|
9.3.2023 |
PL |
Dziennik Urzędowy Unii Europejskiej |
C 87/14 |
Produkty lecznicze – Wykaz pozwoleń na dopuszczenie do obrotu udzielonych przez państwa EOG należące do EOG w pierwszym półroczu 2022 r.
(2023/C 87/08)
Podkomitet I ds. swobodnego przepływu towarów
Do wiadomości Wspólnego Komitetu EOG
W nawiązaniu do decyzji Wspólnego Komitetu EOG nr 74/1999 z dnia 28 maja 1999 r. Wspólnemu Komitetowi EOG przekazuje się celem przyjęcia do wiadomości na posiedzeniu 28 października 2022 r. następujące wykazy dotyczące pozwoleń na dopuszczenie do obrotu produktów leczniczych za okres od 1 stycznia 2022 r. do 30 czerwca 2022 r.:
|
Załącznik I |
Wykaz nowych pozwoleń na dopuszczenie do obrotu |
|
Załącznik II |
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu |
|
Załącznik III |
Wykaz przedłużonych pozwoleń na dopuszczenie do obrotu |
|
Załącznik IV |
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu |
|
Załącznik V |
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu |
ZAŁĄCZNIK I
Wykaz nowych pozwoleń na dopuszczenie do obrotu
W okresie od 1 stycznia 2022 r. do 30 czerwca 2022 r. udzielono następujących pozwoleń na dopuszczenie do obrotu w państwach EFTA należących do EOG:
|
Numer EU |
Produkt |
Państwo |
Data udzielenia pozwolenia |
|
EU/1/21/1540 |
Dasatinib Accord |
Norwegia |
7.4.2022 |
|
EU/1/21/1540 |
Dasatinib Accord |
Islandia |
8.4.2022 |
|
EU/1/21/1540 |
Dasatinib Accord |
Liechtenstein |
31.3.2022 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Norwegia |
7.4.2022 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Islandia |
8.4.2022 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Liechtenstein |
31.3.2022 |
|
EU/1/21/1569 |
QINLOCK |
Norwegia |
11.1.2022 |
|
EU/1/21/1578 |
Ontilyv |
Norwegia |
25.2.2022 |
|
EU/1/21/1578 |
Ontilyv |
Islandia |
24.2.2022 |
|
EU/1/21/1578 |
Ontilyv |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1579 |
Nexviadyme |
Liechtenstein |
30.6.2022 |
|
EU/1/21/1586 |
Voraxaze |
Norwegia |
24.1.2022 |
|
EU/1/21/1586 |
Voraxaze |
Islandia |
10.2.2022 |
|
EU/1/21/1586 |
Voraxaze |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1596 |
Tepmetko |
Norwegia |
22.2.2022 |
|
EU/1/21/1596 |
Tepmetko |
Islandia |
22.2.2022 |
|
EU/1/21/1596 |
Tepmetko |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1598 |
Sitagliptin SUN |
Norwegia |
3.1.2022 |
|
EU/1/21/1599 |
Vyepti |
Norwegia |
7.2.2022 |
|
EU/1/21/1599 |
Vyepti |
Islandia |
28.1.2022 |
|
EU/1/21/1599 |
Vyepti |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1600 |
Tecovirimat SIGA |
Norwegia |
17.1.2022 |
|
EU/1/21/1600 |
Tecovirimat SIGA |
Islandia |
14.1.2022 |
|
EU/1/21/1600 |
Tecovirimat SIGA |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1602 |
Uplizna |
Norwegia |
16.5.2022 |
|
EU/1/21/1602 |
Uplizna |
Islandia |
13.5.2022 |
|
EU/1/21/1602 |
Uplizna |
Liechtenstein |
30.4.2022 |
|
EU/1/21/1603 |
Lumykras |
Norwegia |
11.1.2022 |
|
EU/1/21/1603 |
Lumykras |
Islandia |
25.1.2022 |
|
EU/1/21/1603 |
Lumykras |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1604 |
Riltrava Aerosphere |
Norwegia |
11.1.2022 |
|
EU/1/21/1604 |
Riltrava Aerosphere |
Islandia |
19.1.2022 |
|
EU/1/21/1604 |
Riltrava Aerosphere |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1605 |
Tavneos |
Norwegia |
19.1.2022 |
|
EU/1/21/1605 |
Tavneos |
Islandia |
14.2.2022 |
|
EU/1/21/1605 |
Tavneos |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1606 |
Yselty |
Norwegia |
22.6.2022 |
|
EU/1/21/1606 |
Yselty |
Islandia |
21.6.2022 |
|
EU/1/21/1606 |
Yselty |
Liechtenstein |
30.6.2022 |
|
EU/1/21/1607 |
Lonapegsomatropin Ascendis Pharma |
Norwegia |
21.1.2022 |
|
EU/1/21/1607 |
Lonapegsomatropin Ascendis Pharma |
Islandia |
1.2.2022 |
|
EU/1/21/1607 |
Lonapegsomatropin Ascendis Pharma |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1608 |
