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Document E2023G0309(01)
Medicinal Products – List of marketing authorisations granted by the EEA EFTA States for the first half of 2022 2023/C 87/08 Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee
Läkemedel – Förteckningar över godkännanden för försäljning som beviljats av EFTAstaterna i EES under första halvåret 2022 2023/C 87/08 Underkommitté I – fri rörlighet för varor För gemensamma EES-kommitténs kännedom
Läkemedel – Förteckningar över godkännanden för försäljning som beviljats av EFTAstaterna i EES under första halvåret 2022 2023/C 87/08 Underkommitté I – fri rörlighet för varor För gemensamma EES-kommitténs kännedom
OJ C 87, 9.3.2023, p. 14–31
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
9.3.2023 |
SV |
Europeiska unionens officiella tidning |
C 87/14 |
Läkemedel – Förteckningar över godkännanden för försäljning som beviljats av EFTAstaterna i EES under första halvåret 2022
(2023/C 87/08)
Underkommitté I – fri rörlighet för varor
För gemensamma EES-kommitténs kännedom
Med hänvisning till gemensamma EES-kommitténs beslut nr 74/1999 av den 28 maj 1999 uppmanas gemensamma EES-kommittén att vid mötet den 28 oktober 2022 notera följande förteckningar över godkännanden för försäljning av läkemedel som beviljats under perioden 1 januari–30 juni 2022:
|
Bilaga I |
Förteckning över nya godkännanden för försäljning |
|
Bilaga II |
Förteckning över förnyade godkännanden för försäljning |
|
Bilaga III |
Förteckning över utvidgade godkännanden för försäljning |
|
Bilaga IV |
Förteckning över tillbakadragna godkännanden för försäljning |
|
Bilaga V |
Förteckning över tillfälligt återkallade godkännanden för försäljning |
BILAGA I
Förteckning över nya godkännanden för försäljning
Följande godkännanden för försäljning har beviljats i Eftastaterna i EES under perioden 1 januari–30 juni 2022:
|
EU-nummer |
Produkt |
Land |
Datum för godkännande |
|
EU/1/21/1540 |
Dasatinib Accord |
Norge |
7.4.2022 |
|
EU/1/21/1540 |
Dasatinib Accord |
Island |
8.4.2022 |
|
EU/1/21/1540 |
Dasatinib Accord |
Liechtenstein |
31.3.2022 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Norge |
7.4.2022 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Island |
8.4.2022 |
|
EU/1/21/1541 |
Dasatinib Accordpharma |
Liechtenstein |
31.3.2022 |
|
EU/1/21/1569 |
QINLOCK |
Norge |
11.1.2022 |
|
EU/1/21/1578 |
Ontilyv |
Norge |
25.2.2022 |
|
EU/1/21/1578 |
Ontilyv |
Island |
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 |
Norge |
24.1.2022 |
|
EU/1/21/1586 |
Voraxaze |
Island |
10.2.2022 |
|
EU/1/21/1586 |
Voraxaze |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1596 |
Tepmetko |
Norge |
22.2.2022 |
|
EU/1/21/1596 |
Tepmetko |
Island |
22.2.2022 |
|
EU/1/21/1596 |
Tepmetko |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1598 |
Sitagliptin SUN |
Norge |
3.1.2022 |
|
EU/1/21/1599 |
Vyepti |
Norge |
7.2.2022 |
|
EU/1/21/1599 |
Vyepti |
Island |
28.1.2022 |
|
EU/1/21/1599 |
Vyepti |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1600 |
Tecovirimat SIGA |
Norge |
17.1.2022 |
|
EU/1/21/1600 |
Tecovirimat SIGA |
Island |
14.1.2022 |
|
EU/1/21/1600 |
Tecovirimat SIGA |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1602 |
Uplizna |
Norge |
16.5.2022 |
|
EU/1/21/1602 |
Uplizna |
Island |
13.5.2022 |
|
EU/1/21/1602 |
Uplizna |
Liechtenstein |
30.4.2022 |
|
EU/1/21/1603 |
Lumykras |
Norge |
11.1.2022 |
|
EU/1/21/1603 |
Lumykras |
Island |
25.1.2022 |
|
EU/1/21/1603 |
Lumykras |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1604 |
