|
30.8.2018 |
SK |
Úradný vestník Európskej únie |
C 305/15 |
Lieky – Zoznam povolení na uvedenie na trh udelených štátmi EZVO, ktoré sú členmi EHP, za druhý polrok 2017
(2018/C 305/12)
Podvýbor I pre voľný pohyb tovaru
Na vedomie Spoločnému výboru EHP
So zreteľom na rozhodnutie Spoločného výboru EHP č. 74/1999 z 28. mája 1999 sa Spoločný výbor EHP vyzýva, aby na svojom zasadnutí 23. marca 2018 vzal na vedomie tieto zoznamy povolení na uvedenie liekov na trh za obdobie od 1. júla do 31. decembra 2017:
|
Príloha I |
Zoznam nových povolení |
|
Príloha II |
Zoznam povolení, ktorých platnosť bola obnovená |
|
Príloha III |
Zoznam povolení, ktorých platnosť bola predĺžená |
|
Príloha IV |
Zoznam povolení, ktoré boli zrušené |
|
Príloha V |
Zoznam povolení, ktorých platnosť bola pozastavená |
PRÍLOHA I
Zoznam nových povolení
V období od 1. júla do 31. decembra 2017 boli v štátoch EZVO, ktoré sú členmi EHP, udelené tieto povolenia:
|
Číslo EÚ |
Výrobok |
Krajina |
Dátum udelenia povolenia |
|
EÚ/1/02/226 |
InductOs |
Island |
18. 8. 2017 |
|
EÚ/1/15/999 |
Zykadia (Zmena na nepodmienené povolenie) |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/16/1138 |
Venclyxto |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/16/1155 |
Kyntheum |
Island |
16. 8. 2017 |
|
EÚ/1/16/1155 |
Kyntheum |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/16/1155 |
Kyntheum |
Nórsko |
14. 8. 2017 |
|
EÚ/1/17/1179 |
Veltassa |
Island |
11. 8. 2017 |
|
EÚ/1/17/1179 |
Veltassa |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1179 |
Veltassa |
Nórsko |
9. 8. 2017 |
|
EÚ/1/17/1181 |
Spherox |
Island |
24. 7. 2017 |
|
EÚ/1/17/1181 |
Spherox |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1181 |
Spherox |
Nórsko |
13. 9. 2017 |
|
EÚ/1/17/1184 |
Riximyo |
Island |
11. 7. 2017 |
|
EÚ/1/17/1185 |
Rixathon |
Island |
11. 7. 2017 |
|
EÚ/1/17/1191 |
Dinutuximab beta Apeiron |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1194 |
Febuxostat Mylan |
Island |
11. 7. 2017 |
|
EÚ/1/17/1195 |
Erelzi |
Island |
14. 7. 2017 |
|
EÚ/1/17/1195 |
Erelzi |
Nórsko |
7. 7. 2017 |
|
EÚ/1/17/1196 |
Kevzara |
Island |
14. 7. 2017 |
|
EÚ/1/17/1196 |
Kevzara |
Nórsko |
5. 7. 2017 |
|
EÚ/1/17/1197 |
Oxervate |
Island |
24. 7. 2017 |
|
EÚ/1/17/1197 |
OXERVATE |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1197 |
OXERVATE |
Nórsko |
17. 7. 2017 |
|
EÚ/1/17/1199 |
Cuprior |
Island |
13. 9. 2017 |
|
EÚ/1/17/1199 |
Cuprior |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1199 |
Cuprior |
Nórsko |
13. 9. 2017 |
|
EÚ/1/17/1200 |
Besponsa |
Island |
24. 7. 2017 |
|
EÚ/1/17/1200 |
Besponsa |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1200 |
Besponsa |
Nórsko |
13. 7. 2017 |
|
EÚ/1/17/1201 |
Skilarence |
Island |
14. 7. 2017 |
