|
9.10.2014 |
MT |
Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 356/37 |
Prodotti mediċinali — Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni mogħtija mill-Istati tal-EFTA taż-ŻEE għat-tieni parti tas-sena 2012
2014/C 356/08
Sottokumitat I rigward il-moviment ħieles tal-merkanzija
Għall-attenzjoni tal-Kumitat Konġunt taż-ŻEE
B’referenza għad-Deċiżjoni tal-Kumitat Konġunt taż-ŻEE Nru. 74/1999 tat-28 ta’ Mejju 1999, il-Kumitat Konġunt taż-ŻEE huwa mistieden li jinnota l-listi li ġejjin rigward awtorizzazzjonijiet ta’ kummerċjalizzazzjoni għal prodotti mediċinali għall-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2012, fil-laqgħa tagħhom tat-8 ta’ Novembru 2013:
|
Anness I |
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni ġodda |
|
Anness II |
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni mġedda |
|
Anness III |
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni estiżi |
|
Anness IV |
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni rtirati |
|
Anness V |
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni sospiżi |
ANNESS I
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni ġodda
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ingħataw fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2012:
|
Numru tal-UE |
Prodott |
Il-pajjiż |
Data tal-awtorizzazzjoni |
|
UE/1/11/685/001-005 |
Ibandronic acid Sandoz |
In-Norveġja |
31.7.2012 |
|
UE/1/11/719/001-062 |
Telmisartan Teva Pharma |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/11/744/001-002 |
Topotecan Eagle |
In-Norveġja |
30.8.2012 |
|
UE/1/11/747/001 |
Colobreathe |
In-Norveġja |
11.7.2012 |
|
UE/1/11/748/001-006 |
Docetaxel Mylan |
In-Norveġja |
17.12.2012 |
|
UE/1/12/762/001-018 |
Capecitabine Accord |
In-Norveġja |
13.8.2012 |
|
UE/1/12/768/001 |
Riluzole Zentiva |
In-Norveġja |
16.8.2012 |
|
UE/1/12/769/001-003 |
Docetaxel Accord |
In-Norveġja |
13.8.2012 |
|
UE/1/12/771/001-006 |
Zoledronic Acid Teva |
L-Islanda |
10.9.2012 |
|
UE/1/12/771/001-006 |
Zoledronic acid Teva |
In-Norveġja |
12.10.2012 |
|
UE/1/12/772/001-004 |
Zoledronic acid Teva Pharma |
L-Islanda |
10.9.2012 |
|
UE/1/12/772/001-004 |
Zoledronic acid Teva Pharma |
In-Norveġja |
10.10.2012 |
|
UE/1/12/773/001-003 |
Jakavi |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/773/001-003 |
Jakavi |
In-Norveġja |
5.9.2012 |
|
UE/1/12/773/001-003 |
Jakavi |
L-Islanda |
19.9.2012 |
|
UE/1/12/774/001-002 |
Rienso |
In-Norveġja |
14.8.2012 |
|
UE/1/12/774/001-002 |
Rienso |
L-Islanda |
20.7.2012 |
|
UE/1/12/774/001-002 |
Rienso |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/775/001 |
NovoThirteen |
L-Islanda |
17.9.2012 |
|
UE/1/12/775/001 |
Novo Thirteen |
In-Norveġja |
19.9.2012 |
|
UE/1/12/775/001 |
Novo Thirteen |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/12/776/001-016 |
Fycompa |
In-Norveġja |
27.8.2012 |
|
UE/1/12/776/001-016 |
Fycompa |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/776/001-016 |
Fycompa |
L-Islanda |
11.9.2012 |
|
UE/1/12/777/001-006 |
Inlyta |
L-Islanda |
14.9.2012 |
|
UE/1/12/777/001-006 |
Inlyta |
In-Norveġja |
21.9.2012 |
|
