomet |
Norge |
10.10.2013 |
|
EU/1/13/844 |
Vipidia |
Liechtenstein |
31.10.2013 |
|
EU/1/13/844 |
Vipidia |
Island |
15.10.2013 |
|
EU/1/13/844 |
Vipidia |
Norge |
10.10.2013 |
|
EU/1/13/845 |
Imatinib Accord |
Island |
18.7.2013 |
|
EU/1/13/845 |
Imatinib Accord |
Norge |
18.7.2013 |
|
EU/1/13/846 |
Xtandi |
Island |
19.7.2013 |
|
EU/1/13/846 |
Xtandi |
Norge |
17.7.2013 |
|
EU/1/13/847 |
MACI |
Liechtenstein |
31.8.2013 |
|
EU/1/13/847 |
MACI |
Island |
24.7.2013 |
|
EU/1/13/847 |
MACI |
Norge |
17.7.2013 |
|
EU/1/13/848 |
Erivedge |
Liechtenstein |
31.8.2013 |
|
EU/1/13/848 |
Erivedge |
Island |
8.8.2013 |
|
EU/1/13/848 |
Erivedge |
Norge |
13.8.2013 |
|
EU/1/13/849 |
Somatropin Biopartners |
Liechtenstein |
31.8.2013 |
|
EU/1/13/849 |
Somatropin Biopartners |
Island |
22.8.2013 |
|
EU/1/13/849 |
Somatropin Biopartners |
Norge |
10.9.2013 |
|
EU/1/13/850 |
Pomalidomide Celgene |
Island |
23.8.2013 |
|
EU/1/13/850 |
Pomalidomide Celgene |
Liechtenstein |
31.10.2013 |
|
EU/1/13/850 |
Pomalidomide Celgene |
Norge |
15.8.2013 |
|
EU/1/13/851 |
Lojuxta |
Liechtenstein |
31.8.2013 |
|
EU/1/13/851 |
Lojuxta |
Island |
21.8.2013 |
|
EU/1/13/851 |
Lojuxta |
Norge |
28.8.2013 |
|
EU/1/13/852 |
Atosiban SUN |
Liechtenstein |
31.8.2013 |
|
EU/1/13/852 |
Atosiban SUN |
Island |
20.8.2013 |
|
EU/1/13/852 |
Atosiban SUN |
Norge |
29.8.2013 |
|
EU/1/13/853 |
Remsima |
Liechtenstein |
31.10.2013 |
|
EU/1/13/853 |
Remsima |
Island |
20.9.2013 |
|
EU/1/13/853 |
Remsima |
Norge |
17.9.2013 |
|
EU/1/13/854 |
Inflectra |
Liechtenstein |
31.10.2013 |
|
EU/1/13/854 |
Inflectra |
Island |
20.9.2013 |
|
EU/1/13/854 |
Inflectra |
Norge |
10.10.2013 |
|
EU/1/13/855 |
Imvanex |
Liechtenstein |
31.8.2013 |
|
EU/1/13/855 |
IMVANEX |
Island |
23.8.2013 |
|
EU/1/13/855 |
Imvanex |
Norge |
17.9.2013 |
|
EU/1/13/856 |
Lonquex |
Island |
20.8.2013 |
|
EU/1/13/856 |
Lonquex |
Norge |
23.8.2013 |
|
EU/1/13/857 |
Voncento |
Liechtenstein |
31.10.2013 |
|
EU/1/13/857 |
Voncento |
Island |
11.10.2013 |
|
EU/1/13/857 |
Voncento |
Norge |
16.9.2013 |
|
EU/1/13/858 |
Stivarga |
Liechtenstein |
31.10.2013 |
|
EU/1/13/858 |
Stivarga |
Island |
19.9.2013 |
|
EU/1/13/858 |
Stivarga |
Norge |
9.9.2013 |
|
EU/1/13/859 |
Levodopa/Carbidopa/Entacapone Sandoz |
Island |
22.11.2013 |
|
EU/1/13/859 |
Levodopa/Carbidopa/Entacapone Sandoz |
Norge |
10.12.2013 |
|
EU/1/13/860 |
Nexium Control |
Liechtenstein |
31.10.2013 |
|
EU/1/13/860 |
Nexium Control |
Island |
9.9.2013 |
|
EU/1/13/860 |
Nexium Control |
Norge |
6.9.2013 |
|
EU/1/13/861 |
Procysbi |
Liechtenstein |
31.10.2013 |
|
EU/1/13/861 |
Procysbi |
Island |
23.9.2013 |
