PODKOMITET I DS. SWOBODNEGO PRZEPŁYWU TOWARÓW - PRODUKTY LECZNICZE - WYKAZ POZWOLEŃ NA DOPUSZCZENIE DO OBROTU UDZIELONYCH PRZEZ PAŃSTWA EOG-EFTA W DRUGIM PÓŁROCZU 2025 R. - Do wiadomości Wspólnego Komitetu EOG
PODKOMITET I DS. SWOBODNEGO PRZEPŁYWU TOWARÓWPRODUKTY LECZNICZEWYKAZ POZWOLEŃ NA DOPUSZCZENIE DO OBROTU UDZIELONYCH PRZEZ PAŃSTWA EOG-EFTA W DRUGIM PÓŁROCZU 2025 R.(C/2026/3563)
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 20 marca 2026 r. następujące wykazy dotyczące pozwoleń na dopuszczenie do obrotu produktów leczniczych za okres od dnia 1 lipca do dnia 31 grudnia 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 lipca do dnia 31 grudnia 2025 r. w państwach EFTA należących do EOG udzielono następujących pozwoleń na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data udzielenia pozwolenia |
| EU/1/25/1983 | Acvybra | Islandia | 15.12.2025 |
| EU/1/25/1983 | Acvybra | Liechtenstein | 30.11.2025 |
| EU/1/25/1983 | Acvybra | Norwegia | 16.12.2025 |
| EU/1/25/1965 | Afiveg | Islandia | 3.9.2025 |
| EU/1/25/1965 | Afiveg | Liechtenstein | 31.8.2025 |
| EU/1/25/1965 | Afiveg | Norwegia | 25.8.2025 |
| EU/1/25/1943 | Alyftrek | Islandia | 17.7.2025 |
| EU/1/25/1943 | Alyftrek | Norwegia | 3.7.2025 |
| EU/1/25/1929 | Attrogy | Islandia | 7.8.2025 |
| EU/1/25/1929 | Attrogy | Liechtenstein | 31.7.2025 |
| EU/1/25/1929 | Attrogy | Norwegia | 31.7.2025 |
| EU/1/25/1951 | Aucatzyl | Islandia | 28.7.2025 |
| EU/1/25/1951 | Aucatzyl | Liechtenstein | 31.7.2025 |
| EU/1/25/1951 | Aucatzyl | Norwegia | 29.7.2025 |
| EU/1/24/1896 | Avtozma | Islandia | 24.7.2025 |
| EU/1/25/1978 | Bildyos | Islandia | 20.10.2025 |
| EU/1/25/1978 | Bildyos | Liechtenstein | 30.9.2025 |
| EU/1/25/1978 | Bildyos | Norwegia | 16.10.2025 |
| EU/1/25/1979 | Bilprevda | Islandia | 20.10.2025 |
| EU/1/25/1979 | Bilprevda | Liechtenstein | 30.9.2025 |
| EU/1/25/1979 | Bilprevda | Norwegia | 15.10.2025 |
| EU/2/25/348 | Biobhyo | Islandia | 11.12.2025 |
| EU/2/25/348 | Biobhyo | Liechtenstein | 31.8.2025 |
| EU/2/25/348 | Biobhyo | Norwegia | 10.9.2025 |
| EU/1/25/1948 | Blenrep | Islandia | 8.8.2025 |
| EU/1/25/1948 | Blenrep | Liechtenstein | 31.7.2025 |
| EU/1/25/1948 | Blenrep | Norwegia | 23.7.2025 |
| EU/1/25/1953 | Bomyntra | Islandia | 7.8.2025 |
| EU/1/25/1953 | Bomyntra | Liechtenstein | 31.7.2025 |
| EU/1/25/1953 | Bomyntra | Norwegia | 18.8.2025 |
| EU/2/25/350 | BRAVECTO CombiUNO | Islandia | 8.8.2025 |
| EU/2/25/350 | BRAVECTO CombiUNO | Liechtenstein | 31.7.2025 |
| EU/2/25/350 | BRAVECTO CombiUNO | Norwegia | 7.8.2025 |
| EU/1/25/1995 | Brinsupri | Islandia | 15.12.2025 |
| EU/1/25/1995 | Brinsupri | Liechtenstein | 30.11.2025 |
| EU/1/25/1995 | Brinsupri | Norwegia | 25.11.2025 |
| EU/2/25/334 | CEVAC REOMUNE | Islandia | 17.10.2025 |
| EU/2/25/334 | CEVAC REOMUNE | Liechtenstein | 31.8.2025 |
| EU/2/25/334 | CEVAC REOMUNE | Norwegia | 22.9.2025 |
| EU/1/25/1954 | Conexxence | Islandia | 7.8.2025 |
| EU/1/25/1954 | Conexxence | Liechtenstein | 31.7.2025 |
| EU/1/25/1954 | Conexxence | Norwegia | 18.8.2025 |
| EU/1/25/1949 | Dazublys | Liechtenstein | 31.7.2025 |
| EU/1/25/1949 | Dazublys | Norwegia | 17.7.2025 |
| EU/1/25/1985 | Degevma | Islandia | 15.12.2025 |
| EU/1/25/1985 | Degevma | Liechtenstein | 30.11.2025 |
| EU/1/25/1985 | Degevma | Norwegia | 2.12.2025 |
| EU/1/25/1936 | Denbrayce | Islandia | 16.7.2025 |
| EU/1/25/1936 | Denbrayce | Norwegia | 2.7.2025 |
| EU/1/25/1993 | Denosumab Intas | Islandia | 12.12.2025 |
| EU/1/25/1993 | Denosumab Intas | Liechtenstein | 30.11.2025 |
| EU/1/25/1993 | Denosumab Intas | Norwegia | 9.12.2025 |
| EU/1/25/1930 | Duvyzat | Islandia | 15.7.2025 |
| EU/1/25/1963 | Eiyzey | Islandia | 3.9.2025 |
