PODKOMITET I DS. SWOBODNEGO PRZEPŁYWU TOWARÓW - PRODUKTY LECZNICZE - WYKAZ POZWOLEŃ NA DOPUSZCZENIE DO OBROTU UDZIELONYCH PRZEZ PAŃSTWA EOG-EFTA W PIERWSZYM PÓŁROCZU 2025 R.
PODKOMITET I DS. SWOBODNEGO PRZEPŁYWU TOWARÓWPRODUKTY LECZNICZE
WYKAZ POZWOLEŃ NA DOPUSZCZENIE DO OBROTU UDZIELONYCH PRZEZ PAŃSTWA EOG-EFTA W PIERWSZYM PÓŁROCZU 2025 R.
(C/2026/1275)
(Dz.U.UE C z dnia 26 lutego 2026 r.)
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 w dniu 19 września 2025 r. następujące wykazy dotyczące pozwoleń na dopuszczenie do obrotu produktów leczniczych za okres od dnia 1 stycznia do dnia 30 czerwca 2025 r.:
ZAŁĄCZNIK I Wykaz nowych pozwoleń na dopuszczenie do obrotu
ZAŁĄCZNIK II Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
ZAŁĄCZNIK III Wykaz pozwoleń na dopuszczenie do obrotu, których obowiązywanie przedłużono
ZAŁĄCZNIK IV Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
ZAŁĄCZNIK V Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
ZAŁĄCZNIK IWykaz nowych pozwoleń na dopuszczenie do obrotu
Wykaz nowych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 stycznia do dnia 30 czerwca 2025 r. w państwach EFTA należących do EOG udzielono następujących pozwoleń na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data udzielenia pozwolenia |
| EU/1/24/1880 | Absimky | Islandia | 16.1.2025 |
| EU/1/24/1880 | Absimky | Norwegia | 2.1.2025 |
| EU/1/24/1888 | Ahzantive | Islandia | 22.1.2025 |
| EU/1/24/1888 | Ahzantive | Liechtenstein | 31.1.2025 |
| EU/1/24/1888 | Ahzantive | Norwegia | 23.1.2025 |
| EU/1/24/1881 | Alhemo | Islandia | 17.1.2025 |
| EU/1/24/1881 | Alhemo | Norwegia | 20.12.2024 (1) |
| EU/1/25/1943 | Alyftrek | Liechtenstein | 30.6.2025 |
| EU/1/24/1885 | ANDEMBRY | Islandia | 27.2.2025 |
| EU/1/24/1885 | ANDEMBRY | Liechtenstein | 28.2.2025 |
| EU/1/24/1885 | ANDEMBRY | Norwegia | 13.2.2025 |
| EU/2/24/323 | ArthriCox | Norwegia | 21.1.2025 |
| EU/1/24/1883 | AUGTYRO | Islandia | 20.1.2025 |
| EU/1/24/1883 | AUGTYRO | Liechtenstein | 31.1.2025 |
| EU/1/24/1883 | AUGTYRO | Norwegia | 17.1.2025 |
| EU/1/24/1896 | Avtozma | Liechtenstein | 28.2.2025 |
| EU/1/24/1896 | Avtozma | Norwegia | 14.4.2025 |
| EU/1/24/1887 | Baiama | Islandia | 22.1.2025 |
| EU/1/24/1887 | Baiama | Liechtenstein | 31.1.2025 |
| EU/1/24/1887 | Baiama | Norwegia | 23.1.2025 |
| EU/1/24/1906 | BEYONTTRA | Islandia | 26.2.2025 |
| EU/1/24/1906 | BEYONTTRA | Liechtenstein | 28.2.2025 |
| EU/1/24/1906 | BEYONTTRA | Norwegia | 13.2.2025 |
| EU/2/24/331 | BLUEVAC-3 | Islandia | 21.3.2025 |
| EU/2/24/331 | BLUEVAC-3 | Liechtenstein | 28.2.2025 |
| EU/2/24/331 | BLUEVAC-3 | Norwegia | 25.2.2025 |
| EU/2/24/325 | Bravecto TriUNO | Islandia | 16.1.2025 |
| EU/1/24/1809 | Buprenorphine Neuraxpharm | Islandia | 17.1.2025 |
| EU/1/24/1809 | Buprenorphine Neuraxpharm | Norwegia | 13.1.2025 |
| EU/2/24/328 | Carprofen Orion | Islandia | 17.1.2025 |
| EU/2/24/328 | Carprofen Orion | Norwegia | 10.2.2025 |
| EU/1/25/1913 | CAPVAXIVE | Islandia | 30.4.2025 |
| EU/1/25/1913 | CAPVAXIVE | Liechtenstein | 31.3.2025 |
| EU/1/25/1913 | CAPVAXIVE | Norwegia | 27.3.2025 |
| EU/1/25/1915 | Datroway | Islandia | 29.4.2025 |
| EU/1/25/1915 | Datroway | Liechtenstein | 30.4.2025 |
| EU/1/25/1915 | Datroway | Norwegia | 10.4.2025 |
| EU/1/25/1936 | Denbrayce | Liechtenstein | 30.6.2025 |
| EU/1/25/1919 | Deqsiga | Islandia | 16.5.2025 |
| EU/1/25/1919 | Deqsiga | Liechtenstein | 31.5.2025 |