Wegovy |
Norwegia |
12.1.2022 |
|
EU/1/21/1608 |
Wegovy |
Islandia |
19.1.2022 |
|
EU/1/21/1608 |
Wegovy |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1611 |
Vildagliptin/Metformin hydrochloride Accord |
Norwegia |
6.4.2022 |
|
EU/1/21/1611 |
Vildagliptin/Metformin hydrochloride Accord |
Islandia |
19.4.2022 |
|
EU/1/21/1611 |
Vildagliptin/Metformin hydrochloride Accord |
Liechtenstein |
31.3.2022 |
|
EU/1/21/1612 |
Apexxnar |
Norwegia |
22.2.2022 |
|
EU/1/21/1612 |
Apexxnar |
Islandia |
22.2.2022 |
|
EU/1/21/1612 |
Apexxnar |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1615 |
Padcev |
Norwegia |
21.4.2022 |
|
EU/1/21/1615 |
Padcev |
Islandia |
4.5.2022 |
|
EU/1/21/1615 |
Padcev |
Liechtenstein |
30.4.2022 |
|
EU/1/21/1616 |
Kerendia |
Norwegia |
22.2.2022 |
|
EU/1/21/1616 |
Kerendia |
Islandia |
24.2.2022 |
|
EU/1/21/1616 |
Kerendia |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1617 |
Ngenla |
Norwegia |
22.2.2022 |
|
EU/1/21/1617 |
Ngenla |
Islandia |
22.2.2022 |
|
EU/1/21/1617 |
Ngenla |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1619 |
Sitagliptin/Metformin hydrochloride Mylan |
Norwegia |
24.3.2022 |
|
EU/1/21/1619 |
Sitagliptin/Metformin hydrochloride Mylan |
Islandia |
15.3.2022 |
|
EU/1/21/1619 |
Sitagliptin/Metformin hydrochloride Mylan |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1620 |
Sapropterin Dipharma |
Norwegia |
22.2.2022 |
|
EU/1/21/1620 |
Sapropterin Dipharma |
Islandia |
22.2.2022 |
|
EU/1/21/1620 |
Sapropterin Dipharma |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1621 |
OKEDI |
Norwegia |
21.2.2022 |
|
EU/1/21/1621 |
OKEDI |
Islandia |
16.2.2022 |
|
EU/1/21/1621 |
OKEDI |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1622 |
Oxbryta |
Norwegia |
21.2.2022 |
|
EU/1/21/1622 |
Oxbryta |
Islandia |
22.2.2022 |
|
EU/1/21/1622 |
Oxbryta |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1623 |
Saphnelo |
Norwegia |
21.2.2022 |
|
EU/1/21/1623 |
Saphnelo |
Islandia |
21.2.2022 |
|
EU/1/21/1623 |
Saphnelo |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1624 |
Szczepionka przeciwko COVID-19 (inaktywowana, adjuwantowa) Valneva |
Norwegia |
27.6.2022 |
|
EU/1/21/1624 |
Szczepionka przeciwko COVID-19 (inaktywowana, adjuwantowa) Valneva |
Islandia |
28.6.2022 |
|
EU/1/21/1624 |
Szczepionka przeciwko COVID-19 (inaktywowana, adjuwantowa) Valneva |
Liechtenstein |
30.6.2022 |
|
EU/1/22/1625 |
Paxlovid |
Norwegia |
28.1.2022 |
|
EU/1/22/1625 |
Paxlovid |
Islandia |
1.2.2022 |
|
EU/1/22/1625 |
Paxlovid |
Liechtenstein |
31.1.2022 |
|
EU/1/22/1628 |
Sondelbay |
Norwegia |
7.4.2022 |
|
EU/1/22/1628 |
Sondelbay |
Islandia |
20.4.2022 |
|
EU/1/22/1628 |
Sondelbay |
Liechtenstein |
31.3.2022 |
|
EU/1/22/1629 |
Zolsketil pegylated liposomal |
Islandia |
10.6.2022 |
|
EU/1/22/1629 |
Zolsketil pegylated liposomal |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1630 |
Kimmtrak |
Norwegia |
12.4.2022 |
|
EU/1/22/1630 |
Kimmtrak |
Islandia |
27.4.2022 |
|
EU/1/22/1630 |
Kimmtrak |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1631 |
Breyanzi |
Norwegia |
20.4.2022 |
|
EU/1/22/1631 |
Breyanzi |
Islandia |
4.5.2022 |
|
EU/1/22/1631 |
Breyanzi |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1632 |
Stimufend |
Norwegia |
7.4.2022 |
|
EU/1/22/1632 |
Stimufend |
Islandia |
20.4.2022 |
|
EU/1/22/1632 |
Stimufend |
Liechtenstein |
31.3.2022 |
|
EU/1/22/1633 |
Sitagliptin Accord |
Norwegia |
16.5.2022 |
|
EU/1/22/1633 |
Sitagliptin Accord |
Islandia |
17.5.2022 |
|
EU/1/22/1633 |
Sitagliptin Accord |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1634 |
Dimethyl Fumarate Mylan |
Norwegia |
23.5.2022 |
|
EU/1/22/1634 |
Dimethyl Fumarate Mylan |
Islandia |
18.5.2022 |
|
EU/1/22/1634 |
