Úřední věstník
Evropské unie
CS
Řada C
|
|
Úřední věstník |
CS Řada C |
|
C/2024/4358 |
4.7.2024 |
Léčivé přípravky – Seznam registrací udělených státy ESVO EHP ve druhé polovině roku 2023
(C/2024/4358)
Podvýbor I pro volný pohyb zboží
(Na vědomí Smíšenému výboru EHP)
S ohledem na rozhodnutí Smíšeného výboru EHP č. 74/1999 ze dne 28. května 1999 se Smíšený výbor EHP vyzývá, aby na svém zasedání konaném dne 15. března 2024 vzal na vědomí tyto seznamy registrací léčivých přípravků za období od 1. července do 31. prosince 2023:
|
Příloha I |
Seznam nových registrací |
|
Příloha II |
Seznam obnovených registrací |
|
Příloha III |
Seznam prodloužených registrací |
|
Příloha IV |
Seznam zrušených registrací |
|
Příloha V |
Seznam pozastavených registrací |
PŘÍLOHA I
Seznam nových registrací
Státy ESVO EHP udělily v období od 1. července do 31. prosince 2023 tyto registrace:
|
Číslo EU |
Výrobek |
Země |
Datum registrace |
|
EU/1/23/1752 |
Abrysvo |
Island |
6.9.2023 |
|
EU/1/23/1752 |
Abrysvo |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/23/1752 |
Abrysvo |
Norsko |
9.10.2023 |
|
EU/1/23/1776 |
AGAMREE |
Island |
28.12.2023 |
|
EU/1/23/1776 |
AGAMREE |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/23/1776 |
AGAMREE |
Norsko |
19.12.2023 |
|
EU/1/23/1722 |
AKEEGA |
Norsko |
25.7.2023 |
|
EU/1/23/1760 |
Apretude |
Island |
16.10.2023 |
|
EU/1/23/1760 |
Apretude |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1760 |
Apretude |
Norsko |
9.10.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Island |
30.8.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Norsko |
29.8.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Island |
4.12.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Norsko |
20.11.2023 |
|
EU/2/23/303 |
Bovilis Cryptium |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/23/1716 |
Camzyos |
Island |
9.8.2023 |
|
EU/1/23/1716 |
Camzyos |
Norsko |
12.7.2023 |
|
EU/1/23/1763 |
Catiolanze |
Island |
4.12.2023 |
|
EU/1/23/1763 |
Catiolanze |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/23/1763 |
Catiolanze |
Norsko |
12.12.2023 |
|
EU/1/23/1742 |
Columvi |
Island |
9.8.2023 |
|
EU/1/23/1742 |
Columvi |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/23/1742 |
Columvi |
Norsko |
13.7.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Island |
23.10.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Norsko |
10.10.2023 |
|
EU/1/22/1711 |
Dimethyl Fumarate Accord |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/22/1634 |
Dimethyl fumarate Mylan |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/22/1637 |
Dimethyl fumarate Neuraxpharm |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/22/1635 |
Dimethyl fumarate Polpharma |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/22/1702 |
Dimethyl Fumarate Teva |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/23/1765 |
Ebglyss |
Island |
4.12.2023 |
|
EU/1/23/1765 |
Ebglyss |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/23/1765 |
Ebglyss |
Norsko |
30.11.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Island |
18.12.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Norsko |
13.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Island |
18.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Norsko |
18.12.2023 |
|
EU/2/23/297 |
Eluracat |
Island |
9.8.2023 |
|
EU/2/23/297 |
Eluracat |
Norsko |
23.8.2023 |
|
EU/1/23/1747 |
Enrylaze |
Island |
19.10.2023 |
|
EU/1/23/1747 |
Enrylaze |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1747 |
Enrylaze |
Norsko |
10.10.2023 |
|
EU/1/23/1767 |