| EU/1/25/1963 | Eiyzey | Liechtenstein | 31.8.2025 |
| EU/1/25/1963 | Eiyzey | Norwegia | 20.8.2025 |
| EU/1/25/1975 | Ekterly | Islandia | 20.10.2025 |
| EU/1/25/1975 | Ekterly | Liechtenstein | 30.9.2025 |
| EU/1/25/1975 | Ekterly | Norwegia | 14.10.2025 |
| EU/2/25/337 | Elmaro | Norwegia | 29.7.2025 |
| EU/2/25/343 | Emevet | Islandia | 17.7.2025 |
| EU/1/25/1966 | Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris | Islandia | 2.9.2025 |
| EU/1/25/1966 | Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris | Liechtenstein | 31.8.2025 |
| EU/1/25/1966 | Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris | Norwegia | 26.8.2025 |
| EU/1/25/1952 | Emtricitabine/Tenofovir Alafenamide Viatris | Islandia | 7.8.2025 |
| EU/1/25/1952 | Emtricitabine/Tenofovir alafenamide Viatris | Liechtenstein | 31.7.2025 |
| EU/1/25/1952 | Emtricitabine/Tenofovir alafenamide Viatris | Norwegia | 30.7.2025 |
| EU/1/25/1944 | Enwylma | Islandia | 16.7.2025 |
| EU/1/25/1944 | Enwylma | Norwegia | 15.8.2025 |
| EU/1/25/1946 | Evfraxy | Islandia | 17.7.2025 |
| EU/1/25/1946 | Evfraxy | Norwegia | 2.7.2025 |
| EU/1/25/1972 | Eyluxvi | Islandia | 17.10.2025 |
| EU/1/25/1972 | Eyluxvi | Liechtenstein | 30.9.2025 |
| EU/1/25/1972 | Eyluxvi | Norwegia | 14.10.2025 |
| EU/1/25/1950 | Ezmekly | Islandia | 28.7.2025 |
| EU/1/25/1950 | Ezmekly | Liechtenstein | 31.7.2025 |
| EU/1/25/1950 | Ezmekly | Norwegia | 25.7.2025 |
| EU/2/25/346 | Fluralaner Intervet | Islandia | 28.7.2025 |
| EU/2/25/346 | Fluralaner Intervet | Liechtenstein | 31.7.2025 |
| EU/2/25/346 | Fluralaner Intervet | Norwegia | 30.7.2025 |
| EU/1/25/1988 | Gobivaz | Islandia | 12.12.2025 |
| EU/1/25/1988 | Gobivaz | Liechtenstein | 30.11.2025 |
| EU/1/25/1988 | Gobivaz | Norwegia | 9.12.2025 |
| EU/2/25/352 | Hemosyvet | Islandia | 5.11.2025 |
| EU/2/25/352 | Hemosyvet | Liechtenstein | 31.10.2025 |
| EU/2/25/352 | Hemosyvet | Norwegia | 6.11.2025 |
| EU/1/25/1989 | Imaavy | Liechtenstein | 30.11.2025 |
| EU/1/25/1924 | Imreplys | Islandia | 16.10.2025 |
| EU/1/25/1924 | Imreplys | Liechtenstein | 31.8.2025 |
| EU/1/25/1924 | Imreplys | Norwegia | 10.9.2025 |
| EU/2/25/347 | Innovax-ND-IBD-ILT | Islandia | 17.7.2025 |
| EU/2/25/347 | Innovax-ND-IBD-ILT | Liechtenstein | 31.7.2025 |
| EU/2/25/347 | Innovax-ND-IBD-ILT | Norwegia | 30.7.2025 |
| EU/1/25/1942 | Itovebi | Islandia | 7.8.2025 |
| EU/1/25/1942 | Itovebi | Liechtenstein | 31.7.2025 |
| EU/1/25/1942 | Itovebi | Norwegia | 28.7.2025 |
| EU/1/25/1935 | Izamby | Islandia | 16.7.2025 |
| EU/1/25/1935 | Izamby | Norwegia | 2.7.2025 |
| EU/1/25/1921 | Jubereq | Islandia | 15.7.2025 |
| EU/1/25/1933 | Junod | Islandia | 16.7.2025 |
| EU/1/25/1933 | Junod | Norwegia | 3.7.2025 |
| EU/1/25/1980 | Kefdensis | Islandia | 15.12.2025 |
| EU/1/25/1980 | Kefdensis | Liechtenstein | 30.11.2025 |
| EU/1/25/1980 | Kefdensis | Norwegia | 9.12.2025 |
| EU/1/25/1926 | Kisunla | Islandia | 20.10.2025 |
| EU/1/25/1926 | Kisunla | Liechtenstein | 30.9.2025 |
| EU/1/25/1926 | Kisunla | Norwegia | 16.10.2025 |
| EU/1/25/1992 | Kyinsu | Liechtenstein | 30.11.2025 |
| EU/1/25/1992 | Kyinsu | Norwegia | 9.12.2025 |
| EU/2/25/355 | Lenivia | Liechtenstein | 30.11.2025 |
| EU/1/25/1991 | Lynkuet | Islandia | 12.12.2025 |
| EU/1/25/1991 | Lynkuet | Liechtenstein | 30.11.2025 |
| EU/1/25/1991 | Lynkuet | Norwegia | 9.12.2025 |
| EU/1/25/1955 | Maapliv | Islandia | 8.8.2025 |
| EU/1/25/1955 | Maapliv | Liechtenstein | 31.7.2025 |
| EU/1/25/1955 | Maapliv | Norwegia | 4.8.2025 |
| EU/1/25/1970 | Macitentan Accord | Islandia | 20.10.2025 |
| EU/1/25/1970 | Macitentan Accord | Liechtenstein | 30.9.2025 |
| EU/1/25/1970 | Macitentan Accord | Norwegia | 16.10.2025 |
| EU/1/25/1971 | Macitentan AccordPharma | Islandia | 20.10.2025 |