Dimethyl fumarate Mylan |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1635 |
Dimethyl fumarate Polpharma |
Norwegia |
20.5.2022 |
|
EU/1/22/1635 |
Dimethyl fumarate Polpharma |
Islandia |
19.5.2022 |
|
EU/1/22/1635 |
Dimethyl fumarate Polpharma |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1637 |
Dimethyl fumarate Neuraxpharm |
Norwegia |
20.5.2022 |
|
EU/1/22/1637 |
Dimethyl fumarate Neuraxpharm |
Islandia |
19.5.2022 |
|
EU/1/22/1637 |
Dimethyl fumarate Neuraxpharm |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1638 |
Quviviq |
Norwegia |
20.5.2022 |
|
EU/1/22/1638 |
Quviviq |
Islandia |
28.6.2022 |
|
EU/1/22/1638 |
Quviviq |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1639 |
Truvelog Mix 30 |
Norwegia |
29.4.2022 |
|
EU/1/22/1639 |
Truvelog Mix 30 |
Islandia |
12.5.2022 |
|
EU/1/22/1639 |
Truvelog Mix 30 |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1640 |
Amversio |
Norwegia |
20.5.2022 |
|
EU/1/22/1640 |
Amversio |
Islandia |
19.5.2022 |
|
EU/1/22/1640 |
Amversio |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1641 |
PreHevbri |
Norwegia |
16.5.2022 |
|
EU/1/22/1641 |
PreHevbri |
Islandia |
18.5.2022 |
|
EU/1/22/1641 |
PreHevbri |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1642 |
Orgovyx |
Norwegia |
16.5.2022 |
|
EU/1/22/1642 |
Orgovyx |
Islandia |
12.5.2022 |
|
EU/1/22/1642 |
Orgovyx |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1643 |
Kapruvia |
Norwegia |
25.4.2022 |
|
EU/1/22/1643 |
Kapruvia |
Islandia |
11.5.2022 |
|
EU/1/22/1643 |
Kapruvia |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1644 |
Inpremzia |
Norwegia |
20.5.2022 |
|
EU/1/22/1644 |
Inpremzia |
Islandia |
18.5.2022 |
|
EU/1/22/1644 |
Inpremzia |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1645 |
Vydura |
Norwegia |
29.4.2022 |
|
EU/1/22/1645 |
Vydura |
Islandia |
11.5.2022 |
|
EU/1/22/1645 |
Vydura |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1646 |
Amifampridine SERB |
Norwegia |
31.5.2022 |
|
EU/1/22/1646 |
Amifampridine SERB |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1647 |
Camcevi |
Norwegia |
31.5.2022 |
|
EU/1/22/1647 |
Camcevi |
Islandia |
9.6.2022 |
|
EU/1/22/1647 |
Camcevi |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1648 |
Carvykti |
Norwegia |
31.5.2022 |
|
EU/1/22/1648 |
Carvykti |
Islandia |
9.6.2022 |
|
EU/1/22/1648 |
Carvykti |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1649 |
Lunsumio |
Norwegia |
16.6.2022 |
|
EU/1/22/1649 |
Lunsumio |
Islandia |
15.6.2022 |
|
EU/1/22/1649 |
Lunsumio |
Liechtenstein |
30.6.2022 |
|
EU/1/22/1650 |
Tabrecta |
Liechtenstein |
30.6.2022 |
|
EU/1/22/1651 |
Evusheld |
Norwegia |
28.3.2022 |
|
EU/1/22/1651 |
Evusheld |
Islandia |
30.3.2022 |
|
EU/1/22/1651 |
Evusheld |
Liechtenstein |
31.3.2022 |
|
EU/1/22/1652 |
Filsuvez |
Liechtenstein |
30.6.2022 |
|
EU/1/22/1655 |
Pirfenidone AET |
Liechtenstein |
30.6.2022 |
|
EU/1/22/1659 |
Xenpozyme |
Liechtenstein |
30.6.2022 |
|
EU/2/21/279 |
Zenalpha |
Norwegia |
7.1.2022 |
|
EU/2/21/280 |
Imoxat |
Norwegia |
7.1.2022 |
|
EU/2/21/281 |
CircoMax |
Norwegia |
17.1.2022 |
|
EU/2/21/281 |
CircoMax |
Liechtenstein |
31.1.2022 |
|
EU/2/22/282 |
RenuTend |
Norwegia |
29.4.2022 |
|
EU/2/22/282 |
RenuTend |
Islandia |
24.5.2022 |
|
EU/2/22/282 |
RenuTend |
Liechtenstein |
30.4.2022 |
|
EU/2/22/283 |
Chanaxin |
Norwegia |
9.6.2022 |
|
EU/2/22/283 |
Chanaxin |
Islandia |
14.6.2022 |
|
EU/2/22/283 |
Chanaxin |
Liechtenstein |
30.4.2022 |
ZAŁĄCZNIK II
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
W okresie od 1 stycznia 2022 r. do 30 czerwca 2022 r. odnowiono następujące pozwolenia na dopuszczenie do obrotu w państwach EFTA należących do EOG:
|
Numer EU |
Produkt |
Państwo |
Data odnowienia pozwolenia |
|
EU/1/11/699 |
Fampyra |
Norwegia |
9.5.2022 |
|
EU/1/11/699 |
Fampyra |