Finlee |
Island |
4.12.2023 |
|
EU/1/23/1767 |
Finlee |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/23/1767 |
Finlee |
Norsko |
12.12.2023 |
|
EU/1/23/1762 |
Herwenda |
Island |
4.12.2023 |
|
EU/1/23/1762 |
Herwenda |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/23/1762 |
Herwenda |
Norsko |
12.12.2023 |
|
EU/1/23/1756 |
Inaqovi |
Island |
13.10.2023 |
|
EU/1/23/1756 |
Inaqovi |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1756 |
Inaqovi |
Norsko |
28.9.2023 |
|
EU/1/23/1738 |
Jaypirca |
Island |
28.11.2023 |
|
EU/1/23/1738 |
Jaypirca |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/23/1738 |
Jaypirca |
Norsko |
8.11.2023 |
|
EU/1/23/1755 |
Litfulo |
Island |
13.10.2023 |
|
EU/1/23/1755 |
Litfulo |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1755 |
Litfulo |
Norsko |
9.10.2023 |
|
EU/1/23/1774 |
Loargys |
Island |
28.12.2023 |
|
EU/1/23/1774 |
Loargys |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/23/1774 |
Loargys |
Norsko |
19.12.2023 |
|
EU/2/23/301 |
Loxitab |
Island |
26.10.2023 |
|
EU/2/23/301 |
Loxitab |
Lichtenštejnsko |
31.10.2023 |
|
EU/2/23/301 |
Loxitab |
Norsko |
1.11.2023 |
|
EU/1/21/1613 |
Lyfnua |
Island |
19.10.2023 |
|
EU/1/21/1613 |
Lyfnua |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/21/1613 |
Lyfnua |
Norsko |
10.10.2023 |
|
EU/1/23/1741 |
Lytgobi |
Island |
9.8.2023 |
|
EU/1/23/1741 |
Lytgobi |
Norsko |
11.7.2023 |
|
EU/1/23/1741 |
Lytgobi |
Lichtenštejnsko |
31.7.2023 |
|
EU/2/23/304 |
Nobivac LoVo L4 |
Island |
11.12.2023 |
|
EU/2/23/304 |
Nobivac LoVo L4 |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/23/1737 |
Opfolda |
Island |
9.8.2023 |
|
EU/1/23/1737 |
Opfolda |
Norsko |
12.7.2023 |
|
EU/1/23/1757 |
ORSERDU |
Island |
19.10.2023 |
|
EU/1/23/1757 |
ORSERDU |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1757 |
ORSERDU |
Norsko |
10.10.2023 |
|
EU/2/23/299 |
Oxmax |
Island |
26.10.2023 |
|
EU/2/23/299 |
Oxmax |
Lichtenštejnsko |
31.10.2023 |
|
EU/2/23/299 |
Oxmax |
Norsko |
26.10.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Island |
27.11.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Lichtenštejnsko |
31.10.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Norsko |
26.10.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Island |
27.11.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Lichtenštejnsko |
31.10.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Norsko |
24.10.2023 |
|
EU/1/23/1746 |
Pylclari |
Island |
16.8.2023 |
|
EU/1/23/1746 |
Pylclari |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/23/1746 |
Pylclari |
Norsko |
15.8.2023 |
|
EU/1/23/1775 |
Rezzayo |
Island |
29.12.2023 |
|
EU/1/23/1775 |
Rezzayo |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/23/1775 |
Rezzayo |
Norsko |
28.12.2023 |
|
EU/2/23/305 |
Senvelgo |
Island |
13.12.2023 |
|
EU/2/23/305 |
Senvelgo |
Lichtenštejnsko |
30.11.2023 |
|
EU/2/23/305 |
Senvelgo |
Norsko |
28.11.2023 |
|
EU/1/23/1739 |
Sugammadex Piramal |
Island |
9.8.2023 |
|
EU/1/23/1739 |
Sugammadex Piramal |
Norsko |
12.7.2023 |
|
EU/1/23/1748 |
TALVEY |
Island |
31.8.2023 |
|
EU/1/23/1748 |
TALVEY |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/23/1748 |
TALVEY |
Norsko |
29.8.2023 |
|
EU/1/23/1759 |
Tepkinly |
Island |
20.10.2023 |
|
EU/1/23/1759 |
Tepkinly |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1759 |
Tepkinly |
Norsko |
10.10.2023 |
|
EU/1/23/1758 |
Tevimbra |
Island |
19.10.2023 |
|
EU/1/23/1758 |
Tevimbra |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1758 |
Tevimbra |
Norsko |
10.10.2023 |
|
