This document is an excerpt from the EUR-Lex website
Document E2014G1009(03)
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2012
Ravimid – EMP EFTA riikide poolt 2012. aasta teisel poolaastal antud müügilubade nimekiri
Ravimid – EMP EFTA riikide poolt 2012. aasta teisel poolaastal antud müügilubade nimekiri
ELT C 356, 9.10.2014, p. 37–51
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
9.10.2014 |
ET |
Euroopa Liidu Teataja |
C 356/37 |
Ravimid – EMP EFTA riikide poolt 2012. aasta teisel poolaastal antud müügilubade nimekiri
2014/C 356/08
Kaupade vaba liikumise I allkomitee
Teadmiseks EMP ühiskomiteele
Vastavalt EMP ühiskomitee 28. mai 1999. aasta otsusele nr 74/1999 kutsutakse EMP ühiskomiteed 8. novembril 2013 toimuval koosolekul arvesse võtma järgmisi ajavahemikus 1. juuli – 31. detsember 2012 antud ravimite müügilubade nimekirju:
|
I lisa |
Uute müügilubade nimekiri |
|
II lisa |
Uuendatud müügilubade nimekiri |
|
III lisa |
Pikendatud müügilubade nimekiri |
|
IV lisa |
Äravõetud müügilubade nimekiri |
|
V lisa |
Peatatud müügilubade nimekiri |
I LISA
Uute müügilubade nimekiri
Ajavahemikus 1. juuli – 31. detsember 2012 anti EMP EFTA riikides välja järgmised müügiload:
|
ELi number |
Toode |
Riik |
Loa andmise kuupäev |
|
EU/1/11/685/001–005 |
Ibandroonhape Sandoz |
Norra |
31.7.2012 |
|
EU/1/11/719/001–062 |
Telmisartan Teva Pharma |
Liechtenstein |
31.12.2012 |
|
EU/1/11/744/001–002 |
Topotecan Eagle |
Norra |
30.8.2012 |
|
EU/1/11/747/001 |
Colobreathe |
Norra |
11.7.2012 |
|
EU/1/11/748/001–006 |
Docetaxel Mylan |
Norra |
17.12.2012 |
|
EU/1/12/762/001–018 |
Capecitabine Accord |
Norra |
13.8.2012 |
|
EU/1/12/768/001 |
Riluzole Zentiva |
Norra |
16.8.2012 |
|
EU/1/12/769/001–003 |
Docetaxel Accord |
Norra |
13.8.2012 |
|
EU/1/12/771/001–006 |
Soledroonhape Teva |
Island |
10.9.2012 |
|
EU/1/12/771/001–006 |
Soledroonhape Teva |
Norra |
12.10.2012 |
|
EU/1/12/772/001–004 |
Soledroonhape Teva Pharma |
Island |
10.9.2012 |
|
EU/1/12/772/001–004 |
Soledroonhape Teva Pharma |
Norra |
10.10.2012 |
|
EU/1/12/773/001–003 |
Jakavi |
Liechtenstein |
31.8.2012 |
|
EU/1/12/773/001–003 |
Jakavi |
Norra |
5.9.2012 |
|
EU/1/12/773/001–003 |
Jakavi |
Island |
19.9.2012 |
|
EU/1/12/774/001–002 |
Rienso |
Norra |
14.8.2012 |
|
EU/1/12/774/001–002 |
Rienso |
Island |
20.7.2012 |
|
EU/1/12/774/001–002 |
Rienso |
Liechtenstein |
31.12.2012 |
|
EU/1/12/775/001 |
NovoThirteen |
Island |
17.9.2012 |
|
EU/1/12/775/001 |
Novo Thirteen |
Norra |
19.9.2012 |
|
EU/1/12/775/001 |
Novo Thirteen |
Liechtenstein |
31.10.2012 |
|
EU/1/12/776/001–016 |
Fycompa |
Norra |
27.8.2012 |
|
EU/1/12/776/001–016 |
Fycompa |
Liechtenstein |
31.8.2012 |
|
EU/1/12/776/001–016 |
Fycompa |
Island |
11.9.2012 |
|
EU/1/12/777/001–006 |