| EU/1/25/1971 | Macitentan AccordPharma | Liechtenstein | 30.9.2025 |
| EU/1/25/1971 | Macitentan AccordPharma | Norwegia | 16.10.2025 |
| EU/1/25/1964 | MYNZEPLI | Islandia | 2.9.2025 |
| EU/1/25/1964 | MYNZEPLI | Liechtenstein | 31.8.2025 |
| EU/1/25/1964 | MYNZEPLI | Norwegia | 22.8.2025 |
| EU/1/25/1959 | Nintedanib Viatris | Islandia | 2.9.2025 |
| EU/1/25/1959 | Nintedanib Viatris | Liechtenstein | 31.8.2025 |
| EU/1/25/1959 | Nintedanib Viatris | Norwegia | 28.8.2025 |
| EU/2/25/344 | Nobilis Multriva Gm+REOm | Islandia | 29.8.2025 |
| EU/2/25/344 | Nobilis Multriva Gm+REOm | Norwegia | 5.8.2025 |
| EU/2/25/342 | Nobilis Multriva IBm+ND | Islandia | 17.7.2025 |
| EU/2/25/339 | Nobilis Multriva IBm+ND+EDS | Norwegia | 6.8.2025 |
| EU/2/25/345 | Nobilis Multriva IBm+ND+Gm+REOm+EDS | Islandia | 17.7.2025 |
| EU/2/25/345 | Nobilis Multriva IBm+ND+Gm+REOm+EDS | Norwegia | 3.7.2025 |
| EU/2/24/333 | Nobilis Multriva REOm | Norwegia | 6.8.2025 |
| EU/2/25/351 | Numelvi | Islandia | 8.8.2025 |
| EU/2/25/351 | Numelvi | Liechtenstein | 31.7.2025 |
| EU/2/25/351 | Numelvi | Norwegia | 5.8.2025 |
| EU/1/25/1938 | Oczyesa | Islandia | 17.7.2025 |
| EU/1/25/1938 | Oczyesa | Norwegia | 2.7.2025 |
| EU/1/25/1932 | Ogsiveo | Islandia | 2.9.2025 |
| EU/1/25/1932 | Ogsiveo | Liechtenstein | 31.8.2025 |
| EU/1/25/1932 | Ogsiveo | Norwegia | 20.8.2025 |
| EU/2/25/336 | Omeprazole TriviumVet | Norwegia | 31.7.2025 |
| EU/1/25/1922 | Osvyrti | Islandia | 15.7.2025 |
| EU/1/25/1986 | Ponlimsi | Islandia | 12.12.2025 |
| EU/1/25/1986 | Ponlimsi | Liechtenstein | 30.11.2025 |
| EU/1/25/1986 | Ponlimsi | Norwegia | 2.12.2025 |
| EU/2/25/353 | Portela | Islandia | 5.11.2025 |
| EU/2/25/353 | Portela | Liechtenstein | 31.10.2025 |
| EU/2/25/353 | Portela | Norwegia | 6.11.2025 |
| EU/2/25/338 | Prevestrus vet | Norwegia | 31.7.2025 |
| EU/1/25/1925 | Qoyvolma | Islandia | 15.7.2025 |
| EU/1/25/1962 | Rezdiffra | Islandia | 16.10.2025 |
| EU/1/25/1962 | Rezdiffra | Liechtenstein | 31.8.2025 |
| EU/1/25/1962 | Rezdiffra | Norwegia | 3.9.2025 |
| EU/1/25/1947 | RIULVY | Liechtenstein | 31.7.2025 |
| EU/1/25/1947 | RIULVY | Norwegia | 8.8.2025 |
| EU/1/25/1994 | Rivaroxaban Koanaa | Liechtenstein | 30.11.2025 |
| EU/1/25/1994 | Rivaroxaban Koanaa | Norwegia | 9.12.2025 |
| EU/1/25/1958 | Rolcya | Liechtenstein | 31.7.2025 |
| EU/1/25/1958 | Rolcya | Norwegia | 5.8.2025 |
| EU/1/25/1968 | ROMVIMZA | Islandia | 20.10.2025 |
| EU/1/25/1968 | ROMVIMZA | Liechtenstein | 30.9.2025 |
| EU/1/25/1968 | ROMVIMZA | Norwegia | 15.10.2025 |
| EU/1/25/1920 | Ryjunea | Islandia | 15.7.2025 |
| EU/1/25/1939 | Sephience | Islandia | 16.7.2025 |
| EU/1/25/1941 | Tepezza | Islandia | 16.7.2025 |
| EU/1/25/1969 | Tryngolza | Islandia | 20.10.2025 |
| EU/1/25/1969 | Tryngolza | Liechtenstein | 30.9.2025 |
| EU/1/25/1969 | Tryngolza | Norwegia | 16.10.2025 |
| EU/1/25/1987 | Usgena | Islandia | 12.12.2025 |
| EU/1/25/1987 | Usgena | Liechtenstein | 30.11.2025 |
| EU/1/25/1987 | Usgena | Norwegia | 9.12.2025 |
| EU/1/25/1973 | Usrenty | Islandia | 20.10.2025 |
| EU/1/25/1973 | Usrenty | Liechtenstein | 30.9.2025 |
| EU/1/25/1973 | Usrenty | Norwegia | 26.11.2025 |
| EU/1/25/1957 | Usymro | Islandia | 15.10.2025 |
| EU/1/25/1957 | Usymro | Liechtenstein | 31.8.2025 |
| EU/1/25/1957 | Usymro | Norwegia | 28.8.2025 |
| EU/2/25/356 | Vaxxinact H5 | Liechtenstein | 31.12.2025 |
| EU/2/25/354 | Vaxxitek HVT+IBD+H5 | Liechtenstein | 30.11.2025 |
| EU/2/25/354 | Vaxxitek HVT+IBD+H5 | Norwegia | 26.11.2025 |
| EU/2/25/335 | Vectormune HVT-AIV PFU | Islandia | 3.9.2025 |
| EU/1/25/1945 | Vevzuo | Islandia | 16.7.2025 |
| EU/1/25/1945 | Vevzuo | Norwegia | 3.7.2025 |
| EU/1/25/1961 | Vgenfli | Islandia | 2.9.2025 |