Riltrava Aerosphere |
Norge |
11.1.2022 |
|
EU/1/21/1604 |
Riltrava Aerosphere |
Island |
19.1.2022 |
|
EU/1/21/1604 |
Riltrava Aerosphere |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1605 |
Tavneos |
Norge |
19.1.2022 |
|
EU/1/21/1605 |
Tavneos |
Island |
14.2.2022 |
|
EU/1/21/1605 |
Tavneos |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1606 |
Yselty |
Norge |
22.6.2022 |
|
EU/1/21/1606 |
Yselty |
Island |
21.6.2022 |
|
EU/1/21/1606 |
Yselty |
Liechtenstein |
30.6.2022 |
|
EU/1/21/1607 |
Lonapegsomatropin Ascendis Pharma |
Norge |
21.1.2022 |
|
EU/1/21/1607 |
Lonapegsomatropin Ascendis Pharma |
Island |
1.2.2022 |
|
EU/1/21/1607 |
Lonapegsomatropin Ascendis Pharma |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1608 |
Wegovy |
Norge |
12.1.2022 |
|
EU/1/21/1608 |
Wegovy |
Island |
19.1.2022 |
|
EU/1/21/1608 |
Wegovy |
Liechtenstein |
31.1.2022 |
|
EU/1/21/1611 |
Vildagliptin/Metformin hydrochloride Accord |
Norge |
6.4.2022 |
|
EU/1/21/1611 |
Vildagliptin/Metformin hydrochloride Accord |
Island |
19.4.2022 |
|
EU/1/21/1611 |
Vildagliptin/Metformin hydrochloride Accord |
Liechtenstein |
31.3.2022 |
|
EU/1/21/1612 |
Apexxnar |
Norge |
22.2.2022 |
|
EU/1/21/1612 |
Apexxnar |
Island |
22.2.2022 |
|
EU/1/21/1612 |
Apexxnar |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1615 |
Padcev |
Norge |
21.4.2022 |
|
EU/1/21/1615 |
Padcev |
Island |
4.5.2022 |
|
EU/1/21/1615 |
Padcev |
Liechtenstein |
30.4.2022 |
|
EU/1/21/1616 |
Kerendia |
Norge |
22.2.2022 |
|
EU/1/21/1616 |
Kerendia |
Island |
24.2.2022 |
|
EU/1/21/1616 |
Kerendia |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1617 |
Ngenla |
Norge |
22.2.2022 |
|
EU/1/21/1617 |
Ngenla |
Island |
22.2.2022 |
|
EU/1/21/1617 |
Ngenla |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1619 |
Sitagliptin/Metformin hydrochloride Mylan |
Norge |
24.3.2022 |
|
EU/1/21/1619 |
Sitagliptin/Metformin hydrochloride Mylan |
Island |
15.3.2022 |
|
EU/1/21/1619 |
Sitagliptin/Metformin hydrochloride Mylan |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1620 |
Sapropterin Dipharma |
Norge |
22.2.2022 |
|
EU/1/21/1620 |
Sapropterin Dipharma |
Island |
22.2.2022 |
|
EU/1/21/1620 |
Sapropterin Dipharma |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1621 |
OKEDI |
Norge |
21.2.2022 |
|
EU/1/21/1621 |
OKEDI |
Island |
16.2.2022 |
|
EU/1/21/1621 |
OKEDI |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1622 |
Oxbryta |
Norge |
21.2.2022 |
|
EU/1/21/1622 |
Oxbryta |
Island |
22.2.2022 |
|
EU/1/21/1622 |
Oxbryta |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1623 |
Saphnelo |
Norge |
21.2.2022 |
|
EU/1/21/1623 |
Saphnelo |
Island |
21.2.2022 |
|
EU/1/21/1623 |
Saphnelo |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1624 |
Covid-19 Vaccine (inaktiverat, med adjuvans) Valneva |
Norge |
27.6.2022 |
|
EU/1/21/1624 |
Covid-19 Vaccine (inaktiverat, med adjuvans) Valneva |
Island |
28.6.2022 |
|
EU/1/21/1624 |
Covid-19 Vaccine (inaktiverat, med adjuvans) Valneva |
Liechtenstein |
30.6.2022 |
|
EU/1/22/1625 |
Paxlovid |
Norge |
28.1.2022 |
|
EU/1/22/1625 |
Paxlovid |
Island |
1.2.2022 |
|
EU/1/22/1625 |
Paxlovid |
Liechtenstein |
31.1.2022 |
|
EU/1/22/1628 |
Sondelbay |
Norge |
7.4.2022 |
|
EU/1/22/1628 |
Sondelbay |
Island |
20.4.2022 |
|
EU/1/22/1628 |
Sondelbay |
Liechtenstein |
31.3.2022 |
|
EU/1/22/1629 |
Zolsketil pegylated liposomal |
Island |
10.6.2022 |
|
EU/1/22/1629 |
Zolsketil pegylated liposomal |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1630 |