Inlyta |
Island |
14.9.2012 |
|
EU/1/12/777/001–006 |
Inlyta |
Norra |
21.9.2012 |
|
EU/1/12/777/001–006 |
Inlyta |
Liechtenstein |
31.10.2012 |
|
EU/1/12/778/001–003 |
Eklira Genuair |
Island |
13.8.2012 |
|
EU/1/12/778/001–003 |
Eklira Genuair |
Norra |
15.8.2012 |
|
EU/1/12/778/001–003 |
Eklira Genuair |
Liechtenstein |
31.8.2012 |
|
EU/1/12/779/001–006 |
Soledroonhape Actavis |
Norra |
15.8.2012 |
|
EU/1/12/779/001–006 |
Soledroonhape Actavis |
Island |
27.8.2012 |
|
EU/1/12/779/001–006 |
Soledroonhape Actavis |
Liechtenstein |
31.8.2012 |
|
EU/1/12/780/001–028 |
Jentadueto |
Norra |
31.7.2012 |
|
EU/1/12/780/001–028 |
Jentadueto |
Liechtenstein |
31.8.2012 |
|
EU/1/12/780/001–028 |
Jentadueto |
Island |
17.8.2012 |
|
EU/1/12/781/001–003 |
Bretaris Genuair |
Island |
13.8.2012 |
|
EU/1/12/781/001–003 |
Bretaris Genuair |
Norra |
15.8.2012 |
|
EU/1/12/781/001–003 |
Bretaris Genuair |
Liechtenstein |
31.8.2012 |
|
EU/1/12/782/001–002 |
Kalydeco |
Norra |
6.8.2012 |
|
EU/1/12/782/001–002 |
Kalydeco |
Island |
21.8.2012 |
|
EU/1/12/782/001–002 |
Kalydeco |
Liechtenstein |
31.8.2012 |
|
EU/1/12/783/001–003 |
Zyclara |
Liechtenstein |
31.8.2012 |
|
EU/1/12/783/001–003 |
Zyclara |
Island |
12.9.2012 |
|
EU/1/12/783/001–003 |
Zyclara |
Norra |
10.10.2012 |
|
EU/1/12/784/001 |
Cuprymina |
Island |
7.9.2012 |
|
EU/1/12/784/001 |
Cuprymina |
Norra |
25.9.2012 |
|
EU/1/12/784/001 |
Cuprymina |
Liechtenstein |
31.10.2012 |
|
EU/1/12/785/001 |
Zinforo |
Liechtenstein |
31.8.2012 |
|
EU/1/12/785/001 |
Zinforo |
Island |
6.9.2012 |
|
EU/1/12/785/001 |
Zinforo |
Norra |
17.9.2012 |
|
EU/1/12/786/001–003 |
Zoledronic acid Mylan |
Liechtenstein |
31.8.2012 |
|
EU/1/12/786/001–003 |
Soledroonhape Mylan |
Island |
4.9.2012 |
|
EU/1/12/786/001–003 |
Zoledronic acid Mylan |
Norra |
12.10.2012 |
|
EU/1/12/787/001 |
Revestive |
Island |
14.9.2012 |
|
EU/1/12/787/001 |
Revestive |
Norra |
26.9.2012 |
|
EU/1/12/787/001 |
Revestive |
Liechtenstein |
31.10.2012 |
|
EU/1/12/788/001–006 |
Seebri Breezhaler |
Island |
16.10.2012 |
|
EU/1/12/788/001–006 |
Seebri Breezhaler |
Norra |
17.10.2012 |
|
EU/1/12/789/001–006 |
Enurev Breezhaler |
Island |
17.10.2012 |
|
EU/1/12/789/001–006 |
Enurev Breezhaler |
Norra |
29.10.2012 |
|
EU/1/12/790/001–006 |
Tovanor Breezhaler |
Island |
17.10.2012 |
|
EU/1/12/790/001–006 |
Tovanor Breezhaler |
Norra |
29.10.2012 |
|
EU/1/12/791/001 |
Glybera |
Island |
15.11.2012 |
|
EU/1/12/791/001 |
Glybera |
Norra |
6.12.2012 |
|
EU/1/12/792/001 |
Dacogen |
Island |
15.10.2012 |
|
EU/1/12/792/001 |
Dacogen |
Norra |
17.10.2012 |
|
EU/1/12/792/001 |
Dacogen |
Liechtenstein |
31.10.2012 |
|
EU/1/12/793/001–004 |
Xalkori |
Island |
8.11.2012 |
|
EU/1/12/793/001–004 |
Xalkori |
Norra |
14.11.2012 |
|
EU/1/12/793/001–004 |