| EU/1/25/1961 | Vgenfli | Liechtenstein | 31.8.2025 |
| EU/1/25/1961 | Vgenfli | Norwegia | 18.8.2025 |
| EU/1/25/1967 | Vivlipeg | Islandia | 16.10.2025 |
| EU/1/25/1967 | Vivlipeg | Liechtenstein | 31.8.2025 |
| EU/1/25/1967 | Vivlipeg | Norwegia | 3.9.2025 |
| EU/1/25/1912 | Voranigo | Islandia | 20.10.2025 |
| EU/1/25/1912 | Voranigo | Liechtenstein | 30.9.2025 |
| EU/1/25/1912 | Voranigo | Norwegia | 15.10.2025 |
| EU/1/25/1974 | WAYRILZ | Liechtenstein | 31.12.2025 |
| EU/1/25/1927 | Winlevi | Islandia | 5.11.2025 |
| EU/1/25/1927 | Winlevi | Liechtenstein | 31.10.2025 |
| EU/1/25/1927 | Winlevi | Norwegia | 3.11.2025 |
| EU/1/25/1982 | Xbonzy | Islandia | 12.12.2025 |
| EU/1/25/1982 | Xbonzy | Liechtenstein | 30.11.2025 |
| EU/1/25/1982 | Xbonzy | Norwegia | 9.12.2025 |
| EU/1/25/1923 | Xoanacyl | Islandia | 15.7.2025 |
| EU/1/25/1934 | Yaxwer | Islandia | 16.7.2025 |
| EU/1/25/1934 | Yaxwer | Norwegia | 30.7.2025 |
| EU/1/25/1976 | Yeytuo | Islandia | 10.9.2025 |
| EU/1/25/1976 | Yeytuo | Liechtenstein | 31.8.2025 |
| EU/1/25/1976 | Yeytuo | Norwegia | 28.8.2025 |
| EU/1/25/1937 | Zadenvi | Islandia | 16.7.2025 |
| EU/1/25/1937 | Zadenvi | Norwegia | 16.7.2025 |
| EU/1/25/1960 | Zemcelpro | Islandia | 2.9.2025 |
| EU/1/25/1960 | Zemcelpro | Liechtenstein | 31.8.2025 |
| EU/1/25/1960 | Zemcelpro | Norwegia | 1.9.2025 |
| EU/2/25/349 | Zenrelia | Islandia | 8.8.2025 |
| EU/2/25/349 | Zenrelia | Liechtenstein | 31.7.2025 |
| EU/2/25/349 | Zenrelia | Norwegia | 4.8.2025 |
| EU/1/25/1931 | Ziihera | Islandia | 16.7.2025 |
| EU/1/25/1931 | Ziihera | Norwegia | 3.7.2025 |
| EU/1/25/1977 | Zurzuvae | Islandia | 17.10.2025 |
| EU/1/25/1977 | Zurzuvae | Liechtenstein | 30.9.2025 |
| EU/1/25/1977 | Zurzuvae | Norwegia | 16.10.2025 |
| EU/1/25/1981 | Zvogra | Islandia | 15.12.2025 |
| EU/1/25/1981 | Zvogra | Liechtenstein | 30.11.2025 |
| EU/1/25/1981 | Zvogra | Norwegia | 9.12.2025 |
ZAŁĄCZNIK IIWykaz odnowionych pozwoleń na dopuszczenie do obrotu
Wykaz odnowionych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2025 r. w państwach EFTA należących do EOG odnowiono następujące pozwolenia na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data |
| EU/1/21/1553 | Abiraterone Krka | Liechtenstein | 31.12.2025 |
| EU/1/20/1469 | Arikayce liposomal | Islandia | 11.7.2025 |
| EU/1/20/1475 | Arsenic trioxide medac | Liechtenstein | 31.7.2025 |
| EU/1/20/1475 | Arsenic trioxide medac | Norwegia | 29.7.2025 |
| EU/1/24/1883 | AUGTYRO | Liechtenstein | 31.12.2025 |
| EU/1/20/1454 | Aybintio | Islandia | 11.7.2025 |
| EU/1/20/1473 | AYVAKYT | Islandia | 26.8.2025 |
| EU/1/20/1473 | AYVAKYT | Liechtenstein | 31.7.2025 |
| EU/1/20/1473 | AYVAKYT | Norwegia | 6.8.2025 |
| EU/1/20/1505 | Byfavo | Islandia | 10.12.2025 |
| EU/1/20/1505 | Byfavo | Liechtenstein | 30.11.2025 |
| EU/1/20/1505 | Byfavo | Norwegia | 9.12.2025 |
| EU/1/20/1448 | Cabazitaxel Accord | Islandia | 11.7.2025 |
| EU/1/20/1479 | Calquence | Islandia | 26.8.2025 |
| EU/1/20/1479 | Calquence | Liechtenstein | 31.7.2025 |
| EU/1/20/1479 | Calquence | Norwegia | 6.8.2025 |
| EU/1/23/1787 | Casgevy | Norwegia | 12.8.2025 |
| EU/1/23/1742 | Columvi | Islandia | 15.7.2025 |
| EU/1/13/875 | Deltyba | Norwegia | 5.8.2025 |
| EU/1/23/1770 | Elrexfio | Islandia | 15.9.2025 |
| EU/1/23/1770 | Elrexfio | Liechtenstein | 30.9.2025 |
| EU/1/23/1770 | Elrexfio | Norwegia | 29.9.2025 |
| EU/1/20/1504 | Elzonris | Liechtenstein | 30.9.2025 |
| EU/1/20/1504 | Elzonris | Norwegia | 2.12.2025 |
| EU/1/20/1508 | Enhertu | Islandia | 11.12.2025 |
| EU/1/20/1508 | Enhertu | Liechtenstein | 30.11.2025 |
| EU/1/19/1392 | Ervebo | Islandia | 17.10.2025 |
| EU/1/19/1392 | Ervebo | Liechtenstein | 30.9.2025 |