Kimmtrak |
Norge |
12.4.2022 |
|
EU/1/22/1630 |
Kimmtrak |
Island |
27.4.2022 |
|
EU/1/22/1630 |
Kimmtrak |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1631 |
Breyanzi |
Norge |
20.4.2022 |
|
EU/1/22/1631 |
Breyanzi |
Island |
4.5.2022 |
|
EU/1/22/1631 |
Breyanzi |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1632 |
Stimufend |
Norge |
7.4.2022 |
|
EU/1/22/1632 |
Stimufend |
Island |
20.4.2022 |
|
EU/1/22/1632 |
Stimufend |
Liechtenstein |
31.3.2022 |
|
EU/1/22/1633 |
Sitagliptin Accord |
Norge |
16.5.2022 |
|
EU/1/22/1633 |
Sitagliptin Accord |
Island |
17.5.2022 |
|
EU/1/22/1633 |
Sitagliptin Accord |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1634 |
Dimethyl Fumarate Mylan |
Norge |
23.5.2022 |
|
EU/1/22/1634 |
Dimethyl Fumarate Mylan |
Island |
18.5.2022 |
|
EU/1/22/1634 |
Dimethyl fumarate Mylan |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1635 |
Dimethyl fumarate Polpharma |
Norge |
20.5.2022 |
|
EU/1/22/1635 |
Dimethyl fumarate Polpharma |
Island |
19.5.2022 |
|
EU/1/22/1635 |
Dimethyl fumarate Polpharma |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1637 |
Dimethyl fumarate Neuraxpharm |
Norge |
20.5.2022 |
|
EU/1/22/1637 |
Dimethyl fumarate Neuraxpharm |
Island |
19.5.2022 |
|
EU/1/22/1637 |
Dimethyl fumarate Neuraxpharm |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1638 |
Quviviq |
Norge |
20.5.2022 |
|
EU/1/22/1638 |
Quviviq |
Island |
28.6.2022 |
|
EU/1/22/1638 |
Quviviq |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1639 |
Truvelog Mix 30 |
Norge |
29.4.2022 |
|
EU/1/22/1639 |
Truvelog Mix 30 |
Island |
12.5.2022 |
|
EU/1/22/1639 |
Truvelog Mix 30 |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1640 |
Amversio |
Norge |
20.5.2022 |
|
EU/1/22/1640 |
Amversio |
Island |
19.5.2022 |
|
EU/1/22/1640 |
Amversio |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1641 |
PreHevbri |
Norge |
16.5.2022 |
|
EU/1/22/1641 |
PreHevbri |
Island |
18.5.2022 |
|
EU/1/22/1641 |
PreHevbri |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1642 |
Orgovyx |
Norge |
16.5.2022 |
|
EU/1/22/1642 |
Orgovyx |
Island |
12.5.2022 |
|
EU/1/22/1642 |
Orgovyx |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1643 |
Kapruvia |
Norge |
25.4.2022 |
|
EU/1/22/1643 |
Kapruvia |
Island |
11.5.2022 |
|
EU/1/22/1643 |
Kapruvia |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1644 |
Inpremzia |
Norge |
20.5.2022 |
|
EU/1/22/1644 |
Inpremzia |
Island |
18.5.2022 |
|
EU/1/22/1644 |
Inpremzia |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1645 |
Vydura |
Norge |
29.4.2022 |
|
EU/1/22/1645 |
Vydura |
Island |
11.5.2022 |
|
EU/1/22/1645 |
Vydura |
Liechtenstein |
30.4.2022 |
|
EU/1/22/1646 |
Amifampridine SERB |
Norge |
31.5.2022 |
|
EU/1/22/1646 |
Amifampridine SERB |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1647 |
Camcevi |
Norge |
31.5.2022 |
|
EU/1/22/1647 |
Camcevi |
Island |
9.6.2022 |
|
EU/1/22/1647 |
Camcevi |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1648 |
Carvykti |
Norge |
31.5.2022 |
|
EU/1/22/1648 |
Carvykti |
Island |
9.6.2022 |
|
EU/1/22/1648 |
Carvykti |
Liechtenstein |
31.5.2022 |
|
EU/1/22/1649 |
Lunsumio |
Norge |
16.6.2022 |
|
EU/1/22/1649 |
Lunsumio |
Island |
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 |
Norge |
28.3.2022 |
|
EU/1/22/1651 |
Evusheld |
Island |
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 |
Norge |
7.1.2022 |
|
EU/2/21/280 |
Imoxat |
Norge |
7.1.2022 |
|
EU/2/21/281 |
CircoMax |
Norge |
17.1.2022 |
|
EU/2/21/281 |
CircoMax |
Liechtenstein |
