Jurnalul Ofícial
al Uniunii Europene
RO
Seria C
|
|
Jurnalul Ofícial |
RO Seria C |
|
C/2024/4358 |
4.7.2024 |
Medicamente - Lista autorizațiilor de comercializare acordate de Statele AELS care fac parte din SEE în a doua jumătate a anului 2023
(C/2024/4358)
Subcomitetul I pentru libera circulație a mărfurilor
În atenția Comitetului mixt al SEE
Cu trimitere la Decizia nr. 74/1999 a Comitetului mixt al SEE din 28 mai 1999, Comitetul mixt al SEE este invitat să ia notă, la reuniunea sa din 15 martie 2024, de următoarele liste cuprinzând autorizații de comercializare a medicamentelor pentru perioada 1 iulie – 31 decembrie 2023:
|
Anexa I |
Lista noilor autorizații de comercializare |
|
Anexa II |
Lista autorizațiilor de comercializare reînnoite |
|
Anexa III |
Lista autorizațiilor de comercializare prelungite |
|
Anexa IV |
Lista autorizațiilor de comercializare retrase |
|
Anexa V |
Lista autorizațiilor de comercializare suspendate |
ANEXA I
Lista noilor autorizații de comercializare
Următoarele autorizații de comercializare au fost acordate în statele AELS care fac parte din SEE în perioada 1 iulie – 31 decembrie 2023:
|
Număr EU |
Medicament |
Țara |
Data autorizației |
|
EU/1/23/1752 |
Abrysvo |
Islanda |
6.9.2023 |
|
EU/1/23/1752 |
Abrysvo |
Liechtenstein |
31.8.2023 |
|
EU/1/23/1752 |
Abrysvo |
Norvegia |
9.10.2023 |
|
EU/1/23/1776 |
AGAMREE |
Islanda |
28.12.2023 |
|
EU/1/23/1776 |
AGAMREE |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1776 |
AGAMREE |
Norvegia |
19.12.2023 |
|
EU/1/23/1722 |
AKEEGA |
Norvegia |
25.7.2023 |
|
EU/1/23/1760 |
Apretude |
Islanda |
16.10.2023 |
|
EU/1/23/1760 |
Apretude |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1760 |
Apretude |
Norvegia |
9.10.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Islanda |
30.8.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Liechtenstein |
31.8.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Norvegia |
29.8.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Islanda |
4.12.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Norvegia |
20.11.2023 |
|
EU/2/23/303 |
Bovilis Cryptium |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1716 |
Camzyos |
Islanda |
9.8.2023 |
|
EU/1/23/1716 |
Camzyos |
Norvegia |
12.7.2023 |
|
EU/1/23/1763 |
Catiolanze |
Islanda |
4.12.2023 |
|
EU/1/23/1763 |
Catiolanze |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1763 |
Catiolanze |
Norvegia |
12.12.2023 |
|
EU/1/23/1742 |
Columvi |
Islanda |
9.8.2023 |
|
EU/1/23/1742 |
Columvi |
Liechtenstein |
31.7.2023 |
|
EU/1/23/1742 |
Columvi |
Norvegia |
13.7.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Islanda |
23.10.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Norvegia |
10.10.2023 |
|
EU/1/22/1711 |
Dimethyl Fumarate Accord |
Liechtenstein |
31.12.2023 |
|
EU/1/22/1634 |
Dimethyl fumarate Mylan |
Liechtenstein |
31.12.2023 |
|
EU/1/22/1637 |
Dimethyl fumarate Neuraxpharm |
Liechtenstein |
31.12.2023 |
|
EU/1/22/1635 |
Dimethyl fumarate Polpharma |
Liechtenstein |
31.12.2023 |
|
EU/1/22/1702 |
Dimethyl Fumarate Teva |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1765 |
Ebglyss |
Islanda |
4.12.2023 |
|
EU/1/23/1765 |
Ebglyss |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1765 |
Ebglyss |
Norvegia |
30.11.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Islanda |
18.12.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Norvegia |
13.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Islanda |
18.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Norvegia |
18.12.2023 |
|
EU/2/23/297 |
Eluracat |
Islanda |
9.8.2023 |
|
EU/2/23/297 |
Eluracat |
Norvegia |
23.8.2023 |
|
EU/1/23/1747 |