|
EU/1/13/861 |
Procysbi |
Norge |
24.9.2013 |
|
EU/1/13/862 |
Ultibro Breezhaler |
Liechtenstein |
31.10.2013 |
|
EU/1/13/862 |
Ultibro Breezhaler |
Island |
15.10.2013 |
|
EU/1/13/862 |
Ultibro Breezhaler |
Norge |
18.10.2013 |
|
EU/1/13/863 |
Xoterna Breezhaler |
Liechtenstein |
31.10.2013 |
|
EU/1/13/863 |
Xoterna Breezhaler |
Island |
14.10.2013 |
|
EU/1/13/863 |
Xoterna Breezhaler |
Norge |
18.10.2013 |
|
EU/1/13/865 |
Tafinlar |
Liechtenstein |
31.10.2013 |
|
EU/1/13/865 |
Tafinlar |
Island |
19.9.2013 |
|
EU/1/13/865 |
Tafinlar |
Norge |
18.9.2013 |
|
EU/1/13/866 |
Cholib |
Liechtenstein |
31.10.2013 |
|
EU/1/13/866 |
Cholib |
Island |
19.9.2013 |
|
EU/1/13/866 |
Cholib |
Norge |
24.9.2013 |
|
EU/1/13/867 |
Provenge |
Liechtenstein |
31.10.2013 |
|
EU/1/13/867 |
Provenge |
Island |
19.9.2013 |
|
EU/1/13/867 |
Provenge |
Norge |
24.9.2013 |
|
EU/1/13/868 |
EVARREST |
Liechtenstein |
31.10.2013 |
|
EU/1/13/868 |
EVARREST |
Island |
21.10.2013 |
|
EU/1/13/868 |
Evarrest |
Norge |
18.10.2013 |
|
EU/1/13/869 |
Lemtrada |
Liechtenstein |
31.10.2013 |
|
EU/1/13/869 |
Lemtrada |
Island |
23.9.2013 |
|
EU/1/13/869 |
Lemtrada |
Norge |
10.10.2013 |
|
EU/1/13/870 |
Orphacol |
Liechtenstein |
31.10.2013 |
|
EU/1/13/870 |
Orphacol |
Island |
10.10.2013 |
|
EU/1/13/870 |
Orphacol |
Norge |
25.9.2013 |
|
EU/1/13/871 |
Ovaleap |
Liechtenstein |
31.10.2013 |
|
EU/1/13/871 |
Ovaleap |
Island |
22.10.2013 |
|
EU/1/13/871 |
Ovaleap |
Norge |
17.10.2013 |
|
EU/1/13/872 |
Tybost |
Liechtenstein |
31.10.2013 |
|
EU/1/13/872 |
Tybost |
Island |
11.10.2013 |
|
EU/1/13/872 |
Tybost |
Norge |
17.10.2013 |
|
EU/1/13/873 |
Xofigo |
Liechtenstein |
31.12.2013 |
|
EU/1/13/873 |
Xofigo |
Island |
11.12.2013 |
|
EU/1/13/873 |
Xofigo |
Norge |
9.12.2013 |
|
EU/1/13/876 |
Imatinib Medac |
Liechtenstein |
31.10.2013 |
|
EU/1/13/876 |
Imatinib medac |
Island |
17.10.2013 |
|
EU/1/13/876 |
Imatinib medac |
Norge |
16.10.2013 |
|
EU/1/13/877 |
Grastofil |
Liechtenstein |
31.10.2013 |
|
EU/1/13/877 |
Grastofil |
Island |
12.11.2013 |
|
EU/1/13/877 |
Grastofil |
Norge |
18.11.2013 |
|
EU/1/13/878 |
Defitelio |
Liechtenstein |
31.10.2013 |
|
EU/1/13/878 |
Defitelio |
Island |
12.11.2013 |
|
EU/1/13/878 |
Defitelio |
Norge |
21.11.2013 |
|
EU/1/13/879 |
Giotrif |
Island |
18.10.2013 |
|
EU/1/13/879 |
Giotrif |
Norge |
16.10.2013 |
|
EU/1/13/880 |
Memantine Accord |
Island |
16.12.2013 |
|
EU/1/13/880 |
Memantine Accord |
Norge |
17.12.2013 |
|
EU/1/13/880 |
Memantin Accord |
Liechtenstein |
31.12.2013 |
|
EU/1/13/881 |
Lidocaine/Prilocaine Plethora |
Liechtenstein |
31.12.2013 |
|
EU/1/13/881 |