Xalkori |
Liechtenstein |
31.12.2012 |
|
EU/1/12/794/001 |
Adcetris |
Norra |
10.12.2012 |
|
EU/1/12/794/001 |
Adectris |
Liechtenstein |
31.12.2012 |
|
EU/1/12/795/001–010 |
Forxiga |
Norra |
6.12.2012 |
|
EU/1/12/795/001–010 |
Forxiga |
Island |
7.12.2012 |
|
EU/1/12/796/001–002 |
Picato |
Norra |
27.11.2012 |
|
EU/1/12/796/001–002 |
Picato |
Island |
7.12.2012 |
|
EU/1/12/796/001–002 |
Picato |
Liechtenstein |
31.12.2012 |
|
EU/1/12/797/001–002 |
Eylea |
Norra |
6.12.2012 |
|
EU/1/12/797/001–002 |
Eylea |
Island |
13.12.2012 |
|
EU/1/12/798/001–004 |
Ibandroonhape Accord |
Norra |
12.12.2012 |
|
EU/1/12/798/001–004 |
Ibandroonhape Accord |
Island |
10.12.2012 |
|
EU/1/12/798/001–004 |
Ibandroonhape Accord |
Liechtenstein |
31.12.2012 |
|
EU/1/12/799/001–029 |
Memantine Merz |
Island |
12.12.2012 |
|
EU/1/12/799/001–029 |
Memantine Merz |
Liechtenstein |
31.12.2012 |
|
EU/1/12/800/001–004 |
Soledroonhape Hospira |
Island |
7.12.2012 |
|
EU/1/12/800/001–004 |
Soledroonhape Hospira |
Norra |
17.12.2012 |
|
EU/1/12/800/001–004 |
Soledroonhape Hospira |
Liechtenstein |
31.12.2012 |
|
EU/1/12/801/001–004 |
Constella |
Island |
13.12.2012 |
|
EU/1/12/801/001–004 |
Constella |
Liechtenstein |
31.12.2012 |
|
EU/1/12/801/001–004 |
Constella |
Norra |
17.12.2012 |
|
EU/1/12/802/001–042 |
Capecitabine medac |
Norra |
13.12.2012 |
|
EU/1/12/802/001–042 |
Capecitabine medac |
Island |
18.12.2012 |
|
EU/1/12/802/001–042 |
Capecitabine medac |
Liechtenstein |
31.12.2012 |
|
EU/2/09/099/001–006 |
Suvaxyn PCV |
Island |
8.11.2012 |
|
EU/2/11/122/001–003 |
Bluevac BTV8 |
Norra |
18.7.2012 |
|
EU/2/12/138/001–003 |
RevitaCAM |
Norra |
19.9.2012 |
|
EU/2/12/140/001–008 |
Poulvac E. Coli |
Island |
23.7.2012 |
|
EU/2/12/141/001–009 |
Porcilis ColiClos |
Island |
5.7.2012 |
|
EU/2/12/141/001–009 |
Porcilis ColiClos |
Norra |
31.7.2012 |
|
EU/2/12/141/001–009 |
Porcilis ColiClos |
Liechtenstein |
31.8.2012 |
|
EU/2/12/142/001–006 |
Cardalis 2,5/20 mg |
Island |
20.8.2012 |
|
EU/2/12/143/001–005 |
Nobivac L4 |
Island |
20.8.2012 |
|
EU/2/12/143/001–005 |
Nobivac L4 |
Norra |
28.8.2012 |
|
EU/2/12/143/001–005 |
Nobivac L4 |
Liechtenstein |
31.8.2012 |
II LISA
Uuendatud müügilubade nimekiri
Ajavahemikus 1. juuli – 31. detsember 2012 uuendati EMP EFTA riikides järgmisi müügilube:
|
ELi number |
Toode |
Riik |
Loa andmise kuupäev |
|
EU/1/01/187/001 |
DepoCyte |
Norra |
13.8.2012 |
|
EU/1/01/197/001–005 |
Foscan |
Norra |
7.9.2012 |
|
EU/1/02/222/001–005 |
Tamiflu |
Norra |
21.8.2012 |
|
EU/1/02/223/001–003 |
Evra |
Island |
5.7.2012 |
|
EU/1/02/223/001–003 |
Evra |
Norra |
27.8.2012 |
|
EU/1/02/223/001–003 |
Evra |
Liechtenstein |
31.8.2012 |
|
EU/1/02/224/001–005 |
Ambirix |
Island |
21.8.2012 |
|
EU/1/02/224/001–005 |