Enrylaze |
Islanda |
19.10.2023 |
|
EU/1/23/1747 |
Enrylaze |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1747 |
Enrylaze |
Norvegia |
10.10.2023 |
|
EU/1/23/1767 |
Finlee |
Islanda |
4.12.2023 |
|
EU/1/23/1767 |
Finlee |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1767 |
Finlee |
Norvegia |
12.12.2023 |
|
EU/1/23/1762 |
Herwenda |
Islanda |
4.12.2023 |
|
EU/1/23/1762 |
Herwenda |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1762 |
Herwenda |
Norvegia |
12.12.2023 |
|
EU/1/23/1756 |
Inaqovi |
Islanda |
13.10.2023 |
|
EU/1/23/1756 |
Inaqovi |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1756 |
Inaqovi |
Norvegia |
28.9.2023 |
|
EU/1/23/1738 |
Jaypirca |
Islanda |
28.11.2023 |
|
EU/1/23/1738 |
Jaypirca |
Liechtenstein |
31.10.2023 |
|
EU/1/23/1738 |
Jaypirca |
Norvegia |
8.11.2023 |
|
EU/1/23/1755 |
Litfulo |
Islanda |
13.10.2023 |
|
EU/1/23/1755 |
Litfulo |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1755 |
Litfulo |
Norvegia |
9.10.2023 |
|
EU/1/23/1774 |
Loargys |
Islanda |
28.12.2023 |
|
EU/1/23/1774 |
Loargys |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1774 |
Loargys |
Norvegia |
19.12.2023 |
|
EU/2/23/301 |
Loxitab |
Islanda |
26.10.2023 |
|
EU/2/23/301 |
Loxitab |
Liechtenstein |
31.10.2023 |
|
EU/2/23/301 |
Loxitab |
Norvegia |
1.11.2023 |
|
EU/1/21/1613 |
Lyfnua |
Islanda |
19.10.2023 |
|
EU/1/21/1613 |
Lyfnua |
Liechtenstein |
30.9.2023 |
|
EU/1/21/1613 |
Lyfnua |
Norvegia |
10.10.2023 |
|
EU/1/23/1741 |
Lytgobi |
Islanda |
9.8.2023 |
|
EU/1/23/1741 |
Lytgobi |
Norvegia |
11.7.2023 |
|
EU/1/23/1741 |
Lytgobi |
Liechtenstein |
31.7.2023 |
|
EU/2/23/304 |
Nobivac LoVo L4 |
Islanda |
11.12.2023 |
|
EU/2/23/304 |
Nobivac LoVo L4 |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1737 |
Opfolda |
Islanda |
9.8.2023 |
|
EU/1/23/1737 |
Opfolda |
Norvegia |
12.7.2023 |
|
EU/1/23/1757 |
ORSERDU |
Islanda |
19.10.2023 |
|
EU/1/23/1757 |
ORSERDU |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1757 |
ORSERDU |
Norvegia |
10.10.2023 |
|
EU/2/23/299 |
Oxmax |
Islanda |
26.10.2023 |
|
EU/2/23/299 |
Oxmax |
Liechtenstein |
31.10.2023 |
|
EU/2/23/299 |
Oxmax |
Norvegia |
26.10.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Islanda |
27.11.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Liechtenstein |
31.10.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Norvegia |
26.10.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Islanda |
27.11.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Liechtenstein |
31.10.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Norvegia |
24.10.2023 |
|
EU/1/23/1746 |
Pylclari |
Islanda |
16.8.2023 |
|
EU/1/23/1746 |
Pylclari |
Liechtenstein |
31.7.2023 |
|
EU/1/23/1746 |
Pylclari |
Norvegia |
15.8.2023 |
|
EU/1/23/1775 |
Rezzayo |
Islanda |
29.12.2023 |
|
EU/1/23/1775 |
Rezzayo |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1775 |
Rezzayo |
Norvegia |
28.12.2023 |
|
EU/2/23/305 |
Senvelgo |
Islanda |
13.12.2023 |
|
EU/2/23/305 |
Senvelgo |
Liechtenstein |
30.11.2023 |
|
EU/2/23/305 |
Senvelgo |
Norvegia |
28.11.2023 |
|
EU/1/23/1739 |
Sugammadex Piramal |
Islanda |
9.8.2023 |
|
EU/1/23/1739 |
Sugammadex Piramal |
Norvegia |
12.7.2023 |
|
EU/1/23/1748 |
TALVEY |
Islanda |
31.8.2023 |
|
EU/1/23/1748 |
TALVEY |
Liechtenstein |
31.8.2023 |
|
EU/1/23/1748 |
TALVEY |
Norvegia |
29.8.2023 |
|
EU/1/23/1759 |
Tepkinly |
Islanda |
20.10.2023 |
|
EU/1/23/1759 |
Tepkinly |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1759 |
Tepkinly |
Norvegia |
10.10.2023 |
|
EU/1/23/1758 |
Tevimbra |
Islanda |
19.10.2023 |
|
EU/1/23/1758 |
Tevimbra |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1758 |