Lidocaine/Prilocaine Plethora |
Island |
12.12.2013 |
|
EU/1/13/881 |
Lidocaine/Prilocaine Plethora |
Norge |
16.12.2013 |
|
EU/1/13/882 |
ABILIFY MAINTENA |
Liechtenstein |
31.12.2013 |
|
EU/1/13/882 |
ABILIFY MAINTENA |
Island |
12.12.2013 |
|
EU/1/13/882 |
Abilify Maintena |
Norge |
16.12.2013 |
|
EU/1/13/883 |
Vitekta |
Liechtenstein |
31.12.2013 |
|
EU/1/13/883 |
Vitekta |
Island |
11.12.2013 |
|
EU/1/13/883 |
Vitekta |
Norge |
16.12.2013 |
|
EU/1/13/884 |
Invokana |
Liechtenstein |
31.12.2013 |
|
EU/1/13/884 |
Invokana |
Island |
12.12.2013 |
|
EU/1/13/884 |
Invokana |
Norge |
16.12.2013 |
|
EU/1/13/885 |
Kadcyla |
Liechtenstein |
31.12.2013 |
|
EU/1/13/885 |
Kadcyla |
Island |
12.12.2013 |
|
EU/1/13/885 |
Kadcyla |
Norge |
16.12.2013 |
|
EU/1/13/886 |
Relvar Ellipta |
Island |
11.12.2013 |
|
EU/1/13/886 |
Relvar Ellipta |
Liechtenstein |
31.12.2013 |
|
EU/1/13/886 |
Relvar Ellipta |
Norge |
25.11.2013 |
|
EU/1/13/887 |
Fluenz Tetra |
Norge |
4.12.2013 |
|
EU/1/13/888 |
NovoEight |
Liechtenstein |
31.12.2013 |
|
EU/1/13/888 |
NovoEight |
Island |
11.12.2013 |
|
EU/1/13/888 |
NovoEight |
Norge |
16.12.2013 |
|
EU/1/13/893 |
Opsumit |
Norge |
20.12.2013 |
|
EU/2/13/148 |
Meloxidolor |
Norge |
6.8.2013 |
|
EU/2/13/150 |
Oncept IL-2 |
Island |
18.7.2013 |
|
EU/2/13/152 |
ProZinc |
Island |
8.8.2013 |
|
EU/2/13/152 |
ProZinc |
Norge |
5.8.2013 |
|
EU/2/13/153 |
Aftovaxpur Doe |
Liechtenstein |
31.8.2013 |
|
EU/2/13/153 |
Aftovaxpur Doe |
Island |
9.8.2013 |
|
EU/2/13/153 |
Aftovaxpur Doe |
Norge |
15.7.2013 |
|
EU/2/13/154 |
Apoquel |
Liechtenstein |
31.10.2013 |
|
EU/2/13/154 |
Apoquel |
Island |
20.9.2013 |
|
EU/2/13/154 |
Apoquel |
Norge |
12.9.2013 |
|
EU/2/13/155 |
Trifexis |
Liechtenstein |
31.10.2013 |
|
EU/2/13/155 |
Trifexis |
Island |
14.10.2013 |
|
EU/2/13/156 |
Vectra 3D |
Liechtenstein |
31.12.2013 |
|
EU/2/13/156 |
Vectra 3D |
Island |
23.12.2013 |
|
EU/2/13/157 |
BROADLINE |
Liechtenstein |
31.12.2013 |
|
EU/2/13/157 |
BROADLINE |
Island |
23.12.2013 |
BILAG II
Liste over fornyede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet fornyet i EØS-EFTA-staterne i perioden 1. juli-31. december 2013:
|
EU-nummer |
Vare |
Land |
Godkendelsesdato |
|
EU/1/03/255 |
Ventavis |
Liechtenstein |
31.10.2013 |
|
EU/1/03/255 |
Ventavis |
Island |
9.9.2013 |
|
EU/1/03/255 |
Ventavis |
Norge |
18.9.2013 |
|
EU/1/06/380 |
Prezista |
Island |
11.10.2013 |
|
EU/1/06/380 |
Prezista |
Norge |
18.10.2013 |
|
EU/1/07/440 |
Tyverb |
Island |
26.8.2013 |
|
EU/1/08/444 |
Ratiograstim |
Liechtenstein |
31.8.2013 |
|
EU/1/08/444 |
Ratiograstim |
Island |
19.8.2013 |
|
EU/1/08/444 |