|
EÚ/1/17/1201 |
Skilarence |
Nórsko |
7. 7. 2017 |
|
EÚ/1/17/1202 |
Ucedane |
Island |
12. 7. 2017 |
|
EÚ/1/17/1202 |
Ucedane |
Nórsko |
5. 7. 2017 |
|
EÚ/1/17/1203 |
Insulin lispro Sanofi |
Island |
11. 8. 2017 |
|
EÚ/1/17/1203 |
Insulin Lispro Sanofi |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1203 |
Insulin lispro Sanofi |
Nórsko |
18. 8. 2017 |
|
EÚ/1/17/1205 |
Blitzima |
Island |
9. 8. 2017 |
|
EÚ/1/17/1205 |
Blitzima |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1205 |
Blitzima |
Nórsko |
1. 8. 2017 |
|
EÚ/1/17/1206 |
Tuxella |
Island |
9. 8. 2017 |
|
EÚ/1/17/1206 |
Tuxella |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1206 |
Tuxella |
Nórsko |
1. 8. 2017 |
|
EÚ/1/17/1207 |
Ritemvia |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1207 |
Ritemvia |
Island |
10. 8. 2017 |
|
EÚ/1/17/1207 |
Ritemvia |
Nórsko |
1. 8. 2017 |
|
EÚ/1/17/1208 |
Trimbow |
Island |
11. 8. 2017 |
|
EÚ/1/17/1208 |
Trimbow |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1208 |
Trimbow |
Nórsko |
9. 8. 2017 |
|
EÚ/1/17/1209 |
Reagila |
Island |
9. 8. 2017 |
|
EÚ/1/17/1209 |
Reagila |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1209 |
Reaglia |
Nórsko |
9. 8. 2017 |
|
EÚ/1/17/1210 |
Efavirenz/Emtricitabin/Tenofovirdisproksil Zentiva |
Nórsko |
8. 8. 2017 |
|
EÚ/1/17/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Island |
10. 8. 2017 |
|
EÚ/1/17/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1211 |
Entecavir Accord |
Island |
5. 10. 2017 |
|
EÚ/1/17/1211 |
Entecavir Accord |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1211 |
Entecavir Accord |
Nórsko |
20. 10. 2017 |
|
EÚ/1/17/1212 |
Mavenclad |
Island |
13. 9. 2017 |
|
EÚ/1/17/1212 |
MAVENCLAD |
Nórsko |
30. 8. 2017 |
|
EÚ/1/17/1212 |
MAVENCLAD |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1213 |
Maviret |
Island |
17. 8. 2017 |
|
EÚ/1/17/1213 |
Maviret |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1213 |
Maviret |
Nórsko |
7. 8. 2017 |
|
EÚ/1/17/1214 |
Bavencio |
Island |
4. 10. 2017 |
|
EÚ/1/17/1214 |
Bavencio |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1214 |
Bavencio |
Nórsko |
25. 9. 2017 |
|
EÚ/1/17/1215 |
Fotivda |
Island |
13. 9. 2017 |
|
EÚ/1/17/1215 |
Fotivda |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1215 |
Fotivda |
Nórsko |
31. 8. 2017 |
|
EÚ/1/17/1216 |
Imraldi |
Island |
12. 9. 2017 |
|
EÚ/1/17/1216 |
Imraldi |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1216 |
Imraldi |
Nórsko |
11. 9. 2017 |
|
EÚ/1/17/1217 |
Nitisinone MendeliKABS |
Island |
19. 9. 2017 |
|
EÚ/1/17/1217 |
Nitisinone MendeliKABS |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1217 |
Nitisinone MendeliKABS |
Nórsko |
1. 9. 2017 |
|
EÚ/1/17/1218 |
Rydapt |
Island |
4. 10. 2017 |