EU/1/23/1754 |
Tyenne |
Island |
18.10.2023 |
|
EU/1/23/1754 |
Tyenne |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1754 |
Tyenne |
Norsko |
23.10.2023 |
|
EU/1/23/1745 |
Tyruko |
Island |
20.10.2023 |
|
EU/1/23/1745 |
Tyruko |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1745 |
Tyruko |
Norsko |
5.10.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Island |
28.11.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Norsko |
12.12.2023 |
|
EU/1/23/1771 |
Veoza |
Island |
18.12.2023 |
|
EU/1/23/1771 |
Veoza |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/23/1771 |
Veoza |
Norsko |
18.12.2023 |
|
EU/1/23/1773 |
Vueway |
Island |
18.12.2023 |
|
EU/1/23/1773 |
Vueway |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/23/1773 |
Vueway |
Norsko |
15.12.2023 |
|
EU/1/23/1751 |
Yesafili |
Island |
19.10.2023 |
|
EU/1/23/1751 |
Yesafili |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/23/1751 |
Yesafili |
Norsko |
25.10.2023 |
|
EU/1/23/1766 |
Yorvipath |
Island |
4.12.2023 |
|
EU/1/23/1766 |
Yorvipath |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/23/1766 |
Yorvipath |
Norsko |
12.12.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Island |
12.10.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Lichtenštejnsko |
30.9.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Norsko |
11.10.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Island |
15.12.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Norsko |
12.12.2023 |
|
EU/1/23/1761 |
Zoonotic Influenza Vaccine Seqirus |
Island |
25.10.2023 |
|
EU/1/23/1761 |
Zoonotic Influenza Vaccine Seqirus |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/23/1761 |
Zoonotic Influenza Vaccine Seqirus |
Norsko |
25.10.2023 |
|
EU/1/23/1743 |
ZTALMY |
Island |
16.8.2023 |
|
EU/1/23/1743 |
ZTALMY |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/23/1743 |
ZTALMY |
Norsko |
15.8.2023 |
PŘÍLOHA II
Seznam obnovených registrací
Státy ESVO EHP obnovily v období od 1. července do 31. prosince 2023 tyto registrace:
|
Číslo EU |
Výrobek |
Země |
Datum registrace |
|
EU/1/21/1539 |
Abecma |
Norsko |
15.8.2023 |
|
EU/1/19/1358 |
AJOVY |
Island |
28.11.2023 |
|
EU/1/19/1358 |
AJOVY |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/19/1358 |
AJOVY |
Norsko |
20.11.2023 |
|
EU/1/18/1264 |
Alunbrig |
Island |
6.9.2023 |
|
EU/1/18/1264 |
Alunbrig |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1292 |
Apealea |
Island |
5.10.2023 |
|
EU/1/18/1292 |
Apealea |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/18/1292 |
Apealea |
Norsko |
10.10.2023 |
|
EU/2/19/249 |
Aservo EquiHaler |
Norsko |
22.8.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Island |
28.12.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Norsko |
19.12.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Island |
14.8.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Norsko |
15.8.2023 |
|
EU/1/18/1352 |
Besremi |
Island |
28.12.2023 |
|
EU/1/18/1352 |
Besremi |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/18/1352 |
Besremi |
Norsko |
19.12.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Island |
20.10.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Norsko |
26.10.2023 |
|
EU/1/18/1314 |
Braftovi |
Island |
4.7.2023 |
|
EU/1/18/1314 |
Braftovi |
Lichtenštejnsko |
30.6.2023 |
|
EU/1/18/1314 |
Braftovi |
Norsko |
17.7.2023 |
|
EU/1/18/1336 |
Buvidal |
Island |
15.8.2023 |
|
EU/1/18/1336 |
Buvidal |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1336 |
Buvidal |
Norsko |
15.8.2023 |
|
EU/2/15/183 |
Canigen L4 |
Norsko |
8.8.2023 |