Liechtenstein |
30.4.2022 |
|
EU/1/11/749 |
Caprelsa |
Norwegia |
24.1.2022 |
|
EU/1/11/749 |
Caprelsa |
Islandia |
20.1.2022 |
|
EU/1/11/749 |
Caprelsa |
Liechtenstein |
31.1.2022 |
|
EU/1/12/782 |
Kalydeco |
Norwegia |
20.5.2022 |
|
EU/1/12/782 |
Kalydeco |
Liechtenstein |
30.4.2022 |
|
EU/1/12/784 |
Cuprymina |
Islandia |
28.6.2022 |
|
EU/1/12/784 |
Cuprymina |
Liechtenstein |
30.6.2022 |
|
EU/1/13/818 |
Bosulif |
Norwegia |
16.5.2022 |
|
EU/1/13/818 |
Bosulif |
Islandia |
20.4.2022 |
|
EU/1/13/818 |
Bosulif |
Liechtenstein |
31.3.2022 |
|
EU/1/13/875 |
Deltyba |
Norwegia |
30.3.2022 |
|
EU/1/13/875 |
Deltyba |
Islandia |
6.4.2022 |
|
EU/1/13/875 |
Deltyba |
Liechtenstein |
31.3.2022 |
|
EU/1/13/901 |
Sirturo |
Norwegia |
26.1.2022 |
|
EU/1/13/901 |
Sirturo |
Islandia |
14.1.2022 |
|
EU/1/13/901 |
Sirturo |
Liechtenstein |
31.1.2022 |
|
EU/1/13/902 |
Translarna |
Islandia |
28.6.2022 |
|
EU/1/13/902 |
Translarna |
Liechtenstein |
30.6.2022 |
|
EU/1/14/987 |
Holoclar |
Norwegia |
8.4.2022 |
|
EU/1/14/987 |
Holoclar |
Islandia |
11.1.2022 |
|
EU/1/14/987 |
Holoclar |
Liechtenstein |
31.1.2022 |
|
EU/1/15/1078 |
Natpar |
Norwegia |
19.4.2022 |
|
EU/1/15/1078 |
Natpar |
Islandia |
6.4.2022 |
|
EU/1/15/1078 |
Natpar |
Liechtenstein |
31.3.2022 |
|
EU/1/15/999 |
Zykadia |
Norwegia |
22.2.2022 |
|
EU/1/15/999 |
Zykadia |
Islandia |
22.2.2022 |
|
EU/1/15/999 |
Zykadia |
Liechtenstein |
28.2.2022 |
|
EU/1/16/1086 |
Tagrisso |
Norwegia |
6.4.2022 |
|
EU/1/16/1086 |
Tagrisso |
Islandia |
20.4.2022 |
|
EU/1/16/1086 |
Tagrisso |
Liechtenstein |
31.3.2022 |
|
EU/1/16/1089 |
Pandemic influenza vaccine H5N1 AstraZeneca |
Norwegia |
8.4.2022 |
|
EU/1/16/1089 |
Pandemic influenza vaccine H5N1 AstraZeneca |
Islandia |
16.3.2022 |
|
EU/1/16/1089 |
Pandemic influenza vaccine H5N1 AstraZeneca |
Liechtenstein |
31.3.2022 |
|
EU/1/16/1101 |
Darzalex |
Norwegia |
21.1.2022 |
|
EU/1/16/1101 |
Darzalex |
Islandia |
14.1.2022 |
|
EU/1/16/1101 |
Darzalex |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1139 |
Ocaliva |
Norwegia |
24.1.2022 |
|
EU/1/16/1139 |
Ocaliva |
Islandia |
21.1.2022 |
|
EU/1/16/1139 |
Ocaliva |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1152 |
Roteas |
Norwegia |
13.1.2022 |
|
EU/1/16/1152 |
Roteas |
Islandia |
11.1.2022 |
|
EU/1/16/1152 |
Roteas |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1154 |
Vemlidy |
Norwegia |
4.1.2022 |
|
EU/1/16/1154 |
Vemlidy |
Islandia |
5.1.2022 |
|
EU/1/16/1154 |
Vemlidy |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1155 |
Kyntheum |
Norwegia |
29.4.2022 |
|
EU/1/16/1155 |
Kyntheum |
Islandia |
11.5.2022 |
|
EU/1/16/1155 |
Kyntheum |
Liechtenstein |
30.4.2022 |
|
EU/1/16/1171 |
Ledaga |
Norwegia |
17.1.2022 |
|
EU/1/16/1171 |
Ledaga |
Islandia |
14.1.2022 |
|
EU/1/16/1171 |
Ledaga |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1172 |
Jylamvo |
Norwegia |
24.1.2022 |
|
EU/1/17/1172 |
Jylamvo |
Islandia |
5.1.2022 |
|
EU/1/17/1172 |
Jylamvo |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1174 |
Rolufta Ellipta |
Norwegia |
14.1.2022 |
|
EU/1/17/1174 |
Rolufta Ellipta |
Islandia |
14.1.2022 |
|
EU/1/17/1174 |
Rolufta Ellipta |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1175 |
Daptomycin Hospira |
Norwegia |
13.1.2022 |
|
EU/1/17/1175 |
Daptomycin Hospira |
Islandia |
25.1.2022 |
|
EU/1/17/1176 |
Yargesa |
Norwegia |
24.1.2022 |
|
EU/1/17/1176 |
Yargesa |
Islandia |
20.1.2022 |
|
EU/1/17/1176 |
Yargesa |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1178 |
Xeljanz |
Norwegia |
14.3.2022 |
|
EU/1/17/1178 |
Xeljanz |
Islandia |
15.3.2022 |
|
EU/1/17/1178 |
Xeljanz |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1179 |
Veltassa |
Norwegia |
6.4.2022 |
|
EU/1/17/1179 |
Veltassa |
Islandia |
19.4.2022 |
|
EU/1/17/1179 |