|
EÚ/1/17/1218 |
Rydapt |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1218 |
Rydapt |
Nórsko |
25. 9. 2017 |
|
EÚ/1/17/1220 |
Tecentriq |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1220 |
Tecentriq |
Nórsko |
27. 9. 2017 |
|
EÚ/1/17/1220 |
Tecentriq |
Island |
5. 10. 2017 |
|
EÚ/1/17/1221 |
Kisqali |
Island |
12. 9. 2017 |
|
EÚ/1/17/1221 |
Kisqali |
Nórsko |
30. 8. 2017 |
|
EÚ/1/17/1221 |
Kisqali |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Island |
8. 11. 2017 |
|
EÚ/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Nórsko |
27. 9. 2017 |
|
EÚ/1/17/1223 |
Vosevi |
Island |
16. 8. 2017 |
|
EÚ/1/17/1223 |
Vosevi |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/17/1223 |
Vosevi |
Nórsko |
8. 8. 2017 |
|
EÚ/1/17/1224 |
Xermelo |
Island |
4. 10. 2017 |
|
EÚ/1/17/1224 |
Xermelo |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1224 |
Xermelo |
Nórsko |
3. 10. 2017 |
|
EÚ/1/17/1225 |
Symtuza |
Island |
5. 10. 2017 |
|
EÚ/1/17/1225 |
Symtuza |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1225 |
Symtuza |
Nórsko |
11. 10. 2017 |
|
EÚ/1/17/1226 |
Lutathera |
Island |
10. 10. 2017 |
|
EÚ/1/17/1226 |
Lutathera |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1226 |
Lutathera |
Nórsko |
3. 10. 2017 |
|
EÚ/1/17/1227 |
Entecavir Mylan |
Island |
4. 10. 2017 |
|
EÚ/1/17/1227 |
Entecavir Mylan |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1227 |
Entecavir Mylan |
Nórsko |
27. 9. 2017 |
|
EÚ/1/17/1228 |
Tookad |
Island |
29. 11. 2017 |
|
EÚ/1/17/1228 |
TOOKAD |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1228 |
TOOKAD |
Nórsko |
22. 11. 2017 |
|
EÚ/1/17/1229 |
Dupixent |
Island |
10. 10. 2017 |
|
EÚ/1/17/1229 |
Dupixent |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1229 |
Dupixent |
Nórsko |
10. 10. 2017 |
|
EÚ/1/17/1230 |
Lacosamide Accord |
Island |
5. 10. 2017 |
|
EÚ/1/17/1230 |
Lacosamide Accord |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/17/1230 |
Lacosamide Accord |
Nórsko |
27. 9. 2017 |
|
EÚ/1/17/1232 |
Miglustat Gen.Orph |
Island |
30. 11. 2017 |
|
EÚ/1/17/1232 |
Miglustat Gen.Orph |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1232 |
Miglustat Gen.Orph |
Nórsko |
27. 11. 2017 |
|
EÚ/1/17/1233 |
Zubsolv |
Island |
29. 11. 2017 |
|
EÚ/1/17/1233 |
Zubsolv |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1233 |
Zubsolv |
Nórsko |
22. 11. 2017 |
|
EÚ/1/17/1234 |
Tremfya |
Island |
4. 12. 2017 |
|
EÚ/1/17/1235 |
Zejula |
Island |
4. 12. 2017 |
|
EÚ/1/17/1235 |
Zejula |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1235 |
Zejula |
Nórsko |
27. 11. 2017 |
|
EÚ/1/17/1236 |
Trelegy Ellipta |
Island |
30. 11. 2017 |
|
EÚ/1/17/1236 |
Trelegy Ellipta |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1236 |