Ambirix |
Norra |
27.8.2012 |
|
EU/1/02/224/001–005 |
Ambirix |
Liechtenstein |
31.8.2012 |
|
EU/1/02/226/001 |
InductOs |
Norra |
2.8.2012 |
|
EU/1/02/226/001 |
InductOs |
Island |
14.8.2012 |
|
EU/1/02/237/001–009 |
Cialis |
Norra |
11.10.2012 |
|
EU/1/02/237/001–009 |
Cialis |
Island |
17.10.2012 |
|
EU/1/02/237/001–009 |
Cialis |
Liechtenstein |
31.10.2012 |
|
EU/1/02/238/001 |
Zavesca |
Island |
22.10.2012 |
|
EU/1/02/238/001 |
Zavesca |
Norra |
29.10.2012 |
|
EU/1/02/238/001 |
Zavesca |
Liechtenstein |
31.10.2012 |
|
EU/1/05/314/001 |
Kepivance |
Norra |
11.9.2012 |
|
EU/1/06/339/001–002 |
Preotact |
Norra |
28.8.2012 |
|
EU/1/06/367/001–012 |
Diacomit |
Norra |
12.12.2012 |
|
EU/1/06/367/001–012 |
Diacomit |
Island |
13.12.2012 |
|
EU/1/06/367/001–012 |
Diacomit |
Liechtenstein |
31.12.2012 |
|
EU/1/06/371/001–039 |
Dafiro |
Norra |
26.9.2012 |
|
EU/1/06/376/001–039 |
Irbesartan Zentiva |
Island |
28.9.2012 |
|
EU/1/07/393/001 |
Soliris |
Island |
5.7.2012 |
|
EU/1/07/393/001 |
Soliris |
Norra |
13.8.2012 |
|
EU/1/07/394/001–009 |
Optaflu |
Island |
8.11.2012 |
|
EU/1/07/395/001–095 |
Invega |
Island |
31.8.2012 |
|
EU/1/07/395/001–095 |
Invega |
Norra |
11.9.2012 |
|
EU/1/07/397/001–004 |
Siklos |
Island |
23.7.2012 |
|
EU/1/07/397/001–004 |
Siklos |
Norra |
9.8.2012 |
|
EU/1/07/398/001–014 |
Optimark |
Island |
5.7.2012 |
|
EU/1/07/398/001–014 |
Optimark |
Liechtenstein |
31.8.2012 |
|
EU/1/07/401/007–016 |
alli |
Island |
20.7.2012 |
|
EU/1/07/401/007–016 |
alli |
Liechtenstein |
31.8.2012 |
|
EU/1/07/402/001 |
Increlex |
Island |
29.8.2012 |
|
EU/1/07/402/001 |
Increlex |
Liechtenstein |
31.8.2012 |
|
EU/1/07/402/001 |
Increlex |
Norra |
3.9.2012 |
|
EU/1/07/403/001 |
Atriance |
Island |
20.7.2012 |
|
EU/1/07/403/001 |
Atriance |
Norra |
7.8.2012 |
|
EU/1/07/403/001 |
Atriance |
Liechtenstein |
31.8.2012 |
|
EU/1/07/404/001–008 |
Flebogamma DIF |
Island |
11.9.2012 |
|
EU/1/07/404/001–008 |
Flebogamma DIF |
Norra |
12.10.2012 |
|
EU/1/07/405/001–040 |
Rasilez |
Liechtenstein |
31.8.2012 |
|
EU/1/07/405/001–040 |
Rasilez |
Island |
19.9.2012 |
|
EU/1/07/405/001–040 |
Rasilez |
Norra |
10.10.2012 |
|
EU/1/07/409/001–040 |
Riprazo |
Island |
12.9.2012 |
|
EU/1/07/409/001–040 |
Riprazo |
Norra |
10.10.2012 |
|
EU/1/07/409/001–040 |
Riprazo |
Liechtenstein |
31.8.2012 |
|
EU/1/07/410/001–052 |
Binocrit |
Norra |
27.8.2012 |
|
EU/1/07/410/001–052 |
Binocrit |
Island |
20.7.2012 |
|
EU/1/07/410/001–052 |
Binocrit |
Liechtenstein |
31.8.2012 |
|
EU/1/07/411/001–052 |
Epoetin alfa Hexal |
Island |
19.7.2012 |
|
EU/1/07/411/001–052 |
Epoetin alfa Hexal |
Norra |
27.8.2012 |
|
EU/1/07/411/001–052 |
Epoetin alfa Hexal |
Liechtenstein |
31.8.2012 |
|
EU/1/07/412/001–052 |
Abseamed |
Island |
20.7.2012 |
|
