This document is an excerpt from the EUR-Lex website
Document E2016G0922(01)
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2015
Läkemedel – Förteckningar över försäljningstillstånd som beviljats av Eftastaterna i EES under första halvåret 2015
Läkemedel – Förteckningar över försäljningstillstånd som beviljats av Eftastaterna i EES under första halvåret 2015
EUT C 347, 22.9.2016, p. 4–18
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
22.9.2016 |
SV |
Europeiska unionens officiella tidning |
C 347/4 |
Läkemedel – Förteckningar över försäljningstillstånd som beviljats av Eftastaterna i EES under första halvåret 2015
(2016/C 347/04)
Underkommitté I – Fri rörlighet för varor
För gemensamma EES-kommitténs kännedom
På grundval av gemensamma ESS-kommitténs beslut nr 74/1999 av den 28 maj 1999 uppmanas gemensamma EES-kommittén att vid mötet den 29 april 2016 notera följande förteckningar över försäljningstillstånd för läkemedel under perioden 1 januari–30 juni 2015:
|
Bilaga I |
Förteckning över nya försäljningstillstånd |
|
Bilaga II |
Förteckning över förlängda försäljningstillstånd |
|
Bilaga III |
Förteckning över utvidgade försäljningstillstånd |
|
Bilaga IV |
Förteckning över återkallade försäljningstillstånd |
|
Bilaga V |
Förteckning över upphävda försäljningstillstånd |
BILAGA I
Förteckning över nya försäljningstillstånd
Följande försäljningstillstånd har beviljats i Eftastaterna i EES för perioden 1 januari–30 juni 2015:
|
EU-nummer |
Produkt |
Land |
Datum för godkännande |
|
EU/1/07/423 |
Vectibix |
Liechtenstein |
28.2.2015 |
|
EU/1/11/709 |
Buccolam |
Liechtenstein |
28.2.2015 |
|
EU/1/11/721 |
Paglitaz |
Liechtenstein |
28.2.2015 |
|
EU/1/11/745 |
Desloratadine Actavis |
Liechtenstein |
28.2.2015 |
|
EU/1/12/755 |
Pioglitazone Actavis |
Liechtenstein |
28.2.2015 |
|
EU/1/12/757 |
Pioglitazone Teva |
Liechtenstein |
28.2.2015 |
|
EU/1/12/758 |
Pioglitazone Teva Pharma |
Liechtenstein |
28.2.2015 |
|
EU/1/12/760 |
Bronchitol |
Liechtenstein |
28.2.2015 |
|
EU/1/12/811 |
Lyxumia |
Liechtenstein |
28.2.2015 |
|
EU/1/13/817 |
Actelsar HCT |
Liechtenstein |
28.2.2015 |
|
EU/1/13/822 |
PHEBURANE |
Liechtenstein |
28.2.2015 |
|
EU/1/13/830 |
Stribild |
Liechtenstein |
28.2.2015 |
|
EU/1/13/835 |
Voriconazole Accord |
Liechtenstein |
28.2.2015 |
|
EU/1/13/845 |
Imatinib Accord |
Liechtenstein |
28.2.2015 |
|
EU/1/13/846 |
Xtandi |
Liechtenstein |
28.2.2015 |
|
EU/1/13/859 |
Levodopa-Carbidopa-Entacapone Sandoz |