|
EU/2/22/283 |
Chanaxin |
Norsko |
22.8.2023 |
|
EU/2/17/222 |
Clevor |
Norsko |
22.8.2023 |
|
EU/2/18/225 |
Dany’s BienenWohl |
Norsko |
16.8.2023 |
|
EU/1/18/1310 |
Deferiprone Lipomed |
Island |
4.7.2023 |
|
EU/1/18/1310 |
Deferiprone Lipomed |
Norsko |
17.7.2023 |
|
EU/1/13/878 |
Defitelio |
Norsko |
15.8.2023 |
|
EU/1/18/1333 |
Delstrigo |
Island |
10.8.2023 |
|
EU/1/18/1333 |
Delstrigo |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1333 |
Delstrigo |
Norsko |
17.7.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Island |
31.8.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Norsko |
6.9.2023 |
|
EU/1/20/1437 |
Dovprela |
Island |
10.8.2023 |
|
EU/1/20/1437 |
Dovprela |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/20/1437 |
Dovprela |
Norsko |
15.8.2023 |
|
EU/1/18/1330 |
Emgality |
Island |
12.9.2023 |
|
EU/1/18/1330 |
Emgality |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/18/1330 |
Emgality |
Norsko |
6.9.2023 |
|
EU/1/20/1508 |
Enhertu |
Island |
2.11.2023 |
|
EU/1/20/1508 |
Enhertu |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/20/1508 |
Enhertu |
Norsko |
30.10.2023 |
|
EU/1/18/1342 |
Erleada |
Island |
20.10.2023 |
|
EU/1/18/1342 |
Erleada |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/18/1342 |
Erleada |
Norsko |
26.10.2023 |
|
EU/2/22/284 |
Evanovo |
Norsko |
12.12.2023 |
|
EU/1/18/1347 |
Febuxostat Krka |
Island |
28.12.2023 |
|
EU/1/18/1347 |
Febuxostat Krka |
Lichtenštejnsko |
31.12.2023 |
|
EU/2/19/238 |
Felisecto Plus |
Norsko |
12.12.2023 |
|
EU/2/21/277 |
Felpreva |
Norsko |
18.9.2023 |
|
EU/2/19/235 |
Forceris |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/13/881 |
Fortacin |
Island |
20.10.2023 |
|
EU/1/13/881 |
Fortacin |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/13/881 |
Fortacin |
Norsko |
25.10.2023 |
|
EU/1/18/1329 |
Fulphila |
Island |
18.10.2023 |
|
EU/1/18/1329 |
Fulphila |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/18/1329 |
Fulphila |
Norsko |
15.9.2023 |
|
EU/1/21/1555 |
GAVRETO |
Island |
20.10.2023 |
|
EU/1/21/1555 |
GAVRETO |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/21/1555 |
GAVRETO |
Norsko |
26.10.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Island |
10.8.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Lichtenštejnsko |
30.6.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Norsko |
17.7.2023 |
|
EU/1/22/1715 |
Hemgenix |
Island |
19.12.2023 |
|
EU/1/22/1715 |
Hemgenix |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/22/1715 |
Hemgenix |
Norsko |
19.12.2023 |
|
EU/1/20/1446 |
Hepcludex |
Island |
11.8.2023 |
|
EU/1/20/1446 |
Hepcludex |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/20/1446 |
Hepcludex |
Norsko |
15.8.2023 |
|
EU/1/18/1319 |
Hulio |
Island |
16.8.2023 |
|
EU/1/18/1319 |
Hulio |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/18/1319 |
Hulio |
Norsko |
21.9.2023 |
|
EU/2/18/230 |
Hydrocortisone aceponate Ecuphar |
Norsko |
22.8.2023 |
|
EU/1/19/1356 |
Idacio |
Island |
27.11.2023 |
|
EU/1/19/1356 |
Idacio |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/19/1356 |
Idacio |
Norsko |
8.11.2023 |
|
EU/1/20/1471 |
Idefirix |
Island |
11.8.2023 |
|
EU/1/20/1471 |
Idefirix |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/20/1471 |
Idefirix |
Norsko |
16.8.2023 |
|
EU/1/18/1323 |
Ilumetri |
Island |
11.8.2023 |
|
EU/1/18/1323 |
Ilumetri |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1323 |
Ilumetri |
Norsko |
15.8.2023 |
|
EU/2/21/280 |
Imoxat |
Norsko |
15.8.2023 |
|
EU/2/20/256 |
Innovax-ND-ILT |
Norsko |
1.11.2023 |
|
