Publicatieblad
van de Europese Unie
NL
C-serie
|
|
Publicatieblad |
NL C-serie |
|
C/2024/4358 |
4.7.2024 |
Geneesmiddelen — Lijst van door de EER/EVA-staten voor de tweede helft van 2023 afgegeven vergunningen om een geneesmiddel in de handel te brengen
(C/2024/4358)
Subcomité I betreffende het vrije verkeer van goederen
Te noteren door het Gemengd Comité van de EER
Met verwijzing naar Besluit nr. 74/1999 van het Gemengd Comité van de EER van 28 mei 1999 wordt het Gemengd Comité van de EER uitgenodigd om op zijn bijeenkomst van 15 maart 2024 de navolgende lijsten te noteren betreffende vergunningen om een geneesmiddel in de handel te brengen voor de periode 1 juli – 31 december 2023:
|
Bijlage I |
Lijst van nieuwe vergunningen om een geneesmiddel in de handel te brengen |
|
Bijlage II |
Lijst van hernieuwde vergunningen om een geneesmiddel in de handel te brengen |
|
Bijlage III |
Lijst van verlengde vergunningen om een geneesmiddel in de handel te brengen |
|
Bijlage IV |
Lijst van ingetrokken vergunningen om een geneesmiddel in de handel te brengen |
|
Bijlage V |
Lijst van opgeschorte vergunningen om een geneesmiddel in de handel te brengen |
BIJLAGE I
Lijst van nieuwe vergunningen om een geneesmiddel in de handel te brengen
In de EER/EVA-staten zijn in de periode 1 juli – 31 december 2023 de volgende vergunningen om een geneesmiddel in de handel te brengen, afgegeven:
|
EU-nummer |
Product |
Land |
Datum van afgifte |
|
EU/1/23/1752 |
Abrysvo |
IJsland |
6.9.2023 |
|
EU/1/23/1752 |
Abrysvo |
Liechtenstein |
31.8.2023 |
|
EU/1/23/1752 |
Abrysvo |
Noorwegen |
9.10.2023 |
|
EU/1/23/1776 |
AGAMREE |
IJsland |
28.12.2023 |
|
EU/1/23/1776 |
AGAMREE |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1776 |
AGAMREE |
Noorwegen |
19.12.2023 |
|
EU/1/23/1722 |
AKEEGA |
Noorwegen |
25.7.2023 |
|
EU/1/23/1760 |
Apretude |
IJsland |
16.10.2023 |
|
EU/1/23/1760 |
Apretude |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1760 |
Apretude |
Noorwegen |
9.10.2023 |
|
EU/1/23/1750 |
AQUIPTA |
IJsland |
30.8.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Liechtenstein |
31.8.2023 |
|
EU/1/23/1750 |
AQUIPTA |
Noorwegen |
29.8.2023 |
|
EU/1/23/1717 |
AQUMELDI |
IJsland |
4.12.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1717 |
AQUMELDI |
Noorwegen |
20.11.2023 |
|
EU/2/23/303 |
Bovilis Cryptium |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1716 |
Camzyos |
IJsland |
9.8.2023 |
|
EU/1/23/1716 |
Camzyos |
Noorwegen |
12.7.2023 |
|
EU/1/23/1763 |
Catiolanze |
IJsland |
4.12.2023 |
|
EU/1/23/1763 |
Catiolanze |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1763 |
Catiolanze |
Noorwegen |
12.12.2023 |
|
EU/1/23/1742 |
Columvi |
IJsland |
9.8.2023 |
|
EU/1/23/1742 |
Columvi |
Liechtenstein |
31.7.2023 |
|
EU/1/23/1742 |
Columvi |
Noorwegen |
13.7.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
IJsland |
23.10.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1753 |
Degarelix Accord |
Noorwegen |
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 |
IJsland |
4.12.2023 |
|
EU/1/23/1765 |
Ebglyss |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1765 |
Ebglyss |
Noorwegen |
30.11.2023 |
|
EU/1/23/1770 |
ELREXFIO |
IJsland |
18.12.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1770 |
ELREXFIO |
Noorwegen |
13.12.2023 |
|
EU/1/23/1772 |
Elucirem |
IJsland |
18.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1772 |
Elucirem |
Noorwegen |
18.12.2023 |
|
EU/2/23/297 |
Eluracat |
IJsland |
9.8.2023 |
|
EU/2/23/297 |
Eluracat |
Noorwegen |
23.8.2023 |
|
EU/1/23/1747 |
Enrylaze |
IJsland |
19.10.2023 |
|
EU/1/23/1747 |
Enrylaze |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1747 |
Enrylaze |
Noorwegen |