| EU/1/19/1392 | Ervebo | Norwegia | 22.10.2025 |
| EU/1/20/1489 | EXPAREL liposomal | Islandia | 26.8.2025 |
| EU/1/20/1489 | EXPAREL liposomal | Liechtenstein | 31.7.2025 |
| EU/1/20/1489 | EXPAREL liposomal | Norwegia | 4.8.2025 |
| EU/1/20/1477 | Fampridine Accord | Islandia | 11.7.2025 |
| EU/1/20/1434 | Fetcroja | Islandia | 3.9.2025 |
| EU/1/23/1788 | Filspari | Norwegia | 5.8.2025 |
| EU/1/20/1491 | Fintepla | Islandia | 10.12.2025 |
| EU/1/20/1491 | Fintepla | Liechtenstein | 30.11.2025 |
| EU/1/20/1491 | Fintepla | Norwegia | 18.12.2025 |
| EU/1/20/1503 | Heplisav B | Liechtenstein | 30.11.2025 |
| EU/1/20/1503 | Heplisav B | Norwegia | 10.12.2025 |
| EU/1/20/1471 | Idefirix | Islandia | 11.7.2025 |
| EU/1/20/1471 | Idefirix | Norwegia | 5.8.2025 |
| EU/1/24/1807 | Incellipan | Islandia | 3.9.2025 |
| EU/2/24/315 | Innovax-ND-H5 | Norwegia | 7.8.2025 |
| EU/1/20/1514 | Inrebic | Liechtenstein | 31.12.2025 |
| EU/1/24/1855 | Iqirvo | Islandia | 26.8.2025 |
| EU/1/24/1855 | Iqirvo | Liechtenstein | 31.7.2025 |
| EU/1/24/1855 | Iqirvo | Norwegia | 6.8.2025 |
| EU/1/23/1738 | Jaypirca | Islandia | 17.10.2025 |
| EU/1/23/1738 | Jaypirca | Liechtenstein | 30.9.2025 |
| EU/1/23/1738 | Jaypirca | Norwegia | 22.9.2025 |
| EU/1/20/1480 | Jyseleca | Islandia | 10.7.2025 |
| EU/1/20/1468 | Kaftrio | Islandia | 10.7.2025 |
| EU/1/20/1506 | Kirsty | Islandia | 18.11.2025 |
| EU/1/20/1506 | Kirsty | Liechtenstein | 31.10.2025 |
| EU/1/20/1506 | Kirsty | Norwegia | 3.12.2025 |
| EU/1/21/1522 | Koselugo | Norwegia | 5.8.2025 |
| EU/1/23/1744 | Krazati | Islandia | 10.12.2025 |
| EU/1/23/1744 | Krazati | Liechtenstein | 30.11.2025 |
| EU/1/23/1744 | Krazati | Norwegia | 18.12.2025 |
| EU/1/20/1519 | Lenalidomide Krka | Liechtenstein | 31.12.2025 |
| EU/1/20/1490 | Lenalidomide Mylan | Islandia | 2.9.2025 |
| EU/1/20/1490 | Lenalidomide Mylan | Liechtenstein | 31.8.2025 |
| EU/1/20/1490 | Lenalidomide Mylan | Norwegia | 1.9.2025 |
| EU/1/20/1494 | Leqvio | Islandia | 26.8.2025 |
| EU/1/20/1494 | Leqvio | Liechtenstein | 31.7.2025 |
| EU/1/20/1494 | Leqvio | Norwegia | 4.8.2025 |
| EU/1/20/1493 | Libmeldy | Islandia | 11.12.2025 |
| EU/1/20/1493 | Libmeldy | Liechtenstein | 30.11.2025 |
| EU/1/20/1493 | Libmeldy | Norwegia | 18.12.2025 |
| EU/1/20/1470 | Lumeblue | Islandia | 10.7.2025 |
| EU/1/21/1603 | Lumykras | Liechtenstein | 30.11.2025 |
| EU/1/21/1603 | Lumykras | Norwegia | 15.12.2025 |
| EU/1/23/1741 | Lytgobi | Islandia | 10.7.2025 |
| EU/1/24/1898 | Lyvdelzi | Liechtenstein | 31.12.2025 |
| EU/1/20/1483 | MenQuadfi | Islandia | 11.7.2025 |
| EU/1/20/1483 | MenQuadfi | Liechtenstein | 31.7.2025 |
| EU/1/20/1483 | MenQuadfi | Norwegia | 16.7.2025 |
| EU/1/21/1570 | Minjuvi | Islandia | 17.10.2025 |
| EU/1/21/1570 | Minjuvi | Liechtenstein | 30.9.2025 |
| EU/1/21/1570 | Minjuvi | Norwegia | 29.9.2025 |
| EU/1/20/1425 | Nilemdo | Norwegia | 12.8.2025 |
| EU/1/20/1486 | Nyvepria | Islandia | 26.8.2025 |
| EU/1/20/1486 | Nyvepria | Liechtenstein | 31.8.2025 |
| EU/1/20/1486 | Nyvepria | Norwegia | 8.8.2025 |
| EU/1/15/1035 | Obizur | Islandia | 1.9.2025 |
| EU/1/15/1035 | Obizur | Liechtenstein | 31.8.2025 |
| EU/1/15/1035 | Obizur | Norwegia | 20.8.2025 |
| EU/1/15/1018 | Omidria | Norwegia | 16.7.2025 |
| EU/1/21/1530 | Ontozry | Islandia | 10.12.2025 |
| EU/1/21/1530 | Ontozry | Liechtenstein | 30.11.2025 |
| EU/1/24/1530 | Ontozry | Norwegia | 18.12.2025 |
| EU/1/24/1843 | Ordspono | Islandia | 26.8.2025 |
| EU/1/24/1843 | Ordspono | Liechtenstein | 31.7.2025 |
| EU/1/24/1843 | Ordspono | Norwegia | 1.9.2025 |
| EU/1/15/1059 | Orkambi | Islandia | 17.10.2025 |
| EU/1/15/1059 | Orkambi | Liechtenstein | 30.9.2025 |
| EU/1/15/1059 | Orkambi | Norwegia | 27.10.2025 |
