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Document E2018G0614(01)
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2017
Vaistai. EEE ELPA valstybių 2017 m. pirmajam pusmečiui suteiktų rinkodaros leidimų sąrašas
Vaistai. EEE ELPA valstybių 2017 m. pirmajam pusmečiui suteiktų rinkodaros leidimų sąrašas
OJ C 205, 14.6.2018, p. 7–26
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
14.6.2018 |
LT |
Europos Sąjungos oficialusis leidinys |
C 205/7 |
Vaistai. EEE ELPA valstybių 2017 m. pirmajam pusmečiui suteiktų rinkodaros leidimų sąrašas
(2018/C 205/05)
Laisvo prekių judėjimo I pakomitetis
Turi nurodyti EEE jungtinis komitetas
Remiantis 1999 m. gegužės 28 d. EEE jungtinio komiteto sprendimu Nr. 74/1999, EEE jungtinis komitetas raginamas 2017 m. gruodžio 15 d. susitikime nurodyti šiuos 2017 m. sausio 1 d. – birželio 30 d. vaistų rinkodaros leidimų sąrašus:
|
I priedas |
Naujų rinkodaros leidimų sąrašas |
|
II priedas |
Atnaujintų rinkodaros leidimų sąrašas |
|
III priedas |
Pratęstų rinkodaros leidimų sąrašas |
|
IV priedas |
Panaikintų rinkodaros leidimų sąrašas |
|
V priedas |
Sustabdytų rinkodaros leidimų sąrašas |
I PRIEDAS
Naujų rinkodaros leidimų sąrašas
2017 m. sausio 1 d. – birželio 30 d. EEE ELPA valstybėse suteikti šie rinkodaros leidimai:
|
ES numeris |
Produktas |
Šalis |
Leidimo suteikimo data |
|
ES/1/11/699 |
Fampyra (perėjimas prie nesąlygotos autorizacijos) |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/771 |
Zoledronsäure Teva |
Lichtenšteinas |
2017 6 30 |
|
ES/1/15/1049 |
Cystadrops |
Lichtenšteinas |
2017 2 28 |
|
ES/1/15/1049 |
Cystadrops |
Norvegija |
2017 1 27 |
|
ES/1/15/1049 |
CYSTADROPS |
Islandija |
2017 1 30 |
|
ES/1/15/1078 |
Natpar |
Lichtenšteinas |
2017 4 30 |
|
ES/1/15/1078 |
Natpar |
Norvegija |
2017 5 10 |
|
ES/1/15/1078 |
Natpar |
Islandija |
2017 5 15 |
|
ES/1/16/1086 |
TAGRISSO (perėjimas prie nesąlygotos autorizacijos) |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1110 |
Chenodeoxycholic acid Leadiant |
Norvegija |
2017 4 20 |
|
ES/1/16/1110 |
Chenodeoxycholic acid Leadiant |
Lichtenšteinas |
2017 6 30 |
|
ES/1/16/1110 |
Chenodeoxycholic acid Leadiant |
Islandija |
2017 5 9 |
|
ES/1/16/1133 |
Emtricitabine/Tenofovir disoproxil Mylan |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1133 |
Emtricitabine/Tenofovir disoproxil Mylan |
Norvegija |
2017 1 16 |
|
ES/1/16/1133 |
Emtricitabine/Tenofovir disoproxil Mylan |
Islandija |
2017 1 5 |
|
ES/1/16/1139 |
OCALIVA |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1140 |
Darunavir Mylan |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1140 |
Darunavir Mylan |
Norvegija |
2017 1 16 |
|
ES/1/16/1140 |
Darunavir Mylan |
Islandija |
2017 1 11 |
|
ES/1/16/1150 |
Rekovelle |
Norvegija |
2017 1 6 |
|
ES/1/16/1150 |
REKOVELLE |
Islandija |
2017 1 4 |
|
ES/1/16/1152 |
Roteas |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1152 |