10.10.2023 |
|
EU/1/23/1767 |
Finlee |
IJsland |
4.12.2023 |
|
EU/1/23/1767 |
Finlee |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1767 |
Finlee |
Noorwegen |
12.12.2023 |
|
EU/1/23/1762 |
Herwenda |
IJsland |
4.12.2023 |
|
EU/1/23/1762 |
Herwenda |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1762 |
Herwenda |
Noorwegen |
12.12.2023 |
|
EU/1/23/1756 |
Inaqovi |
IJsland |
13.10.2023 |
|
EU/1/23/1756 |
Inaqovi |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1756 |
Inaqovi |
Noorwegen |
28.9.2023 |
|
EU/1/23/1738 |
Jaypirca |
IJsland |
28.11.2023 |
|
EU/1/23/1738 |
Jaypirca |
Liechtenstein |
31.10.2023 |
|
EU/1/23/1738 |
Jaypirca |
Noorwegen |
8.11.2023 |
|
EU/1/23/1755 |
Litfulo |
IJsland |
13.10.2023 |
|
EU/1/23/1755 |
Litfulo |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1755 |
Litfulo |
Noorwegen |
9.10.2023 |
|
EU/1/23/1774 |
Loargys |
IJsland |
28.12.2023 |
|
EU/1/23/1774 |
Loargys |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1774 |
Loargys |
Noorwegen |
19.12.2023 |
|
EU/2/23/301 |
Loxitab |
IJsland |
26.10.2023 |
|
EU/2/23/301 |
Loxitab |
Liechtenstein |
31.10.2023 |
|
EU/2/23/301 |
Loxitab |
Noorwegen |
1.11.2023 |
|
EU/1/21/1613 |
Lyfnua |
IJsland |
19.10.2023 |
|
EU/1/21/1613 |
Lyfnua |
Liechtenstein |
30.9.2023 |
|
EU/1/21/1613 |
Lyfnua |
Noorwegen |
10.10.2023 |
|
EU/1/23/1741 |
Lytgobi |
IJsland |
9.8.2023 |
|
EU/1/23/1741 |
Lytgobi |
Noorwegen |
11.7.2023 |
|
EU/1/23/1741 |
Lytgobi |
Liechtenstein |
31.7.2023 |
|
EU/2/23/304 |
Nobivac LoVo L4 |
IJsland |
11.12.2023 |
|
EU/2/23/304 |
Nobivac LoVo L4 |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1737 |
Opfolda |
IJsland |
9.8.2023 |
|
EU/1/23/1737 |
Opfolda |
Noorwegen |
12.7.2023 |
|
EU/1/23/1757 |
ORSERDU |
IJsland |
19.10.2023 |
|
EU/1/23/1757 |
ORSERDU |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1757 |
ORSERDU |
Noorwegen |
10.10.2023 |
|
EU/2/23/299 |
Oxmax |
IJsland |
26.10.2023 |
|
EU/2/23/299 |
Oxmax |
Liechtenstein |
31.10.2023 |
|
EU/2/23/299 |
Oxmax |
Noorwegen |
26.10.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
IJsland |
27.11.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Liechtenstein |
31.10.2023 |
|
EU/2/23/300 |
Poulvac Procerta HVT-IBD |
Noorwegen |
26.10.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
IJsland |
27.11.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Liechtenstein |
31.10.2023 |
|
EU/2/23/302 |
Prevexxion RN+HVT |
Noorwegen |
24.10.2023 |
|
EU/1/23/1746 |
Pylclari |
IJsland |
16.8.2023 |
|
EU/1/23/1746 |
Pylclari |
Liechtenstein |
31.7.2023 |
|
EU/1/23/1746 |
Pylclari |
Noorwegen |
15.8.2023 |
|
EU/1/23/1775 |
Rezzayo |
IJsland |
29.12.2023 |
|
EU/1/23/1775 |
Rezzayo |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1775 |
Rezzayo |
Noorwegen |
28.12.2023 |
|
EU/2/23/305 |
Senvelgo |
IJsland |
13.12.2023 |
|
EU/2/23/305 |
Senvelgo |
Liechtenstein |
30.11.2023 |
|
EU/2/23/305 |
Senvelgo |
Noorwegen |
28.11.2023 |
|
EU/1/23/1739 |
Sugammadex Piramal |
IJsland |
9.8.2023 |
|
EU/1/23/1739 |
Sugammadex Piramal |
Noorwegen |
12.7.2023 |
|
EU/1/23/1748 |
TALVEY |
IJsland |
31.8.2023 |
|
EU/1/23/1748 |
TALVEY |
Liechtenstein |
31.8.2023 |
|
EU/1/23/1748 |
TALVEY |
Noorwegen |
29.8.2023 |
|
EU/1/23/1759 |
Tepkinly |
IJsland |
20.10.2023 |
|
EU/1/23/1759 |
Tepkinly |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1759 |
Tepkinly |
Noorwegen |
10.10.2023 |
|
EU/1/23/1758 |
Tevimbra |
IJsland |
19.10.2023 |
|
EU/1/23/1758 |
Tevimbra |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1758 |
Tevimbra |
Noorwegen |
10.10.2023 |
|
EU/1/23/1754 |
Tyenne |
IJsland |
18.10.2023 |
|
EU/1/23/1754 |
Tyenne |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1754 |
Tyenne |
Noorwegen |