Ratiograstim |
Norge |
15.8.2013 |
|
EU/1/08/445 |
Tevagrastim |
Liechtenstein |
31.8.2013 |
|
EU/1/08/445 |
Tevagrastim |
Island |
19.8.2013 |
|
EU/1/08/445 |
Tevagrastim |
Norge |
15.8.2013 |
|
EU/1/08/450 |
Biograstim |
Liechtenstein |
31.8.2013 |
|
EU/1/08/450 |
Biograstim |
Island |
20.8.2013 |
|
EU/1/08/450 |
Biograstim |
Norge |
27.8.2013 |
|
EU/1/08/456 |
Velmetia |
Norge |
11.9.2013 |
|
EU/1/08/457 |
Efficib |
Norge |
11.9.2013 |
|
EU/1/08/466 |
Bridion |
Liechtenstein |
31.8.2013 |
|
EU/1/08/466 |
Bridion |
Island |
17.7.2013 |
|
EU/1/08/466 |
Bridion |
Norge |
19.7.2013 |
|
EU/1/08/467 |
Doribax |
Norge |
29.7.2013 |
|
EU/1/08/468 |
INTELENCE |
Island |
17.7.2013 |
|
EU/1/08/468 |
Intelence |
Norge |
24.7.2013 |
|
EU/1/08/470 |
Vimpat |
Liechtenstein |
31.8.2013 |
|
EU/1/08/470 |
Vimpat |
Island |
21.8.2013 |
|
EU/1/08/470 |
Vimpat |
Norge |
13.8.2013 |
|
EU/1/08/473 |
Evicel |
Liechtenstein |
31.12.2013 |
|
EU/1/08/473 |
Evicel |
Island |
16.12.2013 |
|
EU/1/08/473 |
Evicel |
Norge |
18.12.2013 |
|
EU/1/08/477 |
Ceplene |
Liechtenstein |
31.10.2013 |
|
EU/1/08/477 |
Ceplene |
Island |
11.9.2013 |
|
EU/1/08/477 |
Ceplene |
Norge |
18.9.2013 |
|
EU/1/08/479 |
Zypadhera |
Island |
9.9.2013 |
|
EU/1/08/479 |
Zypadhera |
Norge |
9.9.2013 |
|
EU/1/08/480 |
Ifirmasta |
Liechtenstein |
31.8.2013 |
|
EU/1/08/480 |
Ifirmasta |
Island |
9.9.2013 |
|
EU/1/08/480 |
Ifirmasta |
Norge |
11.9.2013 |
|
EU/1/08/481 |
Kuvan |
Liechtenstein |
31.12.2013 |
|
EU/1/08/481 |
Kuvan |
Island |
11.12.2013 |
|
EU/1/08/481 |
Kuvan |
Norge |
10.12.2013 |
|
EU/1/08/482 |
Azarga |
Island |
5.9.2013 |
|
EU/1/08/482 |
Azarga |
Norge |
18.9.2013 |
|
EU/1/08/483 |
Zomarist |
Island |
21.8.2013 |
|
EU/1/08/483 |
Zomarist |
Norge |
5.9.2013 |
|
EU/1/08/484 |
Icandra |
Island |
21.8.2013 |
|
EU/1/08/484 |
Icandra |
Norge |
5.9.2013 |
|
EU/1/08/485 |
Jalra |
Liechtenstein |
31.12.2013 |
|
EU/1/08/485 |
Jalra |
Island |
16.12.2013 |
|
EU/1/08/485 |
Jalra |
Norge |
16.12.2013 |
|
EU/1/08/486 |
Xiliarx |
Liechtenstein |
31.12.2013 |
|
EU/1/08/486 |
Xiliarx |
Island |
16.12.2013 |
|
EU/1/08/486 |
Xiliarx |
Norge |
16.12.2013 |
|
EU/1/08/488 |
Vidaza |
Liechtenstein |
31.12.2013 |
|
EU/1/08/488 |
Vidaza |
Island |
10.12.2013 |
|
EU/1/08/488 |
Vidaza |
Norge |
16.12.2013 |
|
EU/1/08/489 |
Opgenra |
Liechtenstein |
31.12.2013 |
|
EU/1/08/489 |
Opgenra |
Island |
16.12.2013 |
|
EU/1/08/489 |
Opgenra |
Norge |
16.12.2013 |
|
EU/1/08/490 |
Pramipexole Teva |
Island |
23.9.2013 |
|
EU/1/08/490 |
Pramipexole Teva |
Norge |
20.9.2013 |
|
EU/1/08/491 |
Rasilez HCT |
Liechtenstein |
31.12.2013 |
|
EU/1/08/491 |