| EU/1/25/1919 | Deqsiga | Norwegia | 7.5.2025 |
| EU/1/25/1930 | DUVYZAT | Liechtenstein | 30.6.2025 |
| EU/1/25/1930 | DUVYZAT | Norwegia | 10.6.2025 |
| EU/1/25/1914 | Dyrupeg | Islandia | 29.4.2025 |
| EU/1/25/1914 | Dyrupeg | Liechtenstein | 31.3.2025 |
| EU/1/25/1914 | Dyrupeg | Norwegia | 7.4.2025 |
| EU/2/25/337 | Elmaro | Islandia | 20.5.2025 |
| EU/2/25/337 | Elmaro | Liechtenstein | 31.3.2025 |
| EU/1/24/1903 | Eltrombopag Accord | Islandia | 28.4.2025 |
| EU/1/25/1903 | Eltrombopag Accord | Liechtenstein | 31.3.2025 |
| EU/1/24/1903 | Eltrombopag Accord | Norwegia | 7.4.2025 |
| EU/1/24/1869 | Eltrombopag Viatris | Islandia | 16.1.2025 |
| EU/1/24/1897 | Emcitate | Islandia | 26.2.2025 |
| EU/1/24/1897 | Emcitate | Liechtenstein | 28.2.2025 |
| EU/1/24/1897 | Emcitate | Norwegia | 18.2.2025 |
| EU/2/25/343 | Emevet | Liechtenstein | 30.6.2025 |
| EU/2/25/343 | Emevet | Norwegia | 25.6.2025 |
| EU/1/25/1944 | Enwylma | Liechtenstein | 30.6.2025 |
| EU/1/25/1946 | Evfraxy | Liechtenstein | 30.6.2025 |
| EU/1/24/1895 | Eydenzelt | Islandia | 26.2.2025 |
| EU/1/24/1895 | Eydenzelt | Liechtenstein | 28.2.2025 |
| EU/1/24/1895 | Eydenzelt | Norwegia | 14.4.2025 |
| EU/1/24/1884 | Gohibic | Islandia | 20.1.2025 |
| EU/1/24/1884 | Gohibic | Liechtenstein | 31.1.2025 |
| EU/1/24/1884 | Gohibic | Norwegia | 16.1.2025 |
| EU/2/25/341 | HEPIZOVAC | Islandia | 20.5.2025 |
| EU/2/25/341 | HEPIZOVAC | Liechtenstein | 30.4.2025 |
| EU/2/25/341 | HEPIZOVAC | Norwegia | 13.5.2025 |
| EU/1/24/1870 | HETRONIFLY | Islandia | 25.2.2025 |
| EU/1/24/1870 | HETRONIFLY | Liechtenstein | 31.1.2025 |
| EU/1/24/1870 | HETRONIFLY | Norwegia | 11.2.2025 |
| EU/2/24/330 | Icthiovac ERM | Islandia | 28.1.2025 |
| EU/2/24/330 | Icthiovac ERM | Liechtenstein | 31.1.2025 |
| EU/2/24/330 | Icthiovac ERM | Norwegia | 19.2.2025 |
| EU/1/24/1872 | IMULDOSA | Islandia | 16.1.2025 |
| EU/1/24/1872 | IMULDOSA | Norwegia | 2.1.2025 |
| EU/1/25/1935 | Izamby | Liechtenstein | 30.6.2025 |
| EU/1/25/1921 | Jubereq | Liechtenstein | 31.5.2025 |
| EU/1/25/1921 | Jubereq | Norwegia | 2.6.2025 |
| EU/1/25/1933 | Junod | Liechtenstein | 30.6.2025 |
| EU/1/24/1900 | KAVIGALE | Islandia | 15.5.2025 |
| EU/1/24/1900 | KAVIGALE | Liechtenstein | 31.1.2025 |
| EU/1/24/1900 | KAVIGALE | Norwegia | 28.1.2025 |
| EU/1/24/1826 | Korjuny | Islandia | 27.2.2025 |
| EU/1/24/1826 | Korjuny | Liechtenstein | 28.2.2025 |
| EU/1/24/1826 | Korjuny | Norwegia | 13.2.2025 |
| EU/1/24/1873 | Kostaive | Islandia | 26.2.2025 |
| EU/1/24/1873 | Kostaive | Liechtenstein | 28.2.2025 |
| EU/1/24/1873 | Kostaive | Norwegia | 18.2.2025 |
| EU/1/24/1886 | Lazcluze | Islandia | 28.1.2025 |
| EU/1/24/1886 | Lazcluze | Liechtenstein | 31.1.2025 |
| EU/1/24/1886 | Lazcluze | Norwegia | 20.2.2025 |
| EU/1/24/1891 | LEQEMBI | Islandia | 16.4.2025 |
| EU/1/24/1891 | LEQEMBI | Liechtenstein | 30.4.2025 |
| EU/1/24/1891 | LEQEMBI | Norwegia | 22.4.2025 |
| EU/1/25/1917 | LYNOZYFIC | Islandia | 16.5.2025 |
| EU/1/25/1917 | LYNOZYFIC | Liechtenstein | 30.4.2025 |
| EU/1/25/1917 | LYNOZYFIC | Norwegia | 29.4.2025 |
| EU/1/24/1901 | Nemluvio | Islandia | 26.2.2025 |
| EU/1/24/1901 | Nemluvio | Liechtenstein | 28.2.2025 |
| EU/1/24/1901 | Nemluvio | Norwegia | 7.4.2025 |
| EU/2/25/342 | Nobilis Multriva IBm+ND | Liechtenstein | 30.6.2025 |
| EU/2/25/342 | Nobilis Multriva IBm+ND | Norwegia | 19.6.2025 |
| EU/2/25/339 | Nobilis Multriva IBm+ND+EDS | Islandia | 20.5.2025 |