23.10.2023 |
|
EU/1/23/1745 |
Tyruko |
IJsland |
20.10.2023 |
|
EU/1/23/1745 |
Tyruko |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1745 |
Tyruko |
Noorwegen |
5.10.2023 |
|
EU/1/23/1768 |
VANFLYTA |
IJsland |
28.11.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1768 |
VANFLYTA |
Noorwegen |
12.12.2023 |
|
EU/1/23/1771 |
Veoza |
IJsland |
18.12.2023 |
|
EU/1/23/1771 |
Veoza |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1771 |
Veoza |
Noorwegen |
18.12.2023 |
|
EU/1/23/1773 |
Vueway |
IJsland |
18.12.2023 |
|
EU/1/23/1773 |
Vueway |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1773 |
Vueway |
Noorwegen |
15.12.2023 |
|
EU/1/23/1751 |
Yesafili |
IJsland |
19.10.2023 |
|
EU/1/23/1751 |
Yesafili |
Liechtenstein |
30.9.2023 |
|
EU/1/23/1751 |
Yesafili |
Noorwegen |
25.10.2023 |
|
EU/1/23/1766 |
Yorvipath |
IJsland |
4.12.2023 |
|
EU/1/23/1766 |
Yorvipath |
Liechtenstein |
30.11.2023 |
|
EU/1/23/1766 |
Yorvipath |
Noorwegen |
12.12.2023 |
|
EU/2/23/298 |
YURVAC RHD |
IJsland |
12.10.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Liechtenstein |
30.9.2023 |
|
EU/2/23/298 |
YURVAC RHD |
Noorwegen |
11.10.2023 |
|
EU/1/23/1764 |
Zilbrysq |
IJsland |
15.12.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Liechtenstein |
31.12.2023 |
|
EU/1/23/1764 |
Zilbrysq |
Noorwegen |
12.12.2023 |
|
EU/1/23/1761 |
Zoönotisch influenzavaccin Seqirus |
IJsland |
25.10.2023 |
|
EU/1/23/1761 |
Zoönotisch influenzavaccin Seqirus |
Liechtenstein |
31.10.2023 |
|
EU/1/23/1761 |
Zoönotisch influenzavaccin Seqirus |
Noorwegen |
25.10.2023 |
|
EU/1/23/1743 |
ZTALMY |
IJsland |
16.8.2023 |
|
EU/1/23/1743 |
ZTALMY |
Liechtenstein |
31.7.2023 |
|
EU/1/23/1743 |
ZTALMY |
Noorwegen |
15.8.2023 |
BIJLAGE II
Lijst van hernieuwde vergunningen om een geneesmiddel in de handel te brengen
In de EER/EVA-staten zijn in de periode 1 juli – 31 december 2023 de volgende hernieuwde vergunningen om een geneesmiddel in de handel te brengen, afgegeven:
|
EU-nummer |
Product |
Land |
Datum van afgifte |
|
EU/1/21/1539 |
Abecma |
Noorwegen |
15.8.2023 |
|
EU/1/19/1358 |
AJOVY |
IJsland |
28.11.2023 |
|
EU/1/19/1358 |
AJOVY |
Liechtenstein |
30.11.2023 |
|
EU/1/19/1358 |
AJOVY |
Noorwegen |
20.11.2023 |
|
EU/1/18/1264 |
Alunbrig |
IJsland |
6.9.2023 |
|
EU/1/18/1264 |
Alunbrig |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1292 |
Apealea |
IJsland |
5.10.2023 |
|
EU/1/18/1292 |
Apealea |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1292 |
Apealea |
Noorwegen |
10.10.2023 |
|
EU/2/19/249 |
Aservo EquiHaler |
Noorwegen |
22.8.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
IJsland |
28.12.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Liechtenstein |
31.12.2023 |
|
EU/1/19/1353 |
Atazanavir Krka |
Noorwegen |
19.12.2023 |
|
EU/1/20/1473 |
AYVAKYT |
IJsland |
14.8.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1473 |
AYVAKYT |
Noorwegen |
15.8.2023 |
|
EU/1/18/1352 |
Besremi |
IJsland |
28.12.2023 |
|
EU/1/18/1352 |
Besremi |
Liechtenstein |
31.12.2023 |
|
EU/1/18/1352 |
Besremi |
Noorwegen |
19.12.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
IJsland |
20.10.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1339 |
Bevespi Aerosphere |
Noorwegen |
26.10.2023 |
|
EU/1/18/1314 |
Braftovi |
IJsland |
4.7.2023 |
|
EU/1/18/1314 |
Braftovi |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1314 |
Braftovi |
Noorwegen |
17.7.2023 |
|
EU/1/18/1336 |
Buvidal |
IJsland |
15.8.2023 |
|
EU/1/18/1336 |
Buvidal |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1336 |
Buvidal |
Noorwegen |
15.8.2023 |
|
EU/2/15/183 |
Canigen L4 |
Noorwegen |
08.8.2023 |
|
EU/2/22/283 |
Chanaxin |
Noorwegen |
22.8.2023 |
|
EU/2/17/222 |