EU/2/18/232 |
Isemid |
Island |
18.12.2023 |
|
EU/2/18/232 |
Isemid |
Lichtenštejnsko |
30.12.2023 |
|
EU/2/18/232 |
Isemid |
Norsko |
12.12.2023 |
|
EU/1/18/1324 |
Jivi |
Island |
4.7.2023 |
|
EU/1/18/1324 |
Jivi |
Norsko |
13.7.2023 |
|
EU/1/18/1302 |
Kigabeq |
Island |
9.8.2023 |
|
EU/1/18/1302 |
Kigabeq |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1302 |
Kigabeq |
Norsko |
17.7.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Island |
11.8.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Norsko |
16.8.2023 |
|
EU/1/21/1552 |
Koselugo |
Norsko |
18.7.2023 |
|
EU/2/18/234 |
Kriptazen |
Lichtenštejnsko |
30.12.2023 |
|
EU/2/18/234 |
Kriptazen |
Norsko |
20.12.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Island |
29.8.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Norsko |
24.8.2023 |
|
EU/1/21/1603 |
Lumykras |
Island |
29.11.2023 |
|
EU/1/21/1603 |
Lumykras |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/21/1603 |
Lumykras |
Norsko |
20.11.2023 |
|
EU/1/18/1331 |
Luxturna |
Island |
11.8.2023 |
|
EU/1/18/1331 |
Luxturna |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1331 |
Luxturna |
Norsko |
15.8.2023 |
|
EU/1/18/1315 |
Mektovi |
Island |
4.7.2023 |
|
EU/1/18/1315 |
Mektovi |
Norsko |
13.7.2023 |
|
EU/1/18/1301 |
Mepsevii |
Island |
15.8.2023 |
|
EU/1/18/1301 |
Mepsevii |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1301 |
Mepsevii |
Norsko |
15.8.2023 |
|
EU/2/20/259 |
MHYOSPHERE PCV ID |
Norsko |
22.8.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Island |
29.11.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Norsko |
11.12.2023 |
|
EU/1/21/1570 |
Minjuvi |
Island |
11.8.2023 |
|
EU/1/21/1570 |
Minjuvi |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/21/1570 |
Minjuvi |
Norsko |
16.8.2023 |
|
EU/2/17/220 |
MiPet Easecto |
Norsko |
22.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Island |
30.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Norsko |
14.8.2023 |
|
EU/2/19/241 |
NASYM |
Norsko |
15.9.2023 |
|
EU/1/15/1078 |
Natpar |
Norsko |
25.10.2023 |
|
EU/2/20/267 |
NexGard Combo |
Norsko |
22.8.2023 |
|
EU/1/16/1094 |
Ninlaro |
Island |
12.9.2023 |
|
EU/1/16/1094 |
Ninlaro |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/16/1094 |
Ninlaro |
Norsko |
6.9.2023 |
|
EU/2/20/265 |
Nobivac DP Plus |
Norsko |
8.8.2023 |
|
EU/1/16/1139 |
Ocaliva |
Island |
29.11.2023 |
|
EU/1/16/1139 |
Ocaliva |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/16/1139 |
Ocaliva |
Norsko |
12.12.2023 |
|
EU/1/18/1341 |
Ogivri |
Island |
23.8.2023 |
|
EU/1/18/1341 |
Ogivri |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/18/1341 |
Ogivri |
Norsko |
15.8.2023 |
|
EU/1/18/1313 |
Pelgraz |
Norsko |
13.7.2023 |
|
EU/1/18/1328 |
Pelmeg |
Island |
13.12.2023 |
|
EU/1/18/1328 |
Pelmeg |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/18/1328 |
Pelmeg |
Norsko |
12.12.2023 |
|
EU/1/18/1332 |
Pifeltro |
Island |
10.8.2023 |
|
EU/1/18/1332 |
Pifeltro |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1332 |
Pifeltro |
Norsko |
17.7.2023 |
|
EU/1/18/1335 |
Poteligeo |
Island |
4.10.2023 |
|
EU/1/18/1335 |
Poteligeo |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/18/1335 |
Poteligeo |
Norsko |
10.10.2023 |
|
EU/1/18/1291 |
Rizmoic |
Island |
28.11.2023 |
|
EU/1/18/1291 |
Rizmoic |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/18/1291 |
Rizmoic |
Norsko |
8.11.2023 |
|
EU/1/22/1668 |
Roctavian |
Island |
14.8.2023 |
|
EU/1/22/1668 |
Roctavian |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/22/1668 |
Roctavian |
Norsko |