Tevimbra |
Norvegia |
10.10.2023 |
|
EU/1/23/1754 |
Tyenne |
Islanda |
18.10.2023 |
|
EU/1/23/1754 |
Tyenne |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1754 |
Tyenne |
Norvegia |
23.10.2023 |
|
EU/1/23/1745 |
Tyruko |
Islanda |
20.10.2023 |
|
EU/1/23/1745 |
Tyruko |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1745 |
Tyruko |
Norvegia |
5.10.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Islanda |
28.11.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Norvegia |
12.12.2023 |
|
EU/1/23/1771 |
Veoza |
Islanda |
18.12.2023 |
|
EU/1/23/1771 |
Veoza |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1771 |
Veoza |
Norvegia |
18.12.2023 |
|
EU/1/23/1773 |
Vueway |
Islanda |
18.12.2023 |
|
EU/1/23/1773 |
Vueway |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1773 |
Vueway |
Norvegia |
15.12.2023 |
|
EU/1/23/1751 |
Yesafili |
Islanda |
19.10.2023 |
|
EU/1/23/1751 |
Yesafili |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1751 |
Yesafili |
Norvegia |
25.10.2023 |
|
EU/1/23/1766 |
Yorvipath |
Islanda |
4.12.2023 |
|
EU/1/23/1766 |
Yorvipath |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1766 |
Yorvipath |
Norvegia |
12.12.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Islanda |
12.10.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Liechtenstein |
30.9.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Norvegia |
11.10.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Islanda |
15.12.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Norvegia |
12.12.2023 |
|
EU/1/23/1761 |
Zoonotic Influenza Vaccine Seqirus |
Islanda |
25.10.2023 |
|
EU/1/23/1761 |
Zoonotic Influenza Vaccine Seqirus |
Liechtenstein |
31.10.2023 |
|
EU/1/23/1761 |
Zoonotic Influenza Vaccine Seqirus |
Norvegia |
25.10.2023 |
|
EU/1/23/1743 |
ZTALMY |
Islanda |
16.8.2023 |
|
EU/1/23/1743 |
ZTALMY |
Liechtenstein |
31.7.2023 |
|
EU/1/23/1743 |
ZTALMY |
Norvegia |
15.8.2023 |
ANEXA II
Lista autorizațiilor de comercializare reînnoite
Următoarele autorizații de comercializare au fost reînnoite în statele AELS care fac parte din SEE în perioada 1 iulie – 31 decembrie 2023:
|
Număr EU |
Medicament |
Țara |
Data autorizației |
|
EU/1/21/1539 |
Abecma |
Norvegia |
15.8.2023 |
|
EU/1/19/1358 |
AJOVY |
Islanda |
28.11.2023 |
|
EU/1/19/1358 |
AJOVY |
Liechtenstein |
30.11.2023 |
|
EU/1/19/1358 |
AJOVY |
Norvegia |
20.11.2023 |
|
EU/1/18/1264 |
Alunbrig |
Islanda |
6.9.2023 |
|
EU/1/18/1264 |
Alunbrig |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1292 |
Apealea |
Islanda |
5.10.2023 |
|
EU/1/18/1292 |
Apealea |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1292 |
Apealea |
Norvegia |
10.10.2023 |
|
EU/2/19/249 |
Aservo EquiHaler |
Norvegia |
22.8.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Islanda |
28.12.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Liechtenstein |
31.12.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Norvegia |
19.12.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Islanda |
14.8.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Norvegia |
15.8.2023 |
|
EU/1/18/1352 |
Besremi |
Islanda |
28.12.2023 |
|
EU/1/18/1352 |
Besremi |
Liechtenstein |
31.12.2023 |
|
EU/1/18/1352 |
Besremi |
Norvegia |
19.12.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Islanda |
20.10.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Norvegia |
26.10.2023 |
|
EU/1/18/1314 |
Braftovi |
Islanda |
4.7.2023 |
|
EU/1/18/1314 |
Braftovi |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1314 |
Braftovi |
Norvegia |
17.7.2023 |
|
EU/1/18/1336 |
Buvidal |
Islanda |
15.8.2023 |
|
EU/1/18/1336 |
Buvidal |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1336 |