UE/1/12/777/001-006 |
Inlyta |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/12/778/001-003 |
Eklira Genuair |
L-Islanda |
13.8.2012 |
|
UE/1/12/778/001-003 |
Eklira Genuair |
In-Norveġja |
15.8.2012 |
|
UE/1/12/778/001-003 |
Eklira Genuair |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/779/001-006 |
Zoledronic acid medac |
In-Norveġja |
15.8.2012 |
|
UE/1/12/779/001-006 |
Zoledronic acid medac |
L-Islanda |
27.8.2012 |
|
UE/1/12/779/001-006 |
Zoledronic acid medac |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/780/001-028 |
Jentadueto |
In-Norveġja |
31.7.2012 |
|
UE/1/12/780/001-028 |
Jentadueto |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/780/001-028 |
Jentadueto |
L-Islanda |
17.8.2012 |
|
UE/1/12/781/001-003 |
Bretaris Genuair |
L-Islanda |
13.8.2012 |
|
UE/1/12/781/001-003 |
Bretaris Genuair |
In-Norveġja |
15.8.2012 |
|
UE/1/12/781/001-003 |
Bretaris Genuair |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/782/001-002 |
Kalydeco |
In-Norveġja |
6.8.2012 |
|
UE/1/12/782/001-002 |
Kalydeco |
L-Islanda |
21.8.2012 |
|
UE/1/12/782/001-002 |
Kalydeco |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/783/001-003 |
Zyclara |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/783/001-003 |
Zyclara |
L-Islanda |
12.9.2012 |
|
UE/1/12/783/001-003 |
Zyclara |
In-Norveġja |
10.10.2012 |
|
UE/1/12/784/001 |
Cuprymina |
L-Islanda |
7.9.2012 |
|
UE/1/12/784/001 |
Cuprymina |
In-Norveġja |
25.9.2012 |
|
UE/1/12/784/001 |
Cuprymina |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/12/785/001 |
Zinforo |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/785/001 |
Zinforo |
L-Islanda |
6.9.2012 |
|
UE/1/12/785/001 |
Zinforo |
In-Norveġja |
17.9.2012 |
|
UE/1/12/786/001-003 |
Zoledronic acid Mylan |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/786/001-003 |
Zoledronic acid Mylan |
L-Islanda |
4.9.2012 |
|
UE/1/12/786/001-003 |
Zoledronic acid Mylan |
In-Norveġja |
12.10.2012 |
|
UE/1/12/787/001 |
Revestive |
L-Islanda |
14.9.2012 |
|
UE/1/12/787/001 |
Revestive |
In-Norveġja |
26.9.2012 |
|
UE/1/12/787/001 |
Revestive |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/12/788/001-006 |
Seebri Breezhaler |
L-Islanda |
16.10.2012 |
|
UE/1/12/788/001-006 |
Seebri Breezhaler |
In-Norveġja |
17.10.2012 |
|
UE/1/12/789/001-006 |
Enurev Breezhaler |
L-Islanda |
17.10.2012 |
|
UE/1/12/789/001-006 |
Enurev Breezhaler |
In-Norveġja |
29.10.2012 |
|
UE/1/12/790/001-006 |
Tovanor Breezhaler |
L-Islanda |
17.10.2012 |
|
UE/1/12/790/001-006 |
Tovanor Breezhaler |
In-Norveġja |
29.10.2012 |
|
UE/1/12/791/001 |
Glybera |
L-Islanda |
15.11.2012 |
|
UE/1/12/791/001 |
Glybera |
In-Norveġja |
6.12.2012 |
|
UE/1/12/792/001 |
Dacogen |
L-Islanda |
15.10.2012 |
|
UE/1/12/792/001 |
Dacogen |
In-Norveġja |
17.10.2012 |
|
UE/1/12/792/001 |
Dacogen |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/12/793/001-004 |
Xalkori |
L-Islanda |
8.11.2012 |
|
UE/1/12/793/001-004 |
Xalkori |
In-Norveġja |
14.11.2012 |
|
UE/1/12/793/001-004 |
Xalkori |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/794/001 |
Adcetris |
In-Norveġja |
10.12.2012 |
|