Veltassa |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1181 |
Spherox |
Norwegia |
8.6.2022 |
|
EU/1/17/1181 |
Spherox |
Islandia |
19.5.2022 |
|
EU/1/17/1181 |
Spherox |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1182 |
Emtricitabine/Tenofovir disoproxil Krka d.d. |
Norwegia |
24.1.2022 |
|
EU/1/17/1182 |
Emtricitabine/Tenofovir disoproxil Krka d.d. |
Islandia |
21.1.2022 |
|
EU/1/17/1182 |
Emtricitabine/Tenofovir disoproxil Krka d.d. |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1184 |
Riximyo |
Norwegia |
22.2.2022 |
|
EU/1/17/1184 |
Riximyo |
Islandia |
23.2.2022 |
|
EU/1/17/1184 |
Riximyo |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1185 |
Rixathon |
Norwegia |
14.3.2022 |
|
EU/1/17/1185 |
Rixathon |
Islandia |
15.3.2022 |
|
EU/1/17/1185 |
Rixathon |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1186 |
Axumin |
Norwegia |
16.2.2022 |
|
EU/1/17/1186 |
Axumin |
Islandia |
16.2.2022 |
|
EU/1/17/1186 |
Axumin |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1187 |
Trumenba |
Norwegia |
9.5.2022 |
|
EU/1/17/1187 |
Trumenba |
Islandia |
11.5.2022 |
|
EU/1/17/1187 |
Trumenba |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1188 |
Spinraza |
Norwegia |
7.2.2022 |
|
EU/1/17/1188 |
Spinraza |
Islandia |
11.2.2022 |
|
EU/1/17/1188 |
Spinraza |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1189 |
Elmiron |
Norwegia |
26.1.2022 |
|
EU/1/17/1189 |
Elmiron |
Islandia |
21.1.2022 |
|
EU/1/17/1189 |
Elmiron |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1190 |
Ivabradine Accord |
Norwegia |
18.2.2022 |
|
EU/1/17/1190 |
Ivabradine Accord |
Islandia |
22.2.2022 |
|
EU/1/17/1190 |
Ivabradine Accord |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1191 |
Qarziba |
Norwegia |
27.1.2022 |
|
EU/1/17/1191 |
Qarziba |
Islandia |
19.1.2022 |
|
EU/1/17/1191 |
Qarziba |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1192 |
Brineura |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1192 |
Brineura |
Norwegia |
15.5.2022 |
|
EU/1/17/1193 |
Refixia |
Norwegia |
5.4.2022 |
|
EU/1/17/1193 |
Refixia |
Islandia |
15.3.2022 |
|
EU/1/17/1193 |
Refixia |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1194 |
Febuxostat Mylan |
Norwegia |
21.2.2022 |
|
EU/1/17/1194 |
Febuxostat Mylan |
Islandia |
23.2.2022 |
|
EU/1/17/1194 |
Febuxostat Mylan |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1195 |
Erelzi |
Islandia |
27.4.2022 |
|
EU/1/17/1195 |
Erelzi |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1196 |
Kevzara |
Norwegia |
9.5.2022 |
|
EU/1/17/1196 |
Kevzara |
Islandia |
11.5.2022 |
|
EU/1/17/1196 |
Kevzara |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1197 |
Oxervate |
Norwegia |
12.4.2022 |
|
EU/1/17/1197 |
Oxervate |
Islandia |
20.4.2022 |
|
EU/1/17/1197 |
Oxervate |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1200 |
Besponsa |
Norwegia |
22.2.2022 |
|
EU/1/17/1200 |
Besponsa |
Islandia |
21.2.2022 |
|
EU/1/17/1200 |
Besponsa |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1201 |
Skilarence |
Norwegia |
24.2.2022 |
|
EU/1/17/1201 |
Skilarence |
Islandia |
24.2.2022 |
|
EU/1/17/1201 |
Skilarence |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1202 |
Ucedane |
Norwegia |
29.4.2022 |
|
EU/1/17/1202 |
Ucedane |
Islandia |
25.4.2022 |
|
EU/1/17/1202 |
Ucedane |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1203 |
Insulin lispro Sanofi |
Norwegia |
29.4.2022 |
|
EU/1/17/1203 |
Insulin lispro Sanofi |
Islandia |
3.5.2022 |
|
EU/1/17/1203 |
Insulin lispro Sanofi |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1205 |
Blitzima |
Norwegia |
29.4.2022 |
|
EU/1/17/1205 |
Blitzima |
Islandia |
6.5.2022 |
|
EU/1/17/1205 |
Blitzima |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1208 |
Trimbow |
Norwegia |
31.3.2022 |
|
EU/1/17/1208 |
Trimbow |
Islandia |