Buvidal |
Norvegia |
15.8.2023 |
|
EU/2/15/183 |
Canigen L4 |
Norvegia |
8.8.2023 |
|
EU/2/22/283 |
Chanaxin |
Norvegia |
22.8.2023 |
|
EU/2/17/222 |
Clevor |
Norvegia |
22.8.2023 |
|
EU/2/18/225 |
Dany’s BienenWohl |
Norvegia |
16.8.2023 |
|
EU/1/18/1310 |
Deferiprone Lipomed |
Islanda |
4.7.2023 |
|
EU/1/18/1310 |
Deferiprone Lipomed |
Norvegia |
17.7.2023 |
|
EU/1/13/878 |
Defitelio |
Norvegia |
15.8.2023 |
|
EU/1/18/1333 |
Delstrigo |
Islanda |
10.8.2023 |
|
EU/1/18/1333 |
Delstrigo |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1333 |
Delstrigo |
Norvegia |
17.7.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Islanda |
31.8.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Norvegia |
6.9.2023 |
|
EU/1/20/1437 |
Dovprela |
Islanda |
10.8.2023 |
|
EU/1/20/1437 |
Dovprela |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1437 |
Dovprela |
Norvegia |
15.8.2023 |
|
EU/1/18/1330 |
Emgality |
Islanda |
12.9.2023 |
|
EU/1/18/1330 |
Emgality |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1330 |
Emgality |
Norvegia |
6.9.2023 |
|
EU/1/20/1508 |
Enhertu |
Islanda |
2.11.2023 |
|
EU/1/20/1508 |
Enhertu |
Liechtenstein |
31.10.2023 |
|
EU/1/20/1508 |
Enhertu |
Norvegia |
30.10.2023 |
|
EU/1/18/1342 |
Erleada |
Islanda |
20.10.2023 |
|
EU/1/18/1342 |
Erleada |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1342 |
Erleada |
Norvegia |
26.10.2023 |
|
EU/2/22/284 |
Evanovo |
Norvegia |
12.12.2023 |
|
EU/1/18/1347 |
Febuxostat Krka |
Islanda |
28.12.2023 |
|
EU/1/18/1347 |
Febuxostat Krka |
Liechtenstein |
31.12.2023 |
|
EU/2/19/238 |
Felisecto Plus |
Norvegia |
12.12.2023 |
|
EU/2/21/277 |
Felpreva |
Norvegia |
18.9.2023 |
|
EU/2/19/235 |
Forceris |
Liechtenstein |
31.7.2023 |
|
EU/1/13/881 |
Fortacin |
Islanda |
20.10.2023 |
|
EU/1/13/881 |
Fortacin |
Liechtenstein |
30.9.2023 |
|
EU/1/13/881 |
Fortacin |
Norvegia |
25.10.2023 |
|
EU/1/18/1329 |
Fulphila |
Islanda |
18.10.2023 |
|
EU/1/18/1329 |
Fulphila |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1329 |
Fulphila |
Norvegia |
15.9.2023 |
|
EU/1/21/1555 |
GAVRETO |
Islanda |
20.10.2023 |
|
EU/1/21/1555 |
GAVRETO |
Liechtenstein |
30.9.2023 |
|
EU/1/21/1555 |
GAVRETO |
Norvegia |
26.10.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Islanda |
10.8.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Norvegia |
17.7.2023 |
|
EU/1/22/1715 |
Hemgenix |
Islanda |
19.12.2023 |
|
EU/1/22/1715 |
Hemgenix |
Liechtenstein |
31.12.2023 |
|
EU/1/22/1715 |
Hemgenix |
Norvegia |
19.12.2023 |
|
EU/1/20/1446 |
Hepcludex |
Islanda |
11.8.2023 |
|
EU/1/20/1446 |
Hepcludex |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1446 |
Hepcludex |
Norvegia |
15.8.2023 |
|
EU/1/18/1319 |
Hulio |
Islanda |
16.8.2023 |
|
EU/1/18/1319 |
Hulio |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1319 |
Hulio |
Norvegia |
21.9.2023 |
|
EU/2/18/230 |
Hydrocortisone aceponate Ecuphar |
Norvegia |
22.8.2023 |
|
EU/1/19/1356 |
Idacio |
Islanda |
27.11.2023 |
|
EU/1/19/1356 |
Idacio |
Liechtenstein |
31.10.2023 |
|
EU/1/19/1356 |
Idacio |
Norvegia |
8.11.2023 |
|
EU/1/20/1471 |
Idefirix |
Islanda |
11.8.2023 |
|
EU/1/20/1471 |
Idefirix |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1471 |
Idefirix |
Norvegia |
16.8.2023 |
|
EU/1/18/1323 |
Ilumetri |
Islanda |
11.8.2023 |
|
EU/1/18/1323 |
Ilumetri |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1323 |
Ilumetri |
Norvegia |
15.8.2023 |
|
EU/2/21/280 |
Imoxat |
Norvegia |
15.8.2023 |
|
EU/2/20/256 |
Innovax-ND-ILT |
Norvegia |
1.11.2023 |
|
EU/2/18/232 |
Isemid |
Islanda |
18.12.2023 |
|
EU/2/18/232 |
Isemid |
Liechtenstein |
30.12.2023 |
|
EU/2/18/232 |
Isemid |
Norvegia |
12.12.2023 |