EU/1/07/412/001–052 |
Abseamed |
Norra |
27.8.2012 |
|
EU/1/07/413/001–003 |
Gliolan |
Island |
7.9.2012 |
|
EU/1/07/413/001–003 |
Gliolan |
Norra |
15.10.2012 |
|
EU/1/07/413/001–003 |
Gliolan |
Liechtenstein |
31.10.2012 |
|
EU/1/07/414/001–010, 018 |
Galvus |
Island |
17.8.2012 |
|
EU/1/07/414/001–010, 018 |
Galvus |
Norra |
31.7.2012 |
|
EU/1/07/415/001–056 |
Zalasta |
Norra |
24.8.2012 |
|
EU/1/07/415/001–056 |
Zalasta |
Island |
25.8.2012 |
|
EU/1/07/415/001–056 |
Zalasta |
Liechtenstein |
31.8.2012 |
|
EU/1/07/416/002 |
Ecalta |
Island |
3.9.2012 |
|
EU/1/07/416/002 |
Ecalta |
Liechtenstein |
31.8.2012 |
|
EU/1/07/416/002 |
Ecalta |
Norra |
26.9.2012 |
|
EU/1/07/417/001–002 |
Yondelis |
Island |
28.8.2012 |
|
EU/1/07/417/001–002 |
Yondelis |
Liechtenstein |
31.8.2012 |
|
EU/1/07/417/001–002 |
Yondelis |
Norra |
17.9.2012 |
|
EU/1/07/418/001–010 |
Celsentri |
Liechtenstein |
31.8.2012 |
|
EU/1/07/418/001–010 |
Celsentri |
Island |
12.9.2012 |
|
EU/1/07/418/001–010 |
Celsentri |
Norra |
18.9.2012 |
|
EU/1/07/419/001–012 |
Cervarix |
Island |
12.10.2012 |
|
EU/1/07/419/001–012 |
Cervarix |
Norra |
12.10.2012 |
|
EU/1/07/419/001–012 |
Cervarix |
Liechtenstein |
31.10.2012 |
|
EU/1/07/420/001–002 |
Cyanokit |
Island |
14.8.2012 |
|
EU/1/07/420/001–002 |
Cyanokit |
Norra |
17.8.2012 |
|
EU/1/07/420/001–002 |
Cyanokit |
Liechtenstein |
31.8.2012 |
|
EU/1/07/421/001–009 |
Glubrava |
Island |
12.10.2012 |
|
EU/1/07/421/001–009 |
Glubrava |
Norra |
12.10.2012 |
|
EU/1/07/421/001–009 |
Glubrava |
Liechtenstein |
31.10.2012 |
|
EU/1/07/422/001–012 |
Tasigna |
Norra |
24.10.2012 |
|
EU/1/07/422/001–012 |
Tasigna |
Liechtenstein |
31.10.2012 |
|
EU/1/07/422/001–012 |
Tasigna |
Island |
6.12.2012 |
|
EU/1/07/424/001 |
Torisel |
Island |
12.10.2012 |
|
EU/1/07/424/001 |
Torisel |
Norra |
22.10.2012 |
|
EU/1/07/424/001 |
Torisel |
Liechtenstein |
31.10.2012 |
|
EU/1/07/425/001–018 |
Eucreas |
Norra |
31.7.2012 |
|
EU/1/07/425/001–018 |
Eucreas |
Island |
21.8.2012 |
|
EU/1/07/425/001–018 |
Eucreas |
Liechtenstein |
31.8.2012 |
|
EU/1/07/426/001–011 |
Olanzapine Neopharma |
Island |
17.10.2012 |
|
EU/1/07/426/001–011 |
Olanzapine Neopharma |
Norra |
24.10.2012 |
|
EU/1/07/426/001–011 |
Olanzapine Neopharma |
Liechtenstein |
31.10.2012 |
|
EU/1/07/427/001–057 |
Olanzapine Teva |
Norra |
6.12.2012 |
|
EU/1/07/427/001–057 |
Olanzapine Teva |
Island |
7.12.2012 |
|
EU/1/07/427/001–057 |
Olanzapine Teva |
Liechtenstein |
31.12.2012 |
|
EU/1/07/430/001–002 |
Atripla |
Norra |
26.9.2012 |
|
EU/1/07/430/001–002 |
Atripla |
Island |
12.10.2012 |
|
EU/1/07/431/001–025 |
Retacrit |
Island |
7.12.2012 |
|
EU/1/07/431/001–025 |
Retacrit |
Norra |
17.12.2012 |
|
EU/1/07/431/001–025 |
Retacrit |
Liechtenstein |
31.12.2012 |
|
EU/1/07/432/001–022 |