31.1.2022 |
|
EU/2/22/282 |
RenuTend |
Norge |
29.4.2022 |
|
EU/2/22/282 |
RenuTend |
Island |
24.5.2022 |
|
EU/2/22/282 |
RenuTend |
Liechtenstein |
30.4.2022 |
|
EU/2/22/283 |
Chanaxin |
Norge |
9.6.2022 |
|
EU/2/22/283 |
Chanaxin |
Island |
14.6.2022 |
|
EU/2/22/283 |
Chanaxin |
Liechtenstein |
30.4.2022 |
BILAGA II
Förteckning över förnyade godkännanden för försäljning
Följande godkännanden för försäljning har förnyats i Eftastaterna i EES under perioden 1 januari–30 juni 2022:
|
EU-nummer |
Produkt |
Land |
Datum för godkännande |
|
EU/1/11/699 |
Fampyra |
Norge |
9.5.2022 |
|
EU/1/11/699 |
Fampyra |
Liechtenstein |
30.4.2022 |
|
EU/1/11/749 |
Caprelsa |
Norge |
24.1.2022 |
|
EU/1/11/749 |
Caprelsa |
Island |
20.1.2022 |
|
EU/1/11/749 |
Caprelsa |
Liechtenstein |
31.1.2022 |
|
EU/1/12/782 |
Kalydeco |
Norge |
20.5.2022 |
|
EU/1/12/782 |
Kalydeco |
Liechtenstein |
30.4.2022 |
|
EU/1/12/784 |
Cuprymina |
Island |
28.6.2022 |
|
EU/1/12/784 |
Cuprymina |
Liechtenstein |
30.6.2022 |
|
EU/1/13/818 |
Bosulif |
Norge |
16.5.2022 |
|
EU/1/13/818 |
Bosulif |
Island |
20.4.2022 |
|
EU/1/13/818 |
Bosulif |
Liechtenstein |
31.3.2022 |
|
EU/1/13/875 |
Deltyba |
Norge |
30.3.2022 |
|
EU/1/13/875 |
Deltyba |
Island |
6.4.2022 |
|
EU/1/13/875 |
Deltyba |
Liechtenstein |
31.3.2022 |
|
EU/1/13/901 |
Sirturo |
Norge |
26.1.2022 |
|
EU/1/13/901 |
Sirturo |
Island |
14.1.2022 |
|
EU/1/13/901 |
Sirturo |
Liechtenstein |
31.1.2022 |
|
EU/1/13/902 |
Translarna |
Island |
28.6.2022 |
|
EU/1/13/902 |
Translarna |
Liechtenstein |
30.6.2022 |
|
EU/1/14/987 |
Holoclar |
Norge |
8.4.2022 |
|
EU/1/14/987 |
Holoclar |
Island |
11.1.2022 |
|
EU/1/14/987 |
Holoclar |
Liechtenstein |
31.1.2022 |
|
EU/1/15/1078 |
Natpar |
Norge |
19.4.2022 |
|
EU/1/15/1078 |
Natpar |
Island |
6.4.2022 |
|
EU/1/15/1078 |
Natpar |
Liechtenstein |
31.3.2022 |
|
EU/1/15/999 |
Zykadia |
Norge |
22.2.2022 |
|
EU/1/15/999 |
Zykadia |
Island |
22.2.2022 |
|
EU/1/15/999 |
Zykadia |
Liechtenstein |
28.2.2022 |
|
EU/1/16/1086 |
Tagrisso |
Norge |
6.4.2022 |
|
EU/1/16/1086 |
Tagrisso |
Island |
20.4.2022 |
|
EU/1/16/1086 |
Tagrisso |
Liechtenstein |
31.3.2022 |
|
EU/1/16/1089 |
Pandemic influenza vaccine H5N1 AstraZeneca |
Norge |
8.4.2022 |
|
EU/1/16/1089 |
Pandemic influenza vaccine H5N1 AstraZeneca |
Island |
16.3.2022 |
|
EU/1/16/1089 |
Pandemic influenza vaccine H5N1 AstraZeneca |
Liechtenstein |
31.3.2022 |
|
EU/1/16/1101 |
Darzalex |
Norge |
21.1.2022 |
|
EU/1/16/1101 |
Darzalex |
Island |
14.1.2022 |
|
EU/1/16/1101 |
Darzalex |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1139 |
Ocaliva |
Norge |
24.1.2022 |
|
EU/1/16/1139 |
Ocaliva |
Island |
21.1.2022 |
|
EU/1/16/1139 |
Ocaliva |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1152 |
Roteas |
Norge |
13.1.2022 |
|
EU/1/16/1152 |
Roteas |
Island |
11.1.2022 |
|
EU/1/16/1152 |
Roteas |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1154 |
Vemlidy |
Norge |
4.1.2022 |
|
EU/1/16/1154 |
Vemlidy |
Island |
5.1.2022 |
|
EU/1/16/1154 |
Vemlidy |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1155 |
Kyntheum |
Norge |
29.4.2022 |
|
EU/1/16/1155 |
Kyntheum |
Island |
11.5.2022 |
|
EU/1/16/1155 |
Kyntheum |
Liechtenstein |
30.4.2022 |
|
EU/1/16/1171 |
Ledaga |
Norge |
17.1.2022 |
|
EU/1/16/1171 |
Ledaga |
Island |
14.1.2022 |
|
EU/1/16/1171 |
Ledaga |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1172 |
Jylamvo |
Norge |
24.1.2022 |
|
EU/1/17/1172 |
Jylamvo |
Island |
5.1.2022 |
|
EU/1/17/1172 |
Jylamvo |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1174 |