UE/1/12/794/001 |
Adectris |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/795/001-010 |
Forxiga |
In-Norveġja |
6.12.2012 |
|
UE/1/12/795/001-010 |
Forxiga |
L-Islanda |
7.12.2012 |
|
UE/1/12/796/001-002 |
Picato |
In-Norveġja |
27.11.2012 |
|
UE/1/12/796/001-002 |
Picato |
L-Islanda |
7.12.2012 |
|
UE/1/12/796/001-002 |
Picato |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/797/001-002 |
Eylea |
In-Norveġja |
6.12.2012 |
|
UE/1/12/797/001-002 |
Eylea |
L-Islanda |
13.12.2012 |
|
UE/1/12/798/001-004 |
Ibandronic acid Accord |
In-Norveġja |
12.12.2012 |
|
UE/1/12/798/001-004 |
Ibandronic acid Accord |
L-Islanda |
10.12.2012 |
|
UE/1/12/798/001-004 |
Ibandronic acid Accord |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/799/001-029 |
Memantine Merz |
L-Islanda |
12.12.2012 |
|
UE/1/12/799/001-029 |
Memantine Merz |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/800/001-004 |
Zoledronic Acid Hospira |
L-Islanda |
7.12.2012 |
|
UE/1/12/800/001-004 |
Zoledronic acid Hospira |
In-Norveġja |
17.12.2012 |
|
UE/1/12/800/001-004 |
Zoledronic acid Hospira |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/801/001-004 |
Constella |
L-Islanda |
13.12.2012 |
|
UE/1/12/801/001-004 |
Constella |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/801/001-004 |
Constella |
In-Norveġja |
17.12.2012 |
|
UE/1/12/802/001-042 |
Capecitabine medac |
In-Norveġja |
13.12.2012 |
|
UE/1/12/802/001-042 |
Capecitabine medac |
L-Islanda |
18.12.2012 |
|
UE/1/12/802/001-042 |
Capecitabine medac |
Il-Liechtenstein |
31.12.2012 |
|
UE/2/09/099/001-006 |
Suvaxyn PCV |
L-Islanda |
8.11.2012 |
|
UE/2/11/122/001-003 |
Bluevac BTV8 |
In-Norveġja |
18.7.2012 |
|
UE/2/12/138/001-003 |
RevitaCAM |
In-Norveġja |
19.9.2012 |
|
UE/2/12/140/001-008 |
Poulvac E. Coli |
L-Islanda |
23.7.2012 |
|
UE/2/12/141/001-009 |
Porcilis ColiClos |
L-Islanda |
5.7.2012 |
|
UE/2/12/141/001-009 |
Porcilis ColiClos |
In-Norveġja |
31.7.2012 |
|
UE/2/12/141/001-009 |
Porcilis ColiClos |
Il-Liechtenstein |
31.8.2012 |
|
UE/2/12/142/001-006 |
Cardalis 2,5/20 mg |
L-Islanda |
20.8.2012 |
|
UE/2/12/143/001-005 |
Nobivac L4 |
L-Islanda |
20.8.2012 |
|
UE/2/12/143/001-005 |
Nobivac L4 |
In-Norveġja |
28.8.2012 |
|
UE/2/12/143/001-005 |
Nobivac L4 |
Il-Liechtenstein |
31.8.2012 |
ANNESS II
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni mġedda
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ġew imġedda fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2012:
|
Numru tal-UE |
Prodott |
Il-pajjiż |
Data tal-awtorizzazzjoni |
|
UE/1/01/187/001 |
DepoCyte |
In-Norveġja |
13.8.2012 |
|
UE/1/01/197/001-005 |
Foscan |
In-Norveġja |
7.9.2012 |
|
UE/1/02/222/001-005 |
Tamiflu |
In-Norveġja |
21.8.2012 |
|
UE/1/02/223/001-003 |
Evra |
L-Islanda |
5.7.2012 |
|
UE/1/02/223/001-003 |
Evra |
In-Norveġja |
27.8.2012 |
|
UE/1/02/223/001-003 |
Evra |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/02/224/001-005 |
Ambirix |
L-Islanda |
21.8.2012 |
|
UE/1/02/224/001-005 |
Ambirix |
In-Norveġja |
27.8.2012 |
|
UE/1/02/224/001-005 |
Ambirix |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/02/226/001 |
InductOs |