Clevor |
Noorwegen |
22.8.2023 |
|
EU/2/18/225 |
Dany’s BienenWohl |
Noorwegen |
16.8.2023 |
|
EU/1/18/1310 |
Deferiprone Lipomed |
IJsland |
4.7.2023 |
|
EU/1/18/1310 |
Deferiprone Lipomed |
Noorwegen |
17.7.2023 |
|
EU/1/13/878 |
Defitelio |
Noorwegen |
15.8.2023 |
|
EU/1/18/1333 |
Delstrigo |
IJsland |
10.8.2023 |
|
EU/1/18/1333 |
Delstrigo |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1333 |
Delstrigo |
Noorwegen |
17.7.2023 |
|
EU/1/18/1338 |
Dengvaxia |
IJsland |
31.8.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1338 |
Dengvaxia |
Noorwegen |
6.9.2023 |
|
EU/1/20/1437 |
Dovprela |
IJsland |
10.8.2023 |
|
EU/1/20/1437 |
Dovprela |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1437 |
Dovprela |
Noorwegen |
15.8.2023 |
|
EU/1/18/1330 |
Emgality |
IJsland |
12.9.2023 |
|
EU/1/18/1330 |
Emgality |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1330 |
Emgality |
Noorwegen |
6.9.2023 |
|
EU/1/20/1508 |
Enhertu |
IJsland |
2.11.2023 |
|
EU/1/20/1508 |
Enhertu |
Liechtenstein |
31.10.2023 |
|
EU/1/20/1508 |
Enhertu |
Noorwegen |
30.10.2023 |
|
EU/1/18/1342 |
Erleada |
IJsland |
20.10.2023 |
|
EU/1/18/1342 |
Erleada |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1342 |
Erleada |
Noorwegen |
26.10.2023 |
|
EU/2/22/284 |
Evanovo |
Noorwegen |
12.12.2023 |
|
EU/1/18/1347 |
Febuxostat Krka |
IJsland |
28.12.2023 |
|
EU/1/18/1347 |
Febuxostat Krka |
Liechtenstein |
31.12.2023 |
|
EU/2/19/238 |
Felisecto Plus |
Noorwegen |
12.12.2023 |
|
EU/2/21/277 |
Felpreva |
Noorwegen |
18.9.2023 |
|
EU/2/19/235 |
Forceris |
Liechtenstein |
31.7.2023 |
|
EU/1/13/881 |
Fortacin |
IJsland |
20.10.2023 |
|
EU/1/13/881 |
Fortacin |
Liechtenstein |
30.9.2023 |
|
EU/1/13/881 |
Fortacin |
Noorwegen |
25.10.2023 |
|
EU/1/18/1329 |
Fulphila |
IJsland |
18.10.2023 |
|
EU/1/18/1329 |
Fulphila |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1329 |
Fulphila |
Noorwegen |
15.9.2023 |
|
EU/1/21/1555 |
GAVRETO |
IJsland |
20.10.2023 |
|
EU/1/21/1555 |
GAVRETO |
Liechtenstein |
30.9.2023 |
|
EU/1/21/1555 |
GAVRETO |
Noorwegen |
26.10.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
IJsland |
10.8.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1321 |
Gefitinib Mylan |
Noorwegen |
17.7.2023 |
|
EU/1/22/1715 |
Hemgenix |
IJsland |
19.12.2023 |
|
EU/1/22/1715 |
Hemgenix |
Liechtenstein |
31.12.2023 |
|
EU/1/22/1715 |
Hemgenix |
Noorwegen |
19.12.2023 |
|
EU/1/20/1446 |
Hepcludex |
IJsland |
11.8.2023 |
|
EU/1/20/1446 |
Hepcludex |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1446 |
Hepcludex |
Noorwegen |
15.8.2023 |
|
EU/1/18/1319 |
Hulio |
IJsland |
16.8.2023 |
|
EU/1/18/1319 |
Hulio |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1319 |
Hulio |
Noorwegen |
21.9.2023 |
|
EU/2/18/230 |
Hydrocortisone aceponate Ecuphar |
Noorwegen |
22.8.2023 |
|
EU/1/19/1356 |
Idacio |
IJsland |
27.11.2023 |
|
EU/1/19/1356 |
Idacio |
Liechtenstein |
31.10.2023 |
|
EU/1/19/1356 |
Idacio |
Noorwegen |
8.11.2023 |
|
EU/1/20/1471 |
Idefirix |
IJsland |
11.8.2023 |
|
EU/1/20/1471 |
Idefirix |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1471 |
Idefirix |
Noorwegen |
16.8.2023 |
|
EU/1/18/1323 |
Ilumetri |
IJsland |
11.8.2023 |
|
EU/1/18/1323 |
Ilumetri |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1323 |
Ilumetri |
Noorwegen |
15.8.2023 |
|
EU/2/21/280 |
Imoxat |
Noorwegen |
15.8.2023 |
|
EU/2/20/256 |
Innovax-ND-ILT |
Noorwegen |
1.11.2023 |
|
EU/2/18/232 |
Isemid |
IJsland |
18.12.2023 |
|
EU/2/18/232 |
Isemid |
Liechtenstein |
30.12.2023 |
|
EU/2/18/232 |
Isemid |
Noorwegen |
12.12.2023 |
|
EU/1/18/1324 |
Jivi |
IJsland |
4.7.2023 |
|
EU/1/18/1324 |
Jivi |
Noorwegen |
13.7.2023 |
|
EU/1/18/1302 |
Kigabeq |
IJsland |
9.8.2023 |
|