|
EU/1/18/1324 |
Jivi |
Islanda |
4.7.2023 |
|
EU/1/18/1324 |
Jivi |
Norvegia |
13.7.2023 |
|
EU/1/18/1302 |
Kigabeq |
Islanda |
9.8.2023 |
|
EU/1/18/1302 |
Kigabeq |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1302 |
Kigabeq |
Norvegia |
17.7.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Islanda |
11.8.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Liechtenstein |
31.7.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Norvegia |
16.8.2023 |
|
EU/1/21/1552 |
Koselugo |
Norvegia |
18.7.2023 |
|
EU/2/18/234 |
Kriptazen |
Liechtenstein |
30.12.2023 |
|
EU/2/18/234 |
Kriptazen |
Norvegia |
20.12.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Islanda |
29.8.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Norvegia |
24.8.2023 |
|
EU/1/21/1603 |
Lumykras |
Islanda |
29.11.2023 |
|
EU/1/21/1603 |
Lumykras |
Liechtenstein |
30.11.2023 |
|
EU/1/21/1603 |
Lumykras |
Norvegia |
20.11.2023 |
|
EU/1/18/1331 |
Luxturna |
Islanda |
11.8.2023 |
|
EU/1/18/1331 |
Luxturna |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1331 |
Luxturna |
Norvegia |
15.8.2023 |
|
EU/1/18/1315 |
Mektovi |
Islanda |
4.7.2023 |
|
EU/1/18/1315 |
Mektovi |
Norvegia |
13.7.2023 |
|
EU/1/18/1301 |
Mepsevii |
Islanda |
15.8.2023 |
|
EU/1/18/1301 |
Mepsevii |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1301 |
Mepsevii |
Norvegia |
15.8.2023 |
|
EU/2/20/259 |
MHYOSPHERE PCV ID |
Norvegia |
22.8.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Islanda |
29.11.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Norvegia |
11.12.2023 |
|
EU/1/21/1570 |
Minjuvi |
Islanda |
11.8.2023 |
|
EU/1/21/1570 |
Minjuvi |
Liechtenstein |
31.7.2023 |
|
EU/1/21/1570 |
Minjuvi |
Norvegia |
16.8.2023 |
|
EU/2/17/220 |
MiPet Easecto |
Norvegia |
22.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Islanda |
30.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Norvegia |
14.8.2023 |
|
EU/2/19/241 |
NASYM |
Norvegia |
15.9.2023 |
|
EU/1/15/1078 |
Natpar |
Norvegia |
25.10.2023 |
|
EU/2/20/267 |
NexGard Combo |
Norvegia |
22.8.2023 |
|
EU/1/16/1094 |
Ninlaro |
Islanda |
12.9.2023 |
|
EU/1/16/1094 |
Ninlaro |
Liechtenstein |
30.9.2023 |
|
EU/1/16/1094 |
Ninlaro |
Norvegia |
6.9.2023 |
|
EU/2/20/265 |
Nobivac DP Plus |
Norvegia |
8.8.2023 |
|
EU/1/16/1139 |
Ocaliva |
Islanda |
29.11.2023 |
|
EU/1/16/1139 |
Ocaliva |
Liechtenstein |
30.11.2023 |
|
EU/1/16/1139 |
Ocaliva |
Norvegia |
12.12.2023 |
|
EU/1/18/1341 |
Ogivri |
Islanda |
23.8.2023 |
|
EU/1/18/1341 |
Ogivri |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1341 |
Ogivri |
Norvegia |
15.8.2023 |
|
EU/1/18/1313 |
Pelgraz |
Norvegia |
13.7.2023 |
|
EU/1/18/1328 |
Pelmeg |
Islanda |
13.12.2023 |
|
EU/1/18/1328 |
Pelmeg |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1328 |
Pelmeg |
Norvegia |
12.12.2023 |
|
EU/1/18/1332 |
Pifeltro |
Islanda |
10.8.2023 |
|
EU/1/18/1332 |
Pifeltro |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1332 |
Pifeltro |
Norvegia |
17.7.2023 |
|
EU/1/18/1335 |
Poteligeo |
Islanda |
4.10.2023 |
|
EU/1/18/1335 |
Poteligeo |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1335 |
Poteligeo |
Norvegia |
10.10.2023 |
|
EU/1/18/1291 |
Rizmoic |
Islanda |
28.11.2023 |
|
EU/1/18/1291 |
Rizmoic |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1291 |
Rizmoic |
Norvegia |
8.11.2023 |
|
EU/1/22/1668 |
Roctavian |
Islanda |
14.8.2023 |
|
EU/1/22/1668 |
Roctavian |
Liechtenstein |
31.7.2023 |
|
EU/1/22/1668 |
Roctavian |
Norvegia |
16.8.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Islanda |
10.8.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Norvegia |
8.8.2023 |
|
EU/1/18/1294 |
RXULTI |
Norvegia |
15.8.2023 |