19.4.2022 |
|
EU/1/17/1208 |
Trimbow |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1209 |
Reagila |
Norwegia |
20.4.2022 |
|
EU/1/17/1209 |
Reagila |
Islandia |
20.4.2022 |
|
EU/1/17/1209 |
Reagila |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Norwegia |
31.5.2022 |
|
EU/1/7/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Islandia |
9.6.2022 |
|
EU/1/17/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1212 |
Mavenclad |
Norwegia |
29.4.2022 |
|
EU/1/17/1212 |
Mavenclad |
Islandia |
11.5.2022 |
|
EU/1/17/1212 |
Mavenclad |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1213 |
Maviret |
Islandia |
20.4.2022 |
|
EU/1/17/1213 |
Maviret |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1216 |
Imraldi |
Norwegia |
9.5.2022 |
|
EU/1/17/1216 |
Imraldi |
Islandia |
17.5.2022 |
|
EU/1/17/1216 |
Imraldi |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1218 |
Rydapt |
Islandia |
10.6.2022 |
|
EU/1/17/1218 |
Rydapt |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1220 |
Tecentriq |
Norwegia |
29.4.2022 |
|
EU/1/17/1220 |
Tecentriq |
Islandia |
6.5.2022 |
|
EU/1/17/1220 |
Tecentriq |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1221 |
Kisqali |
Norwegia |
20.4.2022 |
|
EU/1/17/1221 |
Kisqali |
Islandia |
27.4.2022 |
|
EU/1/17/1221 |
Kisqali |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Islandia |
9.6.2022 |
|
EU/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1223 |
Vosevi |
Norwegia |
20.5.2022 |
|
EU/1/17/1223 |
Vosevi |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1224 |
Xermelo |
Liechtenstein |
30.6.2022 |
|
EU/1/17/1225 |
Symtuza |
Norwegia |
31.5.2022 |
|
EU/1/17/1225 |
Symtuza |
Islandia |
9.6.2022 |
|
EU/1/17/1225 |
Symtuza |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1227 |
Entecavir Mylan |
Liechtenstein |
30.6.2022 |
|
EU/1/17/1250 |
Rubraca |
Norwegia |
24.3.2022 |
|
EU/1/17/1250 |
Rubraca |
Islandia |
16.3.2022 |
|
EU/1/17/1250 |
Rubraca |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1262 |
Crysvita |
Norwegia |
11.2.2022 |
|
EU/1/17/1262 |
Crysvita |
Islandia |
25.1.2022 |
|
EU/1/17/1262 |
Crysvita |
Liechtenstein |
31.1.2022 |
|
EU/1/18/1345 |
Ondexxya |
Norwegia |
30.6.2022 |
|
EU/1/18/1345 |
Ondexxya |
Islandia |
17.5.2022 |
|
EU/1/18/1345 |
Ondexxya |
Liechtenstein |
30.4.2022 |
|
EU/1/19/1355 |
Lorviqua |
Islandia |
25.4.2022 |
|
EU/1/19/1355 |
Lorviqua |
Liechtenstein |
30.4.2022 |
|
EU/1/19/1360 |
Waylivra |
Norwegia |
24.2.2022 |
|
EU/1/19/1360 |
Waylivra |
Islandia |
21.2.2022 |
|
EU/1/19/1360 |
Waylivra |
Liechtenstein |
28.2.2022 |
|
EU/1/20/1437 |
Dovprela |
Liechtenstein |
30.6.2022 |
|
EU/1/20/1443 |
Zolgensma |
Norwegia |
31.5.2022 |
|
EU/1/20/1443 |
Zolgensma |
Islandia |
9.6.2022 |
|
EU/1/20/1443 |
Zolgensma |
Liechtenstein |
31.5.2022 |
|
EU/1/20/1446 |
Hepcludex |
Liechtenstein |
30.6.2022 |
|
EU/1/20/1459 |
Veklury |
Norwegia |
29.4.2022 |
|
EU/1/20/1459 |
Veklury |
Islandia |
4.5.2022 |
|
EU/1/20/1459 |
Veklury |
Liechtenstein |
30.4.2022 |
|
EU/1/20/1460 |
Rozlytrek |
Liechtenstein |
31.5.2022 |
|
EU/1/20/1474 |
BLENREP |
Liechtenstein |
30.6.2022 |
|
EU/1/20/1525 |
Szczepionka przeciwko COVID-19 Janssen (JCOVDEN) |
Norwegia |
24.1.2022 |
|
EU/1/20/1525 |
Szczepionka przeciwko COVID-19 Janssen (JCOVDEN) |
Islandia |
14.2.2022 |
|
EU/1/20/1525 |
Szczepionka przeciwko COVID-19 Janssen (JCOVDEN) |
Liechtenstein |
31.1.2022 |
|
EU/1/20/1527 |
Retsevmo |
Norwegia |
26.1.2022 |
|
EU/1/20/1527 |
Retsevmo |
Islandia |
4.1.2022 |
|
EU/1/21/1535 |
Pemazyre |
Norwegia |
22.2.2022 |
|
EU/1/21/1535 |
Pemazyre |
Islandia |
23.2.2022 |
|
EU/1/21/1535 |
Pemazyre |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1537 |
NEXPOVIO |
Norwegia |
2.6.2022 |
|
EU/1/21/1537 |
NEXPOVIO |
Islandia |
19.5.2022 |
|
EU/1/21/1537 |