Rasilez HCT |
Island |
25.11.2013 |
|
EU/1/08/491 |
Rasilez HCT |
Norge |
18.12.2013 |
|
EU/1/08/492 |
RoActemra |
Island |
17.10.2013 |
|
EU/1/08/492 |
RoActemra |
Norge |
16.10.2013 |
|
EU/1/08/494 |
Stelara |
Liechtenstein |
31.10.2013 |
|
EU/1/08/494 |
Stelara |
Island |
14.10.2013 |
|
EU/1/08/494 |
Stelara |
Norge |
2.10.2013 |
|
EU/1/08/495 |
Zarzio |
Liechtenstein |
31.12.2013 |
|
EU/1/08/495 |
Zarzio |
Island |
26.11.2013 |
|
EU/1/08/495 |
Zarzio |
Norge |
16.12.2013 |
|
EU/1/08/496 |
Filgrastim Hexal |
Liechtenstein |
31.12.2013 |
|
EU/1/08/496 |
Filgrastim Hexal |
Island |
25.11.2013 |
|
EU/1/08/496 |
Filgrastim Hexal |
Norge |
16.12.2013 |
|
EU/1/08/498 |
Thymanax |
Liechtenstein |
31.12.2013 |
|
EU/1/08/498 |
Thymanax |
Island |
25.11.2013 |
|
EU/1/08/498 |
Thymanax |
Norge |
16.12.2013 |
|
EU/1/08/499 |
Valdoxan |
Island |
25.11.2013 |
|
EU/1/08/499 |
Valdoxan |
Norge |
17.12.2013 |
|
EU/1/08/503 |
Efient |
Liechtenstein |
31.12.2013 |
|
EU/1/08/503 |
Efient |
Island |
10.12.2013 |
|
EU/1/08/503 |
Efient |
Norge |
18.12.2013 |
|
EU/1/08/504 |
Firmagon |
Island |
10.12.2013 |
|
EU/1/08/504 |
Firmagon |
Norge |
16.12.2013 |
|
EU/1/08/505 |
Intanza |
Island |
17.10.2013 |
|
EU/1/08/505 |
Intanza |
Norge |
22.10.2013 |
|
EU/1/08/507 |
IDflu |
Island |
17.10.2013 |
|
EU/1/08/507 |
IDflu |
Norge |
22.10.2013 |
|
EU/1/10/628 |
Votrient |
Island |
1.8.2013 |
|
EU/1/10/628 |
Votrient |
Norge |
13.8.2013 |
|
EU/1/11/699 |
Fampyra |
Island |
17.7.2013 |
|
EU/1/11/699 |
Fampyra |
Norge |
12.8.2013 |
|
EU/1/11/710 |
Votubia |
Liechtenstein |
31.8.2013 |
|
EU/1/11/710 |
Votubia |
Island |
9.8.2013 |
|
EU/1/11/710 |
Votubia |
Norge |
13.8.2013 |
|
EU/1/12/793 |
Xalkori |
Island |
10.9.2013 |
|
EU/1/12/793 |
Xalkori |
Norge |
26.8.2013 |
|
EU/1/12/794 |
Adcetris |
Island |
9.9.2013 |
|
EU/1/12/794 |
Adcetris |
Norge |
23.9.2013 |
|
EU/1/99/103 |
ReFacto AF |
Liechtenstein |
31.12.2013 |
|
EU/1/99/103 |
Refacto AF |
Norge |
18.12.2013 |
|
EU/2/07/075 |
Circovac |
Norge |
9.8.2013 |
|
EU/2/08/080 |
Reconcile |
Liechtenstein |
31.8.2013 |
|
EU/2/08/080 |
Reconcile |
Island |
8.8.2013 |
|
EU/2/08/082 |
Zactran |
Liechtenstein |
31.8.2013 |
|
EU/2/08/082 |
Zactran |
Island |
9.8.2013 |
|
EU/2/08/082 |
Zactran |
Norge |
12.8.2013 |
|
EU/2/08/084 |
Trocoxil |
Island |
4.9.2013 |
|
EU/2/08/086 |
Equip WNV |
Liechtenstein |
31.10.2013 |
|
EU/2/08/086 |
Equip WNV |
Island |
24.9.2013 |
|
EU/2/08/087 |
Masivet |
Liechtenstein |
31.10.2013 |
|
EU/2/08/087 |
Masivet |
Island |
17.10.2013 |
|
EU/2/08/089 |
Onsior |
Island |
22.11.2013 |
|
EU/2/08/091 |
Porcilis PCV |
Liechtenstein |