16.8.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Island |
10.8.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Norsko |
8.8.2023 |
|
EU/1/18/1294 |
RXULTI |
Norsko |
15.8.2023 |
|
EU/1/21/1594 |
Rybrevant |
Island |
15.9.2023 |
|
EU/1/21/1594 |
Rybrevant |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/21/1594 |
Rybrevant |
Norsko |
25.10.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Island |
29.11.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Norsko |
12.12.2023 |
|
EU/1/13/901 |
Sirturo |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/13/901 |
Sirturo |
Norsko |
7.12.2023 |
|
EU/1/13/901 |
Sirturo |
Island |
13.12.2023 |
|
EU/1/18/1318 |
Slenyto |
Norsko |
15.8.2023 |
|
EU/1/22/1688 |
Spevigo |
Island |
20.10.2023 |
|
EU/1/22/1688 |
Spevigo |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/18/1306 |
Symkevi |
Island |
31.8.2023 |
|
EU/1/18/1306 |
Symkevi |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/18/1306 |
Symkevi |
Norsko |
29.8.2023 |
|
EU/2/18/231 |
Syvazul BTV |
Norsko |
22.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Island |
30.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Norsko |
24.8.2023 |
|
EU/1/20/1492 |
Tecartus |
Island |
28.12.2023 |
|
EU/1/20/1492 |
Tecartus |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/13/837 |
Tecfidera |
Island |
19.10.2023 |
|
EU/1/13/837 |
Tecfidera |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/13/837 |
Tecfidera |
Norsko |
23.10.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Island |
11.8.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Norsko |
16.8.2023 |
|
EU/2/20/252 |
Tulissin |
Norsko |
22.8.2023 |
|
EU/2/18/227 |
UBAC |
Norsko |
22.8.2023 |
|
EU/1/18/1334 |
Vaborem |
Island |
11.8.2023 |
|
EU/1/18/1334 |
Vaborem |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1334 |
Vaborem |
Norsko |
15.8.2023 |
|
EU/1/18/1350 |
Vantobra |
Island |
20.10.2023 |
|
EU/1/18/1350 |
Vantobra |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/18/1350 |
Vantobra |
Norsko |
25.10.2023 |
|
EU/2/20/266 |
Vectormune FP ILT |
Norsko |
18.9.2023 |
|
EU/2/20/250 |
Vectormune FP ILT+AE |
Norsko |
18.9.2023 |
|
EU/1/16/1138 |
Venclyxto |
Island |
30.8.2023 |
|
EU/1/16/1138 |
Venclyxto |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/16/1138 |
Venclyxto |
Norsko |
24.8.2023 |
|
EU/2/14/169 |
Versican Plus DHPPi |
Norsko |
19.9.2023 |
|
EU/2/14/164 |
Versican Plus DHPPi/L4 |
Norsko |
18.9.2023 |
|
EU/2/14/163 |
Versican Plus DHPPi/L4R |
Norsko |
21.9.2023 |
|
EU/2/14/171 |
Versican Plus L4 |
Norsko |
18.9.2023 |
|
EU/1/18/1307 |
Verzenios |
Island |
10.8.2023 |
|
EU/1/18/1307 |
Verzenios |
Lichtenštejnsko |
30.6.2023 |
|
EU/1/18/1307 |
Verzenios |
Norsko |
13.7.2023 |
|
EU/1/18/1298 |
Veyvondi |
Island |
4.7.2023 |
|
EU/1/18/1298 |
Veyvondi |
Lichtenštejnsko |
30.6.2023 |
|
EU/1/18/1298 |
Veyvondi |
Norsko |
13.7.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Island |
10.8.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Norsko |
15.8.2023 |
|
EU/1/19/1354 |
Vizimpro |
Island |
18.12.2023 |
|
EU/1/19/1354 |
Vizimpro |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/19/1354 |
Vizimpro |
Norsko |
12.12.2023 |
|
EU/1/18/1308 |
Vyxeos liposomal |
Norsko |
15.8.2023 |
|
EU/1/13/873 |
Xofigo |
Island |
27.11.2023 |
|
EU/1/13/873 |
Xofigo |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/13/873 |
Xofigo |
Norsko |
30.11.2023 |
|
EU/1/18/1299 |
Yescarta |
Island |
11.8.2023 |
|
EU/1/18/1299 |
Yescarta |
Lichtenštejnsko |
31.7.2023 |
|
EU/1/18/1299 |
Yescarta |
Norsko |