Roteas |
Norvegija |
2017 5 10 |
|
ES/1/16/1152 |
Roteas |
Islandija |
2017 5 10 |
|
ES/1/16/1153 |
Tadalafil Generics |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1153 |
Tadalafil Generics |
Norvegija |
2017 1 24 |
|
ES/1/16/1153 |
Tadalafil Generics |
Islandija |
2017 1 13 |
|
ES/1/16/1154 |
Vemlidy |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1154 |
Vemlidy |
Norvegija |
2017 2 1 |
|
ES/1/16/1154 |
Vemlidy |
Islandija |
2017 1 13 |
|
ES/1/16/1156 |
ZINPLAVA |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1156 |
ZINPLAVA |
Norvegija |
2017 1 26 |
|
ES/1/16/1156 |
Zinplava |
Islandija |
2017 1 24 |
|
ES/1/16/1157 |
Suliqua |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1157 |
Suliqua |
Norvegija |
2017 1 25 |
|
ES/1/16/1157 |
Suliqua |
Islandija |
2017 1 24 |
|
ES/1/16/1158 |
AFSTYLA |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1158 |
AFSTYLA |
Norvegija |
2017 1 11 |
|
ES/1/16/1158 |
Afstyla |
Islandija |
2017 1 11 |
|
ES/1/16/1159 |
Terrosa |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1159 |
Terrosa |
Norvegija |
2017 1 11 |
|
ES/1/16/1159 |
Terrosa |
Islandija |
2017 1 11 |
|
ES/1/16/1160 |
Fiasp |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1160 |
Fiasp |
Norvegija |
2017 1 25 |
|
ES/1/16/1160 |
Fiasp |
Islandija |
2017 1 23 |
|
ES/1/16/1161 |
Movymia |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1161 |
Movymia |
Norvegija |
2017 1 26 |
|
ES/1/16/1161 |
Movymia |
Islandija |
2017 1 24 |
|
ES/1/16/1162 |
Lusduna |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1162 |
Lusduna |
Norvegija |
2017 1 19 |
|
ES/1/16/1162 |
Lusduna |
Islandija |
2017 1 12 |
|
ES/1/16/1163 |
SOLYMBIC |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1163 |
SOLYMBIC |
Norvegija |
2017 4 6 |
|
ES/1/16/1163 |
Solymbic |
Islandija |
2017 4 6 |
|
ES/1/16/1164 |
AMGEVITA |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1164 |
AMGEVITA |
Norvegija |
2017 4 6 |
|
ES/1/16/1164 |
Amgevita |
Islandija |
2017 4 6 |
|
ES/1/16/1165 |
LIFMIOR |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1165 |
LIFMIOR |
Norvegija |
2017 2 21 |
|
ES/1/16/1165 |
Lifmior |
Islandija |
2017 2 21 |
|
ES/1/16/1166 |
Pregabalin Zentiva k.s |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1166 |
Pregabalin Zentiva k.s. |
Norvegija |
2017 3 13 |
|
ES/1/16/1166 |
Pregabalin Zentiva k.s. |
Islandija |
2017 3 14 |
|
ES/1/16/1167 |
Truxima |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1167 |
Truxima |
Norvegija |
2017 2 28 |
|
ES/1/16/1167 |
Truxima |
Islandija |
2017 3 15 |
|
ES/1/16/1168 |
Vihuma |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1168 |
Vihuma |
Norvegija |
2017 3 17 |
|
ES/1/16/1168 |
Vihuma |
Islandija |
2017 3 10 |
|
ES/1/16/1169 |
Alecensa |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1169 |
Alecensa |
Norvegija |
2017 3 7 |
|
ES/1/16/1169 |
Alecensa |
Islandija |