31.12.2013 |
BILAG III
Liste over udvidede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet udvidet i EØS-EFTA-staterne i perioden 1. juli-31. december 2013:
|
EU-nummer |
Vare |
Land |
Godkendelsesdato |
|
EU/1/00/145/002 |
Herceptin |
Norge |
6.9.2013 |
|
EU/1/00/145/002 |
Herceptin |
Island |
9.9.2013 |
|
EU/1/02/203/005-007 |
Kineret |
Norge |
13.12.2013 |
|
EU/1/02/203/005-007 |
Kineret |
Island |
13.12.2013 |
|
EU/1/03/249/016 |
Vivanza |
Norge |
5.8.2013 |
|
EU/1/03/249/016 |
Vivanza |
Island |
17.7.2013 |
|
EU/1/07/436/003-004 |
Isentress |
Norge |
4.7.2013 |
|
EU/1/08/469/026-045 |
Oprymea |
Norge |
25.11.2013 |
|
EU/1/08/469/026-045 |
Oprymea |
Island |
22.11.2013 |
|
EU/1/09/546/005-008 |
Simponi |
Norge |
7.10.2013 |
|
EU/1/09/546/005-008 |
Simponi |
Island |
12.9.2013 |
|
EU/1/10/612/007-009 |
Revolade |
Norge |
10.10.2013 |
|
EU/1/10/612/007-009 |
Revolade |
Island |
11.10.2013 |
|
EU/1/10/637/010-013 |
Leflunomide medac |
Norge |
27.8.2013 |
|
EU/1/10/637/010-013 |
Leflunomide medac |
Island |
19.8.2013 |
|
EU/1/11/706/034-038 |
Levodopa/Carbidopa/Entacapone Orion |
Norge |
18.10.2013 |
|
EU/1/11/706/034-038 |
Levodopa/Carbidopa/Entacapone Orion |
Island |
18.7.2013 |
|
EU/1/11/710/009-015 |
Votubia |
Norge |
13.12.2013 |
|
EU/1/12/777/007-012 |
Inlyta |
Norge |
18.9.2013 |
|
EU/1/12/777/007-012 |
Inlyta |
Island |
4.9.2013 |
|
EU/1/97/030/202-203 |
Insuman Implantable |
Norge |
18.10.2013 |
|
EU/2/04/044/015-016 |
Aivlosin |
Island |
23.12.2013 |
|
EU/2/08/090/029-031 |
Loxicom |
Norge |
26.9.2013 |
|
EU/2/09/098/002-007 |
Melovem |
Island |
21.10.2013 |
|
EU/2/10/115/011-019 |
Comfortis |
Norge |
6.8.2013 |
|
EU/2/10/115/020-021 |
Comfortis |
Island |
11.12.2013 |
BILAG IV
Liste over tilbagetrukne markedsføringstilladelser
Følgende markedsføringstilladelser er blevet trukket tilbage i EØS-EFTA-staterne i perioden 1. juli-31. december 2013:
|
EU-nummer |
Vare |
Land |
Dato for inddragelsen |
|
EU/1/01/189 |
Replagal |
Norge |
14.8.2013 |
|
EU/1/03/266 |
Bondenza |
Island |
12.11.2013 |
|
EU/1/09/554 |
Clopidogrel ratiopharm |
Norge |
25.11.2013 |
|
EU/1/10/656 |
Possia |
Liechtenstein |
31.8.2013 |
|
EU/1/11/687 |
Hizentra |
Norge |
14.8.2013 |
|
EU/1/11/730 |
Rasitrio |
Island |
20.9.2013 |
|
EU/1/11/730 |
Rasitrio |
Norge |
3.9.2013 |
|
EU/1/12/754 |
Sepioglin |
Island |
12.11.2013 |
|
EU/2/00/022 |
Ibaflin |
Liechtenstein |
31.8.2013 |
|
EU/2/09/093 |
Netvax |
Liechtenstein |
31.10.2013 |
|
EU/2/09/093 |
Netvax |
Island |
16.10.2013 |
|
EU/2/09/093 |
Netvax |
Norge |
19.9.2013 |
|
EU/2/98/010 |
Econor |
Norge |
5.8.2013 |
BILAG V