| EU/2/25/339 | Nobilis Multriva IBm+ND+EDS | Liechtenstein | 30.4.2025 |
| EU/2/25/345 | Nobilis Multriva IBm+ND+Gm+REOm +EDS | Liechtenstein | 30.6.2025 |
| EU/2/25/344 | Nobilis Multriva Gm+REOm | Liechtenstein | 30.6.2025 |
| EU/2/24/333 | Nobilis Multriva REOm | Islandia | 21.3.2025 |
| EU/2/24/333 | Nobilis Multriva REOm | Liechtenstein | 28.2.2025 |
| EU/1/24/1890 | Obodence | Islandia | 26.2.2025 |
| EU/1/24/1890 | Obodence | Liechtenstein | 28.2.2025 |
| EU/1/24/1890 | Obodence | Norwegia | 14.2.2025 |
| EU/2/25/336 | Omeprazole TriviumVet | Islandia | 20.5.2025 |
| EU/2/25/336 | Omeprazole TriviumVet | Liechtenstein | 30.4.2025 |
| EU/1/25/1938 | Oczyesa | Liechtenstein | 30.6.2025 |
| EU/1/24/1904 | Osenvelt | Islandia | 27.2.2025 |
| EU/1/24/1904 | Osenvelt | Liechtenstein | 28.2.2025 |
| EU/1/24/1904 | Osenvelt | Norwegia | 25.2.2025 |
| EU/1/25/1922 | Osvyrti | Liechtenstein | 31.5.2025 |
| EU/1/25/1922 | Osvyrti | Norwegia | 2.6.2025 |
| EU/1/25/1909 | PAVBLU | Islandia | 29.4.2025 |
| EU/1/25/1909 | PAVBLU | Liechtenstein | 30.4.2025 |
| EU/1/25/1909 | PAVBLU | Norwegia | 8.4.2025 |
| EU/1/24/1908 | Paxneury | Islandia | 24.3.2025 |
| EU/1/24/1908 | Paxneury | Liechtenstein | 28.2.2025 |
| EU/1/24/1908 | Paxneury | Norwegia | 10.3.2025 |
| EU/1/24/1871 | Penbraya | Islandia | 27.1.2025 |
| EU/2/24/324 | Poulvac Procerta HVT-IBD-ND | Islandia | 22.5.2025 |
| EU/2/24/324 | Poulvac Procerta HVT-IBD-ND | Liechtenstein | 31.1.2025 |
| EU/2/24/324 | Poulvac Procerta HVT-IBD-ND | Norwegia | 7.3.2025 |
| EU/2/25/340 | PRAZIVETIN | Islandia | 20.5.2025 |
| EU/2/25/340 | PRAZIVETIN | Liechtenstein | 30.4.2025 |
| EU/2/25/340 | PRAZIVETIN | Norwegia | 26.5.2025 |
| EU/2/25/338 | Prevestrus vet | Islandia | 20.5.2025 |
| EU/2/25/338 | Prevestrus vet | Liechtenstein | 30.4.2025 |
| EU/1/25/1925 | Qoyvolma | Liechtenstein | 30.6.2025 |
| EU/1/25/1925 | Qoyvolma | Norwegia | 18.6.2025 |
| EU/1/25/1920 | Ryjunea | Liechtenstein | 30.6.2025 |
| EU/1/25/1920 | Ryjunea | Norwegia | 10.6.2025 |
| EU/1/24/1894 | Rytelo | Islandia | 24.3.2025 |
| EU/1/22/1894 | Rytelo | Liechtenstein | 28.2.2025 |
| EU/1/24/1894 | Rytelo | Norwegia | 13.3.2025 |
| EU/1/24/1898 | Seladelpar Gilead | Islandia | 28.2.2025 |
| EU/1/24/1898 | Seladelpar Gilead | Liechtenstein | 28.2.2025 |
| EU/1/24/1898 | Seladelpar Gilead | Norwegia | 25.2.2025 |
| EU/1/25/1939 | Sephience | Liechtenstein | 30.6.2025 |
| EU/1/25/1939 | Sephience | Norwegia | 30.6.2025 |
| EU/1/24/1882 | SIILTIBCY | Islandia | 22.1.2025 |
| EU/1/24/1882 | SIILTIBCY | Liechtenstein | 31.1.2025 |
| EU/1/24/1882 | SIILTIBCY | Norwegia | 23.1.2025 |
| EU/1/24/1905 | Stoboclo | Islandia | 28.2.2025 |
| EU/1/24/1905 | Stoboclo | Liechtenstein | 28.2.2025 |
| EU/1/24/1905 | Stoboclo | Norwegia | 25.2.2025 |
| EU/2/24/332 | Syvazul BTV 3 | Islandia | 21.3.2025 |
| EU/2/24/332 | Syvazul BTV 3 | Liechtenstein | 28.2.2025 |
| EU/2/24/332 | Syvazul BTV 3 | Norwegia | 25.2.2025 |
| EU/1/25/1941 | TEPEZZA | Liechtenstein | 30.6.2025 |
| EU/1/25/1941 | TEPEZZA | Norwegia | 30.6.2025 |
| EU/1/25/1911 | Tivdak | Islandia | 28.4.2025 |
| EU/1/25/1911 | Tivdak | Liechtenstein | 31.3.2025 |
| EU/1/25/1911 | Tivdak | Norwegia | 1.4.2025 |
| EU/2/24/329 | TOLFENAMIC ACID VMD | Islandia | 27.2.2025 |
| EU/2/24/329 | TOLFENAMIC ACID VMD | Liechtenstein | 31.1.2025 |
| EU/2/24/329 | TOLFENAMIC ACID VMD | Norwegia | 10.2.2025 |
| EU/1/24/1902 | Trabectedin Accord | Islandia | 16.5.2025 |