NEXPOVIO |
Liechtenstein |
31.5.2022 |
|
EU/1/21/1538 |
Jemperli |
Norwegia |
22.2.2022 |
|
EU/1/21/1538 |
Jemperli |
Islandia |
22.2.2022 |
|
EU/1/21/1538 |
Jemperli |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1539 |
Abecma |
Liechtenstein |
30.6.2022 |
|
EU/1/21/1552 |
Koselugo |
Norwegia |
12.5.2022 |
|
EU/1/21/1552 |
Koselugo |
Liechtenstein |
30.4.2022 |
|
EU/2/16/203 |
VarroMed |
Norwegia |
24.1.2022 |
|
EU/2/16/203 |
VarroMed |
Islandia |
21.1.2022 |
|
EU/2/16/203 |
VarroMed |
Liechtenstein |
31.1.2022 |
|
EU/2/17/205 |
Cytopoint |
Norwegia |
29.6.2022 |
|
EU/2/17/205 |
Cytopoint |
Liechtenstein |
30.4.2022 |
|
EU/2/17/206 |
Credelio |
Norwegia |
29.6.2022 |
|
EU/2/17/206 |
Credelio |
Liechtenstein |
30.4.2022 |
|
EU/2/17/207 |
Zulvac BTV |
Norwegia |
29.6.2022 |
|
EU/2/17/207 |
Zulvac BTV |
Liechtenstein |
30.4.2022 |
|
EU/2/17/209 |
RESPIPORC FLUpan H1N1 |
Norwegia |
29.6.2022 |
|
EU/2/17/209 |
RESPIPORC FLUpan H1N1 |
Liechtenstein |
30.4.2022 |
|
EU/2/17/210 |
Zeleris |
Norwegia |
30.6.2022 |
|
EU/2/17/210 |
Zeleris |
Islandia |
18.5.2022 |
|
EU/2/17/210 |
Zeleris |
Liechtenstein |
31.5.2022 |
ZAŁĄCZNIK III
Wykaz przedłużonych pozwoleń na dopuszczenie do obrotu
W okresie od 1 stycznia 2022 r. do 30 czerwca 2022 r. przedłużono następujące pozwolenia na dopuszczenie do obrotu w państwach EFTA należących do EOG:
|
Numer EU |
Produkt |
Państwo |
Data przedłużenia pozwolenia |
|
EU/1/05/320/005 |
Noxafil |
Liechtenstein |
31.1.2022 |
|
EU/1/05/320/005 |
Noxafil |
Norwegia |
24.1.2022 |
|
EU/1/05/320/005 |
Noxafil |
Islandia |
20.1.2022 |
|
EU/1/05/324 |
Naglazyme |
Liechtenstein |
30.4.2022 |
|
EU/1/13/837 |
Tecfidera |
Liechtenstein |
31.5.2022 |
|
EU/1/14/930 |
Jardiance |
Liechtenstein |
31.3.2022 |
|
EU/1/14/936/008 |
Nuwiq |
Liechtenstein |
31.1.2022 |
|
EU/1/14/936/008 |
Nuwiq |
Norwegia |
24.1.2022 |
|
EU/1/14/936/008 |
Nuwiq |
Islandia |
20.1.2022 |
|
EU/1/15/1043/009-010 |
Nucala |
Liechtenstein |
30.4.2022 |
|
EU/1/15/1043/009-010 |
Nucala |
Norwegia |
24.5.2022 |
|
EU/1/15/1043/009-010 |
Nucala |
Islandia |
23.6.2022 |
|
EU/1/16/1116/003-004 |
Epclusa |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1116/003-004 |
Epclusa |
Norwegia |
7.1.2022 |
|
EU/1/16/1116/003-004 |
Epclusa |
Islandia |
18.1.2022 |
|
EU/1/17/1217/004 |
Nitisinone MDK |
Islandia |
5.1.2022 |
|
EU/1/17/1229/021-022 |
Dupixent |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1229/021 -022 |
Dupixent |
Islandia |
27.4.2022 |
|
EU/1/17/1235/004-005 |
Zejula |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1235/004-005 |
Zejula |
Norwegia |
30.5.2022 |
|
EU/1/17/1235/004-005 |
Zejula |
Islandia |
10.6.2022 |
|
EU/1/17/1247/015-016 |
Adynovi |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1247/015-016 |
Adynovi |
Norwegia |
14.1.2022 |
|
EU/1/17/1247/015-016 |
Adynovi |
Islandia |
20.1.2022 |
|
EU/1/17/1251/010-011 |
Ozempic |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1251/010-011 |
Ozempic |
Norwegia |
11.1.2022 |
|
EU/1/17/1251/010-011 |
Ozempic |
Islandia |
20.1.2022 |
|
EU/1/18/1274/006-008 |
Trydonis |
Liechtenstein |
31.1.2022 |
|
EU/1/18/1274/006-008 |
Trydonis |
Norwegia |
24.1.2022 |
|
EU/1/18/1274/006-008 |
Trydonis |
Islandia |
21.1.2022 |
|
EU/1/18/1323/003 |
Ilumetri |
Liechtenstein |
30.4.2022 |
|
EU/1/18/1323/003 |
Ilumetri |
Norwegia |
20.5.2022 |
|
EU/1/18/1323/003 |
Ilumetri |
Islandia |
28.6.2022 |
|
EU/1/19/1414/007-008 |
Mayzent |
Liechtenstein |
28.2.2022 |
|
EU/1/19/1414/007-008 |
Mayzent |
Norwegia |
16.2.2022 |
|
EU/1/19/1414/007-008 |
Mayzent |
Islandia |
24.2.2022 |
|
EU/1/20/1422/016-017 |
Lyumjev |
Liechtenstein |
30.4.2022 |
|
EU/1/20/1422/016-017 |
Lyumjev |
Norwegia |
18.5.2022 |
|
EU/1/20/1422/016-017 |
Lyumjev |
Islandia |
17.5.2022 |
|
EU/1/20/1468/002 |
Kaftrio |