In-Norveġja |
2.8.2012 |
|
UE/1/02/226/001 |
InductOs |
L-Islanda |
14.8.2012 |
|
UE/1/02/237/001-009 |
Cialis |
In-Norveġja |
11.10.2012 |
|
UE/1/02/237/001-009 |
Cialis |
L-Islanda |
17.10.2012 |
|
UE/1/02/237/001-009 |
Cialis |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/02/238/001 |
Zavesca |
L-Islanda |
22.10.2012 |
|
UE/1/02/238/001 |
Zavesca |
In-Norveġja |
29.10.2012 |
|
UE/1/02/238/001 |
Zavesca |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/05/314/001 |
Kepivance |
In-Norveġja |
11.9.2012 |
|
UE/1/06/339/001-002 |
Preotact |
In-Norveġja |
28.8.2012 |
|
UE/1/06/367/001-012 |
Diacomit |
In-Norveġja |
12.12.2012 |
|
UE/1/06/367/001-012 |
Diacomit |
L-Islanda |
13.12.2012 |
|
UE/1/06/367/001-012 |
Diacomit |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/06/371/001-039 |
Dafiro |
In-Norveġja |
26.9.2012 |
|
UE/1/06/376/001-039 |
Irbesartan Zentiva |
L-Islanda |
28.9.2012 |
|
UE/1/07/393/001 |
Soliris |
L-Islanda |
5.7.2012 |
|
UE/1/07/393/001 |
Soliris |
In-Norveġja |
13.8.2012 |
|
UE/1/07/394/001-009 |
Optaflu |
L-Islanda |
8.11.2012 |
|
UE/1/07/395/001-095 |
Invega |
L-Islanda |
31.8.2012 |
|
UE/1/07/395/001-095 |
Invega |
In-Norveġja |
11.9.2012 |
|
UE/1/07/397/001-004 |
Siklos |
L-Islanda |
23.7.2012 |
|
UE/1/07/397/001-004 |
Siklos |
In-Norveġja |
9.8.2012 |
|
UE/1/07/398/001-014 |
Optimark |
L-Islanda |
5.7.2012 |
|
UE/1/07/398/001-014 |
Optimark |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/401/007-016 |
alli |
L-Islanda |
20.7.2012 |
|
UE/1/07/401/007-016 |
alli |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/402/001 |
Increlex |
L-Islanda |
29.8.2012 |
|
UE/1/07/402/001 |
Increlex |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/402/001 |
Increlex |
In-Norveġja |
3.9.2012 |
|
UE/1/07/403/001 |
Atriance |
L-Islanda |
20.7.2012 |
|
UE/1/07/403/001 |
Atriance |
In-Norveġja |
7.8.2012 |
|
UE/1/07/403/001 |
Atriance |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/404/001-008 |
Flebogamma DIF |
L-Islanda |
11.9.2012 |
|
UE/1/07/404/001-008 |
Flebogamma DIF |
In-Norveġja |
12.10.2012 |
|
UE/1/07/405/001-040 |
Rasilez |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/405/001-040 |
Rasilez |
L-Islanda |
19.9.2012 |
|
UE/1/07/405/001-040 |
Rasilez |
In-Norveġja |
10.10.2012 |
|
UE/1/07/409/001-040 |
Riprazo |
L-Islanda |
12.9.2012 |
|
UE/1/07/409/001-040 |
Riprazo |
In-Norveġja |
10.10.2012 |
|
UE/1/07/409/001-040 |
Riprazo |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/410/001-052 |
Binocrit |
In-Norveġja |
27.8.2012 |
|
UE/1/07/410/001-052 |
Binocrit |
L-Islanda |
20.7.2012 |
|
UE/1/07/410/001-052 |
Binocrit |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/411/001-052 |
Epoetin alfa Hexal |
L-Islanda |
19.7.2012 |
|
UE/1/07/411/001-052 |
Epoetin alfa Hexal |
In-Norveġja |
27.8.2012 |
|
UE/1/07/411/001-052 |
Epoetin alfa Hexal |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/412/001-052 |
Abseamed |
L-Islanda |
20.7.2012 |
|
UE/1/07/412/001-052 |
Abseamed |
In-Norveġja |
27.8.2012 |
|
UE/1/07/413/001-003 |
Gliolan |
L-Islanda |
7.9.2012 |
|
UE/1/07/413/001-003 |
Gliolan |
In-Norveġja |