15.8.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Island |
10.8.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Lichtenštejnsko |
30.6.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Norsko |
12.7.2023 |
|
EU/1/18/1344 |
Zirabev |
Island |
29.11.2023 |
|
EU/1/18/1344 |
Zirabev |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/18/1344 |
Zirabev |
Norsko |
22.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Island |
29.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Norsko |
12.12.2023 |
PŘÍLOHA III
Seznam prodloužených registrací
Státy ESVO EHP prodloužily v období od 1. července do 31. prosince 2023 tyto registrace:
|
Číslo EU |
Výrobek |
Země |
Datum registrace |
|
EU/1/21/1554/004-005 |
Adtralza |
Island |
9.10.2023 |
|
EU/1/21/1554/004-005 |
Adtralza |
Norsko |
25.10.2023 |
|
EU/1/20/1528/018-024 |
Comirnaty |
Norsko |
31.8.2023 |
|
EU/1/20/1528/015-017 |
Comirnaty Original/Omicron BA.4-5 |
Island |
8.9.2023 |
|
EU/1/20/1528/015-017 |
Comirnaty Original/Omicron BA.4-5 |
Norsko |
9.8.2023 |
|
EU/1/19/1365/002 |
Cufence |
Island |
14.12.2023 |
|
EU/1/19/1365/002 |
Cufence |
Norsko |
12.12.2023 |
|
EU/1/15/1058/023-024 |
Entresto |
Norsko |
16.8.2023 |
|
EU/1/18/1324/004-006 |
Erleada |
Norsko |
30.8.2023 |
|
EU/1/18/1324/004-006 |
Erleada |
Island |
5.10.2023 |
|
EU/1/19/1374/006-007 |
Esperoct |
Island |
24.10.2023 |
|
EU/1/19/1374/006-007 |
Esperoct |
Norsko |
10.10.2023 |
|
EU/1/18/1323/004 |
Ilumetri |
Island |
16.8.2023 |
|
EU/1/18/1323/004 |
Ilumetri |
Norsko |
15.8.2023 |
|
EU/1/20/1468/003-004 |
Kaftrio |
Island |
14.12.2023 |
|
EU/1/20/1468/003-004 |
Kaftrio |
Norsko |
12.12.2023 |
|
EU/1/12/782/008 |
Kalydeco |
Island |
13.12.2023 |
|
EU/1/12/782/008 |
Kalydeco |
Norsko |
12.12.2023 |
|
EU/1/16/1170/017-019 |
OLUMIANT |
Island |
23.10.2023 |
|
EU/1/15/1059/008 |
Orkambi |
Island |
9.8.2023 |
|
EU/1/15/1059/008 |
Orkambi |
Norsko |
12.7.2023 |
|
EU/1/13/822/006 |
PHEBURANE |
Island |
28.12.2023 |
|
EU/1/12/822/006 |
Pheburane |
Norsko |
12.12.2023 |
|
EU/1/20/1501/005-006 |
Sogroya |
Norsko |
16.8.2023 |
|
EU/1/20/1501/005-006 |
Sogroya |
Island |
16.8.2023 |
|
EU/1/18/1340/007-009 |
Takhzyro |
Island |
8.12.2023 |
|
EU/1/18/1340/007-009 |
Takhzyro |
Norsko |
12.12.2023 |
|
EU/1/15/989/002 |
Tenkasi |
Island |
23.10.2023 |
|
EU/1/15/989/002 |
Tenkasi |
Norsko |
10.10.2023 |
|
EU/1/21/1599/003 |
Vyepti |
Island |
18.12.2023 |
|
EU/1/21/1599/003 |
Vyepti |
Norsko |
18.12.2023 |
|
EU/1/22/1674/002 |
Vyvgart |
Island |
1.12.2023 |
|
EU/1/22/1674/002 |
Vyvgart |
Norsko |
12.12.2023 |
|
EU/1/05/319/012-017 |
Xolair |
Island |
29.11.2023 |
|
EU/1/05/319/012-017, |
Xolair |
Norsko |
12.12.2023 |
|
EU/1/20/1513/017 |
Yuflyma |
Island |
8.12.2023 |
|
EU/1/20/1513/017 |
Yuflyma |
Norsko |
12.12.2023 |
PŘÍLOHA IV
Seznam zrušených registrací
Státy ESVO EHP zrušily v období od 1. července do 31. prosince 2023 tyto registrace:
|
Číslo EU |
Výrobek |
Země |
Datum zrušení |
|
EU/2/10/118 |
Activyl |
Island |
29.11.2023 |
|
EU/2/10/118 |
Activyl |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/20/1476 |
Adakveo |
Island |
7.9.2023 |
|
EU/1/20/1476 |
Adakveo |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/20/1476 |
Adakveo |
Norsko |
21.8.2023 |
|
EU/2/13/153 |
Aftovaxpur Doe |
Norsko |
14.9.2023 |
|
EU/1/03/254 |
Busilvex |
Island |
20.7.2023 |
|
EU/2/11/121 |
CaniLeish |
Island |
25.10.2023 |
|
EU/2/11/121 |
CaniLeish |
Lichtenštejnsko |
31.10.2023 |
|
EU/2/11/121 |
CaniLeish |
Norsko |
22.11.2023 |
|
EU/1/15/1055 |
Ciambra |
Island |
25.10.2023 |
|
EU/1/15/1055 |