| EU/2/20/260 | OvuGel | Islandia | 5.11.2025 |
| EU/2/20/260 | OvuGel | Liechtenstein | 31.10.2025 |
| EU/2/20/260 | OvuGel | Norwegia | 26.11.2025 |
| EU/1/20/1496 | Oxlumo | Islandia | 26.8.2025 |
| EU/1/20/1496 | Oxlumo | Liechtenstein | 31.8.2025 |
| EU/1/20/1496 | Oxlumo | Norwegia | 11.8.2025 |
| EU/1/21/1535 | Pemazyre | Islandia | 11.7.2025 |
| EU/1/21/1535 | Pemazyre | Liechtenstein | 31.7.2025 |
| EU/1/21/1535 | Pemazyre | Norwegia | 30.7.2025 |
| EU/1/20/1487 | PHELINUN | Islandia | 10.7.2025 |
| EU/1/20/1497 | Phesgo | Islandia | 17.10.2025 |
| EU/1/20/1497 | Phesgo | Liechtenstein | 30.9.2025 |
| EU/1/20/1497 | Phesgo | Norwegia | 23.10.2025 |
| EU/1/15/1020 | Raxone | Islandia | 11.7.2025 |
| EU/1/15/1020 | Raxone | Norwegia | 3.7.2025 |
| EU/1/20/1482 | Rekambys | Islandia | 1.9.2025 |
| EU/1/20/1482 | Rekambys | Liechtenstein | 31.8.2025 |
| EU/1/20/1482 | Rekambys | Norwegia | 20.8.2025 |
| EU/1/20/1527 | Retsevmo | Liechtenstein | 31.12.2025 |
| EU/1/20/1488 | Rivaroxaban Accord | Islandia | 1.9.2025 |
| EU/1/20/1488 | Rivaroxaban Accord | Liechtenstein | 31.8.2025 |
| EU/1/20/1488 | Rivaroxaban Accord | Norwegia | 11.8.2025 |
| EU/1/20/1502 | Roclanda | Islandia | 15.10.2025 |
| EU/1/20/1502 | Roclanda | Liechtenstein | 31.8.2025 |
| EU/1/25/1957 | Roclanda | Norwegia | 28.8.2025 |
| EU/1/22/1668 | Roctavian | Liechtenstein | 31.8.2025 |
| EU/1/22/1668 | Roctavian | Norwegia | 10.9.2025 |
| EU/1/20/1460 | Rozlytrek | Islandia | 10.7.2025 |
| EU/1/20/1518 | Rukobia | Islandia | 10.9.2025 |
| EU/1/20/1518 | Rukobia | Liechtenstein | 30.9.2025 |
| EU/1/20/1518 | Rukobia | Norwegia | 11.9.2025 |
| EU/1/21/1533 | Seffalair Spiromax | Liechtenstein | 31.12.2025 |
| EU/1/20/1501 | Sogroya | Islandia | 11.12.2025 |
| EU/1/20/1501 | Sogroya | Liechtenstein | 30.11.2025 |
| EU/1/20/1501 | Sogroya | Norwegia | 9.12.2025 |
| EU/1/22/1688 | Spevigo | Islandia | 4.11.2025 |
| EU/1/22/1688 | Spevigo | Liechtenstein | 31.10.2025 |
| EU/1/22/1688 | Spevigo | Norwegia | 24.11.2025 |
| EU/1/20/1511 | Sunitinib Accord | Islandia | 11.12.2025 |
| EU/1/20/1511 | Sunitinib Accord | Liechtenstein | 30.11.2025 |
| EU/1/20/1511 | Sunitinib Accord | Norwegia | 9.12.2025 |
| EU/1/20/1484 | Supemtek Tetra | Liechtenstein | 31.7.2025 |
| EU/1/20/1484 | Supemtek Tetra | Norwegia | 28.7.2025 |
| EU/1/23/1748 | TALVEY | Islandia | 1.9.2025 |
| EU/1/23/1748 | TALVEY | Liechtenstein | 31.8.2025 |
| EU/1/23/1748 | TALVEY | Norwegia | 14.8.2025 |
| EU/1/20/1492 | Tecartus | Islandia | 10.12.2025 |
| EU/1/20/1492 | Tecartus | Liechtenstein | 30.11.2025 |
| EU/1/22/1675 | Tecvayli | Islandia | 1.9.2025 |
| EU/1/22/1675 | Tecvayli | Liechtenstein | 31.8.2025 |
| EU/1/22/1675 | Tecvayli | Norwegia | 14.8.2025 |
| EU/1/23/1759 | Tepkinly | Islandia | 24.7.2025 |
| EU/1/23/1759 | Tepkinly | Liechtenstein | 31.7.2025 |
| EU/1/23/1759 | Tepkinly | Norwegia | 31.7.2025 |
| EU/1/20/1498 | Trixeo Aerosphere | Islandia | 1.9.2025 |
| EU/1/20/1498 | Trixeo Aerosphere | Liechtenstein | 31.8.2025 |
| EU/1/20/1498 | Trixeo Aerosphere | Norwegia | 20.8.2025 |
| EU/1/20/1526 | Tukysa | Islandia | 17.10.2025 |
| EU/1/20/1526 | Tukysa | Liechtenstein | 30.9.2025 |
| EU/1/20/1526 | Tukysa | Norwegia | 10.11.2025 |
| EU/1/19/1385 | VITRAKVI | Islandia | 28.7.2025 |
| EU/1/19/1385 | VITRAKVI | Liechtenstein | 31.7.2025 |
| EU/1/19/1385 | VITRAKVI | Norwegia | 28.7.2025 |
| EU/1/20/1481 | Vocabria | Islandia | 1.9.2025 |
| EU/1/20/1481 | Vocabria | Liechtenstein | 31.8.2025 |
| EU/1/20/1481 | Vocabria | Norwegia | 20.8.2025 |
| EU/1/20/1500 | Xofluza | Islandia | 10.12.2025 |
| EU/1/20/1500 | Xofluza | Liechtenstein | 30.11.2025 |
| EU/1/20/1500 | Xofluza | Norwegia | 18.12.2025 |
| EU/1/22/1695 | Zynlonta | Islandia | 4.11.2025 |