| EU/1/24/1902 | Trabectedin Accord | Liechtenstein | 30.4.2025 |
| EU/1/24/1902 | Trabectedin Accord | Norwegia | 16.6.2025 |
| EU/1/24/1864 | Tuznue | Norwegia | 24.4.2025 |
| EU/1/24/1907 | Tuzulby | Islandia | 24.3.2025 |
| EU/1/24/1907 | Tuzulby | Liechtenstein | 28.2.2025 |
| EU/1/24/1907 | Tuzulby | Norwegia | 10.3.2025 |
| EU/2/25/335 | Vectormune HVT-AIV | Liechtenstein | 31.3.2025 |
| EU/2/25/335 | Vectormune HVT-AIV | Norwegia | 8.4.2025 |
| EU/1/25/1945 | Vevzuo | Liechtenstein | 30.6.2025 |
| EU/1/25/1916 | VIMKUNYA | Islandia | 21.3.2025 |
| EU/1/25/1916 | VIMKUNYA | Liechtenstein | 28.2.2025 |
| EU/1/25/1916 | VIMKUNYA | Norwegia | 4.3.2025 |
| EU/1/25/1918 | Vyjuvek | Islandia | 16.5.2025 |
| EU/1/25/1918 | Vyjuvek | Liechtenstein | 30.4.2025 |
| EU/1/25/1918 | Vyjuvek | Norwegia | 30.4.2025 |
| EU/1/24/1907 | Wainzua | Liechtenstein | 28.2.2025 |
| EU/1/24/1875 | Wainzua | Norwegia | 11.3.2025 |
| EU/1/24/1893 | WELIREG | Islandia | 26.2.2025 |
| EU/1/24/1893 | WELIREG | Liechtenstein | 28.2.2025 |
| EU/1/24/1893 | WELIREG | Norwegia | 18.2.2025 |
| EU/1/24/1889 | Xbryk | Islandia | 26.2.2025 |
| EU/1/24/1889 | Xbryk | Liechtenstein | 28.2.2025 |
| EU/1/24/1889 | Xbryk | Norwegia | 14.2.2025 |
| EU/1/25/1923 | Xoanacyl | Liechtenstein | 30.6.2025 |
| EU/1/25/1923 | Xoanacyl | Norwegia | 16.6.2025 |
| EU/1/25/1934 | Yaxwer | Liechtenstein | 30.6.2025 |
| EU/1/24/1892 | Yesintek | Islandia | 27.2.2025 |
| EU/1/24/1892 | Yesintek | Liechtenstein | 28.2.2025 |
| EU/1/24/1892 | Yesintek | Norwegia | 18.2.2025 |
| EU/1/25/1937 | ZADENVI | Liechtenstein | 30.6.2025 |
| EU/1/24/1899 | Zefylti | Islandia | 26.2.2025 |
| EU/1/24/1899 | Zefylti | Liechtenstein | 28.2.2025 |
| EU/1/24/1899 | Zefylti | Norwegia | 18.2.2025 |
| EU/1/25/1931 | Ziihera | Liechtenstein | 30.6.2025 |
| (1) W sposób niezamierzony nie uwzględniono tego pozwolenia w wykazie pozwoleń w drugiej połowie 2024 r. | |||
ZAŁĄCZNIK IIWykaz odnowionych pozwoleń na dopuszczenie do obrotu
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 stycznia do dnia 30 czerwca 2025 r. w państwach EFTA należących do EOG odnowiono następujące pozwolenia na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data udzielenia pozwolenia |
| EU/1/20/1458 | Apixaban Accord | Islandia | 16.5.2025 |
| EU/1/20/1458 | Apixaban Accord | Liechtenstein | 30.4.2025 |
| EU/1/20/1458 | Apixaban Accord | Norwegia | 29.4.2025 |
| EU/1/20/1469 | ARIKAYCE liposomal | Liechtenstein | 30.6.2025 |
| EU/1/20/1469 | ARIKAYCE liposomal | Norwegia | 11.6.2025 |
| EU/1/20/1427 | Arsenic trioxide Mylan | Liechtenstein | 28.2.2025 |
| EU/1/20/1427 | Arsenic trioxide Mylan | Norwegia | 17.3.2025 |
| EU/1/20/1439 | Atectura Breezhaler | Islandia | 25.2.2025 |
| EU/1/20/1439 | Atectura Breezhaler | Liechtenstein | 28.2.2025 |
| EU/1/20/1439 | Atectura Breezhaler | Norwegia | 25.2.2025 |
| EU/1/20/1454 | Aybintio | Liechtenstein | 30.6.2025 |
| EU/1/20/1454 | Aybintio | Norwegia | 11.6.2025 |
| EU/1/19/1413 | Azacitidine Accord | Islandia | 15.1.2025 |
| EU/1/19/1416 | Azacitidine Betapharm | Islandia | 27.1.2025 |
| EU/1/20/1426 | Azacitidine Mylan | Islandia | 15.1.2025 |
| EU/1/17/1214 | Bavencio | Islandia | 21.3.2025 |
| EU/1/17/1214 | Bavencio | Liechtenstein | 31.3.2025 |
| EU/1/17/1214 | Bavencio | Norwegia | 17.3.2025 |
| EU/1/20/1441 | Bemrist Breezhaler | Islandia | 25.2.2025 |
| EU/1/20/1441 | Bemrist Breezhaler | Liechtenstein | 28.2.2025 |