Liste over suspenderede markedsføringstilladelser
Følgende markedsføringstilladelser er blevet suspenderet i EØS-EFTA-staterne i perioden 1. juli-31. december 2013:
|
EU-nummer |
Vare |
Land |
Suspensionsdato |
|
EU/1/09/527 |
Ribavirin Teva Pharma BV |
Liechtenstein |
31.8.2013 |
|
EU/1/09/527 |
Ribavirin Teva Pharma BV |
Island |
24.7.2013 |
V Øvrige meddelelser
ADMINISTRATIVE PROCEDURER
Det Europæiske Personaleudvælgelseskontor (EPSO)
|
6.11.2014 |
DA |
Den Europæiske Unions Tidende |
C 391/30 |
MEDDELELSE OM ALMINDELIG UDVÆLGELSESPRØVE
2014/C 391/05
Det Europæiske Personaleudvælgelseskontor (EPSO) afholder en almindelig udvælgelsesprøve
EPSO/AD/294/14 — Administratorer inden for databeskyttelse (AD 6)
Meddelelsen om udvælgelsesprøven er offentliggjort på 24 sprog i Den Europæiske Unions Tidende C 391 A af 6. november 2014.
Yderligere oplysninger findes på EPSO's hjemmeside http://blogs.ec.europa.eu/eu-careers.info/
Berigtigelser
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6.11.2014 |
DA |
Den Europæiske Unions Tidende |
C 391/31 |
Berigtigelse til meddelelse fra Kommissionen om artikel 4, stk. 3, i Europa-Parlamentets og Rådets direktiv 2009/22/EF om søgsmål med påstand om forbud på området beskyttelse af forbrugernes interesser, der kodificerer direktiv 98/27/EF, vedrørende nationale organer/organisationer, som er beføjet til at anlægge søgsmål i medfør af artikel 2 i ovennævnte direktiv
( Den Europæiske Unions Tidende C 363 af 14. oktober 2014 )
2014/C 391/06
Side 43, tabellen for ROMANIA, i kolonne »Kontaktoplysninger«:
I stedeet for:
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»Bd. N. Băalcescu nr. 32-34, et. 4, |
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Cam. 16, sector 1, |
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RO-010055, Bucuresti |
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Tlf.: (40) 21 311 02 43 |
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Fax: (40) 21 315 71 49 |
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E-mail: office@apc-romania.ro; |
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Website: www.apc-romania.ro.« |
read:
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»Intr. Licurici 2, Bloc 2, Ap. 2, Sector 3, |
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030894 Bucureşti |
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ROMÂNIA |
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Tel./fax +40 213110243 |
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E-mail: office@apc-romania.ro |
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Internet: www.apc-romania.ro«. |