EU/1/18/1302 |
Kigabeq |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1302 |
Kigabeq |
Noorwegen |
17.7.2023 |
|
EU/1/22/1657 |
Kinpeygo |
IJsland |
11.8.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Liechtenstein |
31.7.2023 |
|
EU/1/22/1657 |
Kinpeygo |
Noorwegen |
16.8.2023 |
|
EU/1/21/1552 |
Koselugo |
Noorwegen |
18.7.2023 |
|
EU/2/18/234 |
Kriptazen |
Liechtenstein |
30.12.2023 |
|
EU/2/18/234 |
Kriptazen |
Noorwegen |
20.12.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
IJsland |
29.8.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1316 |
Lenalidomide Accord |
Noorwegen |
24.8.2023 |
|
EU/1/21/1603 |
Lumykras |
IJsland |
29.11.2023 |
|
EU/1/21/1603 |
Lumykras |
Liechtenstein |
30.11.2023 |
|
EU/1/21/1603 |
Lumykras |
Noorwegen |
20.11.2023 |
|
EU/1/18/1331 |
Luxturna |
IJsland |
11.8.2023 |
|
EU/1/18/1331 |
Luxturna |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1331 |
Luxturna |
Noorwegen |
15.8.2023 |
|
EU/1/18/1315 |
Mektovi |
IJsland |
4.7.2023 |
|
EU/1/18/1315 |
Mektovi |
Noorwegen |
13.7.2023 |
|
EU/1/18/1301 |
Mepsevii |
IJsland |
15.8.2023 |
|
EU/1/18/1301 |
Mepsevii |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1301 |
Mepsevii |
Noorwegen |
15.8.2023 |
|
EU/2/20/259 |
MHYOSPHERE PCV ID |
Noorwegen |
22.8.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
IJsland |
29.11.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1346 |
Miglustat Dipharma |
Noorwegen |
11.12.2023 |
|
EU/1/21/1570 |
Minjuvi |
IJsland |
11.8.2023 |
|
EU/1/21/1570 |
Minjuvi |
Liechtenstein |
31.7.2023 |
|
EU/1/21/1570 |
Minjuvi |
Noorwegen |
16.8.2023 |
|
EU/2/17/220 |
MiPet Easecto |
Noorwegen |
22.8.2023 |
|
EU/1/18/1325 |
Namuscla |
IJsland |
30.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1325 |
Namuscla |
Noorwegen |
14.8.2023 |
|
EU/2/19/241 |
NASYM |
Noorwegen |
15.9.2023 |
|
EU/1/15/1078 |
Natpar |
Noorwegen |
25.10.2023 |
|
EU/2/20/267 |
NexGard Combo |
Noorwegen |
22.8.2023 |
|
EU/1/16/1094 |
Ninlaro |
IJsland |
12.9.2023 |
|
EU/1/16/1094 |
Ninlaro |
Liechtenstein |
30.9.2023 |
|
EU/1/16/1094 |
Ninlaro |
Noorwegen |
6.9.2023 |
|
EU/2/20/265 |
Nobivac DP Plus |
Noorwegen |
8.8.2023 |
|
EU/1/16/1139 |
Ocaliva |
IJsland |
29.11.2023 |
|
EU/1/16/1139 |
Ocaliva |
Liechtenstein |
30.11.2023 |
|
EU/1/16/1139 |
Ocaliva |
Noorwegen |
12.12.2023 |
|
EU/1/18/1341 |
Ogivri |
IJsland |
23.8.2023 |
|
EU/1/18/1341 |
Ogivri |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1341 |
Ogivri |
Noorwegen |
15.8.2023 |
|
EU/1/18/1313 |
Pelgraz |
Noorwegen |
13.7.2023 |
|
EU/1/18/1328 |
Pelmeg |
IJsland |
13.12.2023 |
|
EU/1/18/1328 |
Pelmeg |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1328 |
Pelmeg |
Noorwegen |
12.12.2023 |
|
EU/1/18/1332 |
Pifeltro |
IJsland |
10.8.2023 |
|
EU/1/18/1332 |
Pifeltro |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1332 |
Pifeltro |
Noorwegen |
17.7.2023 |
|
EU/1/18/1335 |
Poteligeo |
IJsland |
4.10.2023 |
|
EU/1/18/1335 |
Poteligeo |
Liechtenstein |
30.09.2023 |
|
EU/1/18/1335 |
Poteligeo |
Noorwegen |
10.10.2023 |
|
EU/1/18/1291 |
Rizmoic |
IJsland |
28.11.2023 |
|
EU/1/18/1291 |
Rizmoic |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1291 |
Rizmoic |
Noorwegen |
8.11.2023 |
|
EU/1/22/1668 |
Roctavian |
IJsland |
14.8.2023 |
|
EU/1/22/1668 |
Roctavian |
Liechtenstein |
31.7.2023 |
|
EU/1/22/1668 |
Roctavian |
Noorwegen |
16.8.2023 |
|
EU/1/20/1460 |
Rozlytrek |
IJsland |
10.8.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Liechtenstein |
31.7.2023 |
|
EU/1/20/1460 |
Rozlytrek |
Noorwegen |
8.8.2023 |
|
EU/1/18/1294 |
RXULTI |
Noorwegen |
15.8.2023 |
|
EU/1/21/1594 |
Rybrevant |
IJsland |
15.9.2023 |
|
EU/1/21/1594 |
Rybrevant |
Liechtenstein |
30.9.2023 |