Trelegy Ellipta |
Nórsko |
22. 11. 2017 |
|
EÚ/1/17/1237 |
Elebrato Ellipta |
Island |
30. 11. 2017 |
|
EÚ/1/17/1237 |
Elebrato Ellipta |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1237 |
Elebrato Ellipta |
Nórsko |
27. 11. 2017 |
|
EÚ/1/17/1238 |
Nyxoid |
Island |
29. 11. 2017 |
|
EÚ/1/17/1238 |
Nyxoid |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1238 |
Nyxoid |
Nórsko |
27. 11. 2017 |
|
EÚ/1/17/1239 |
VeraSeal |
Island |
30. 11. 2017 |
|
EÚ/1/17/1239 |
VeraSeal |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1239 |
VeraSeal |
Nórsko |
1. 12. 2017 |
|
EÚ/1/17/1240 |
Cyltezo |
Island |
29. 11. 2017 |
|
EÚ/1/17/1240 |
Cyltezo |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1240 |
Cyltezo |
Nórsko |
1. 12. 2017 |
|
EÚ/1/17/1241 |
Ontruzant |
Island |
30. 11. 2017 |
|
EÚ/1/17/1241 |
Ontruzant |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1241 |
Ontruzant |
Nórsko |
27. 11. 2017 |
|
EÚ/1/17/1242 |
Ritonavir Mylan |
Island |
29. 11. 2017 |
|
EÚ/1/17/1242 |
Ritonavir Mylan |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1242 |
Ritonavir Mylan |
Nórsko |
22. 11. 2017 |
|
EÚ/1/17/1243 |
Imatinib Teva B.V. |
Island |
30. 11. 2017 |
|
EÚ/1/17/1243 |
Imatinib Teva B.V. |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/17/1243 |
Imatinib Teva B.V. |
Nórsko |
22. 11. 2017 |
|
EÚ/1/17/1244 |
Tacforius |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/2/16/197 |
CLYNAV |
Island |
13. 7. 2017 |
|
EÚ/2/16/197 |
CLYNAV |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/2/16/197 |
CLYNAV |
Nórsko |
18. 7. 2017 |
|
EÚ/2/17/211 |
Prevomax |
Island |
13. 7. 2017 |
|
EÚ/2/17/211 |
Prevomax |
Nórsko |
6. 7. 2017 |
|
EÚ/2/17/212 |
Exzolt |
Island |
30. 8. 2017 |
|
EÚ/2/17/212 |
Exzolt |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/2/17/212 |
Exzolt |
Nórsko |
15. 9. 2017 |
|
EÚ/2/17/213 |
Innovax-ND-IBD |
Island |
11. 9. 2017 |
|
EÚ/2/17/213 |
Innovax-ND-IBD |
Nórsko |
18. 9. 2017 |
|
EÚ/2/17/214 |
VEPURED |
Island |
12. 9. 2017 |
|
EÚ/2/17/214 |
VEPURED |
Nórsko |
15. 9. 2017 |
|
EÚ/2/17/215 |
Suvaxyn PRRS MLV |
Island |
11. 9. 2017 |
|
EÚ/2/17/215 |
Suvaxyn PRRS MLV |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/2/17/215 |
Suvaxyn PRRS MLV |
Nórsko |
18. 9. 2017 |
|
EÚ/2/17/217 |
Nobivac LeuFel |
Island |
9. 11. 2017 |
|
EÚ/2/17/217 |
Nobivac LeuFel |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/2/17/217 |
Nobivac LeuFel |
Nórsko |
14. 11. 2017 |
|
EÚ/2/17/218 |
Bovilis Blue-8 |
Island |
1. 12. 2017 |
|
EÚ/2/17/218 |
Bovilis Blue-8 |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/2/17/218 |
Bovilis Blue-8 |
Nórsko |
19. 12. 2017 |
PRÍLOHA II
Zoznam povolení, ktorých platnosť bola obnovená