Silapo |
Island |
22.8.2012 |
|
EU/1/07/432/001–022 |
Silapo |
Norra |
24.8.2012 |
|
EU/1/07/432/001–022 |
Silapo |
Liechtenstein |
31.8.2012 |
|
EU/1/07/433/001 |
Nevanac |
Norra |
15.10.2012 |
|
EU/1/07/433/001 |
Nevanac |
Liechtenstein |
31.10.2012 |
|
EU/1/07/435/001–018 |
Tesavel |
Island |
15.10.2012 |
|
EU/1/07/435/001–018 |
Tesavel |
Norra |
15.10.2012 |
|
EU/1/07/437/001–004 |
IVEMEND |
Island |
7.12.2012 |
|
EU/1/07/437/003–004 |
IVEMEND |
Norra |
6.12.2012 |
|
EU/1/07/437/003–004 |
IVEMEND |
Liechtenstein |
31.12.2012 |
|
EU/1/07/438/001–006 |
Myfenax |
Island |
12.12.2012 |
|
EU/1/07/438/006 |
Myfenax |
Norra |
13.12.2012 |
|
EU/1/07/439/001–006 |
Mycophenolate mofetil Teva |
Island |
12.12.2012 |
|
EU/1/07/439/001–006 |
Mycophenolate mofetil Teva |
Norra |
17.12.2012 |
|
EU/1/08/468/001–002 |
INTELENCE |
Island |
16.8.2012 |
|
EU/1/08/468/001–002 |
INTELENCE |
Norra |
27.8.2012 |
|
EU/1/08/468/001–002 |
INTELENCE |
Liechtenstein |
31.8.2012 |
|
EU/1/11/710/001–007 |
Votubia |
Norra |
16.8.2012 |
|
EU/1/11/710/001–007 |
Votubia |
Island |
25.8.2012 |
|
EU/1/11/710/001–007 |
Votubia |
Liechtenstein |
31.8.2012 |
|
EU/1/97/047/004–007 |
BeneFIX |
Island |
16.8.2012 |
|
EU/1/97/047/004–007 |
BeneFIX |
Norra |
24.8.2012 |
|
EU/1/97/047/004–007 |
BeneFIX |
Liechtenstein |
31.8.2012 |
|
EU/2/02/032/001–002 |
Vaxxitek HVT + IBD |
Island |
23.7.2012 |
|
EU/2/02/032/001–002 |
Vaxxitek HVT + IBD |
Liechtenstein |
31.8.2012 |
|
EU/2/02/034/001 |
Nobivac Bb |
Island |
18.9.2012 |
|
EU/2/02/034/001 |
Nobivac Bb |
Norra |
23.10.2012 |
|
EU/2/02/034/001 |
Nobivac Bb |
Liechtenstein |
31.10.2012 |
|
EU/2/07/072/001–004 |
Suprelorin |
Norra |
31.7.2012 |
|
EU/2/07/072/001–004 |
Suprelorin |
Liechtenstein |
31.8.2012 |
|
EU/2/07/074/001–006 |
Prilactone |
Liechtenstein |
31.8.2012 |
|
EU/2/07/077/001–005 |
Meloxivet |
Island |
6.12.2012 |
|
EU/2/07/077/001–005 |
Meloxivet |
Liechtenstein |
31.10.2012 |
III LISA
Pikendatud müügilubade nimekiri
Ajavahemikus 1. juuli – 31. detsember 2012 pikendati EMP EFTA riikides järgmisi müügilube:
|
ELi number |
Toode |
Riik |
Loa andmise kuupäev |
|
EU/1/01/200/003–009 |
Viread |
Island |
18.12.2012 |
|
EU/1/04/274/001–002 |
Velcade |
Norra |
18.10.2012 |
|
EU/1/04/306/002–003 |
Aloxi |
Norra |
19.11.2012 |
|
EU/1/06/368/169–174 |
Insulin Human Winthrop |
Liechtenstein |
31.8.2012 |
|
EU/1/06/376/034, 036–039 |
Irbesartan Zentiva |
Liechtenstein |
31.10.2012 |
|
EU/1/06/376/034, 036–039 |
Irbesartan Zentiva |
Norra |
30.8.2012 |
|
EU/1/06/377/029–034 |
Irbesartan HCT Zentiva |
Liechtenstein |
31.8.2012 |
|
EU/1/06/377/029–034 |
Irbesartan HCT Zentiva |
Norra |
12.11.2012 |
|
EU/1/06/380/006 |
Prezista |
Island |
14.11.2012 |
|
EU/1/06/380/006 |
Prezista |
Norra |