| EU/1/20/1441 | Bemrist Breezhaler | Norwegia | 21.2.2025 |
| EU/1/19/1397 | Bortezomib Fresenius Kabi | Islandia | 27.1.2025 |
| EU/1/20/1453 | BYANNLI | Islandia | 25.3.2025 |
| EU/1/20/1453 | BYANNLI | Liechtenstein | 31.3.2025 |
| EU/1/20/1453 | BYANNLI | Norwegia | 28.3.2025 |
| EU/1/20/1448 | Cabazitaxel Accord | Liechtenstein | 30.6.2025 |
| EU/1/20/1448 | Cabazitaxel Accord | Norwegia | 12.6.2025 |
| EU/1/23/1787 | Casgevy | Islandia | 25.2.2025 |
| EU/1/23/1787 | Casgevy | Liechtenstein | 28.2.2025 |
| EU/1/20/1429 | Cinacalcet Accordpharma | Islandia | 15.1.2025 |
| EU/2/22/286 | Coxatab | Norwegia | 7.4.2025 |
| EU/1/20/1451 | Daurismo | Islandia | 25.4.2025 |
| EU/1/20/1451 | Daurismo | Liechtenstein | 31.3.2025 |
| EU/1/20/1451 | Daurismo | Norwegia | 7.4.2025 |
| EU/1/19/1412 | Deferasirox Accord | Islandia | 15.1.2025 |
| EU/1/13/875 | Deltyba | Islandia | 16.5.2025 |
| EU/1/13/875 | Deltyba | Liechtenstein | 30.4.2025 |
| EU/1/20/1438 | Enerzair Breezhaler | Islandia | 25.2.2025 |
| EU/1/20/1438 | Enerzair Breezhaler | Liechtenstein | 28.2.2025 |
| EU/1/20/1438 | Enerzair Breezhaler | Norwegia | 25.2.2025 |
| EU/1/23/1770 | Elrexfio | Islandia | 13.1.2025 |
| EU/1/23/1770 | Elrexfio | Norwegia | 2.1.2025 |
| EU/1/20/1477 | Fampridine Accord | Liechtenstein | 30.6.2025 |
| EU/1/20/1477 | Fampridine Accord | Norwegia | 30.6.2025 |
| EU/1/20/1434 | Fetcroja | Liechtenstein | 31.1.2025 |
| EU/1/20/1434 | Fetcroja | Norwegia | 18.2.2025 |
| EU/1/20/1450 | Fingolimod Accord | Islandia | 25.4.2025 |
| EU/1/20/1450 | Fingolimod Accord | Liechtenstein | 30.4.2025 |
| EU/1/20/1450 | Fingolimod Accord | Norwegia | 10.4.2025 |
| EU/1/23/1788 | Filspari | Islandia | 16.5.2025 |
| EU/1/23/1788 | Filspari | Liechtenstein | 28.2.2025 |
| EU/1/20/1433 | Fluad Tetra | Islandia | 15.1.2025 |
| EU/1/20/1433 | Fluad Tetra | Norwegia | 13.1.2025 |
| EU/1/21/1555 | GAVRETO | Islandia | 27.1.2025 |
| EU/1/20/1465 | Gencebok | Islandia | 21.3.2025 |
| EU/1/20/1465 | Gencebok | Liechtenstein | 31.3.2025 |
| EU/1/20/1465 | Gencebok | Norwegia | 13.3.2025 |
| EU/1/20/1428 | Givlaari | Islandia | 14.1.2025 |
| EU/1/19/1403 | GoResp Digihaler | Islandia | 27.2.2025 |
| EU/1/19/1403 | GoResp Digihaler | Liechtenstein | 28.2.2025 |
| EU/1/19/1403 | GoResp Digihaler | Norwegia | 18.2.2025 |
| EU/1/22/1715 | Hemgenix | Islandia | 27.1.2025 |
| EU/2/18/226 | HorStem | Islandia | 28.1.2025 |
| EU/1/20/1471 | Idefirix | Liechtenstein | 30.6.2025 |
| EU/1/24/1807 | Incellipan | Norwegia | 31.3.2025 |
| EU/1/24/1807 | Incellipan | Liechtenstein | 31.3.2025 |
| EU/1/20/1447 | Insulin aspart Sanofi | Islandia | 16.5.2025 |
| EU/1/20/1447 | Insulin aspart Sanofi | Liechtenstein | 30.4.2025 |
| EU/1/20/1447 | Insulin aspart Sanofi | Norwegia | 6.5.2025 |
| EU/1/20/1480 | Jyseleca | Liechtenstein | 30.6.2025 |
| EU/1/20/1480 | Jyseleca | Norwegia | 6.6.2025 |
| EU/1/20/1468 | Kaftrio | Liechtenstein | 31.5.2025 |
| EU/1/20/1468 | Kaftrio | Norwegia | 4.6.2025 |
| EU/1/21/1552 | Koselugo | Islandia | 16.5.2025 |
| EU/1/21/1552 | Koselugo | Liechtenstein | 30.4.2025 |
| EU/1/23/1744 | Krazati | Islandia | 14.1.2025 |
| EU/1/20/1462 | Livogiva | Islandia | 25.4.2025 |
| EU/1/20/1462 | Livogiva | Liechtenstein | 30.4.2025 |
| EU/1/20/1462 | Livogiva | Norwegia | 22.4.2025 |
| EU/1/19/1355 | Lorviqua | Islandia | 16.5.2025 |
| EU/1/19/1355 | Lorviqua | Liechtenstein | 31.5.2025 |
| EU/1/19/1355 | Lorviqua | Norwegia | 19.5.2025 |