V období od 1. júla do 31. decembra 2017 bola v štátoch EZVO, ktoré sú členmi EHP, obnovená platnosť týchto povolení:
|
Číslo EÚ |
Výrobok |
Krajina |
Dátum udelenia povolenia |
|
EÚ/1/07/401 |
alli |
Island |
14. 7. 2017 |
|
EÚ/1/07/401 |
alli |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/07/401 |
alli |
Nórsko |
5. 7. 2017 |
|
EÚ/1/07/402 |
Increlex |
Island |
12. 7. 2017 |
|
EÚ/1/07/402 |
INCRELEX |
Nórsko |
5. 7. 2017 |
|
EÚ/1/07/403 |
Atriance |
Island |
11. 7. 2017 |
|
EÚ/1/07/416 |
Ecalta |
Island |
13. 9. 2017 |
|
EÚ/1/07/416 |
Ecalta |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/07/416 |
Ecalta |
Nórsko |
22. 9. 2017 |
|
EÚ/1/07/421 |
Glubrava |
Island |
30. 11. 2017 |
|
EÚ/1/07/421 |
Glubrava |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/07/421 |
Glubrava |
Nórsko |
22. 11. 2017 |
|
EÚ/1/07/424 |
Torisel |
Island |
24. 7. 2017 |
|
EÚ/1/07/424 |
Torisel |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/07/424 |
Torisel |
Nórsko |
1. 8. 2017 |
|
EÚ/1/08/446 |
Privigen |
Island |
4. 12. 2017 |
|
EÚ/1/08/446 |
Privigen |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/08/446 |
Privigen |
Nórsko |
5. 12. 2017 |
|
EÚ/1/08/453 |
Prepandrix |
Island |
4. 12. 2017 |
|
EÚ/1/08/453 |
Prepandrix |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/08/453 |
Prepandrix |
Nórsko |
5. 12. 2017 |
|
EÚ/1/12/784 |
Cuprymina |
Island |
11. 8. 2017 |
|
EÚ/1/12/784 |
Cuprymina |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/12/784 |
Cuprymina |
Nórsko |
9. 8. 2017 |
|
EÚ/1/12/787 |
Revestive |
Island |
13. 7. 2017 |
|
EÚ/1/12/787 |
Revestive |
Nórsko |
5. 7. 2017 |
|
EÚ/1/12/788 |
Seebri Breezhaler |
Island |
11. 8. 2017 |
|
EÚ/1/12/788 |
Seebri Breezhaler |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/12/788 |
Seebri Breezhaler |
Nórsko |
9. 8. 2017 |
|
EÚ/1/12/789 |
Enurev Breezhaler |
Island |
24. 7. 2017 |
|
EÚ/1/12/789 |
Enurev Breezhaler |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/12/789 |
Enurev Breezhaler |
Nórsko |
9. 8. 2017 |
|
EÚ/1/12/790 |
Tovanor Breezhaler |
Island |
14. 8. 2017 |
|
EÚ/1/12/790 |
Tovanor Breezhaler |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/12/790 |
Tovanor Breezhaler |
Nórsko |
9. 8. 2017 |
|
EÚ/1/12/794 |
Adcetris |
Island |
4. 12. 2017 |
|
EÚ/1/12/794 |
ADCETRIS |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/12/794 |
ADCETRIS |
Nórsko |
27. 11. 2017 |
|
EÚ/1/12/795 |
Forxiga |
Island |
13. 9. 2017 |
|
EÚ/1/12/795 |
Forxiga |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/795 |
Forxiga |
Nórsko |
27. 9. 2017 |
|
EÚ/1/12/796 |
Picato |
Island |
24. 7. 2017 |
|
EÚ/1/12/796 |
Picato |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/12/796 |
Picato |
Nórsko |
8. 8. 2017 |
|
EÚ/1/12/797 |
Eylea |
Island |
10. 8. 2017 |
|
EÚ/1/12/797 |