Liechtenstein |
31.1.2022 |
|
EU/1/20/1468/002 |
Kaftrio |
Norwegia |
7.1.2022 |
|
EU/1/20/1468/002 |
Kaftrio |
Islandia |
19.1.2022 |
|
EU/1/20/1473/004-005 |
AYVAKYT |
Liechtenstein |
31.3.2022 |
|
EU/1/20/1473/004-005 |
AYVAKYT |
Norwegia |
31.3.2022 |
|
EU/1/20/1473/004-005 |
AYVAKYT |
Islandia |
19.4.2022 |
|
EU/1/20/1500/003-004 |
Xofluza |
Liechtenstein |
30.4.2022 |
|
EU/1/20/1500/003-004 |
Xofluza |
Norwegia |
29.4.2022 |
|
EU/1/20/1501/003-004 |
Sogroya |
Liechtenstein |
30.4.2022 |
|
EU/1/20/1501/003-004 |
Sogroya |
Norwegia |
29.4.2022 |
|
EU/1/20/1501/003-004 |
Sogroya |
Islandia |
12.5.2022 |
|
EU/1/20/1513/013-016 |
Yuflyma |
Liechtenstein |
28.2.2022 |
|
EU/1/20/1513/013-016 |
Yuflyma |
Norwegia |
16.2.2022 |
|
EU/1/20/1513/013-016 |
Yuflyma |
Islandia |
15.3.2022 |
|
EU/2/13/154/028-033 |
Apoquel |
Norwegia |
5.1.2022 |
ZAŁĄCZNIK IV
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
W okresie od 1 stycznia 2022 r. do 30 czerwca 2022 r. wycofano następujące pozwolenia na dopuszczenie do obrotu w państwach EFTA należących do EOG:
|
Numer EU |
Produkt |
Państwo |
Data wycofania pozwolenia |
|
EU/1/01/174 |
Starlix |
Norwegia |
16.6.2022 |
|
EU/1/01/174 |
Starlix |
Liechtenstein |
30.4.2022 |
|
EU/1/03/249 |
Vivanza |
Norwegia |
1.3.2022 |
|
EU/1/03/249 |
Vivanza |
Islandia |
10.2.2022 |
|
EU/1/03/249 |
Vivanza |
Liechtenstein |
28.2.2022 |
|
EU/1/03/250 |
Ytracis |
Norwegia |
22.2.2022 |
|
EU/1/03/250 |
Ytracis |
Islandia |
5.1.2022 |
|
EU/1/07/384 |
Docetaxel Zentiva |
Liechtenstein |
31.5.2022 |
|
EU/1/07/384 |
Docetaxel Zentiva |
Islandia |
10.6.2022 |
|
EU/1/07/421 |
Glubrava |
Norwegia |
8.6.2022 |
|
EU/1/07/421 |
Glubrava |
Liechtenstein |
31.5.2022 |
|
EU/1/08/491 |
Rasilez HCT |
Norwegia |
22.2.2022 |
|
EU/1/08/491 |
Rasilez HCT |
Islandia |
11.1.2022 |
|
EU/1/09/519 |
PANTOLOC Control |
Norwegia |
10.1.2022 |
|
EU/1/09/519 |
PANTOLOC Control |
Islandia |
5.1.2022 |
|
EU/1/11/695 |
Leganto |
Norwegia |
18.1.2022 |
|
EU/1/11/695 |
Leganto |
Islandia |
5.1.2022 |
|
EU/1/11/695 |
Leganto |
Liechtenstein |
31.1.2022 |
|
EU/1/11/728 |
Pramipexole Accord |
Norwegia |
22.4.2022 |
|
EU/1/11/728 |
Pramipexole Accord |
Islandia |
4.5.2022 |
|
EU/1/11/728 |
Pramipexole Accord |
Liechtenstein |
30.4.2022 |
|
EU/1/13/825 |
Imatinib Actavis |
Liechtenstein |
31.5.2022 |
|
EU/1/15/1034 |
Pemetrexed Lilly |
Norwegia |
23.3.2022 |
|
EU/1/15/1034 |
Pemetrexed Lilly |
Islandia |
21.1.2022 |
|
EU/1/15/1034 |
Pemetrexed Lilly |
Liechtenstein |
31.3.2022 |
|
EU/1/15/1069 |
Episalvan |
Islandia |
16.6.2022 |
|
EU/1/15/1069 |
Episalvan |
Liechtenstein |
30.6.2022 |
|
EU/1/16/1131 |
Thorinane |
Norwegia |
4.3.2022 |
|
EU/1/16/1131 |
Thorinane |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1183 |
Pemetrexed Pfizer |
Norwegia |
23.3.2022 |
|
EU/1/17/1183 |
Pemetrexed Pfizer |
Islandia |
27.1.2022 |
|
EU/1/17/1183 |
Pemetrexed Pfizer |
Liechtenstein |
31.1.2022 |
|
EU/1/19/1363 |
Zynquista |
Norwegia |
21.4.2022 |
|
EU/1/19/1363 |
Zynquista |
Islandia |
6.4.2022 |
|
EU/1/19/1363 |
Zynquista |
Liechtenstein |
31.3.2022 |
|
EU/1/19/1367 |
Zynteglo |
Norwegia |
21.4.2022 |
|
EU/1/19/1367 |
Zynteglo |
Islandia |
20.4.2022 |
|
EU/1/19/1367 |
Zynteglo |
Liechtenstein |
31.3.2022 |
|
EU/1/19/1387 |
Senstend |
Liechtenstein |
30.6.2022 |
|
EU/1/19/1421 |
Staquis |
Norwegia |
9.2.2022 |
|
EU/1/19/1421 |
Staquis |
Islandia |
10.2.2022 |
|
EU/1/19/1421 |
Staquis |
Liechtenstein |
31.1.2022 |
|
EU/2/14/180 |
Coliprotec F4 |
Norwegia |
22.2.2022 |
ZAŁĄCZNIK V
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
W okresie od 1 stycznia 2022 r. do 30 czerwca 2022 r. zawieszono następujące pozwolenia na dopuszczenie do obrotu w państwach EFTA należących do EOG:
|
Numer EU |
Produkt |
Państwo |
Data zawieszenia pozwolenia |
|
|
|
|
|