Rolufta Ellipta |
Norge |
14.1.2022 |
|
EU/1/17/1174 |
Rolufta Ellipta |
Island |
14.1.2022 |
|
EU/1/17/1174 |
Rolufta Ellipta |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1175 |
Daptomycin Hospira |
Norge |
13.1.2022 |
|
EU/1/17/1175 |
Daptomycin Hospira |
Island |
25.1.2022 |
|
EU/1/17/1176 |
Yargesa |
Norge |
24.1.2022 |
|
EU/1/17/1176 |
Yargesa |
Island |
20.1.2022 |
|
EU/1/17/1176 |
Yargesa |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1178 |
Xeljanz |
Norge |
14.3.2022 |
|
EU/1/17/1178 |
Xeljanz |
Island |
15.3.2022 |
|
EU/1/17/1178 |
Xeljanz |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1179 |
Veltassa |
Norge |
6.4.2022 |
|
EU/1/17/1179 |
Veltassa |
Island |
19.4.2022 |
|
EU/1/17/1179 |
Veltassa |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1181 |
Spherox |
Norge |
8.6.2022 |
|
EU/1/17/1181 |
Spherox |
Island |
19.5.2022 |
|
EU/1/17/1181 |
Spherox |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1182 |
Emtricitabine/Tenofovir disoproxil Krka d.d |
Norge |
24.1.2022 |
|
EU/1/17/1182 |
Emtricitabine/Tenofovir disoproxil Krka d.d. |
Island |
21.1.2022 |
|
EU/1/17/1182 |
Emtricitabine /Tenofovir disoproxil Krka d.d. |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1184 |
Riximyo |
Norge |
22.2.2022 |
|
EU/1/17/1184 |
Riximyo |
Island |
23.2.2022 |
|
EU/1/17/1184 |
Riximyo |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1185 |
Rixathon |
Norge |
14.3.2022 |
|
EU/1/17/1185 |
Rixathon |
Island |
15.3.2022 |
|
EU/1/17/1185 |
Rixathon |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1186 |
Axumin |
Norge |
16.2.2022 |
|
EU/1/17/1186 |
Axumin |
Island |
16.2.2022 |
|
EU/1/17/1186 |
Axumin |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1187 |
Trumenba |
Norge |
9.5.2022 |
|
EU/1/17/1187 |
Trumenba |
Island |
11.5.2022 |
|
EU/1/17/1187 |
Trumenba |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1188 |
Spinraza |
Norge |
7.2.2022 |
|
EU/1/17/1188 |
Spinraza |
Island |
11.2.2022 |
|
EU/1/17/1188 |
Spinraza |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1189 |
Elmiron |
Norge |
26.1.2022 |
|
EU/1/17/1189 |
Elmiron |
Island |
21.1.2022 |
|
EU/1/17/1189 |
Elmiron |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1190 |
Ivabradine Accord |
Norge |
18.2.2022 |
|
EU/1/17/1190 |
Ivabradine Accord |
Island |
22.2.2022 |
|
EU/1/17/1190 |
Ivabradine Accord |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1191 |
Qarziba |
Norge |
27.1.2022 |
|
EU/1/17/1191 |
Qarziba |
Island |
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 |
Norge |
15.5.2022 |
|
EU/1/17/1193 |
Refixia |
Norge |
5.4.2022 |
|
EU/1/17/1193 |
Refixia |
Island |
15.3.2022 |
|
EU/1/17/1193 |
Refixia |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1194 |
Febuxostat Mylan |
Norge |
21.2.2022 |
|
EU/1/17/1194 |
Febuxostat Mylan |
Island |
23.2.2022 |
|
EU/1/17/1194 |
Febuxostat Mylan |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1195 |
Erelzi |
Island |
27.4.2022 |
|
EU/1/17/1195 |
Erelzi |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1196 |
Kevzara |
Norge |
9.5.2022 |
|
EU/1/17/1196 |
Kevzara |
Island |
11.5.2022 |
|
EU/1/17/1196 |
Kevzara |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1197 |
Oxervate |
Norge |
12.4.2022 |
|
EU/1/17/1197 |
Oxervate |
Island |
20.4.2022 |
|
EU/1/17/1197 |
Oxervate |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1200 |
Besponsa |
Norge |
22.2.2022 |
|
EU/1/17/1200 |
Besponsa |
Island |
21.2.2022 |
|
EU/1/17/1200 |
Besponsa |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1201 |