Eylea |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/12/797 |
Eylea |
Nórsko |
18. 8. 2017 |
|
EÚ/1/12/798 |
Ibandronic acid Accord |
Island |
6. 10. 2017 |
|
EÚ/1/12/798 |
Ibandronic acid Accord |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/798 |
Ibandronic acid Accord |
Nórsko |
27. 9. 2017 |
|
EÚ/1/12/799 |
Memantine Merz |
Island |
24. 7. 2017 |
|
EÚ/1/12/799 |
Memantine Merz |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/12/799 |
Memantine Merz |
Nórsko |
9. 8. 2017 |
|
EÚ/1/12/800 |
Zoledronic Acid Hospira |
Island |
11. 9. 2017 |
|
EÚ/1/12/800 |
Zoledronic acid Hospira |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/12/800 |
Zoledronsyre Hospira |
Nórsko |
4. 9. 2017 |
|
EÚ/1/12/801 |
Constella |
Island |
14. 9. 2017 |
|
EÚ/1/12/801 |
Constella |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/801 |
Constella |
Nórsko |
22. 9. 2017 |
|
EÚ/1/12/802 |
Capecitabine medac |
Island |
12. 7. 2017 |
|
EÚ/1/12/803 |
NexoBrid |
Island |
30. 11. 2017 |
|
EÚ/1/12/803 |
NexoBrid |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/12/803 |
NexoBrid |
Nórsko |
11. 12. 2017 |
|
EÚ/1/12/805 |
AMYViD |
Island |
9. 10. 2017 |
|
EÚ/1/12/805 |
Amyvid |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/805 |
Amyvid |
Nórsko |
3. 10. 2017 |
|
EÚ/1/12/806 |
Ryzodeg |
Island |
4. 10. 2017 |
|
EÚ/1/12/806 |
Ryzodeg |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/806 |
Ryzodeg |
Nórsko |
10. 10. 2017 |
|
EÚ/1/12/807 |
Tresiba |
Island |
9. 10. 2017 |
|
EÚ/1/12/807 |
Tresiba |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/807 |
Tresiba |
Nórsko |
10. 10. 2017 |
|
EÚ/1/12/808 |
Imatinib Teva |
Island |
9. 10. 2017 |
|
EÚ/1/12/808 |
Imatinib Teva |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/808 |
Imatinib Teva |
Nórsko |
27. 9. 2017 |
|
EÚ/1/12/809 |
Betmiga |
Island |
6. 10. 2017 |
|
EÚ/1/12/809 |
Betmiga |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/809 |
Betmiga |
Nórsko |
3. 10. 2017 |
|
EÚ/1/12/811 |
Lyxumia |
Island |
6. 10. 2017 |
|
EÚ/1/12/811 |
Lyxumia |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/811 |
Lyxumia |
Nórsko |
9. 10. 2017 |
|
EÚ/1/12/812 |
Bexsero |
Island |
9. 10. 2017 |
|
EÚ/1/12/812 |
Bexsero |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/812 |
Bexsero |
Nórsko |
3. 10. 2017 |
|
EÚ/1/12/814 |
Zaltrap |
Island |
9. 10. 2017 |
|
EÚ/1/12/814 |
ZALTRAP |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/12/814 |
ZALTRAP |
Nórsko |
27. 9. 2017 |
|
EÚ/1/12/815 |
Selincro |
Island |
30. 11. 2017 |
|
EÚ/1/12/815 |
Selincro |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/12/815 |
Selincro |
Nórsko |
1. 12. 2017 |
|
EÚ/1/13/813 |
Perjeta |
Island |
19. 12. 2017 |
|
EÚ/1/13/813 |