| EU/1/22/1695 | Zynlonta | Liechtenstein | 31.10.2025 |
| EU/1/22/1695 | Zynlonta | Norwegia | 13.11.2025 |
ZAŁĄCZNIK IIIWykaz pozwoleń na dopuszczenie do obrotu, których obowiązywanie przedłużono
Wykaz pozwoleń na dopuszczenie do obrotu, których obowiązywanie przedłużono
W okresie od dnia 1 lipca do dnia 31 grudnia 2025 r. w państwach EFTA należących do EOG przedłużono następujące pozwolenia na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data |
| EU/1/13/907/021 | Adempas | Norwegia | 16.7.2025 |
| EU/1/19/1413/003-018 | Azacitidine Accord | Islandia | 17.10.2025 |
| EU/1/19/1413/003-018 | Azacitidine Accord | Norwegia | 9.10.2025 |
| EU/1/13/818/008-009 | Bosulif | Islandia | 14.7.2025 |
| EU/1/21/1576/002 | Brukinsa | Islandia | 15.10.2025 |
| EU/1/21/1576/002 | Brukinsa | Norwegia | 10.9.2025 |
| EU/1/24/1842/007-009 | Enzalutamide Viatris | Islandia | 15.12.2025 |
| EU/1/18/1324/011-012 | Jivi | Islandia | 14.7.2025 |
| EU/1/15/1024/004-005 | KEYTRUDA | Islandia | 15.12.2025 |
| EU/1/22/1649/003-004 | Lunsumio | Islandia | 15.12.2025 |
| EU/1/04/279/047-055 | Lyrica | Norwegia | 7.8.2025 |
| EU/1/24/1817/005-017 | Omlyclo | Islandia | 18.11.2025 |
| EU/1/24/1817/005-017 | Omlyclo | Norwegia | 9.12.2025 |
| EU/1/15/1014/005 | Opdivo | Islandia | 14.7.2025 |
| EU/1/24/1801/004-007 | Pyzchiva | Islandia | 15.10.2025 |
| EU/1/24/1801/004-007 | Pyzchiva | Norwegia | 27.8.2025 |
| EU/1/13/853/018-027 | Remsima | Islandia | 15.12.2025 |
| EU/1/13/853/018-027 | Remsima | Norwegia | 25.11.2025 |
| EU/1/14/967/002 | Rezolsta | Islandia | 28.7.2025 |
| EU/1/14/967/002 | Rezolsta | Norwegia | 6.8.2025 |
| EU/1/23/1779/003 | Rimmyrah | Norwegia | 2.9.2025 |
| EU/1/22/1688/003 | Spevigo | Islandia | 20.8.2025 |
| EU/1/22/1688/003 | Spevigo | Norwegia | 20.8.2025 |
| EU/1/20/1507/027-030 | Spikevax | Norwegia | 7.8.2025 |
| EU/1/19/1377/008-009 | Talzenna | Islandia | 14.7.2025 |
| EU/1/17/1234/010-011 | Tremfya | Norwegia | 20.10.2025 |
| EU/1/17/1234/012 | Tremfya | Norwegia | 20.12.2025 |
| EU/1/20/1500/006-008 | Xofluza | Islandia | 22.8.2025 |
| EU/1/20/1500/006-008 | Xofluza | Norwegia | 1.9.2025 |
ZAŁĄCZNIK IVWykaz wycofanych pozwoleń na dopuszczenie do obrotu
Wykaz wycofanych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2025 r. w państwach EFTA należących do EOG wycofano następujące pozwolenia na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data |
| EU/1/24/1880 | Absimky | Liechtenstein | 31.12.2025 |
| EU/1/24/1880 | Absimky | Norwegia | 15.12.2025 |
| EU/1/24/1838 | Beqvez | Islandia | 10.7.2025 |
| EU/1/09/565 | Biopoin | Islandia | 1.9.2025 |
| EU/1/09/565 | Biopoin | Liechtenstein | 31.8.2025 |
| EU/1/09/565 | Biopoin | Norwegia | 18.8.2025 |
| EU/1/16/1114 | Bortezomib Hospira | Islandia | 29.8.2025 |
| EU/1/16/1114 | Bortezomib Hospira | Liechtenstein | 31.8.2025 |
| EU/1/16/1114 | Bortezomib Hospira | Norwegia | 14.8.2025 |
| EU/1/21/1534 | BroPair Spiromax | Islandia | 9.7.2025 |
| EU/1/21/1534 | BroPair Spiromax | Norwegia | 12.8.2025 |
| EU/1/11/696 | Bydureon | Islandia | 11.12.2025 |
| EU/1/11/696 | Bydureon | Liechtenstein | 30.11.2025 |
| EU/1/11/696 | Bydureon | Norwegia | 10.12.2025 |
| EU/1/06/362 | Byetta | Liechtenstein | 30.11.2025 |
| EU/1/21/1560 | Celsunax | Islandia | 24.7.2025 |
| EU/1/21/1542 | Copiktra | Islandia | 19.12.2025 |
| EU/1/21/1542 | Copiktra | Liechtenstein | 31.1.2025 (1) |
| EU/1/21/1542 | Copiktra | Norwegia | 19.12.2025 |
| EU/1/18/1338 | Dengvaxia | Islandia | 4.11.2025 |
| EU/1/18/1338 | Dengvaxia | Liechtenstein | 31.10.2025 |
| EU/1/18/1338 | Dengvaxia | Norwegia | 17.10.2025 |
| EU/1/19/1418 | Dexmedetomidine Accord | Islandia | 4.9.2025 |
| EU/2/98/010 | Econor | Islandia | 29.8.2025 |