| EU/1/20/1470 | Lumeblue | Liechtenstein | 31.5.2025 |
| EU/1/20/1470 | Lumeblue | Norwegia | 16.6.2025 |
| EU/1/21/1603 | Lumykras | Islandia | 14.1.2025 |
| EU/1/22/1649 | Lunsumio | Islandia | 25.4.2025 |
| EU/1/22/1649 | Lunsumio | Liechtenstein | 30.4.2025 |
| EU/1/22/1649 | Lunsumio | Norwegia | 29.4.2025 |
| EU/1/23/1741 | Lytgobi | Liechtenstein | 30.6.2025 |
| EU/1/23/1741 | Lytgobi | Norwegia | 10.6.2025 |
| EU/1/20/1422 | Lyumjev | Islandia | 21.2.2025 |
| EU/1/20/1422 | Lyumjev | Liechtenstein | 31.1.2025 |
| EU/1/20/1422 | Lyumjev | Norwegia | 23.1.2025 |
| EU/2/19/247 | Mirataz | Islandia | 28.1.2025 |
| EU/1/20/1445 | Mvabea | Islandia | 25.4.2025 |
| EU/1/20/1445 | Mvabea | Liechtenstein | 31.3.2025 |
| EU/1/20/1445 | Mvabea | Norwegia | 7.4.2025 |
| EU/1/15/1078 | Natpar | Islandia | 20.3.2025 |
| EU/1/15/1078 | Natpar | Liechtenstein | 28.2.2025 |
| EU/1/15/1078 | Natpar | Norwegia | 3.3.2025 |
| EU/1/20/1436 | Nepexto | Islandia | 24.2.2025 |
| EU/1/20/1436 | Nepexto | Liechtenstein | 28.2.2025 |
| EU/1/20/1436 | Nepexto | Norwegia | 18.2.2025 |
| EU/1/20/1425 | Nilemdo | Islandia | 14.1.2025 |
| EU/1/20/1424 | Nustendi | Islandia | 14.1.2025 |
| EU/1/18/1345 | Ondexxya | Islandia | 25.4.2025 |
| EU/1/18/1345 | Ondexxya | Liechtenstein | 30.4.2025 |
| EU/1/18/1345 | Ondexxya | Norwegia | 15.4.2025 |
| EU/1/16/1089 | Pandemiczna szczepionka przeciw grypie H5N1 AstraZeneca | Islandia | 21.3.2025 |
| EU/1/16/1089 | Pandemiczna szczepionka przeciw grypie H5N1 AstraZeneca | Liechtenstein | 31.3.2025 |
| EU/1/16/1089 | Pandemiczna szczepionka przeciw grypie H5N1 AstraZeneca | Norwegia | 18.3.2025 |
| EU/1/20/1487 | PHELINUN | Liechtenstein | 31.5.2025 |
| EU/1/20/1487 | PHELINUN | Norwegia | 16.6.2025 |
| EU/1/20/1455 | Piqray | Islandia | 21.2.2025 |
| EU/1/20/1455 | Piqray | Liechtenstein | 28.2.2025 |
| EU/1/20/1455 | Piqray | Norwegia | 14.2.2025 |
| EU/1/15/1020 | Raxone | Liechtenstein | 30.6.2025 |
| EU/1/20/1452 | Reblozyl | Islandia | 25.2.2025 |
| EU/1/20/1452 | Reblozyl | Liechtenstein | 28.2.2025 |
| EU/1/20/1452 | Reblozyl | Norwegia | 25.2.2025 |
| EU/1/21/1597 | Regkirona | Islandia | 29.4.2025 |
| EU/1/20/1527 | Retsevmo | Islandia | 21.1.2025 |
| EU/1/20/1527 | Retsevmo | Liechtenstein | 31.1.2025 |
| EU/1/20/1527 | Retsevmo | Norwegia | 11.3.2025 |
| EU/1/20/1460 | Rozlytrek | Liechtenstein | 30.6.2025 |
| EU/1/20/1460 | Rozlytrek | Norwegia | 24.6.2025 |
| EU/1/20/1431 | Ruxience | Islandia | 10.1.2025 |
| EU/1/20/1430 | Rybelsus | Islandia | 14.1.2025 |
| EU/1/20/1435 | Sarclisa | Islandia | 28.2.2025 |
| EU/1/20/1435 | Sarclisa | Liechtenstein | 28.2.2025 |
| EU/1/20/1435 | Sarclisa | Norwegia | 25.2.2025 |
| EU/1/19/1408 | Sunosi | Islandia | 21.1.2025 |
| EU/1/19/1408 | Sunosi | Liechtenstein | 31.1.2025 |
| EU/1/19/1408 | Sunosi | Norwegia | 17.1.2025 |
| EU/1/22/1688 | Spevigo | Islandia | 13.1.2025 |
| EU/1/19/1405 | TAVLESSE | Islandia | 10.1.2025 |
| EU/1/20/1492 | Tecartus | Islandia | 20.3.2025 |
| EU/1/20/1492 | Tecartus | Liechtenstein | 28.2.2025 |
| EU/1/20/1492 | Tecartus | Norwegia | 12.3.2025 |
| EU/1/19/1394 | Tigecycline Accord | Islandia | 14.1.2025 |
| EU/1/19/1394 | Tigecycline Accord | Norwegia | 9.1.2025 |
| EU/1/19/1419 | Trepulmix | Islandia | 15.1.2025 |
| EU/1/20/1423 | Vaxchora | Islandia | 28.1.2025 |
| EU/1/20/1423 | Vaxchora | Liechtenstein | 31.1.2025 |
| EU/1/20/1423 | Vaxchora | Norwegia | 1.3.2025 |