Liechtenstein |
28.2.2015 |
|
EU/1/13/879 |
Giotrif |
Liechtenstein |
28.2.2015 |
|
EU/1/13/893 |
Opsumit |
Liechtenstein |
28.2.2015 |
|
EU/1/14/932 |
Vantobra |
Island |
17.4.2015 |
|
EU/1/14/932 |
Vantobra |
Norge |
15.4.2015 |
|
EU/1/14/936 |
Nuwiq |
Liechtenstein |
28.2.2015 |
|
EU/1/14/952 |
Sevelamer carbonate Zentiva |
Island |
6.2.2015 |
|
EU/1/14/952 |
Sevelamer carbonate Zentiva |
Liechtenstein |
28.2.2015 |
|
EU/1/14/952 |
Sevelamer carbonate Zentiva |
Norge |
06.2.2015 |
|
EU/1/14/953 |
Tasermity |
Island |
12.3.2015 |
|
EU/1/14/953 |
Tasermity |
Liechtenstein |
28.2.2015 |
|
EU/1/14/953 |
Tasermity |
Norge |
12.3.2015 |
|
EU/1/14/957 |
Cyramza |
Island |
15.1.2015 |
|
EU/1/14/957 |
Cyramza |
Liechtenstein |
28.2.2015 |
|
EU/1/14/957 |
Cyramza |
Norge |
13.1.2015 |
|
EU/1/14/959 |
Lynparza |
Island |
14.1.2015 |
|
EU/1/14/959 |
Lynparza |
Norge |
12.1.2015 |
|
EU/1/14/960 |
DUAVIVE |
Island |
14.1.2015 |
|
EU/1/14/960 |
Duavive |
Norge |
12.1.2015 |
|
EU/1/14/969 |
SCENESSE |
Island |
15.1.2015 |
|
EU/1/14/969 |
Scenesse |
Norge |
15.1.2015 |
|
EU/1/14/970 |
RIXUBIS |
Island |
14.1.2015 |
|
EU/1/14/970 |
Rixubis |
Norge |
13.1.2015 |
|
EU/1/14/972 |
Duloxetine Lilly |
Island |
6.1.2015 |
|
EU/1/14/973 |
Quinsair |
Island |
19.4.2015 |
|
EU/1/14/973 |
Quinsair |
Liechtenstein |
30.4.2015 |
|
EU/1/14/973 |
Quinsair |
Norge |
15.4.2015 |
|
EU/1/14/974 |
Cerdelga |
Island |
5.2.2015 |
|
EU/1/14/974 |
Cerdelga |
Liechtenstein |
28.2.2015 |
|
EU/1/14/974 |
Cerdelga |
Norge |
10.2.2015 |
|
EU/1/14/975 |
Clopidogrel ratiopharm |
Liechtenstein |
28.2.2015 |
|
EU/1/14/975 |
Clopidogrel ratiopharm |
Norge |
5.3.2015 |
|
EU/1/14/975 |
Clopidogrel ratiopharm |
Island |
11.3.2015 |
|
EU/1/14/976 |
Zontivity |
Island |
5.2.2015 |
|
EU/1/14/976 |
Zontivity |
Liechtenstein |
28.2.2015 |
|
EU/1/14/976 |
Zontivity |
Norge |
16.2.2015 |
|
EU/1/14/977 |
Rasagilin ratiopharm |
Liechtenstein |
28.2.2015 |
|
EU/1/14/977 |
Rasagiline ratiopharm |
Island |
22.1.2015 |
|
EU/1/14/977 |
Rasagiline ratiopharm |
Norge |
09.2.2015 |
|
EU/1/14/978 |
Senshio |
Island |
30.1.2015 |
|
EU/1/14/978 |
Senshio |
Liechtenstein |
28.2.2015 |
|
EU/1/14/978 |
Senshio |
Norge |
16.2.2015 |
|
EU/1/14/979 |
Ofev |
Island |
30.1.2015 |
|
EU/1/14/979 |
Ofev |
Liechtenstein |
28.2.2015 |
|
EU/1/14/979 |
Ofev |
Norge |
29.1.2015 |
|
EU/1/14/980 |
Cosentyx |
Island |
4.2.2015 |
|
EU/1/14/980 |
Cosentyx |
Liechtenstein |
28.2.2015 |
|
EU/1/14/980 |