| EU/2/98/010 | Econor | Liechtenstein | 31.8.2025 |
| EU/2/98/010 | Econor | Norwegia | 14.8.2025 |
| EU/1/24/1858 | Eksunbi | Islandia | 1.9.2025 |
| EU/1/24/1858 | Eksunbi | Liechtenstein | 31.8.2025 |
| EU/1/24/1858 | Eksunbi | Norwegia | 26.8.2025 |
| EU/1/22/1651 | Evusheld | Islandia | 16.10.2025 |
| EU/1/22/1651 | Evusheld | Liechtenstein | 30.9.2025 |
| EU/1/22/1651 | Evusheld | Norwegia | 11.9.2025 |
| EU/2/19/238 | Felisecto Plus | Islandia | 29.8.2025 |
| EU/2/19/238 | Felisecto Plus | Liechtenstein | 31.7.2025 |
| EU/2/19/238 | Felisecto Plus | Norwegia | 14.8.2025 |
| EU/1/13/887 | Fluenz Tetra | Islandia | 17.7.2025 |
| EU/1/13/887 | Fluenz Tetra | Liechtenstein | 31.7.2025 |
| EU/1/13/887 | Fluenz Tetra | Norwegia | 12.8.2025 |
| EU/1/13/896 | Granupas | Liechtenstein | 31.12.2025 |
| EU/1/13/896 | Granupas | Norwegia | 17.12.2025 |
| EU/1/11/685 | Ibandronic acid Sandoz | Islandia | 4.9.2025 |
| EU/1/11/685 | Ibandronic acid Sandoz | Liechtenstein | 31.12.2025 |
| EU/1/99/109 | Integrilin | Liechtenstein | 31.12.2025 |
| EU/1/99/109 | Integrilin | Norwegia | 26.11.2025 |
| EU/1/02/214 | Kinzalkomb | Islandia | 16.10.2025 |
| EU/1/02/214 | Kinzalkomb | Liechtenstein | 30.9.2025 |
| EU/1/02/214 | Kinzalkomb | Norwegia | 9.10.2025 |
| EU/1/12/811 | Lyxumia | Liechtenstein | 31.12.2025 |
| EU/1/12/811 | Lyxumia | Norwegia | 18.12.2025 |
| EU/1/04/292 | Mimpara | Norwegia | 18.12.2025 |
| EU/2/17/220 | MiPet Easecto | Islandia | 16.10.2025 |
| EU/2/17/220 | MiPet Easecto | Liechtenstein | 31.8.2025 |
| EU/2/17/220 | MiPet Easecto | Norwegia | 18.9.2025 |
| EU/1/00/164 | NutropinAq | Islandia | 5.11.2025 |
| EU/1/00/164 | NutropinAq | Liechtenstein | 31.10.2025 |
| EU/1/00/164 | NutropinAq | Norwegia | 5.11.2025 |
| EU/1/10/635 | Olanzapine Apotex | Islandia | 15.10.2025 |
| EU/1/10/635 | Olanzapine Apotex | Liechtenstein | 31.8.2025 |
| EU/1/10/635 | Olanzapine Apotex | Norwegia | 15.9.2025 |
| EU/1/15/1018 | Omidria | Islandia | 18.11.2025 |
| EU/1/15/1018 | Omidria | Liechtenstein | 30.11.2025 |
| EU/1/15/1018 | Omidria | Norwegia | 8.12.2025 |
| EU/1/21/1578 | Ontilyv | Islandia | 24.7.2025 |
| EU/1/02/215 | PritorPlus | Islandia | 17.10.2025 |
| EU/1/02/215 | PritorPlus | Liechtenstein | 31.10.2025 |
| EU/1/02/215 | PritorPlus | Norwegia | 5.11.2025 |
| EU/1/21/1601 | Ronapreve | Liechtenstein | 31.12.2025 |
| EU/1/19/1369 | Sixmo | Islandia | 9.7.2025 |
| EU/1/19/1369 | Sixmo | Norwegia | 3.7.2025 |
| EU/1/99/111 | Stocrin | Islandia | 1.9.2025 |
| EU/1/99/111 | Stocrin | Liechtenstein | 31.8.2025 |
| EU/1/99/111 | Stocrin | Norwegia | 18.8.2025 |
| EU/1/04/282 | Telzir | Islandia | 11.12.2025 |
| EU/1/04/282 | Telzir | Liechtenstein | 30.11.2025 |
| EU/1/04/282 | Telzir | Norwegia | 21.11.2025 |
| EU/1/13/872 | Tybost | Islandia | 17.10.2025 |
| EU/1/13/872 | Tybost | Liechtenstein | 30.9.2025 |
| EU/1/13/872 | Tybost | Norwegia | 9.10.2025 |
| (1) W sposób niezamierzony nie uwzględniono tego pozwolenia w wykazie pozwoleń w pierwszej połowie 2025 r. | |||
ZAŁĄCZNIK VWykaz zawieszonych pozwoleń na dopuszczenie do obrotu
Wykaz zawieszonych pozwoleń na dopuszczenie do obrotu
W okresie od dnia 1 lipca do dnia 31 grudnia 2025 r. w państwach EFTA należących do EOG zawieszono następujące pozwolenia na dopuszczenie do obrotu:
| Numer UE | Produkt | Państwo | Data zawieszenia pozwolenia |
Metryka aktu
| Identyfikator: | Dz.U.UE.C.2026.3563 |
| Rodzaj: | informacja |
| Tytuł: | PODKOMITET I DS. SWOBODNEGO PRZEPŁYWU TOWARÓW - PRODUKTY LECZNICZE - WYKAZ POZWOLEŃ NA DOPUSZCZENIE DO OBROTU UDZIELONYCH PRZEZ PAŃSTWA EOG-EFTA W DRUGIM PÓŁROCZU 2025 R. - Do wiadomości Wspólnego Komitetu EOG |
| Data aktu: | 2026-07-02 |
| Data ogłoszenia: | 2026-07-02 |