|
EU/1/21/1594 |
Rybrevant |
Islanda |
15.9.2023 |
|
EU/1/21/1594 |
Rybrevant |
Liechtenstein |
30.9.2023 |
|
EU/1/21/1594 |
Rybrevant |
Norvegia |
25.10.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Islanda |
29.11.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Norvegia |
12.12.2023 |
|
EU/1/13/901 |
Sirturo |
Liechtenstein |
30.11.2023 |
|
EU/1/13/901 |
Sirturo |
Norvegia |
7.12.2023 |
|
EU/1/13/901 |
Sirturo |
Islanda |
13.12.2023 |
|
EU/1/18/1318 |
Slenyto |
Norvegia |
15.8.2023 |
|
EU/1/22/1688 |
Spevigo |
Islanda |
20.10.2023 |
|
EU/1/22/1688 |
Spevigo |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1306 |
Symkevi |
Islanda |
31.8.2023 |
|
EU/1/18/1306 |
Symkevi |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1306 |
Symkevi |
Norvegia |
29.8.2023 |
|
EU/2/18/231 |
Syvazul BTV |
Norvegia |
22.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Islanda |
30.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Norvegia |
24.8.2023 |
|
EU/1/20/1492 |
Tecartus |
Islanda |
28.12.2023 |
|
EU/1/20/1492 |
Tecartus |
Liechtenstein |
31.12.2023 |
|
EU/1/13/837 |
Tecfidera |
Islanda |
19.10.2023 |
|
EU/1/13/837 |
Tecfidera |
Liechtenstein |
30.9.2023 |
|
EU/1/13/837 |
Tecfidera |
Norvegia |
23.10.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Islanda |
11.8.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Liechtenstein |
31.7.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Norvegia |
16.8.2023 |
|
EU/2/20/252 |
Tulissin |
Norvegia |
22.8.2023 |
|
EU/2/18/227 |
UBAC |
Norvegia |
22.8.2023 |
|
EU/1/18/1334 |
Vaborem |
Islanda |
11.8.2023 |
|
EU/1/18/1334 |
Vaborem |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1334 |
Vaborem |
Norvegia |
15.8.2023 |
|
EU/1/18/1350 |
Vantobra |
Islanda |
20.10.2023 |
|
EU/1/18/1350 |
Vantobra |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1350 |
Vantobra |
Norvegia |
25.10.2023 |
|
EU/2/20/266 |
Vectormune FP ILT |
Norvegia |
18.9.2023 |
|
EU/2/20/250 |
Vectormune FP ILT+AE |
Norvegia |
18.9.2023 |
|
EU/1/16/1138 |
Venclyxto |
Islanda |
30.8.2023 |
|
EU/1/16/1138 |
Venclyxto |
Liechtenstein |
31.8.2023 |
|
EU/1/16/1138 |
Venclyxto |
Norvegia |
24.8.2023 |
|
EU/2/14/169 |
Versican Plus DHPPi |
Norvegia |
19.9.2023 |
|
EU/2/14/164 |
Versican Plus DHPPi/L4 |
Norvegia |
18.9.2023 |
|
EU/2/14/163 |
Versican Plus DHPPi/L4R |
Norvegia |
21.9.2023 |
|
EU/2/14/171 |
Versican Plus L4 |
Norvegia |
18.9.2023 |
|
EU/1/18/1307 |
Verzenios |
Islanda |
10.8.2023 |
|
EU/1/18/1307 |
Verzenios |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1307 |
Verzenios |
Norvegia |
13.7.2023 |
|
EU/1/18/1298 |
Veyvondi |
Islanda |
4.7.2023 |
|
EU/1/18/1298 |
Veyvondi |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1298 |
Veyvondi |
Norvegia |
13.7.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Islanda |
10.8.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Liechtenstein |
31.7.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Norvegia |
15.8.2023 |
|
EU/1/19/1354 |
Vizimpro |
Islanda |
18.12.2023 |
|
EU/1/19/1354 |
Vizimpro |
Liechtenstein |
31.12.2023 |
|
EU/1/19/1354 |
Vizimpro |
Norvegia |
12.12.2023 |
|
EU/1/18/1308 |
Vyxeos liposomal |
Norvegia |
15.8.2023 |
|
EU/1/13/873 |
Xofigo |
Islanda |
27.11.2023 |
|
EU/1/13/873 |
Xofigo |
Liechtenstein |
30.9.2023 |
|
EU/1/13/873 |
Xofigo |
Norvegia |
30.11.2023 |
|
EU/1/18/1299 |
Yescarta |
Islanda |
11.8.2023 |
|
EU/1/18/1299 |
Yescarta |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1299 |
Yescarta |
Norvegia |
15.8.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Islanda |
10.8.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Norvegia |
12.7.2023 |
|
EU/1/18/1344 |