|
EU/1/21/1594 |
Rybrevant |
Noorwegen |
25.10.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
IJsland |
29.11.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1343 |
Silodosin Recordati |
Noorwegen |
12.12.2023 |
|
EU/1/13/901 |
Sirturo |
Liechtenstein |
30.11.2023 |
|
EU/1/13/901 |
Sirturo |
Noorwegen |
7.12.2023 |
|
EU/1/13/901 |
Sirturo |
IJsland |
13.12.2023 |
|
EU/1/18/1318 |
Slenyto |
Noorwegen |
15.8.2023 |
|
EU/1/22/1688 |
Spevigo |
IJsland |
20.10.2023 |
|
EU/1/22/1688 |
Spevigo |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1306 |
Symkevi |
IJsland |
31.8.2023 |
|
EU/1/18/1306 |
Symkevi |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1306 |
Symkevi |
Noorwegen |
29.8.2023 |
|
EU/2/18/231 |
Syvazul BTV |
Noorwegen |
22.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
IJsland |
30.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Liechtenstein |
31.8.2023 |
|
EU/1/18/1340 |
TAKHZYRO |
Noorwegen |
24.8.2023 |
|
EU/1/20/1492 |
Tecartus |
IJsland |
28.12.2023 |
|
EU/1/20/1492 |
Tecartus |
Liechtenstein |
31.12.2023 |
|
EU/1/13/837 |
Tecfidera |
IJsland |
19.10.2023 |
|
EU/1/13/837 |
Tecfidera |
Liechtenstein |
30.9.2023 |
|
EU/1/13/837 |
Tecfidera |
Noorwegen |
23.10.2023 |
|
EU/1/22/1675 |
TECVAYLI |
IJsland |
11.8.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Liechtenstein |
31.7.2023 |
|
EU/1/22/1675 |
TECVAYLI |
Noorwegen |
16.8.2023 |
|
EU/2/20/252 |
Tulissin |
Noorwegen |
22.8.2023 |
|
EU/2/18/227 |
UBAC |
Noorwegen |
22.8.2023 |
|
EU/1/18/1334 |
Vaborem |
IJsland |
11.8.2023 |
|
EU/1/18/1334 |
Vaborem |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1334 |
Vaborem |
Noorwegen |
15.8.2023 |
|
EU/1/18/1350 |
Vantobra |
IJsland |
20.10.2023 |
|
EU/1/18/1350 |
Vantobra |
Liechtenstein |
30.9.2023 |
|
EU/1/18/1350 |
Vantobra |
Noorwegen |
25.10.2023 |
|
EU/2/20/266 |
Vectormune FP ILT |
Noorwegen |
18.9.2023 |
|
EU/2/20/250 |
Vectormune FP ILT+AE |
Noorwegen |
18.9.2023 |
|
EU/1/16/1138 |
Venclyxto |
IJsland |
30.8.2023 |
|
EU/1/16/1138 |
Venclyxto |
Liechtenstein |
31.8.2023 |
|
EU/1/16/1138 |
Venclyxto |
Noorwegen |
24.8.2023 |
|
EU/2/14/169 |
Versican Plus DHPPi |
Noorwegen |
19.9.2023 |
|
EU/2/14/164 |
Versican Plus DHPPi/L4 |
Noorwegen |
18.9.2023 |
|
EU/2/14/163 |
Versican Plus DHPPi/L4R |
Noorwegen |
21.9.2023 |
|
EU/2/14/171 |
Versican Plus L4 |
Noorwegen |
18.9.2023 |
|
EU/1/18/1307 |
Verzenios |
IJsland |
10.8.2023 |
|
EU/1/18/1307 |
Verzenios |
Liechtenstein |
30.06.2023 |
|
EU/1/18/1307 |
Verzenios |
Noorwegen |
13.7.2023 |
|
EU/1/18/1298 |
Veyvondi |
IJsland |
4.7.2023 |
|
EU/1/18/1298 |
Veyvondi |
Liechtenstein |
30.06.2023 |
|
EU/1/18/1298 |
Veyvondi |
Noorwegen |
13.7.2023 |
|
EU/1/19/1385 |
VITRAKVI |
IJsland |
10.8.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Liechtenstein |
31.7.2023 |
|
EU/1/19/1385 |
VITRAKVI |
Noorwegen |
15.8.2023 |
|
EU/1/19/1354 |
Vizimpro |
IJsland |
18.12.2023 |
|
EU/1/19/1354 |
Vizimpro |
Liechtenstein |
31.12.2023 |
|
EU/1/19/1354 |
Vizimpro |
Noorwegen |
12.12.2023 |
|
EU/1/18/1308 |
Vyxeos liposomal |
Noorwegen |
15.8.2023 |
|
EU/1/13/873 |
Xofigo |
IJsland |
27.11.2023 |
|
EU/1/13/873 |
Xofigo |
Liechtenstein |
30.9.2023 |
|
EU/1/13/873 |
Xofigo |
Noorwegen |
30.11.2023 |
|
EU/1/18/1299 |
Yescarta |
IJsland |
11.8.2023 |
|
EU/1/18/1299 |
Yescarta |
Liechtenstein |
31.7.2023 |
|
EU/1/18/1299 |
Yescarta |
Noorwegen |
15.8.2023 |
|
EU/1/18/1327 |
Ziextenzo |
IJsland |
10.8.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Liechtenstein |
30.6.2023 |
|
EU/1/18/1327 |
Ziextenzo |
Noorwegen |
12.7.2023 |
|
EU/1/18/1344 |
Zirabev |
IJsland |
29.11.2023 |
|
EU/1/18/1344 |
Zirabev |
Liechtenstein |
30.11.2023 |
|
EU/1/18/1344 |
Zirabev |