24.10.2012 |
|
EU/1/07/389/004–009 |
Orencia |
Liechtenstein |
31.10.2012 |
|
EU/1/07/389/004–009 |
Orencia |
Norra |
13.11.2012 |
|
EU/1/07/389/004–009 |
Orencia |
Island |
19.10.2012 |
|
EU/1/07/391/005–006 |
Revlimid |
Norra |
25.9.2012 |
|
EU/1/07/391/005–006 |
Revlimid |
Island |
11.10.2012 |
|
EU/1/07/440/007 |
Tyverb |
Liechtenstein |
31.8.2012 |
|
EU/1/07/440/007 |
Tyverb |
Norra |
31.7.2012 |
|
EU/1/09/514/021–023 |
Zebinix |
Liechtenstein |
31.8.2012 |
|
EU/1/09/514/021–023 |
Zebinix |
Island |
3.9.2012 |
|
EU/1/09/514/021–023 |
Zebinix |
Norra |
25.9.2012 |
|
EU/1/10/616/025–036 |
Temozolomide HEXAL |
Liechtenstein |
31.8.2012 |
|
EU/1/10/617/025–036 |
Temozolomide Sandoz |
Liechtenstein |
31.8.2012 |
|
EU/1/11/691/006–013 |
Eliquis |
Island |
11.12.2012 |
|
EU/1/11/691/006–013 |
Eliquis |
Norra |
19.12.2012 |
|
EU/1/11/712/029–040 |
Levetiracetam Accord |
Liechtenstein |
31.10.2012 |
|
EU/1/11/731/013–014 |
Komboglyze |
Liechtenstein |
31.10.2012 |
|
EU/1/11/731/013–014 |
Komboglyze |
Norra |
24.9.2012 |
|
EU/1/11/734/012–018 |
Edarbi |
Liechtenstein |
31.8.2012 |
|
EU/1/11/735/012–018 |
Ipreziv |
Liechtenstein |
31.8.2012 |
|
EU/1/12/752/002 |
Vepacel |
Liechtenstein |
31.10.2012 |
|
EU/1/12/765/007–009 |
Sabervel |
Liechtenstein |
31.12.2012 |
|
EU/1/97/030/196–201 |
Insuman |
Liechtenstein |
31.8.2012 |
|
EU/1/97/047/008 |
BeneFIX |
Liechtenstein |
31.8.2012 |
|
EU/1/97/047/008 |
BeneFIX |
Island |
4.9.2012 |
|
EU/1/97/047/008 |
BeneFIX |
Norra |
10.10.2012 |
|
EU/2/02/033/003–004 |
Dexdomitor |
Island |
13.9.2012 |
|
EU/2/02/033/003–004 |
Dexdomitor |
Norra |
30.8.2012 |
|
EU/2/02/033/003–004 |
Dexdomitor |
Liechtenstein |
31.10.2012 |
|
EU/2/07/074/007–009 |
Prilactone |
Liechtenstein |
31.12.2012 |
|
EU/2/07/078/018–020 |
Rheumocam |
Norra |
6.12.2012 |
|
EU/2/07/078/018–020 |
Rheumocam |
Liechtenstein |
31.12.2012 |
|
EU/2/08/090/028 |
Loxicom |
Liechtenstein |
31.12.2012 |
|
EU/2/10/118/015–021 |
Activyl |
Liechtenstein |
31.8.2012 |
|
EU/2/11/134/015–017 |
Inflacam |
Island |
5.9.2012 |
|
EU/2/11/134/015–017 |
Inflacam |
Norra |
1.11.2012 |
|
EU/2/11/134/015–017 |
Inflacam |
Liechtenstein |
31.8.2012 |
|
EU/2/11/134/018–020 |
Inflacam |
Island |
6.12.2012 |
|
EU/2/11/134/018–020 |
Inflacam |
Liechtenstein |
31.12.2012 |
|
EU/2/99/015/003–004 |
Oxyglobin |
Liechtenstein |
31.12.2012 |
IV LISA
Äravõetud müügilubade nimekiri
Ajavahemikus 1. juuli – 31. detsember 2012 võeti EMP EFTA riikides ära järgmised müügiload:
|
ELi number |
Toode |
Riik |
Tagasivõtmise kuupäev |
|
EU/1/00/147/001–012 |
Hexavac |
Island |
23.7.2012 |
|
EU/1/00/147/001–012 |
Hexavac |
Liechtenstein |
31.8.2012 |
|
EU/1/01/193/001–002 |
MabCampath |
Norra |
8.8.2012 |
|
EU/1/01/193/001–002 |
MabCampath |
Island |
30.8.2012 |