Skilarence |
Norge |
24.2.2022 |
|
EU/1/17/1201 |
Skilarence |
Island |
24.2.2022 |
|
EU/1/17/1201 |
Skilarence |
Liechtenstein |
28.2.2022 |
|
EU/1/17/1202 |
Ucedane |
Norge |
29.4.2022 |
|
EU/1/17/1202 |
Ucedane |
Island |
25.4.2022 |
|
EU/1/17/1202 |
Ucedane |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1203 |
Insulin lispro Sanofi |
Norge |
29.4.2022 |
|
EU/1/17/1203 |
Insulin lispro Sanofi |
Island |
3.5.2022 |
|
EU/1/17/1203 |
Insulin lispro Sanofi |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1205 |
Blitzima |
Norge |
29.4.2022 |
|
EU/1/17/1205 |
Blitzima |
Island |
6.5.2022 |
|
EU/1/17/1205 |
Blitzima |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1208 |
Trimbow |
Norge |
31.3.2022 |
|
EU/1/17/1208 |
Trimbow |
Island |
19.4.2022 |
|
EU/1/17/1208 |
Trimbow |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1209 |
Reagila |
Norge |
20.4.2022 |
|
EU/1/17/1209 |
Reagila |
Island |
20.4.2022 |
|
EU/1/17/1209 |
Reagila |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Norge |
31.5.2022 |
|
EU/1/7/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Island |
9.6.2022 |
|
EU/1/17/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1212 |
Mavenclad |
Norge |
29.4.2022 |
|
EU/1/17/1212 |
Mavenclad |
Island |
11.5.2022 |
|
EU/1/17/1212 |
Mavenclad |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1213 |
Maviret |
Island |
20.4.2022 |
|
EU/1/17/1213 |
Maviret |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1216 |
Imraldi |
Norge |
9.5.2022 |
|
EU/1/17/1216 |
Imraldi |
Island |
17.5.2022 |
|
EU/1/17/1216 |
Imraldi |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1218 |
Rydapt |
Island |
10.6.2022 |
|
EU/1/17/1218 |
Rydapt |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1220 |
Tecentriq |
Norge |
29.4.2022 |
|
EU/1/17/1220 |
Tecentriq |
Island |
6.5.2022 |
|
EU/1/17/1220 |
Tecentriq |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1221 |
Kisqali |
Norge |
20.4.2022 |
|
EU/1/17/1221 |
Kisqali |
Island |
27.4.2022 |
|
EU/1/17/1221 |
Kisqali |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Island |
9.6.2022 |
|
EU/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1223 |
Vosevi |
Norge |
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 |
Norge |
31.5.2022 |
|
EU/1/17/1225 |
Symtuza |
Island |
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 |
Norge |
24.3.2022 |
|
EU/1/17/1250 |
Rubraca |
Island |
16.3.2022 |
|
EU/1/17/1250 |
Rubraca |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1262 |
Crysvita |
Norge |
11.2.2022 |
|
EU/1/17/1262 |
Crysvita |
Island |
25.1.2022 |
|
EU/1/17/1262 |
Crysvita |
Liechtenstein |
31.1.2022 |
|
EU/1/18/1345 |
Ondexxya |
Norge |
30.6.2022 |
|
EU/1/18/1345 |
Ondexxya |
Island |
17.5.2022 |
|
EU/1/18/1345 |
Ondexxya |
Liechtenstein |
30.4.2022 |
|
EU/1/19/1355 |
Lorviqua |
Island |
25.4.2022 |
|
EU/1/19/1355 |
Lorviqua |
Liechtenstein |
30.4.2022 |
|
EU/1/19/1360 |
Waylivra |
Norge |
24.2.2022 |
|
EU/1/19/1360 |
Waylivra |
Island |
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 |
Norge |
31.5.2022 |
|
EU/1/20/1443 |
Zolgensma |
Island |
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 |
Norge |
29.4.2022 |
|
EU/1/20/1459 |
Veklury |
Island |
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 |
COVID- 19 Vaccine Janssen (JCOVDEN) |
Norge |
24.1.2022 |
|
EU/1/20/1525 |
COVID-19 Vaccine Janssen (JCOVDEN) |
Island |
14.2.2022 |
|
EU/1/20/1525 |
COVID-19 Vaccine Janssen (JCOVDEN) |
Liechtenstein |
31.1.2022 |
|
EU/1/20/1527 |