2017 3 15 |
|
ES/1/16/1170 |
Olumiant |
Lichtenšteinas |
2017 2 28 |
|
ES/1/16/1170 |
Olumiant |
Norvegija |
2017 2 22 |
|
ES/1/16/1170 |
OLUMIANT |
Islandija |
2017 2 21 |
|
ES/1/16/1171 |
Ledaga |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1171 |
Ledaga |
Norvegija |
2017 3 15 |
|
ES/1/16/1171 |
LEDAGA |
Islandija |
2017 3 14 |
|
ES/1/17/1172 |
Jylamvo |
Lichtenšteinas |
2017 4 30 |
|
ES/1/17/1172 |
Jylamvo |
Norvegija |
2017 4 4 |
|
ES/1/17/1172 |
Jylamvo |
Islandija |
2017 4 26 |
|
ES/1/17/1174 |
Rolufta |
Lichtenšteinas |
2017 4 30 |
|
ES/1/17/1174 |
Rolufta |
Norvegija |
2017 4 7 |
|
ES/1/17/1174 |
Rolufta |
Islandija |
2017 3 24 |
|
ES/1/17/1175 |
Daptomycin Hospira |
Lichtenšteinas |
2017 4 30 |
|
ES/1/17/1175 |
Daptomycin Hospira |
Norvegija |
2017 4 18 |
|
ES/1/17/1175 |
Daptomycin Hospira |
Islandija |
2017 4 7 |
|
ES/1/17/1176 |
Yargesa |
Lichtenšteinas |
2017 4 30 |
|
ES/1/17/1176 |
Yargesa |
Norvegija |
2017 4 7 |
|
ES/1/17/1176 |
Yargesa |
Islandija |
2017 4 7 |
|
ES/1/17/1177 |
Tadalafil Lilly |
Lichtenšteinas |
2017 4 30 |
|
ES/1/17/1177 |
Tadalafil Lilly |
Norvegija |
2017 4 18 |
|
ES/1/17/1177 |
Tadalafil Lilly |
Islandija |
2017 4 6 |
|
ES/1/17/1178 |
Xeljanz |
Lichtenšteinas |
2017 4 30 |
|
ES/1/17/1178 |
Xeljanz |
Norvegija |
2017 4 6 |
|
ES/1/17/1178 |
XELJANZ |
Islandija |
2017 4 6 |
|
ES/1/17/1180 |
Varuby |
Lichtenšteinas |
2017 4 30 |
|
ES/1/17/1180 |
Varuby |
Norvegija |
2017 5 10 |
|
ES/1/17/1180 |
Varuby |
Islandija |
2017 5 10 |
|
ES/1/17/1182 |
Emtricitabine/Tenofovir disoproxil Krka d.d. |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1182 |
Emtricitabine/Tenofovir disoproxil Krka d.d. |
Norvegija |
2017 5 22 |
|
ES/1/17/1182 |
Emtricitabine/Tenofovir disoproxil KrKa d.d. |
Islandija |
2017 5 12 |
|
ES/1/17/1183 |
Pemetrexed Hospira UK Limited |
Norvegija |
2017 5 9 |
|
ES/1/17/1183 |
Pemetrexed Hospira UK Limited |
Islandija |
2017 5 12 |
|
ES/1/17/1183 |
Pemetrexed Hospira UK Ltd. |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1184 |
Riximyo |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1184 |
Riximyo |
Norvegija |
2017 6 26 |
|
ES/1/17/1185 |
Rixathon |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1185 |
Rixathon |
Norvegija |
2017 6 23 |
|
ES/1/17/1186 |
Axumin |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1186 |
Axumin |
Norvegija |
2017 5 31 |
|
ES/1/17/1186 |
Axumin |
Islandija |
2017 6 21 |
|
ES/1/17/1187 |
Trumenba |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1187 |
Trumenba |
Norvegija |
2017 6 9 |
|
ES/1/17/1187 |
Trumenba |
Islandija |
2017 6 21 |
|
ES/1/17/1188 |
Spinraza |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1188 |
Spinraza |
Norvegija |
2017 6 8 |
|
ES/1/17/1188 |
Spinraza |
Islandija |
2017 6 30 |
|
ES/1/17/1189 |
Elmiron |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1189 |
Elmiron |
Norvegija |
2017 6 20 |
|
ES/1/17/1189 |