| EU/1/19/1360 | Waylivra | Islandia | 25.4.2025 |
| EU/1/19/1360 | Waylivra | Liechtenstein | 30.4.2025 |
| EU/1/19/1360 | Waylivra | Norwegia | 15.4.2025 |
| EU/1/20/1457 | Xenleta | Islandia | 15.5.2025 |
| EU/1/20/1457 | Xenleta | Liechtenstein | 30.4.2025 |
| EU/1/20/1457 | Xenleta | Norwegia | 22.4.2025 |
| EU/1/20/1444 | Zabdeno | Islandia | 25.4.2025 |
| EU/1/20/1444 | Zabdeno | Liechtenstein | 31.3.2025 |
| EU/1/20/1444 | Zabdeno | Norwegia | 7.4.2025 |
| EU/1/20/1442 | Zeposia | Islandia | 25.4.2025 |
| EU/1/20/1442 | Zeposia | Liechtenstein | 31.3.2025 |
| EU/1/20/1442 | Zeposia | Norwegia | 31.3.2025 |
| EU/1/20/1456 | Zercepac | Islandia | 25.4.2025 |
| EU/1/20/1456 | Zercepac | Liechtenstein | 30.4.2025 |
| EU/1/20/1456 | Zercepac | Norwegia | 9.4.2025 |
| EU/1/20/1440 | Zimbus Breezhaler | Islandia | 21.2.2025 |
| EU/1/20/1440 | Zimbus Breezhaler | Liechtenstein | 28.2.2025 |
| EU/1/20/1440 | Zimbus Breezhaler | Norwegia | 24.2.2025 |
| EU/1/22/1695 | Zynlonta | Islandia | 10.1.2025 |
ZAŁĄCZNIK IIIWykaz pozwoleń na dopuszczenie do obrotu, których obowiązywanie przedłużono
Wykaz pozwoleń na dopuszczenie do obrotu, których obowiązywanie przedłużono
W okresie od dnia 1 stycznia do dnia 30 czerwca 2025 r. w państwach EFTA należących do EOG przedłużono następujące pozwolenia na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data udzielenia pozwolenia |
| EU/1/23/1717/004-006 | Aqumeldi | Islandia | 20.5.2025 |
| EU/1/23/1717/004-006 | Aqumeldi | Norwegia | 19.6.2025 |
| EU/1/22/1709/005-007 | Bimervax XBB 1.16 | Norwegia | 6.1.2025 |
| EU/1/13/818/008-009 | Bosulif | Norwegia | 6.6.2025 |
| EU/1/14/974/004 | Cerdelga | Islandia | 16.1.2025 |
| EU/1/14/974/004 | Cerdelga | Norwegia | 19.1.2025 |
| EU/1/21/1531/002 | Evrysdi | Norwegia | 4.6.2025 |
| EU/1/21/1589/008-009 | Hukyndra | Islandia | 17.1.2025 |
| EU/1/21/1589/008-009 | Hukyndra | Norwegia | 12.12.2024 (1) |
| EU/1/21/1589/010 | Hukyndra | Norwegia | 21.5.2025 |
| EU/1/12/773/017 | Jakavi | Islandia | 20.1.2025 |
| EU/1/12/773/017 | Jakavi | Norwegia | 16.1.2025 |
| EU/1/18/1324/011-012 | Jivi | Norwegia | 30.6.2025 |
| EU/1/17/1196/013 | Kevzara | Islandia | 21.1.2025 |
| EU/1/17/1196/013 | Kevzara | Norwegia | 20.1.2025 |
| EU/1/04/279/047-055 | LYRICA | Islandia | 19.5.2025 |
| EU/1/14/979/009-012 | Ofev | Islandia | 22.5.2025 |
| EU/1/14/979/009-012 | Ofev | Norwegia | 10.3.2025 |
| EU/1/23/1736/007-010 | Omvoh | Islandia | 25.2.2025 |
| EU/1/23/1736/007-010 | Omvoh | Norwegia | 20.2.2025 |
| EU/1/15/1014/005 | Opdivo | Norwegia | 4.6.2025 |
| EU/1/17/1245/005-006 | Prevymis | Islandia | 20.5.2025 |
| EU/1/17/1245/005-006 | Prevymis | Norwegia | 5.5.2025 |
| EU/1/17/1209/043-050 | Reagila | Islandia | 20.1.2025 |
| EU/1/20/1527/012-023 | Retsevmo | Islandia | 19.5.2025 |
| EU/1/20/1527/012-023 | Retsevmo | Norwegia | 29.4.2025 |
| EU/1/21/1594/002-003 | Rybrevant | Islandia | 25.4.2025 |
| EU/1/21/1594/002-003 | Rybrevant | Norwegia | 15.4.2025 |
| EU/1/20/1507/027-030 | Spikevax XBB 1.5 | Islandia | 19.5.2025 |
| EU/1/18/1340/010-012 | Takhzyro | Islandia | 20.5.2025 |
| EU/1/15/1085/007 | Taltz | Islandia | 25.4.2025 |
| EU/1/15/1085/007 | Taltz | Norwegia | 7.4.2025 |
| EU/1/19/1377/008-009 | Talzenna | Norwegia | 30.6.2025 |
| EU/1/17/1234/005-009 | Tremfya | Islandia | 19.5.2025 |
| EU/1/17/1234/005-009 | Tremfya | Norwegia | 2.6.2025 |
| EU/1/23/1784/005 | Uzpruvo | Islandia | 28.2.2025 |