15.10.2012 |
|
UE/1/07/413/001-003 |
Gliolan |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/07/414/001-010, 018 |
Galvus |
L-Islanda |
17.8.2012 |
|
UE/1/07/414/001-010, 018 |
Galvus |
In-Norveġja |
31.7.2012 |
|
UE/1/07/415/001-056 |
Zalasta |
In-Norveġja |
24.8.2012 |
|
UE/1/07/415/001-056 |
Zalasta |
L-Islanda |
25.8.2012 |
|
UE/1/07/415/001-056 |
Zalasta |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/416/002 |
Ecalta |
L-Islanda |
3.9.2012 |
|
UE/1/07/416/002 |
Ecalta |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/416/002 |
Ecalta |
In-Norveġja |
26.9.2012 |
|
UE/1/07/417/001-002 |
Yondelis |
L-Islanda |
28.8.2012 |
|
UE/1/07/417/001-002 |
Yondelis |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/417/001-002 |
Yondelis |
In-Norveġja |
17.9.2012 |
|
UE/1/07/418/001-010 |
Celsentri |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/418/001-010 |
Celsentri |
L-Islanda |
12.9.2012 |
|
UE/1/07/418/001-010 |
Celsentri |
In-Norveġja |
18.9.2012 |
|
UE/1/07/419/001-012 |
Cervarix |
L-Islanda |
12.10.2012 |
|
UE/1/07/419/001-012 |
Cervarix |
In-Norveġja |
12.10.2012 |
|
UE/1/07/419/001-012 |
Cervarix |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/07/420/001-002 |
Cyanokit |
L-Islanda |
14.8.2012 |
|
UE/1/07/420/001-002 |
Cyanokit |
In-Norveġja |
17.8.2012 |
|
UE/1/07/420/001-002 |
Cyanokit |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/421/001-009 |
Glubrava |
L-Islanda |
12.10.2012 |
|
UE/1/07/421/001-009 |
Glubrava |
In-Norveġja |
12.10.2012 |
|
UE/1/07/421/001-009 |
Glubrava |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/07/422/001-012 |
Tasigna |
In-Norveġja |
24.10.2012 |
|
UE/1/07/422/001-012 |
Tasigna |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/07/422/001-012 |
Tasigna |
L-Islanda |
6.12.2012 |
|
UE/1/07/424/001 |
Torisel |
L-Islanda |
12.10.2012 |
|
UE/1/07/424/001 |
Torisel |
In-Norveġja |
22.10.2012 |
|
UE/1/07/424/001 |
Torisel |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/07/425/001-018 |
Eucreas |
In-Norveġja |
31.7.2012 |
|
UE/1/07/425/001-018 |
Eucreas |
L-Islanda |
21.8.2012 |
|
UE/1/07/425/001-018 |
Eucreas |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/426/001-011 |
Olanzapine Neopharma |
L-Islanda |
17.10.2012 |
|
UE/1/07/426/001-011 |
Olanzapine Neopharma |
In-Norveġja |
24.10.2012 |
|
UE/1/07/426/001-011 |
Olanzapine Neopharma |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/07/427/001-057 |
Olanzapine Teva |
In-Norveġja |
6.12.2012 |
|
UE/1/07/427/001-057 |
Olanzapine Teva |
L-Islanda |
7.12.2012 |
|
UE/1/07/427/001-057 |
Olanzapine Teva |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/07/430/001-002 |
Atripla |
In-Norveġja |
26.9.2012 |
|
UE/1/07/430/001-002 |
Atripla |
L-Islanda |
12.10.2012 |
|
UE/1/07/431/001-025 |
Retacrit |
L-Islanda |
7.12.2012 |
|
UE/1/07/431/001-025 |
Retacrit |
In-Norveġja |
17.12.2012 |
|
UE/1/07/431/001-025 |
Retacrit |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/07/432/001-022 |
Silapo |
L-Islanda |
22.8.2012 |
|
UE/1/07/432/001-022 |
Silapo |
In-Norveġja |
24.8.2012 |
|
UE/1/07/432/001-022 |