Cosentyx |
Norge |
30.1.2015 |
|
EU/1/14/981 |
Otezla |
Island |
5.2.2015 |
|
EU/1/14/981 |
Otezla |
Liechtenstein |
28.2.2015 |
|
EU/1/14/981 |
Otezla |
Norge |
30.1.2015 |
|
EU/1/14/982 |
Viekirax |
Island |
29.1.2015 |
|
EU/1/14/982 |
Viekirax |
Liechtenstein |
28.2.2015 |
|
EU/1/14/982 |
Viekirax |
Norge |
20.1.2015 |
|
EU/1/14/983 |
Exviera |
Island |
29.1.2015 |
|
EU/1/14/983 |
Exviera |
Liechtenstein |
28.2.2015 |
|
EU/1/14/983 |
Exviera |
Norge |
20.1.2015 |
|
EU/1/14/984 |
Xadago |
Island |
11.3.2015 |
|
EU/1/14/984 |
Xadago |
Liechtenstein |
28.2.2015 |
|
EU/1/14/984 |
Xadago |
Norge |
16.3.2015 |
|
EU/1/14/985 |
Raplixa |
Island |
17.4.2015 |
|
EU/1/14/985 |
Raplixa |
Liechtenstein |
30.4.2015 |
|
EU/1/14/985 |
Raplixa |
Norge |
10.4.2015 |
|
EU/1/14/986 |
Xydalba |
Island |
11.3.2015 |
|
EU/1/14/986 |
Xydalba |
Liechtenstein |
28.2.2015 |
|
EU/1/14/986 |
Xydalba |
Norge |
2.3.2015 |
|
EU/1/14/987 |
Holoclar |
Island |
11.3.2015 |
|
EU/1/14/987 |
Holoclar |
Liechtenstein |
28.2.2015 |
|
EU/1/14/987 |
Holoclar |
Norge |
26.2.2015 |
|
EU/1/14/988 |
Mysimba |
Island |
19.4.2015 |
|
EU/1/14/988 |
Mysimba |
Liechtenstein |
30.4.2015 |
|
EU/1/14/988 |
Mysimba |
Norge |
15.4.2015 |
|
EU/1/15/1000 |
Jinarc |
Island |
4.6.2015 |
|
EU/1/15/1000 |
Jinarc |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1000 |
Jinarc |
Norge |
12.6.2015 |
|
EU/1/15/1001 |
Akynzeo |
Island |
4.6.2015 |
|
EU/1/15/1001 |
Akynzeo |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1001 |
Akynzeo |
Norge |
5.6.2015 |
|
EU/1/15/1002 |
Lenvima |
Island |
15.6.2015 |
|
EU/1/15/1002 |
Lenvima |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1002 |
Lenvima |
Norge |
15.6.2015 |
|
EU/1/15/1003 |
Synjardy |
Island |
9.6.2015 |
|
EU/1/15/1003 |
Synjardy |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1003 |
Synjardy |
Norge |
17.6.2015 |
|
EU/1/15/1004 |
Voriconazol Hospira |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1004 |
Voriconazole Hospira |
Island |
4.6.2015 |
|
EU/1/15/1004 |
Voriconazole Hospira |
Norge |
18.6.2015 |
|
EU/1/15/1007 |
Gardasil 9 |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1007 |
Gardasil 9 |
Norge |
18.6.2015 |
|
EU/1/15/1009 |
Aripiprazole Zentiva |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1010 |
Duloxetine Mylan |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1011 |
Pregabalin Sandoz |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1013 |
Lumark |
Liechtenstein |