| EU/1/23/1784/002 + 005 | Uzpruvo | Norwegia | 26.2.2025 |
| (1) W sposób niezamierzony nie uwzględniono tego pozwolenia w wykazie pozwoleń w drugiej połowie 2024 r. | |||
ZAŁĄCZNIK IVWykaz wycofanych pozwoleń na dopuszczenie do obrotu
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 stycznia do dnia 30 czerwca 2025 r. w państwach EFTA należących do EOG wycofano następujące pozwolenia na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data wycofania pozwolenia |
| EU/1/17/1261 | Alofisel | Islandia | 16.1.2025 |
| EU/1/20/1427 | Arsenic trioxide Mylan | Islandia | 29.4.2025 |
| EU/1/20/1427 | Arsenic trioxide Mylan | Liechtenstein | 30.4.2025 |
| EU/1/20/1427 | Arsenic trioxide Mylan | Norwegia | 29.4.2025 |
| EU/1/24/1838 | BEQVEZ | Liechtenstein | 31.5.2025 |
| EU/1/24/1838 | BEQVEZ | Norwegia | 23.5.2025 |
| EU/1/21/1534 | BroPair Spiromax | Liechtenstein | 30.6.2025 |
| EU/1/21/1560 | Celsunax | Liechtenstein | 31.1.2025 |
| EU/1/21/1560 | Celsunax | Norwegia | 21.3.2025 |
| EU/1/08/454 | Extavia | Islandia | 16.1.2025 |
| EU/1/21/1555 | GAVRETO | Islandia | 27.1.2025 |
| EU/1/13/877 | Grastofil | Islandia | 20.1.2025 |
| EU/1/13/877 | Grastofil | Liechtenstein | 31.1.2025 |
| EU/1/13/877 | Grastofil | Norwegia | 16.1.2025 |
| EU/1/22/1690 | Mycapssa | Islandia | 20.3.2025 |
| EU/1/22/1690 | Mycapssa | Liechtenstein | 28.2.2025 |
| EU/1/22/1690 | Mycapssa | Norwegia | 21.3.2025 |
| EU/2/98/008 | Neocolipor | Islandia | 25.2.2025 |
| EU/2/98/008 | Neocolipor | Liechtenstein | 31.1.2025 |
| EU/2/98/008 | Neocolipor | Norwegia | 21.3.2025 |
| EU/1/22/1705 | Pemetrexed Baxter | Islandia | 15.5.2025 |
| EU/1/22/1705 | Pemetrexed Baxter | Liechtenstein | 31.5.2025 |
| EU/1/22/1705 | Pemetrexed Baxter | Norwegia | 17.5.2025 |
| EU/1/24/1871 | Penbraya | Islandia | 27.1.2025 |
| EU/1/24/1871 | Penbraya | Liechtenstein | 31.1.2025 |
| EU/1/24/1871 | Penbraya | Norwegia | 20.1.2025 |
| EU/2/00/027 | Pirsue | Islandia | 15.5.2025 |
| EU/2/00/027 | Pirsue | Liechtenstein | 30.4.2025 |
| EU/2/00/027 | Pirsue | Norwegia | 29.4.2025 |
| EU/1/22/1641 | PreHevbri | Islandia | 15.1.2025 |
| EU/1/21/1597 | Regkirona | Islandia | 29.4.2025 |
| EU/1/21/1597 | Regkirona | Liechtenstein | 30.4.2025 |
| EU/1/21/1597 | Regkirona | Norwegia | 29.4.2025 |
| EU/1/18/1275 | Riarify | Islandia | 20.3.2025 |
| EU/1/18/1275 | Riarify | Liechtenstein | 31.3.2025 |
| EU/1/18/1275 | Riarify | Norwegia | 21.3.2025 |
| EU/1/19/1369 | Sixmo | Liechtenstein | 30.6.2025 |
| EU/1/13/902 | Translarna | Islandia | 30.4.2025 |
| EU/1/13/902 | Translarna | Liechtenstein | 31.3.2025 |
| EU/1/13/902 | Translarna | Norwegia | 23.4.2025 |
| EU/1/06/341 | Zostavax | Islandia | 29.4.2025 |
| EU/1/06/341 | Zostavax | Liechtenstein | 30.4.2025 |
| EU/1/06/341 | Zostavax | Norwegia | 15.4.2025 |
ZAŁĄCZNIK VWykaz zawieszonych pozwoleń na dopuszczenie do obrotu
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 stycznia do dnia 30 czerwca 2025 r. w państwach EFTA należących do EOG zawieszono następujące pozwolenia na dopuszczenie do obrotu:
| Numer EU | Produkt | Państwo | Data zawieszenia pozwolenia |
Metryka aktu
| Identyfikator: | Dz.U.UE.C.2026.1275 |
| Rodzaj: | informacja |
| Tytuł: | PODKOMITET I DS. SWOBODNEGO PRZEPŁYWU TOWARÓW - PRODUKTY LECZNICZE - WYKAZ POZWOLEŃ NA DOPUSZCZENIE DO OBROTU UDZIELONYCH PRZEZ PAŃSTWA EOG-EFTA W PIERWSZYM PÓŁROCZU 2025 R. |
| Data aktu: | 2026-02-26 |
| Data ogłoszenia: | 2026-02-26 |