Silapo |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/433/001 |
Nevanac |
In-Norveġja |
15.10.2012 |
|
UE/1/07/433/001 |
Nevanac |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/07/435/001-018 |
Tesavel |
L-Islanda |
15.10.2012 |
|
UE/1/07/435/001-018 |
Tesavel |
In-Norveġja |
15.10.2012 |
|
UE/1/07/437/001-004 |
IVEMEND |
L-Islanda |
7.12.2012 |
|
UE/1/07/437/003-004 |
IVEMEND |
In-Norveġja |
6.12.2012 |
|
UE/1/07/437/003-004 |
IVEMEND |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/07/438/001-006 |
Myfenax |
L-Islanda |
12.12.2012 |
|
UE/1/07/438/006 |
Myfenax |
In-Norveġja |
13.12.2012 |
|
UE/1/07/439/001-006 |
Mycophenolate mofetil Teva |
L-Islanda |
12.12.2012 |
|
UE/1/07/439/001-006 |
Mycophenolate mofetil Teva |
In-Norveġja |
17.12.2012 |
|
UE/1/08/468/001-002 |
INTELENCE |
L-Islanda |
16.8.2012 |
|
UE/1/08/468/001-002 |
INTELENCE |
In-Norveġja |
27.8.2012 |
|
UE/1/08/468/001-002 |
INTELENCE |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/11/710/001-007 |
Votubia |
In-Norveġja |
16.8.2012 |
|
UE/1/11/710/001-007 |
Votubia |
L-Islanda |
25.8.2012 |
|
UE/1/11/710/001-007 |
Votubia |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/97/047/004-007 |
BeneFIX |
L-Islanda |
16.8.2012 |
|
UE/1/97/047/004-007 |
BeneFIX |
In-Norveġja |
24.8.2012 |
|
UE/1/97/047/004-007 |
BeneFIX |
Il-Liechtenstein |
31.8.2012 |
|
UE/2/02/032/001-002 |
Vaxxitek HVT + IBD |
L-Islanda |
23.7.2012 |
|
UE/2/02/032/001-002 |
Vaxxitek HVT + IBD |
Il-Liechtenstein |
31.8.2012 |
|
UE/2/02/034/001 |
Nobivac Bb |
L-Islanda |
18.9.2012 |
|
UE/2/02/034/001 |
Nobivac Bb |
In-Norveġja |
23.10.2012 |
|
UE/2/02/034/001 |
Nobivac Bb |
Il-Liechtenstein |
31.10.2012 |
|
UE/2/07/072/001-004 |
Suprelorin |
In-Norveġja |
31.7.2012 |
|
UE/2/07/072/001-004 |
Suprelorin |
Il-Liechtenstein |
31.8.2012 |
|
UE/2/07/074/001-006 |
Prilactone |
Il-Liechtenstein |
31.8.2012 |
|
UE/2/07/077/001-005 |
Meloxivet |
L-Islanda |
6.12.2012 |
|
UE/2/07/077/001-005 |
Meloxivet |
Il-Liechtenstein |
31.10.2012 |
ANNESS III
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni estiżi
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ġew estiżi fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2012:
|
Numru tal-UE |
Prodott |
Il-pajjiż |
Data tal-awtorizzazzjoni |
|
UE/1/01/200/003-009 |
Viread |
L-Islanda |
18.12.2012 |
|
UE/1/04/274/001-002 |
Velcade |
In-Norveġja |
18.10.2012 |
|
UE/1/04/306/002-003 |
Aloxi |
In-Norveġja |
19.11.2012 |
|
UE/1/06/368/169-174 |
Insulin Human Winthrop |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/06/376/034, 036-039 |
Irbesartan Zentiva |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/06/376/034, 036-039 |
Irbesartan Zentiva |
In-Norveġja |
30.8.2012 |
|
UE/1/06/377/029-034 |
Irbesartan HCT Zentiva |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/06/377/029-034 |
Irbesartan HCT Zentiva |
In-Norveġja |
12.11.2012 |
|
UE/1/06/380/006 |
Prezista |
L-Islanda |
14.11.2012 |
|
UE/1/06/380/006 |
Prezista |
In-Norveġja |
24.10.2012 |
|
UE/1/07/389/004-009 |
Orencia |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/07/389/004-009 |
Orencia |
In-Norveġja |
13.11.2012 |
|