30.6.2015 |
|
EU/1/15/1014 |
Opdivo |
Liechtenstein |
30.6.2015 |
|
EU/1/15/989 |
Orbactiv |
Island |
17.4.2015 |
|
EU/1/15/989 |
Orbactiv |
Liechtenstein |
30.4.2015 |
|
EU/1/15/989 |
Orbactiv |
Norge |
15.4.2015 |
|
EU/1/15/990 |
Ikervis |
Island |
17.4.2015 |
|
EU/1/15/990 |
IKERVIS |
Liechtenstein |
30.4.2015 |
|
EU/1/15/990 |
IKERVIS |
Norge |
9.4.2015 |
|
EU/1/15/991 |
Sivextro |
Island |
19.4.2015 |
|
EU/1/15/991 |
Sivextro |
Liechtenstein |
30.4.2015 |
|
EU/1/15/991 |
Sivextro |
Norge |
15.4.2015 |
|
EU/1/15/992 |
Saxenda |
Island |
19.4.2015 |
|
EU/1/15/992 |
Saxenda |
Liechtenstein |
30.4.2015 |
|
EU/1/15/992 |
Saxenda |
Norge |
9.4.2015 |
|
EU/1/15/993 |
Lixiana |
Liechtenstein |
30.6.2015 |
|
EU/1/15/994 |
Kengrexal |
Island |
19.4.2015 |
|
EU/1/15/994 |
Kengrexal |
Liechtenstein |
30.4.2015 |
|
EU/1/15/994 |
Kengrexal |
Norge |
10.4.2015 |
|
EU/1/15/995 |
DUTREBIS |
Island |
19.4.2015 |
|
EU/1/15/995 |
DUTREBIS |
Liechtenstein |
30.4.2015 |
|
EU/1/15/995 |
DUTREBIS |
Norge |
10.4.2015 |
|
EU/1/15/996 |
Ristempa |
Island |
11.5.2015 |
|
EU/1/15/996 |
Ristempa |
Liechtenstein |
30.4.2015 |
|
EU/1/15/996 |
Ristempa |
Norge |
13.4.2015 |
|
EU/1/15/999 |
Zykadia |
Island |
4.6.2015 |
|
EU/1/15/999 |
Zykadia |
Liechtenstein |
30.6.2015 |
|
EU/1/15/999 |
Zykadia |
Norge |
27.5.2015 |
|
EU/2/11/122 |
BLUEVAC BTV8 |
Liechtenstein |
28.2.2015 |
|
EU/2/11/131 |
Zulvac 1 Ovis |
Liechtenstein |
28.2.2015 |
|
EU/2/12/140 |
Poulvac E. coli |
Liechtenstein |
28.2.2015 |
|
EU/2/12/142 |
Cardalis |
Liechtenstein |
28.2.2015 |
|
EU/2/13/151 |
Equilis West Nile |
Liechtenstein |
28.2.2015 |
|
EU/2/13/152 |
ProZinc |
Liechtenstein |
28.2.2015 |
|
EU/2/14/162 |
Parvoduk |
Liechtenstein |
28.2.2015 |
|
EU/2/14/176 |
Bovela |
Island |
15.1.2015 |
|
EU/2/14/176 |
Bovela |
Norge |
23.1.2015 |
|
EU/2/14/177 |
Nexgard Spectra |
Island |
30.1.2015 |
|
EU/2/14/177 |
NEXGARD SPECTRA |
Liechtenstein |
28.2.2015 |
|
EU/2/14/177 |
Nexgard Spectra |
Norge |
13.2.2015 |
|
EU/2/14/178 |
Zulvac SBV |
Island |
24.2.2015 |
|
EU/2/14/178 |
Zulvac SBV |
Liechtenstein |
28.2.2015 |
|
EU/2/14/178 |
Zulvac SBV |
Norge |
11.3.2015 |
|
EU/2/14/179 |
Suvaxyn CSF Marker |
Island |
9.4.2015 |
|
EU/2/14/179 |
Suvaxyn CSF Marker |
Liechtenstein |
30.4.2015 |
|
EU/2/14/179 |
Suvaxyn CSF Marker |
Norge |
9.4.2015 |
|
EU/2/14/180 |
Coliprotec F4 |
Island |
15.4.2015 |
|
EU/2/14/180 |
Coliprotec F4 |
Liechtenstein |
30.4.2015 |
|
EU/2/14/180 |