Ciambra |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/15/1055 |
Ciambra |
Norsko |
28.11.2023 |
|
EU/1/09/558 |
Clopidogrel BGR |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/09/558 |
Clopidogrel BGR |
Island |
6.11.2023 |
|
EU/2/10/115 |
Comfortis |
Island |
24.8.2023 |
|
EU/2/10/115 |
Comfortis |
Norsko |
21.9.2023 |
|
EU/1/21/1624 |
COVID-19 Vaccine (inaktivovaná, obsahující adjuvans) Valneva |
Island |
25.10.2023 |
|
EU/1/21/1624 |
COVID-19 Vaccine (inaktivovaná, obsahující adjuvans) Valneva |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/21/1624 |
COVID-19 Vaccine (inaktivovaná, obsahující adjuvans) Valneva |
Norsko |
22.11.2023 |
|
EU/1/17/1248 |
Darunavir Krka d.d. |
Norsko |
23.1.2023 (1) |
|
EU/1/21/1540 |
Dasatinib Accord |
Norsko |
15.9.2023 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Norsko |
15.9.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Island |
11.9.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Norsko |
21.9.2023 |
|
EU/1/22/1644 |
Inpremzia |
Norsko |
14.9.2023 |
|
EU/1/96/026 |
Invirase |
Island |
31.8.2023 |
|
EU/1/96/026 |
Invirase |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/96/026 |
Invirase |
Norsko |
21.9.2023 |
|
EU/1/19/1396 |
Ivozall |
Island |
2.11.2023 |
|
EU/1/19/1396 |
Ivozall |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/19/1396 |
Ivozall |
Norsko |
1.11.2023 |
|
EU/1/13/819 |
JETREA |
Island |
11.9.2023 |
|
EU/1/13/819 |
JETREA |
Lichtenštejnsko |
31.8.2023 |
|
EU/1/13/819 |
JETREA |
Norsko |
11.10.2023 |
|
EU/1/10/663 |
Lamivudine/Zidovudine Teva |
Norsko |
21.9.2023 |
|
EU/1/20/1521 |
Lenalidomide Krka d.d. |
Norsko |
21.9.2023 |
|
EU/1/20/1519 |
Lenalidomide Krka d.d. Novo mesto |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/09/598 |
Nevirapine Teva |
Norsko |
1.11.2023 |
|
EU/1/17/1217 |
Nitisinone MDK |
Norsko |
26.10.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Island |
8.9.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Lichtenštejnsko |
31.8.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Norsko |
24.8.2023 |
|
EU/1/20/1499 |
Onbevzi |
Island |
19.12.2023 |
|
EU/1/20/1499 |
Onbevzi |
Lichtenštejnsko |
31.12.2023 |
|
EU/1/09/571 |
Pandemic influenza vaccine H5N1 BAXTER |
Lichtenštejnsko |
30.9.2023 |
|
EU/1/09/571 |
Pandemic Influenza Vaccine H5N1 BAXTER |
Norsko |
22.11.2023 |
|
EU/1/09/571 |
Pandemic Influenza Vaccine H5N1 BAXTER |
Island |
25.10.2023 |
|
EU/1/12/757 |
Pioglitazone Teva |
Norsko |
21.9.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Island |
24.10.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Norsko |
29.11.2023 |
|
EU/1/16/1166 |
Pregabalin Zentiva k.s., |
Norsko |
14.9.2023 |
|
EU/1/99/107 |
Rebetol |
Island |
26.10.2023 |
|
EU/1/99/107 |
Rebetol |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/99/107 |
Rebetol |
Norsko |
2.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Island |
29.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Lichtenštejnsko |
30.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Norsko |
28.11.2023 |
|
EU/1/20/1478 |
Zynrelef |
Lichtenštejnsko |
31.10.2023 |
|
EU/1/20/1478 |
Zynrelef |
Norsko |
28.11.2023 |
|
EU/1/20/1478 |
Zynrelef |
Island |
25.10.2023 |
(1) Zrušení omylem nebylo zařazeno na seznam za první polovinu roku 2023.
PŘÍLOHA V
Seznam pozastavených registrací
Státy ESVO EHP pozastavily v období od 1. července do 31. prosince 2023 tyto registrace:
|
Číslo EU |
Výrobek |
Země |
Datum pozastavení |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ELI: http://data.europa.eu/eli/C/2024/4358/oj
ISSN 1977-0863 (electronic edition)