UE/1/07/389/004-009 |
Orencia |
L-Islanda |
19.10.2012 |
|
UE/1/07/391/005-006 |
Revlimid |
In-Norveġja |
25.9.2012 |
|
UE/1/07/391/005-006 |
Revlimid |
L-Islanda |
11.10.2012 |
|
UE/1/07/440/007 |
Tyverb |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/07/440/007 |
Tyverb |
In-Norveġja |
31.7.2012 |
|
UE/1/09/514/021-023 |
Zebinix |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/09/514/021-023 |
Zebinix |
L-Islanda |
3.9.2012 |
|
UE/1/09/514/021-023 |
Zebinix |
In-Norveġja |
25.9.2012 |
|
UE/1/10/616/025-036 |
Temozolomide HEXAL |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/10/617/025-036 |
Temozolomide Sandoz |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/11/691/006-013 |
Eliquis |
L-Islanda |
11.12.2012 |
|
UE/1/11/691/006-013 |
Eliquis |
In-Norveġja |
19.12.2012 |
|
UE/1/11/712/029-040 |
Levetiracetam Accord |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/11/731/013-014 |
Komboglyze |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/11/731/013-014 |
Komboglyze |
In-Norveġja |
24.9.2012 |
|
UE/1/11/734/012-018 |
Edarbi |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/11/735/012-018 |
Ipreziv |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/12/752/002 |
Vepacel |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/12/765/007-009 |
Sabervel |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/97/030/196-201 |
Insuman |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/97/047/008 |
BeneFIX |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/97/047/008 |
BeneFIX |
L-Islanda |
4.9.2012 |
|
UE/1/97/047/008 |
BeneFIX |
In-Norveġja |
10.10.2012 |
|
UE/2/02/033/003-004 |
Dexdomitor |
L-Islanda |
13.9.2012 |
|
UE/2/02/033/003-004 |
Dexdomitor |
In-Norveġja |
30.8.2012 |
|
UE/2/02/033/003-004 |
Dexdomitor |
Il-Liechtenstein |
31.10.2012 |
|
UE/2/07/074/007-009 |
Prilactone |
Il-Liechtenstein |
31.12.2012 |
|
UE/2/07/078/018-020 |
Rheumocam |
In-Norveġja |
6.12.2012 |
|
UE/2/07/078/018-020 |
Rheumocam |
Il-Liechtenstein |
31.12.2012 |
|
UE/2/08/090/028 |
Loxicom |
Il-Liechtenstein |
31.12.2012 |
|
UE/2/10/118/015-021 |
Activyl |
Il-Liechtenstein |
31.8.2012 |
|
UE/2/11/134/015-017 |
Inflacam |
L-Islanda |
5.9.2012 |
|
UE/2/11/134/015-017 |
Inflacam |
In-Norveġja |
1.11.2012 |
|
UE/2/11/134/015-017 |
Inflacam |
Il-Liechtenstein |
31.8.2012 |
|
UE/2/11/134/018-020 |
Inflacam |
L-Islanda |
6.12.2012 |
|
UE/2/11/134/018-020 |
Inflacam |
Il-Liechtenstein |
31.12.2012 |
|
UE/2/99/015/003-004 |
Oxyglobin |
Il-Liechtenstein |
31.12.2012 |
ANNESS IV
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni rtirati
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ġew irtirati fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2012:
|
Numru tal-UE |
Prodott |
Il-pajjiż |
Data ta’ rtirar |
|
UE/1/00/147/001-012 |
Hexavac |
L-Islanda |
23.7.2012 |
|
UE/1/00/147/001-012 |
Hexavac |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/01/193/001-002 |
MabCampath |
In-Norveġja |
8.8.2012 |
|
UE/1/01/193/001-002 |
MabCampath |
L-Islanda |
30.8.2012 |
|
UE/1/01/193/001-002 |
MabCampath |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/02/205/005-006 |