Coliprotec F4 |
Norge |
9.4.2015 |
|
EU/2/15/181 |
Sileo |
Liechtenstein |
30.6.2015 |
|
EU/2/15/181 |
Sileo |
Norge |
30.6.2015 |
BILAGA II
Förteckning över förlängda försäljningstillstånd
Följande försäljningstillstånd har förlängts i Eftastaterna i EES för perioden 1 januari–30 juni 2015:
|
EU-nummer |
Produkt |
Land |
Datum för godkännande |
|
EU/1/00/133 |
Optisulin |
Island |
18.3.2015 |
|
EU/1/00/133 |
Optisulin |
Liechtenstein |
28.2.2015 |
|
EU/1/00/133 |
Optisulin |
Norge |
27.2.2015 |
|
EU/1/00/134 |
Lantus |
Island |
17.3.2015 |
|
EU/1/00/134 |
Lantus |
Liechtenstein |
28.2.2015 |
|
EU/1/00/134 |
Lantus |
Norge |
5.3.2015 |
|
EU/1/05/308 |
Aclasta |
Island |
5.2.2015 |
|
EU/1/05/308 |
Aclasta |
Liechtenstein |
28.2.2015 |
|
EU/1/05/308 |
Aclasta |
Norge |
17.2.2015 |
|
EU/1/05/310 |
Fosavance |
Liechtenstein |
30.6.2015 |
|
EU/1/05/310 |
Fosavance |
Norge |
19.5.2015 |
|
EU/1/05/315 |
APTIVUS |
Liechtenstein |
30.6.2015 |
|
EU/1/05/319 |
Xolair |
Liechtenstein |
30.6.2015 |
|
EU/1/07/423 |
Vectibix |
Island |
15.1.2015 |
|
EU/1/07/423 |
Vectibix |
Norge |
29.1.2015 |
|
EU/1/08/506 |
Celvapan |
Island |
3.6.2015 |
|
EU/1/08/506 |
Celvapan |
Liechtenstein |
30.6.2015 |
|
EU/1/08/506 |
Celvapan |
Norge |
27.5.2015 |
|
EU/1/09/601 |
Firdapse |
Island |
18.2.2015 |
|
EU/1/09/610 |
Telmisartan Teva |
Island |
14.1.2015 |
|
EU/1/09/610 |
Telmisartan Teva |
Liechtenstein |
28.2.2015 |
|
EU/1/09/610 |
Telmisartan Teva |
Norge |
13.1.2015 |
|
EU/1/10/612 |
Revolade |
Island |
30.1.2015 |
|
EU/1/10/612 |
Revolade |
Liechtenstein |
28.2.2015 |
|
EU/1/10/612 |
Revolade |
Norge |
29.1.2015 |
|
EU/1/10/615 |
Temozolomide Hospira |
Island |
22.1.2015 |
|
EU/1/10/615 |
Temozolomide Hospira |
Liechtenstein |
28.2.2015 |
|
EU/1/10/615 |
Temozolomide Hospira |
Norge |
28.1.2015 |
|
EU/1/10/618 |
Prolia |
Island |
4.2.2015 |
|
EU/1/10/618 |
Prolia |
Liechtenstein |
28.2.2015 |
|
EU/1/10/618 |
Prolia |
Norge |
9.2.2015 |
|
EU/1/10/620 |
Ristfor |
Island |
14.1.2015 |
|
EU/1/10/620 |
Ristfor |
Norge |
13.1.2015 |
|
EU/1/10/621 |
Ristaben |
Island |
14.1.2015 |
|
EU/1/10/621 |
Ristaben |
Norge |
13.1.2015 |
|
EU/1/10/625 |
Arzerra |
Island |
2.3.2015 |
|
EU/1/10/625 |
Arzerra |
Liechtenstein |
28.2.2015 |
|
EU/1/10/625 |
Arzerra |
Norge |
26.2.2015 |
|
EU/1/10/627 |
Raloxifene Teva |
Island |
20.2.2015 |
|
EU/1/10/627 |
Raloxifene Teva |
Liechtenstein |
28.2.2015 |
|
EU/1/10/627 |
Raloxifene Teva |
Norge |
27.2.2015 |
|
EU/1/10/631 |