Noorwegen |
22.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
IJsland |
29.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Liechtenstein |
30.11.2023 |
|
EU/1/22/1695 |
Zynlonta |
Noorwegen |
12.12.2023 |
BIJLAGE III
Lijst van verlengde vergunningen om een geneesmiddel in de handel te brengen
In de EER/EVA-staten zijn in de periode 1 juli – 31 december 2023 de volgende vergunningen om een geneesmiddel in de handel te brengen, verlengd:
|
EU-nummer |
Product |
Land |
Datum van afgifte |
|
EU/1/21/1554/004-005 |
Adtralza |
IJsland |
9.10.2023 |
|
EU/1/21/1554/004-005 |
Adtralza |
Noorwegen |
25.10.2023 |
|
EU/1/20/1528/018-024 |
Comirnaty |
Noorwegen |
31.8.2023 |
|
EU/1/20/1528/015-017 |
Comirnaty Original/Omicron BA.4-5 |
IJsland |
8.9.2023 |
|
EU/1/20/1528/015-017 |
Comirnaty Original/Omicron BA.4-5 |
Noorwegen |
9.8.2023 |
|
EU/1/19/1365/002 |
Cufence |
IJsland |
14.12.2023 |
|
EU/1/19/1365/002 |
Cufence |
Noorwegen |
12.12.2023 |
|
EU/1/15/1058/023-024 |
Entresto |
Noorwegen |
16.8.2023 |
|
EU/1/18/1324/004-006 |
Erleada |
Noorwegen |
30.8.2023 |
|
EU/1/18/1324/004-006 |
Erleada |
IJsland |
5.10.2023 |
|
EU/1/19/1374/006-007 |
Esperoct |
IJsland |
24.10.2023 |
|
EU/1/19/1374/006-007 |
Esperoct |
Noorwegen |
10.10.2023 |
|
EU/1/18/1323/004 |
Ilumetri |
IJsland |
16.8.2023 |
|
EU/1/18/1323/004 |
Ilumetri |
Noorwegen |
15.8.2023 |
|
EU/1/20/1468/003-004 |
Kaftrio |
IJsland |
14.12.2023 |
|
EU/1/20/1468/003-004 |
Kaftrio |
Noorwegen |
12.12.2023 |
|
EU/1/12/782/008 |
Kalydeco |
IJsland |
13.12.2023 |
|
EU/1/12/782/008 |
Kalydeco |
Noorwegen |
12.12.2023 |
|
EU/1/16/1170/017-019 |
OLUMIANT |
IJsland |
23.10.2023 |
|
EU/1/15/1059/008 |
Orkambi |
IJsland |
9.8.2023 |
|
EU/1/15/1059/008 |
Orkambi |
Noorwegen |
12.7.2023 |
|
EU/1/13/822/006 |
PHEBURANE |
IJsland |
28.12.2023 |
|
EU/1/12/822/006 |
Pheburane |
Noorwegen |
12.12.2023 |
|
EU/1/20/1501/005-006 |
Sogroya |
Noorwegen |
16.8.2023 |
|
EU/1/20/1501/005-006 |
Sogroya |
IJsland |
16.08.2023 |
|
EU/1/18/1340/007-009 |
Takhzyro |
IJsland |
8.12.2023 |
|
EU/1/18/1340/007-009 |
Takhzyro |
Noorwegen |
12.12.2023 |
|
EU/1/15/989/002 |
Tenkasi |
IJsland |
23.10.2023 |
|
EU/1/15/989/002 |
Tenkasi |
Noorwegen |
10.10.2023 |
|
EU/1/21/1599/003 |
Vyepti |
IJsland |
18.12.2023 |
|
EU/1/21/1599/003 |
Vyepti |
Noorwegen |
18.12.2023 |
|
EU/1/22/1674/002 |
Vyvgart |
IJsland |
1.12.2023 |
|
EU/1/22/1674/002 |
Vyvgart |
Noorwegen |
12.12.2023 |
|
EU/1/05/319/012-017 |
Xolair |
IJsland |
29.11.2023 |
|
EU/1/05/319/012-017, |
Xolair |
Noorwegen |
12.12.2023 |
|
EU/1/20/1513/017 |
Yuflyma |
IJsland |
8.12.2023 |
|
EU/1/20/1513/017 |
Yuflyma |
Noorwegen |
12.12.2023 |
BIJLAGE IV
Lijst van ingetrokken vergunningen om een geneesmiddel in de handel te brengen
In de EER/EVA-staten zijn in de periode 1 juli – 31 december 2023 de volgende vergunningen om een geneesmiddel in de handel te brengen, ingetrokken:
|
EU-nummer |
Product |
Land |
Datum van intrekking |
|
EU/2/10/118 |
Activyl |
IJsland |
29.11.2023 |
|
EU/2/10/118 |
Activyl |
Liechtenstein |
30.11.2023 |
|
EU/1/20/1476 |
Adakveo |
IJsland |
7.9.2023 |
|
EU/1/20/1476 |
Adakveo |
Liechtenstein |
31.08.2023 |
|
EU/1/20/1476 |
Adakveo |
Noorwegen |
21.8.2023 |
|
EU/2/13/153 |
Aftovaxpur Doe |
Noorwegen |
14.9.2023 |
|
EU/1/03/254 |
Busilvex |
IJsland |
20.7.2023 |
|
EU/2/11/121 |
CaniLeish |
IJsland |
25.10.2023 |
|
EU/2/11/121 |
CaniLeish |
Liechtenstein |
31.10.2023 |
|
EU/2/11/121 |
CaniLeish |
Noorwegen |
22.11.2023 |
|
EU/1/15/1055 |
Ciambra |
IJsland |
25.10.2023 |
|
EU/1/15/1055 |
Ciambra |
Liechtenstein |
31.10.2023 |
|
EU/1/15/1055 |
Ciambra |
Noorwegen |
28.11.2023 |
|
EU/1/09/558 |
Clopidogrel BGR |
Liechtenstein |
31.10.2023 |
|
EU/1/09/558 |