Perjeta |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/13/817 |
Actelsar HCT |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/13/819 |
JETREA |
Island |
15. 12. 2017 |
|
EÚ/1/13/819 |
JETREA |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/13/819 |
JETREA |
Nórsko |
19. 12. 2017 |
|
EÚ/1/13/902 |
Translarna |
Island |
12. 7. 2017 |
|
EÚ/1/13/902 |
Translarna |
Nórsko |
5. 7. 2017 |
|
EÚ/1/14/987 |
Holoclar |
Island |
19. 12. 2017 |
|
EÚ/1/16/1094 |
Ninlaro |
Island |
6. 10. 2017 |
|
EÚ/1/16/1094 |
Ninlaro |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/16/1094 |
Ninlaro |
Nórsko |
26. 9. 2017 |
|
EÚ/1/16/1121 |
Zalmoxis |
Island |
24. 7. 2017 |
|
EÚ/1/16/1121 |
Zalmoxis |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/16/1121 |
Zalmoxis |
Nórsko |
4. 8. 2017 |
|
EÚ/1/16/1138 |
Venclyxto |
Island |
6. 11. 2017 |
|
EÚ/1/16/1138 |
Venclyxto |
Nórsko |
14. 11. 2017 |
|
EÚ/1/16/1139 |
Ocaliva |
Island |
8. 12. 2017 |
|
EÚ/1/16/1139 |
OCALIVA |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/16/1139 |
OCALIVA |
Nórsko |
18. 12. 2017 |
|
EÚ/1/16/1143 |
Lartruvo |
Island |
6. 10. 2017 |
|
EÚ/1/16/1143 |
Lartruvo |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/16/1143 |
Lartruvo |
Nórsko |
27. 9. 2017 |
|
EÚ/1/16/1169 |
Alecensa |
Island |
8. 12. 2017 |
|
EÚ/1/16/1169 |
Alecensa |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/16/1169 |
Alecensa |
Nórsko |
15. 12. 2017 |
|
EÚ/1/43/890 |
Cometriq |
Nórsko |
3. 8. 2017 |
|
EÚ/2/12/142 |
Cardalis |
Island |
4. 7. 2017 |
|
EÚ/2/12/144 |
Contacera |
Island |
5. 12. 2017 |
|
EÚ/2/12/144 |
Contacera |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/2/12/144 |
Contacera |
Nórsko |
15. 12. 2017 |
|
EÚ/2/12/145 |
Kexxtone |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/2/12/145 |
Kexxtone |
Nórsko |
28. 12. 2017 |
|
EÚ/2/12/147 |
Pexion |
Island |
5. 12. 2017 |
|
EÚ/2/12/147 |
Pexion |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/2/12/147 |
Pexion |
Nórsko |
6. 12. 2017 |
PRÍLOHA III
Zoznam povolení, ktorých platnosť bola predĺžená
V období od 1. júla do 31. decembra 2017 bola v štátoch EZVO, ktoré sú členmi EHP, predĺžená platnosť týchto povolení:
|
Číslo EÚ |
Výrobok |
Krajina |
Dátum udelenia povolenia |
|
EÚ/1/01/177/002 |
SonoVue |
Nórsko |
4. 9. 2017 |
|
EÚ/1/03/256/022 |
Humira |
Island |
19. 12. 2017 |
|
EÚ/1/03/256/022 |
Humira |
Nórsko |
10. 11. 2017 |
|
EÚ/1/04/292/013-015 |
Mimpara |
Island |
15. 9. 2017 |
|
EÚ/1/04/292/013-015 |
Mimpara |
Nórsko |
28. 8. 2017 |
|
EÚ/1/06/356/020-022 |
Exjade |
Nórsko |
28. 11. 2017 |
|
EÚ/1/06/356/020-022 |
Exjade |
Island |
1. 12. 2017 |
|
EÚ/1/07/418/011-013 |
Celsentri |
Nórsko |
3. 8. 2017 |
|
EÚ/1/07/418/011-013 |
Celsentri |
Island |
13. 7. 2017 |
|
EÚ/1/07/422/015 |
Tasigna |
Island |