Lumigan |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/02/209/001-004 |
Dynastat |
In-Norveġja |
18.7.2012 |
|
UE/1/04/281/001-002, 004 |
Erbitux |
In-Norveġja |
30.8.2012 |
|
UE/1/07/407/001-040 |
Sprimeo |
L-Islanda |
23.7.2012 |
|
UE/1/07/407/001-040 |
Sprimeo |
In-Norveġja |
4.7.2012 |
|
UE/1/07/407/001-040 |
Sprimeo |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/09/513/001-020 |
Rivastigmine Teva |
In-Norveġja |
10.9.2012 |
|
UE/1/09/513/001-020 |
Rivastigmine Teva |
L-Islanda |
20.9.2012 |
|
UE/1/09/513/001-020 |
Rivastigmine Teva |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/09/520/001-020 |
Exalief |
L-Islanda |
6.12.2012 |
|
UE/1/09/520/001-020 |
Exalief |
In-Norveġja |
30.7.2012 |
|
UE/1/09/570/001-060 |
Imprida HCT |
L-Islanda |
7.12.2012 |
|
UE/1/09/576/040 |
Irbesartan Teva |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/09/582/001 |
Rilonacept Regeneron |
L-Islanda |
14.11.2012 |
|
UE/1/09/582/001 |
Rilonacept Regeneron |
In-Norveġja |
24.10.2012 |
|
UE/1/10/634/005-011 |
Ribavirin Mylan |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/11/638/001-080 |
Sprimeo HCT |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/11/669/005 |
Teysuno |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/11/679/007 |
Pravafenix |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/11/680/001-080 |
Riprazo HCT |
In-Norveġja |
30.8.2012 |
|
UE/1/11/680/001-080 |
Riprazo HCT |
L-Islanda |
12.9.2012 |
|
UE/1/11/683/001-080 |
Sprimeo HCT |
In-Norveġja |
6.7.2012 |
|
UE/1/11/683/001-080 |
Sprimeo HCT |
L-Islanda |
23.7.2012 |
|
UE/1/11/691/006-013 |
Eliquis |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/11/697/013-024 |
Temozolomide SUN |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/765/007-009 |
Sabervel |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/776/017-023 |
Fycompa |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/12/780/029-034 |
Jentadueto |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/96/006/008-011 |
NovoSeven |
Il-Liechtenstein |
31.12.2012 |
|
UE/1/97/040/001-002 |
Teslascan |
L-Islanda |
14.9.2012 |
|
UE/1/99/099/001-006 |
Zerene |
In-Norveġja |
23.8.2012 |
|
UE/1/99/099/001-006 |
Zerene |
L-Islanda |
7.9.2012 |
|
UE/1/99/099/001-006 |
Zerene |
Il-Liechtenstein |
31.10.2012 |
|
UE/1/99/101/001 |
Regranex |
In-Norveġja |
16.7.2012 |
|
UE/1/99/101/001 |
Regranex |
Il-Liechtenstein |
31.8.2012 |
|
UE/1/99/101/001 |
Regranex |
L-Islanda |
14.8.2012 |
|
UE/1/99/103/009 |
Refacto AF |
Il-Liechtenstein |
31.12.2012 |
ANNESS V
Lista ta’ awtorizzazzjonijiet ta’ kummerċjalizzazzjoni sospiżi
L-awtorizzazzjonijiet ta’ kummerċjalizzazzjoni li ġejjin ġew sospiżi fl-Istati EFTA taż-ŻEE matul il-perjodu bejn l-1 ta’ Lulju u l-31 ta’ Diċembru 2012:
|
Numru tal-UE |
Prodott |
Il-pajjiż |
Data ta’ sospensjoni |
|
UE/1/09/509/001-004 |
Ribavirin Teva |
L-Islanda |
14.12.2012 |
|
UE/1/09/509/001-004 |
Ribavirin Teva |
In-Norveġja |
6.12.2012 |
|
UE/1/09/527/001-016 |
Ribavirin Teva Pharma BV |
L-Islanda |
14.12.2012 |
|
UE/1/09/527/001-016 |
Ribavirin Teva Pharma BV |
In-Norveġja |
6.12.2012 |