Clopidogrel BGR |
IJsland |
6.11.2023 |
|
EU/2/10/115 |
Comfortis |
IJsland |
24.8.2023 |
|
EU/2/10/115 |
Comfortis |
Noorwegen |
21.9.2023 |
|
EU/1/21/1624 |
COVID-19-vaccin (geïnactiveerd, met adjuvans) Valneva |
IJsland |
25.10.2023 |
|
EU/1/21/1624 |
COVID-19-vaccin (geïnactiveerd, met adjuvans) Valneva |
Liechtenstein |
31.10.2023 |
|
EU/1/21/1624 |
COVID-19-vaccin (geïnactiveerd, met adjuvans) Valneva |
Noorwegen |
22.11.2023 |
|
EU/1/17/1248 |
Darunavir Krka d.d. |
Noorwegen |
23.1.2023 (1) |
|
EU/1/21/1540 |
Dasatinib Accord |
Noorwegen |
15.9.2023 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Noorwegen |
15.9.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
IJsland |
11.9.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Liechtenstein |
31.8.2023 |
|
EU/1/21/1568 |
Imatinib Koanaa |
Noorwegen |
21.9.2023 |
|
EU/1/22/1644 |
Inpremzia |
Noorwegen |
14.9.2023 |
|
EU/1/96/026 |
Invirase |
IJsland |
31.8.2023 |
|
EU/1/96/026 |
Invirase |
Liechtenstein |
31.8.2023 |
|
EU/1/96/026 |
Invirase |
Noorwegen |
21.9.2023 |
|
EU/1/19/1396 |
Ivozall |
IJsland |
2.11.2023 |
|
EU/1/19/1396 |
Ivozall |
Liechtenstein |
31.10.2023 |
|
EU/1/19/1396 |
Ivozall |
Noorwegen |
1.11.2023 |
|
EU/1/13/819 |
JETREA |
IJsland |
11.9.2023 |
|
EU/1/13/819 |
JETREA |
Liechtenstein |
31.8.2023 |
|
EU/1/13/819 |
JETREA |
Noorwegen |
11.10.2023 |
|
EU/1/10/663 |
Lamivudine/Zidovudine Teva |
Noorwegen |
21.9.2023 |
|
EU/1/20/1521 |
Lenalidomide Krka d.d. |
Noorwegen |
21.9.2023 |
|
EU/1/20/1519 |
Lenalidomide Krka d.d. Novo mesto |
Liechtenstein |
30.9.2023 |
|
EU/1/09/598 |
Nevirapine Teva |
Noorwegen |
1.11.2023 |
|
EU/1/17/1217 |
Nitisinone MDK |
Noorwegen |
26.10.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
IJsland |
8.9.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Liechtenstein |
31.8.2023 |
|
EU/2/11/132 |
Nobivac Myxo-RHD |
Noorwegen |
24.8.2023 |
|
EU/1/20/1499 |
Onbevzi |
IJsland |
19.12.2023 |
|
EU/1/20/1499 |
Onbevzi |
Liechtenstein |
31.12.2023 |
|
EU/1/09/571 |
Pandemisch influenzavaccin H5N1 BAXTER |
Liechtenstein |
30.9.2023 |
|
EU/1/09/571 |
Pandemisch influenzavaccin H5N1 BAXTER |
Noorwegen |
22.11.2023 |
|
EU/1/09/571 |
Pandemisch influenzavaccin H5N1 BAXTER |
IJsland |
25.10.2023 |
|
EU/1/12/757 |
Pioglitazone Teva |
Noorwegen |
21.9.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
IJsland |
24.10.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Liechtenstein |
31.10.2023 |
|
EU/1/15/1012 |
Pregabalin Sandoz GmbH |
Noorwegen |
29.11.2023 |
|
EU/1/16/1166 |
Pregabalin Zentiva k.s., |
Noorwegen |
14.9.2023 |
|
EU/1/99/107 |
Rebetol |
IJsland |
26.10.2023 |
|
EU/1/99/107 |
Rebetol |
Liechtenstein |
31.10.2023 |
|
EU/1/99/107 |
Rebetol |
Noorwegen |
2.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
IJsland |
29.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Liechtenstein |
30.11.2023 |
|
EU/1/22/1712 |
Tremelimumab AstraZeneca |
Noorwegen |
28.11.2023 |
|
EU/1/20/1478 |
Zynrelef |
Liechtenstein |
31.10.2023 |
|
EU/1/20/1478 |
Zynrelef |
Noorwegen |
28.11.2023 |
|
EU/1/20/1478 |
Zynrelef |
IJsland |
25.10.2023 |
(1) Intrekking was onbedoeld weggelaten van de lijst voor de eerste helft van 2023.
BIJLAGE V
Lijst van opgeschorte vergunningen om een geneesmiddel in de handel te brengen
In de EER/EVA-staten zijn in de periode 1 juli – 31 december 2023 de volgende vergunningen om een geneesmiddel in de handel te brengen, opgeschort:
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EU-nummer |
Product |
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Datum van opschorting |
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ELI: http://data.europa.eu/eli/C/2024/4358/oj
ISSN 1977-0995 (electronic edition)