Nivestim |
Island |
15.6.2015 |
|
EU/1/10/631 |
Nivestim |
Liechtenstein |
30.6.2015 |
|
EU/1/10/631 |
Nivestim |
Norge |
18.6.2015 |
|
EU/1/10/632 |
Tolura |
Island |
17.4.2015 |
|
EU/1/10/632 |
Tolura |
Liechtenstein |
30.4.2015 |
|
EU/1/10/632 |
Tolura |
Norge |
9.4.2015 |
|
EU/1/10/633 |
Topotecan Hospira |
Island |
15.6.2015 |
|
EU/1/10/633 |
Topotecan Hospira |
Liechtenstein |
30.6.2015 |
|
EU/1/10/633 |
Topotecan Hospira |
Norge |
15.6.2015 |
|
EU/1/10/634 |
Ribavirin Mylan |
Liechtenstein |
28.2.2015 |
|
EU/1/10/634 |
Ribavirin Mylan |
Norge |
27.2.2015 |
|
EU/1/10/634 |
Ribavirin Mylan |
Island |
20.2.2015 |
|
EU/1/10/635 |
Olanzapin Apotex |
Liechtenstein |
28.2.2015 |
|
EU/1/10/635 |
Olanzapin Apotex |
Norge |
27.2.2015 |
|
EU/1/10/635 |
Olanzapine Apotex |
Island |
20.2.2015 |
|
EU/1/10/636 |
Daxas |
Island |
12.5.2015 |
|
EU/1/10/636 |
Daxas |
Norge |
15.5.2015 |
|
EU/1/10/637 |
Leflunomid medac |
Liechtenstein |
30.4.2015 |
|
EU/1/10/637 |
Leflunomide medac |
Island |
19.4.2015 |
|
EU/1/10/637 |
Leflunomide medac |
Norge |
9.4.2015 |
|
EU/1/10/638 |
Ozurdex |
Island |
19.4.2015 |
|
EU/1/10/638 |
Ozurdex |
Liechtenstein |
30.4.2015 |
|
EU/1/10/638 |
Ozurdex |
Norge |
9.4.2015 |
|
EU/1/10/639 |
Telmisartan Actavis |
Liechtenstein |
30.6.2015 |
|
EU/1/10/640 |
Sycrest |
Island |
1.6.2015 |
|
EU/1/10/640 |
Sycrest |
Liechtenstein |
30.6.2015 |
|
EU/1/10/640 |
Sycrest |
Norge |
3.6.2015 |
|
EU/1/10/642 |
Ibandronsäure Teva |
Liechtenstein |
30.6.2015 |
|
EU/1/10/643 |
Rapiscan |
Island |
12.5.2015 |
|
EU/1/10/643 |
Rapiscan |
Liechtenstein |
30.6.2015 |
|
EU/1/10/643 |
Rapiscan |
Norge |
15.6.2015 |
|
EU/1/10/646 |
VPRIV |
Liechtenstein |
30.6.2015 |
|
EU/1/10/647 |
Myclausen |
Island |
9.6.2015 |
|
EU/1/10/647 |
Myclausen |
Liechtenstein |
30.6.2015 |
|
EU/1/10/647 |
Myclausen |
Norge |
15.6.2015 |
|
EU/1/10/651 |
Clopidogrel HCS |
Liechtenstein |
30.6.2015 |
|
EU/1/10/654 |
Leflunomid ratiopharm |
Liechtenstein |
30.6.2015 |
|
EU/1/11/666 |
Libertek |
Island |
12.5.2015 |
|
EU/1/11/666 |
Libertek |
Liechtenstein |
30.6.2015 |
|
EU/1/11/666 |
Libertek |
Norge |
15.5.2015 |
|
EU/1/11/668 |
Daliresp |
Island |
12.5.2015 |
|
EU/1/11/668 |
Daliresp |
Liechtenstein |
30.6.2015 |
|
EU/1/11/668 |
Daliresp |
Norge |
15.5.2015 |
|
EU/1/11/749 |
Caprelsa |
Island |
30.1.2015 |
|
EU/1/11/749 |
Caprelsa |
Liechtenstein |
28.2.2015 |
|
EU/1/11/749 |
Caprelsa |
Norge |
29.1.2015 |
|
EU/1/12/764 |
Pixuvri |
Island |