|
EU/1/01/193/001–002 |
MabCampath |
Liechtenstein |
31.8.2012 |
|
EU/1/02/205/005–006 |
Lumigan |
Liechtenstein |
31.12.2012 |
|
EU/1/02/209/001–004 |
Dynastat |
Norra |
18.7.2012 |
|
EU/1/04/281/001–002, 004 |
Erbitux |
Norra |
30.8.2012 |
|
EU/1/07/407/001–040 |
Sprimeo |
Island |
23.7.2012 |
|
EU/1/07/407/001–040 |
Sprimeo |
Norra |
4.7.2012 |
|
EU/1/07/407/001–040 |
Sprimeo |
Liechtenstein |
31.8.2012 |
|
EU/1/09/513/001–020 |
Rivastigmine Teva |
Norra |
10.9.2012 |
|
EU/1/09/513/001–020 |
Rivastigmine Teva |
Island |
20.9.2012 |
|
EU/1/09/513/001–020 |
Rivastigmine Teva |
Liechtenstein |
31.10.2012 |
|
EU/1/09/520/001–020 |
Exalief |
Island |
6.12.2012 |
|
EU/1/09/520/001–020 |
Exalief |
Norra |
30.7.2012 |
|
EU/1/09/570/001–060 |
Imprida HCT |
Island |
7.12.2012 |
|
EU/1/09/576/040 |
Irbesartan Teva |
Liechtenstein |
31.12.2012 |
|
EU/1/09/582/001 |
Rilonacept Regeneron |
Island |
14.11.2012 |
|
EU/1/09/582/001 |
Rilonacept Regeneron |
Norra |
24.10.2012 |
|
EU/1/10/634/005–011 |
Ribavirin Mylan |
Liechtenstein |
31.12.2012 |
|
EU/1/11/638/001–080 |
Sprimeo HCT |
Liechtenstein |
31.8.2012 |
|
EU/1/11/669/005 |
Teysuno |
Liechtenstein |
31.12.2012 |
|
EU/1/11/679/007 |
Pravafenix |
Liechtenstein |
31.12.2012 |
|
EU/1/11/680/001–080 |
Riprazo HCT |
Norra |
30.8.2012 |
|
EU/1/11/680/001–080 |
Riprazo HCT |
Island |
12.9.2012 |
|
EU/1/11/683/001–080 |
Sprimeo HCT |
Norra |
6.7.2012 |
|
EU/1/11/683/001–080 |
Sprimeo HCT |
Island |
23.7.2012 |
|
EU/1/11/691/006–013 |
Eliquis |
Liechtenstein |
31.12.2012 |
|
EU/1/11/697/013–024 |
Temozolomide SUN |
Liechtenstein |
31.12.2012 |
|
EU/1/12/765/007–009 |
Sabervel |
Liechtenstein |
31.12.2012 |
|
EU/1/12/776/017–023 |
Fycompa |
Liechtenstein |
31.12.2012 |
|
EU/1/12/780/029–034 |
Jentadueto |
Liechtenstein |
31.12.2012 |
|
EU/1/96/006/008–011 |
NovoSeven |
Liechtenstein |
31.12.2012 |
|
EU/1/97/040/001–002 |
Teslascan |
Island |
14.9.2012 |
|
EU/1/99/099/001–006 |
Zerene |
Norra |
23.8.2012 |
|
EU/1/99/099/001–006 |
Zerene |
Island |
7.9.2012 |
|
EU/1/99/099/001–006 |
Zerene |
Liechtenstein |
31.10.2012 |
|
EU/1/99/101/001 |
Regranex |
Norra |
16.7.2012 |
|
EU/1/99/101/001 |
Regranex |
Liechtenstein |
31.8.2012 |
|
EU/1/99/101/001 |
Regranex |
Island |
14.8.2012 |
|
EU/1/99/103/009 |
Refacto AF |
Liechtenstein |
31.12.2012 |
V LISA
Peatatud müügilubade nimekiri
Ajavahemikus 1. juuli – 31. detsember 2012 peatati EMP EFTA riikides järgmised müügiload:
|
ELi number |
Toode |
Riik |
Peatamise kuupäev |
|
EU/1/09/509/001–004 |
Ribavirin Teva |
Island |
14.12.2012 |
|
EU/1/09/509/001–004 |
Ribavirin Teva |
Norra |
6.12.2012 |
|
EU/1/09/527/001–016 |
Ribavirin Teva Pharma BV |
Island |
14.12.2012 |
|
EU/1/09/527/001–016 |
Ribavirin Teva Pharma BV |
Norra |
6.12.2012 |