Retsevmo |
Norge |
26.1.2022 |
|
EU/1/20/1527 |
Retsevmo |
Island |
4.1.2022 |
|
EU/1/21/1535 |
Pemazyre |
Norge |
22.2.2022 |
|
EU/1/21/1535 |
Pemazyre |
Island |
23.2.2022 |
|
EU/1/21/1535 |
Pemazyre |
Liechtenstein |
28.2.2022 |
|
EU/1/21/1537 |
NEXPOVIO |
Norge |
2.6.2022 |
|
EU/1/21/1537 |
NEXPOVIO |
Island |
19.5.2022 |
|
EU/1/21/1537 |
NEXPOVIO |
Liechtenstein |
31.5.2022 |
|
EU/1/21/1538 |
Jemperli |
Norge |
22.2.2022 |
|
EU/1/21/1538 |
Jemperli |
Island |
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 |
Norge |
12.5.2022 |
|
EU/1/21/1552 |
Koselugo |
Liechtenstein |
30.4.2022 |
|
EU/2/16/203 |
VarroMed |
Norge |
24.1.2022 |
|
EU/2/16/203 |
VarroMed |
Island |
21.1.2022 |
|
EU/2/16/203 |
VarroMed |
Liechtenstein |
31.1.2022 |
|
EU/2/17/205 |
Cytopoint |
Norge |
29.6.2022 |
|
EU/2/17/205 |
Cytopoint |
Liechtenstein |
30.4.2022 |
|
EU/2/17/206 |
Credelio |
Norge |
29.6.2022 |
|
EU/2/17/206 |
Credelio |
Liechtenstein |
30.4.2022 |
|
EU/2/17/207 |
Zulvac BTV |
Norge |
29.6.2022 |
|
EU/2/17/207 |
Zulvac BTV |
Liechtenstein |
30.4.2022 |
|
EU/2/17/209 |
RESPIPORC FLUpan H1N1 |
Norge |
29.6.2022 |
|
EU/2/17/209 |
RESPIPORC FLUpan H1N1 |
Liechtenstein |
30.4.2022 |
|
EU/2/17/210 |
Zeleris |
Norge |
30.6.2022 |
|
EU/2/17/210 |
Zeleris |
Island |
18.5.2022 |
|
EU/2/17/210 |
Zeleris |
Liechtenstein |
31.5.2022 |
BILAGA III
Förteckning över utvidgade godkännanden för försäljning
Följande godkännanden för försäljning har utvidgats i Eftastaterna i EES under perioden 1 januari–30 juni 2022:
|
EU-nummer |
Produkt |
Land |
Datum för godkännande |
|
EU/1/05/320/005 |
Noxafil |
Liechtenstein |
31.1.2022 |
|
EU/1/05/320/005 |
Noxafil |
Norge |
24.1.2022 |
|
EU/1/05/320/005 |
Noxafil |
Island |
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 |
Norge |
24.1.2022 |
|
EU/1/14/936/008 |
Nuwiq |
Island |
20.1.2022 |
|
EU/1/15/1043/009-010 |
Nucala |
Liechtenstein |
30.4.2022 |
|
EU/1/15/1043/009-010 |
Nucala |
Norge |
24.5.2022 |
|
EU/1/15/1043/009-010 |
Nucala |
Island |
23.6.2022 |
|
EU/1/16/1116/003-004 |
Epclusa |
Liechtenstein |
31.1.2022 |
|
EU/1/16/1116/003-004 |
Epclusa |
Norge |
7.1.2022 |
|
EU/1/16/1116/003-004 |
Epclusa |
Island |
18.1.2022 |
|
EU/1/17/1217/004 |
Nitisinone MDK |
Island |
5.1.2022 |
|
EU/1/17/1229/021-022 |
Dupixent |
Liechtenstein |
30.4.2022 |
|
EU/1/17/1229/021--022 |
Dupixent |
Island |
27.4.2022 |
|
EU/1/17/1235/004-005 |
Zejula |
Liechtenstein |
31.5.2022 |
|
EU/1/17/1235/004-005 |
Zejula |
Norge |
30.5.2022 |
|
EU/1/17/1235/004-005 |
Zejula |
Island |
10.6.2022 |
|
EU/1/17/1247/015-016 |
Adynovi |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1247/015-016 |
Adynovi |
Norge |
14.1.2022 |
|
EU/1/17/1247/015-016 |
Adynovi |
Island |
20.1.2022 |
|
EU/1/17/1251/010-011 |
Ozempic |
Liechtenstein |
31.1.2022 |
|
EU/1/17/1251/010-011 |
Ozempic |
Norge |
11.1.2022 |
|
EU/1/17/1251/010-011 |
Ozempic |
Island |
20.1.2022 |
|
EU/1/18/1274/006-008 |
Trydonis |
Liechtenstein |
31.1.2022 |
|
EU/1/18/1274/006-008 |
Trydonis |
Norge |
24.1.2022 |
|
EU/1/18/1274/006-008 |
Trydonis |
Island |
21.1.2022 |
|
EU/1/18/1323/003 |
Ilumetri |
Liechtenstein |
30.4.2022 |
|
EU/1/18/1323/003 |
Ilumetri |
Norge |
20.5.2022 |
|
EU/1/18/1323/003 |
Ilumetri |
Island |
28.6.2022 |
|
EU/1/19/1414/007-008 |
Mayzent |
Liechtenstein |
28.2.2022 |
|
EU/1/19/1414/007-008 |
Mayzent |
Norge |
16.2.2022 |
|
EU/1/19/1414/007-008 |
Mayzent |
Island |
24.2.2022 |
|
EU/1/20/1422/016-017 |
Lyumjev |
Liechtenstein |
30.4.2022 |
|
EU/1/20/1422/016-017 |
Lyumjev |
Norge |
18.5.2022 |