Zirabev |
Islanda |
29.11.2023 |
|
EU/1/18/1344 |
Zirabev |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1344 |
Zirabev |
Norvegia |
22.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Islanda |
29.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Liechtenstein |
30.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Norvegia |
12.12.2023 |
ANEXA III
Lista autorizațiilor de comercializare prelungite
Următoarele autorizații de comercializare au fost prelungite în statele AELS care fac parte din SEE în perioada 1 iulie – 31 decembrie 2023:
|
Număr EU |
Medicament |
Țara |
Data autorizației |
|
EU/1/21/1554/004-005 |
Adtralza |
Islanda |
9.10.2023 |
|
EU/1/21/1554/004-005 |
Adtralza |
Norvegia |
25.10.2023 |
|
EU/1/20/1528/018-024 |
Comirnaty |
Norvegia |
31.8.2023 |
|
EU/1/20/1528/015-017 |
Comirnaty Original/Omicron BA.4-5 |
Islanda |
8.9.2023 |
|
EU/1/20/1528/015-017 |
Comirnaty Original/Omicron BA.4-5 |
Norvegia |
9.8.2023 |
|
EU/1/19/1365/002 |
Cufence |
Islanda |
14.12.2023 |
|
EU/1/19/1365/002 |
Cufence |
Norvegia |
12.12.2023 |
|
EU/1/15/1058/023-024 |
Entresto |
Norvegia |
16.8.2023 |
|
EU/1/18/1324/004-006 |
Erleada |
Norvegia |
30.8.2023 |
|
EU/1/18/1324/004-006 |
Erleada |
Islanda |
5.10.2023 |
|
EU/1/19/1374/006-007 |
Esperoct |
Islanda |
24.10.2023 |
|
EU/1/19/1374/006-007 |
Esperoct |
Norvegia |
10.10.2023 |
|
EU/1/18/1323/004 |
Ilumetri |
Islanda |
16.8.2023 |
|
EU/1/18/1323/004 |
Ilumetri |
Norvegia |
15.8.2023 |
|
EU/1/20/1468/003-004 |
Kaftrio |
Islanda |
14.12.2023 |
|
EU/1/20/1468/003-004 |
Kaftrio |
Norvegia |
12.12.2023 |
|
EU/1/12/782/008 |
Kalydeco |
Islanda |
13.12.2023 |
|
EU/1/12/782/008 |
Kalydeco |
Norvegia |
12.12.2023 |
|
EU/1/16/1170/017-019 |
OLUMIANT |
Islanda |
23.10.2023 |
|
EU/1/15/1059/008 |
Orkambi |
Islanda |
9.8.2023 |
|
EU/1/15/1059/008 |
Orkambi |
Norvegia |
12.7.2023 |
|
EU/1/13/822/006 |
PHEBURANE |
Islanda |
28.12.2023 |
|
EU/1/12/822/006 |
Pheburane |
Norvegia |
12.12.2023 |
|
EU/1/20/1501/005-006 |
Sogroya |
Norvegia |
16.8.2023 |
|
EU/1/20/1501/005-006 |
Sogroya |
Islanda |
16.8.2023 |
|
EU/1/18/1340/007-009 |
Takhzyro |
Islanda |
8.12.2023 |
|
EU/1/18/1340/007-009 |
Takhzyro |
Norvegia |
12.12.2023 |
|
EU/1/15/989/002 |
Tenkasi |
Islanda |
23.10.2023 |
|
EU/1/15/989/002 |
Tenkasi |
Norvegia |
10.10.2023 |
|
EU/1/21/1599/003 |
Vyepti |
Islanda |
18.12.2023 |
|
EU/1/21/1599/003 |
Vyepti |
Norvegia |
18.12.2023 |
|
EU/1/22/1674/002 |
Vyvgart |
Islanda |
1.12.2023 |
|
EU/1/22/1674/002 |
Vyvgart |
Norvegia |
12.12.2023 |
|
EU/1/05/319/012-017 |
Xolair |
Islanda |
29.11.2023 |
|
EU/1/05/319/012-017, |
Xolair |
Norvegia |
12.12.2023 |
|
EU/1/20/1513/017 |
Yuflyma |
Islanda |
8.12.2023 |
|
EU/1/20/1513/017 |
Yuflyma |
Norvegia |
12.12.2023 |
ANEXA IV
Lista autorizațiilor de comercializare retrase
Următoarele autorizații de comercializare au fost retrase în statele AELS care fac parte din SEE în perioada 1 iulie – 31 decembrie 2023:
|
Număr EU |
Medicament |
Țara |
Data retragerii |
|
EU/2/10/118 |
Activyl |
Islanda |
29.11.2023 |
|
EU/2/10/118 |
Activyl |
Liechtenstein |
30.11.2023 |
|
EU/1/20/1476 |
Adakveo |
Islanda |
7.9.2023 |
|
EU/1/20/1476 |
Adakveo |
Liechtenstein |
31.8.2023 |
|
EU/1/20/1476 |
Adakveo |
Norvegia |
21.8.2023 |
|
EU/2/13/153 |
Aftovaxpur Doe |
Norvegia |
14.9.2023 |
|
EU/1/03/254 |
Busilvex |
Islanda |
20.7.2023 |
|
EU/2/11/121 |
CaniLeish |
Islanda |
25.10.2023 |
|
EU/2/11/121 |
CaniLeish |
Liechtenstein |
31.10.2023 |
|
EU/2/11/121 |
CaniLeish |
Norvegia |
22.11.2023 |
|
EU/1/15/1055 |
Ciambra |
Islanda |
25.10.2023 |
|
EU/1/15/1055 |
Ciambra |
Liechtenstein |
31.10.2023 |
|
EU/1/15/1055 |
Ciambra |
Norvegia |