19.4.2015 |
|
EU/1/12/764 |
Pixuvri |
Norge |
9.4.2015 |
|
EU/1/13/818 |
Bosulif |
Island |
11.3.2015 |
|
EU/1/13/818 |
Bosulif |
Liechtenstein |
28.2.2015 |
|
EU/1/13/818 |
Bosulif |
Norge |
6.3.2015 |
|
EU/1/13/848 |
Erivedge |
Island |
5.6.2015 |
|
EU/1/13/848 |
Erivedge |
Liechtenstein |
30.6.2015 |
|
EU/1/13/848 |
Erivedge |
Norge |
15.6.2015 |
|
EU/1/13/875 |
Deltyba |
Island |
12.5.2015 |
|
EU/1/13/875 |
Deltyba |
Liechtenstein |
30.6.2015 |
|
EU/1/13/875 |
Deltyba |
Norge |
15.5.2015 |
|
EU/1/13/890 |
Cometriq |
Island |
5.2.2015 |
|
EU/1/13/890 |
Cometriq |
Liechtenstein |
28.2.2015 |
|
EU/1/13/890 |
Cometriq |
Norge |
13.2.2015 |
|
EU/1/13/901 |
SIRTURO |
Island |
5.2.2015 |
|
EU/1/13/901 |
Sirturo |
Liechtenstein |
28.2.2015 |
|
EU/1/13/901 |
Sirturo |
Norge |
10.2.2015 |
|
EU/2/05/055 |
Equilis Te |
Liechtenstein |
30.6.2015 |
|
EU/2/05/055 |
Equilis Te |
Norge |
30.6.2015 |
|
EU/2/09/103 |
Respiporc Flu3 |
Norge |
16.1.2015 |
|
EU/2/09/104 |
Zulvac 8 Ovis |
Norge |
14.1.2015 |
|
EU/2/10/106 |
Bovilis BTV8 |
Island |
16.6.2015 |
|
EU/2/10/106 |
Bovilis BTV8 |
Liechtenstein |
30.6.2015 |
|
EU/2/10/106 |
Bovilis BTV8 |
Norge |
26.6.2015 |
|
EU/2/10/109 |
Rhiniseng |
Liechtenstein |
30.6.2015 |
BILAGA III
Förteckning över utvidgade försäljningstillstånd
Följande försäljningstillstånd har utvidgats i Eftastaterna i EES för perioden 1 januari–30 juni 2015:
|
EU-nummer |
Produkt |
Land |
Datum för godkännande |
|
EU/1/00/133/033-035 |
Toujeo |
Island |
12.5.2015 |
|
EU/1/00/133/033-035 |
Toujeo |
Norge |
19.5.2015 |
|
EU/1/01/195/028-029 |
Liprolog KwikPen |
Island |
19.2.2015 |
|
EU/1/04/303/004 |
Orfadin |
Island |
3.6.2015 |
|
EU/1/04/303/004 |
Orfadin |
Norge |
28.5.2015 |
|
EU/1/07/319/009 |
Revlimid |
Norge |
2.3.2015 |
|
EU/1/07/391/009 |
Revlimid |
Island |
10.3.2015 |
|
EU/1/08/469/046-049 |
Oprymea |
Island |
2.3.2015 |
|
EU/1/08/469/050-053 |
Oprymea |
Island |
2.3.2015 |
|
EU/1/08/469/046-049 |
Oprymea |
Norge |
25.2.2015 |
|
EU/1/08/469/050-053 |
Oprymea |
Norge |
25.2.2015 |
|
EU/1/12/771/007-009 |
Zoledronic Acid Teva |
Island |
15.1.2015 |
|
EU/1/12/798/005-006 |
Ibandronic acid Accord |
Island |
19.4.2015 |
|
EU/1/12/798/005-006 |
Ibandronic acid Accord |
Norge |
10.4.2015 |
|
EU/1/13/819/002 |
JETREA |
Island |
13.5.2015 |
|
EU/1/13/819/002 |
Jetrea |
Norge |
13.5.2015 |
|
EU/1/96/007/039-042 |
Humalog KwikPen |
Island |
19.2.2015 |
|
EU/2/06/062/005 |
Cerenia |
Norge |
29.6.2015 |
|