4. 12. 2017 |
|
EÚ/1/07/422/015 |
Tasigna |
Nórsko |
28. 11. 2017 |
|
EÚ/1/07/436/006 |
Isentress |
Island |
9. 8. 2017 |
|
EÚ/1/07/436/006 |
Isentress |
Nórsko |
7. 8. 2017 |
|
EÚ/1/08/481/004-005 |
Kuvan |
Island |
10. 8. 2017 |
|
EÚ/1/08/481/004-005 |
Kuvan |
Nórsko |
13. 7. 2017 |
|
EÚ/1/09/522/003 |
ellaOne |
Island |
1. 12. 2017 |
|
EÚ/1/09/522/003 |
ellaOne |
Nórsko |
10. 11. 2017 |
|
EÚ/1/09/531/022-033 |
Instanyl |
Island |
6. 11. 2017 |
|
EÚ/1/09/539/005-006 |
Samsca |
Island |
5. 10. 2017 |
|
EÚ/1/09/539/005-006 |
Samsca |
Nórsko |
18. 9. 2017 |
|
EÚ/1/10/618 |
Prolia |
Nórsko |
27. 9. 2017 |
|
EÚ/1/11/703 |
Xgeva |
Nórsko |
27. 9. 2017 |
|
EÚ/1/12/753/018-019 |
Signifor |
Island |
4. 10. 2017 |
|
EÚ/1/12/753/018-019 |
Signifor |
Nórsko |
18. 9. 2017 |
|
EÚ/1/12/787/003 |
Revestive |
Nórsko |
5. 7. 2017 |
|
EÚ/1/12/787/003 |
Revestive |
Island |
13. 7. 2017 |
|
EÚ/1/13/846/002-003 |
Xtandi |
Nórsko |
3. 10. 2017 |
|
EÚ/1/13/846/002-003 |
Xtandi |
Island |
6. 10. 2017 |
|
EÚ/1/13/860/003 |
Nexium Control |
Island |
11. 7. 2017 |
|
EÚ/1/13/860/003 |
Nexium Control |
Nórsko |
5. 7. 2017 |
|
EÚ/1/15/1070/002 |
Oncaspar |
Island |
19. 12. 2017 |
PRÍLOHA IV
Zoznam povolení, ktoré boli zrušené
V období od 1. júla do 31. decembra 2017 bola v štátoch EZVO, ktoré sú členmi EHP, zrušená platnosť týchto povolení:
|
Číslo EÚ |
Výrobok |
Krajina |
Dátum zrušenia povolenia |
|
EÚ/1/00/167 |
Prevenar |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/00/167 |
Prevenar |
Nórsko |
11. 12. 2017 |
|
EÚ/1/00/167 |
Prevenar |
Island |
1. 12. 2017 |
|
EÚ/1/07/394 |
Optaflu |
Nórsko |
18. 10. 2017 |
|
EÚ/1/07/398 |
Optimark |
Island |
10. 10. 2017 |
|
EÚ/1/09/561 |
Clopidogrel Teva Pharma |
Island |
11. 7. 2017 |
|
EÚ/1/11/674 |
Repso |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/11/674 |
Repso |
Nórsko |
8. 8. 2017 |
|
EÚ/1/11/674 |
Repso |
Island |
10. 8. 2017 |
|
EÚ/1/13/868 |
EVARREST |
Lichtenštajnsko |
31. 12. 2017 |
|
EÚ/1/13/868 |
EVARREST |
Nórsko |
28. 11. 2017 |
|
EÚ/1/13/868 |
EVARREST |
Island |
4. 12. 2017 |
|
EÚ/1/14/976 |
Zontivity |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/15/996 |
Ristempa |
Lichtenštajnsko |
31. 10. 2017 |
|
EÚ/1/15/996 |
Ristempa |
Nórsko |
9. 10. 2017 |
|
EÚ/1/15/996 |
Ristempa |
Island |
9. 10. 2017 |
|
EÚ/1/16/1113 |
Enzepi |
Island |
11. 8. 2017 |
|
EÚ/1/16/1113 |
Enzepi |
Lichtenštajnsko |
31. 8. 2017 |
|
EÚ/1/16/1113 |
Enzepi |
Nórsko |
8. 8. 2017 |
PRÍLOHA V
Zoznam povolení, ktorých platnosť bola pozastavená
V období od 1. júla do 31. decembra 2017 bola v štátoch EZVO, ktoré sú členmi EHP, pozastavená platnosť týchto povolení:
|
Číslo EÚ |
Výrobok |
Krajina |
Dátum pozastavenia povolenia |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|