28.11.2023 |
|
EU/1/09/558 |
Clopidogrel BGR |
Liechtenstein |
31.10.2023 |
|
EU/1/09/558 |
Clopidogrel BGR |
Islanda |
6.11.2023 |
|
EU/2/10/115 |
Comfortis |
Islanda |
24.8.2023 |
|
EU/2/10/115 |
Comfortis |
Norvegia |
21.9.2023 |
|
EU/1/21/1624 |
COVID-19 Vaccine (inactivated, adjuvanted) Valneva |
Islanda |
25.10.2023 |
|
EU/1/21/1624 |
COVID-19 Vaccine (inactivated, adjuvanted) Valneva |
Liechtenstein |
31.10.2023 |
|
EU/1/21/1624 |
COVID-19 Vaccine (inactivated, adjuvanted) Valneva |
Norvegia |
22.11.2023 |
|
EU/1/17/1248 |
Darunavir Krka d.d. |
Norvegia |
23.1.2023 (1) |
|
EU/1/21/1540 |
Dasatinib Accord |
Norvegia |
15.9.2023 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Norvegia |
15.9.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Islanda |
11.9.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Liechtenstein |
31.8.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Norvegia |
21.9.2023 |
|
EU/1/22/1644 |
Inpremzia |
Norvegia |
14.9.2023 |
|
EU/1/96/026 |
Invirase |
Islanda |
31.8.2023 |
|
EU/1/96/026 |
Invirase |
Liechtenstein |
31.8.2023 |
|
EU/1/96/026 |
Invirase |
Norvegia |
21.9.2023 |
|
EU/1/19/1396 |
Ivozall |
Islanda |
2.11.2023 |
|
EU/1/19/1396 |
Ivozall |
Liechtenstein |
31.10.2023 |
|
EU/1/19/1396 |
Ivozall |
Norvegia |
1.11.2023 |
|
EU/1/13/819 |
JETREA |
Islanda |
11.9.2023 |
|
EU/1/13/819 |
JETREA |
Liechtenstein |
31.8.2023 |
|
EU/1/13/819 |
JETREA |
Norvegia |
11.10.2023 |
|
EU/1/10/663 |
Lamivudine/Zidovudine Teva |
Norvegia |
21.9.2023 |
|
EU/1/20/1521 |
Lenalidomide Krka d.d. |
Norvegia |
21.9.2023 |
|
EU/1/20/1519 |
Lenalidomide Krka d.d. Novo mesto |
Liechtenstein |
30.9.2023 |
|
EU/1/09/598 |
Nevirapine Teva |
Norvegia |
1.11.2023 |
|
EU/1/17/1217 |
Nitisinone MDK |
Norvegia |
26.10.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Islanda |
8.9.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Liechtenstein |
31.8.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Norvegia |
24.8.2023 |
|
EU/1/20/1499 |
Onbevzi |
Islanda |
19.12.2023 |
|
EU/1/20/1499 |
Onbevzi |
Liechtenstein |
31.12.2023 |
|
EU/1/09/571 |
Pandemic influenza vaccine H5N1 BAXTER |
Liechtenstein |
30.9.2023 |
|
EU/1/09/571 |
Pandemic Influenza Vaccine H5N1 BAXTER |
Norvegia |
22.11.2023 |
|
EU/1/09/571 |
Pandemic Influenza Vaccine H5N1 BAXTER |
Islanda |
25.10.2023 |
|
EU/1/12/757 |
Pioglitazone Teva |
Norvegia |
21.9.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Islanda |
24.10.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Liechtenstein |
31.10.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Norvegia |
29.11.2023 |
|
EU/1/16/1166 |
Pregabalin Zentiva k.s., |
Norvegia |
14.9.2023 |
|
EU/1/99/107 |
Rebetol |
Islanda |
26.10.2023 |
|
EU/1/99/107 |
Rebetol |
Liechtenstein |
31.10.2023 |
|
EU/1/99/107 |
Rebetol |
Norvegia |
2.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Islanda |
29.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Liechtenstein |
30.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Norvegia |
28.11.2023 |
|
EU/1/20/1478 |
Zynrelef |
Liechtenstein |
31.10.2023 |
|
EU/1/20/1478 |
Zynrelef |
Norvegia |
28.11.2023 |
|
EU/1/20/1478 |
Zynrelef |
Islanda |
25.10.2023 |
(1) 1 Retragerea a fost omisă în mod neintenționat de pe listă pentru prima jumătate a anului 2023.
ANEXA V
Lista autorizațiilor de comercializare suspendate
Următoarele autorizații de comercializare au fost suspendate în statele AELS care fac parte din SEE în perioada 1 iulie – 31 decembrie 2023:
|
Număr EU |
Medicament |
Țara |
Data suspendării |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ELI: http://data.europa.eu/eli/C/2024/4358/oj
ISSN 1977-1029 (electronic edition)