EU/2/07/078/021 |
Rheumocam |
Island |
4.6.2015 |
|
EU/2/07/078/021 |
Rheumocam |
Norge |
2.6.2015 |
|
EU/2/97/004/050-053 |
Metacam |
Norge |
6.5.2015 |
|
EU/2/97/004/050-053 |
Metacam |
Island |
6.5.2015 |
|
EU/2/99/014/013-016 |
Stronghold |
Norge |
10.4.2015 |
BILAGA IV
Förteckning över återkallade försäljningstillstånd
Följande försäljningstillstånd har återkallats inom Eftastaterna i EES för perioden 1 januari–30 juni 2015:
|
EU-nummer |
Produkt |
Land |
Datum för återkallande |
|
EU/1/07/426 |
Olanzapine Cipla |
Norge |
21.1.2015 |
|
EU/1/08/458 |
Trevaclyn |
Liechtenstein |
28.2.2015 |
|
EU/1/08/459 |
Tredaptive |
Liechtenstein |
28.2.2015 |
|
EU/1/08/460 |
Pelzont |
Liechtenstein |
28.2.2015 |
|
EU/1/09/554 |
Clopidogrel ratiopharm |
Liechtenstein |
28.2.2015 |
|
EU/1/09/560 |
Clopidogrel DURA |
Liechtenstein |
30.6.2015 |
|
EU/1/09/560 |
Clopidogrel Dura |
Norge |
30.6.2015 |
|
EU/1/10/649 |
Clopidogrel Teva Pharma B.V. |
Norge |
21.1.2015 |
|
EU/1/10/650 |
Clopidogrel Teva Generics B.V. |
Island |
5.2.2015 |
|
EU/1/10/664 |
Pumarix |
Island |
20.2.2015 |
|
EU/1/10/664 |
Pumarix |
Liechtenstein |
28.2.2015 |
|
EU/1/10/664 |
Pumarix |
Norge |
31.1.2015 |
|
EU/1/11/686 |
Rasilamlo |
Liechtenstein |
30.6.2015 |
|
EU/1/11/723 |
Pioglitazone Krka |
Norge |
21.1.2015 |
|
EU/1/11/748 |
Docetaxel Mylan (Sunset clause) |
Norge |
3.2.2015 |
|
EU/1/12/754 |
Sepioglin |
Liechtenstein |
28.2.2015 |
|
EU/1/12/774 |
Rienso |
Island |
12.5.2015 |
|
EU/1/12/774 |
Rienso |
Liechtenstein |
30.4.2015 |
|
EU/1/12/774 |
Rienso |
Norge |
19.5.2015 |
|
EU/1/12/804 |
BindRen |
Island |
13.3.2015 |
|
EU/1/12/804 |
BindRen |
Liechtenstein |
30.4.2015 |
|
EU/1/12/804 |
BindRen |
Norge |
14.4.2015 |
|
EU/1/13/867 |
Provenge |
Liechtenstein |
30.6.2015 |
|
EU/1/13/867 |
Provenge |
Norge |
15.6.2015 |
|
EU/1/97/037 |
Vistide |
Norge |
4.2.2015 |
|
EU/2/04/049 |
Purevax RCCh |
Island |
10.2.2015 |
|
EU/2/07/071 |
SLENTROL |
Island |
5.2.2015 |
|
EU/2/07/071 |
Slentrol |
Liechtenstein |
28.2.2015 |
|
EU/2/07/071 |
Slentrol |
Norge |
30.3.2015 |
|
EU/2/11/136 |
TruScient |
Island |
5.2.2015 |
|
EU/2/11/136 |
TruScient |
Liechtenstein |
28.2.2015 |
|
EU/2/11/136 |
TruScient |
Norge |
22.4.2015 |
BILAGA V
Förteckning över upphävda försäljningstillstånd
Följande försäljningstillstånd har upphävts i Eftastaterna i EES för perioden 1 januari–30 juni 2015:
|
EU-nummer |
Produkt |
Land |
Dag för upphävande |
|
EU/1/13/847/001 |
MACI |
Norge |
22.1.2015 |