|
EU/1/20/1422/016-017 |
Lyumjev |
Island |
17.5.2022 |
|
EU/1/20/1468/002 |
Kaftrio |
Liechtenstein |
31.1.2022 |
|
EU/1/20/1468/002 |
Kaftrio |
Norge |
7.1.2022 |
|
EU/1/20/1468/002 |
Kaftrio |
Island |
19.1.2022 |
|
EU/1/20/1473/004-005 |
AYVAKYT |
Liechtenstein |
31.3.2022 |
|
EU/1/20/1473/004-005 |
AYVAKYT |
Norge |
31.3.2022 |
|
EU/1/20/1473/004-005 |
AYVAKYT |
Island |
19.4.2022 |
|
EU/1/20/1500/003-004 |
Xofluza |
Liechtenstein |
30.4.2022 |
|
EU/1/20/1500/003-004 |
Xofluza |
Norge |
29.4.2022 |
|
EU/1/20/1501/003-004 |
Sogroya |
Liechtenstein |
30.4.2022 |
|
EU/1/20/1501/003-004 |
Sogroya |
Norge |
29.4.2022 |
|
EU/1/20/1501/003-004 |
Sogroya |
Island |
12.5.2022 |
|
EU/1/20/1513/013-016 |
Yuflyma |
Liechtenstein |
28.2.2022 |
|
EU/1/20/1513/013-016 |
Yuflyma |
Norge |
16.2.2022 |
|
EU/1/20/1513/013-016 |
Yuflyma |
Island |
15.3.2022 |
|
EU/2/13/154/028-033 |
Apoquel |
Norge |
5.1.2022 |
BILAGA IV
Förteckning över tillbakadragna godkännanden för försäljning
Följande godkännanden för försäljning har dragits tillbaka i Eftastaterna i EES under perioden 1 januari–30 juni 2022:
|
EU-nummer |
Produkt |
Land |
Datum för tillbakadragande |
|
EU/1/01/174 |
Starlix |
Norge |
16.6.2022 |
|
EU/1/01/174 |
Starlix |
Liechtenstein |
30.4.2022 |
|
EU/1/03/249 |
Vivanza |
Norge |
1.3.2022 |
|
EU/1/03/249 |
Vivanza |
Island |
10.2.2022 |
|
EU/1/03/249 |
Vivanza |
Liechtenstein |
28.2.2022 |
|
EU/1/03/250 |
Ytracis |
Norge |
22.2.2022 |
|
EU/1/03/250 |
Ytracis |
Island |
5.1.2022 |
|
EU/1/07/384 |
Docetaxel Zentiva |
Liechtenstein |
31.5.2022 |
|
EU/1/07/384 |
Docetaxel Zentiva |
Island |
10.6.2022 |
|
EU/1/07/421 |
Glubrava |
Norge |
8.6.2022 |
|
EU/1/07/421 |
Glubrava |
Liechtenstein |
31.5.2022 |
|
EU/1/08/491 |
Rasilez HCT |
Norge |
22.2.2022 |
|
EU/1/08/491 |
Rasilez HCT |
Island |
11.1.2022 |
|
EU/1/09/519 |
PANTOLOC Control |
Norge |
10.1.2022 |
|
EU/1/09/519 |
PANTOLOC Control |
Island |
5.1.2022 |
|
EU/1/11/695 |
Leganto |
Norge |
18.1.2022 |
|
EU/1/11/695 |
Leganto |
Island |
5.1.2022 |
|
EU/1/11/695 |
Leganto |
Liechtenstein |
31.1.2022 |
|
EU/1/11/728 |
Pramipexole Accord |
Norge |
22.4.2022 |
|
EU/1/11/728 |
Pramipexole Accord |
Island |
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 |
Norge |
23.3.2022 |
|
EU/1/15/1034 |
Pemetrexed Lilly |
Island |
21.1.2022 |
|
EU/1/15/1034 |
Pemetrexed Lilly |
Liechtenstein |
31.3.2022 |
|
EU/1/15/1069 |
Episalvan |
Island |
16.6.2022 |
|
EU/1/15/1069 |
Episalvan |
Liechtenstein |
30.6.2022 |
|
EU/1/16/1131 |
Thorinane |
Norge |
4.3.2022 |
|
EU/1/16/1131 |
Thorinane |
Liechtenstein |
31.3.2022 |
|
EU/1/17/1183 |
Pemetrexed Pfizer |
Norge |
23.3.2022 |
|
EU/1/17/1183 |
Pemetrexed Pfizer |
Island |
27.1.2022 |
|
EU/1/17/1183 |
Pemetrexed Pfizer |
Liechtenstein |
31.1.2022 |
|
EU/1/19/1363 |
Zynquista |
Norge |
21.4.2022 |
|
EU/1/19/1363 |
Zynquista |
Island |
6.4.2022 |
|
EU/1/19/1363 |
Zynquista |
Liechtenstein |
31.3.2022 |
|
EU/1/19/1367 |
Zynteglo |
Norge |
21.4.2022 |
|
EU/1/19/1367 |
Zynteglo |
Island |
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 |
Norge |
9.2.2022 |
|
EU/1/19/1421 |
Staquis |
Island |
10.2.2022 |
|
EU/1/19/1421 |
Staquis |
Liechtenstein |
31.1.2022 |
|
EU/2/14/180 |
Coliprotec F4 |
Norge |
22.2.2022 |
BILAGA V
Förteckning över tillfälligt återkallade godkännanden för försäljning
Följande godkännanden för försäljning har tillfälligt återkallats i Eftastaterna i EES under perioden 1 januari–30 juni 2022:
|
EU-nummer |
Produkt |
Land |
Datum för det tillfälliga återkallandet |
|
|
|
|
|