Elmiron |
Islandija |
2017 6 30 |
|
ES/1/17/1190 |
Ivabradine Accord |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1190 |
Ivabradine Accord |
Norvegija |
2017 6 12 |
|
ES/1/17/1190 |
Ivabradine Accord |
Islandija |
2017 6 7 |
|
ES/1/17/1191 |
Dinutuximab beta Apeiron |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1191 |
Dinutuximab beta Apeiron |
Norvegija |
2017 5 12 |
|
ES/1/17/1191 |
Dinutuximab beta Apeiron |
Islandija |
2017 5 23 |
|
ES/1/17/1192 |
Brineura |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1192 |
Brineura |
Norvegija |
2017 6 6 |
|
ES/1/17/1192 |
Brineura |
Islandija |
2017 6 30 |
|
ES/1/17/1193 |
Refixia |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1193 |
Refixia |
Norvegija |
2017 6 22 |
|
ES/1/17/1193 |
Refixia |
Islandija |
2017 6 30 |
|
ES/1/17/1194 |
Febuxostat Mylan |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1194 |
Febuxostat Mylan |
Norvegija |
2017 6 26 |
|
ES/1/17/1195 |
Erelzi |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1196 |
Kevzara |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1201 |
Skilarence |
Lichtenšteinas |
2017 6 30 |
|
ES/1/17/1202 |
Ucedane |
Lichtenšteinas |
2017 6 30 |
|
ES/2/16/200 |
Cepedex |
Norvegija |
2017 1 4 |
|
ES/2/16/201 |
Halagon |
Norvegija |
2017 1 4 |
|
ES/2/16/201 |
Halagon |
Islandija |
2017 1 4 |
|
ES/2/16/202 |
Coliprotec F4/F18 |
Lichtenšteinas |
2017 2 28 |
|
ES/2/16/202 |
Coliprotec F4/F18 |
Norvegija |
2017 2 21 |
|
ES/2/16/202 |
Coliprotec F4/F18 |
Islandija |
2017 3 9 |
|
ES/2/16/203 |
VarroMed |
Lichtenšteinas |
2017 2 28 |
|
ES/2/16/203 |
VarroMed |
Norvegija |
2017 2 21 |
|
ES/2/16/203 |
VarroMed |
Islandija |
2017 2 15 |
|
ES/2/16/204 |
Stronghold Plus |
Lichtenšteinas |
2017 2 28 |
|
ES/2/16/204 |
Stronghold Plus |
Norvegija |
2017 2 27 |
|
ES/2/16/204 |
Stronghold Plus |
Islandija |
2017 2 15 |
|
ES/2/17/205 |
CYTOPOINT |
Lichtenšteinas |
2017 4 30 |
|
ES/2/17/205 |
CYTOPOINT |
Norvegija |
2017 5 23 |
|
ES/2/17/205 |
CYTOPOINT |
Islandija |
2017 5 12 |
|
ES/2/17/206 |
Credelio |
Lichtenšteinas |
2017 6 30 |
|
ES/2/17/206 |
Credelio |
Norvegija |
2017 5 23 |
|
ES/2/17/206 |
Credelio |
Islandija |
2017 5 12 |
|
ES/2/17/207 |
Zulvac BTV Ovis |
Norvegija |
2017 5 18 |
|
ES/2/17/207 |
Zulvac BTV Ovis |
Islandija |
2017 5 12 |
|
ES/2/17/208 |
Ingelvac PCV FLEX |
Lichtenšteinas |
2017 6 30 |
|
ES/2/17/208 |
Ingelvac PCV FLEX |
Norvegija |
2017 6 8 |
|
ES/2/17/208 |
Ingelvac PCV FLEX |
Islandija |
2017 6 13 |
|
ES/2/17/209 |
RESPIPORC FLUpan H1N1 |
Lichtenšteinas |
2017 6 30 |
|
ES/2/17/209 |
RESPIPORC FLUpan H1N1 |
Norvegija |
2017 6 2 |
|
ES/2/17/209 |
RESPIPORC FLUpan H1N1 |
Islandija |
2017 6 13 |
|
ES/2/17/210 |
Zeleris |
Norvegija |
2017 6 7 |
|
ES/2/17/210 |
Zeleris |
Islandija |
2017 5 19 |
II PRIEDAS
Atnaujintų rinkodaros leidimų sąrašas
2017 m. sausio 1 d. – birželio 30 d. EEE ELPA valstybėse atnaujinti šie rinkodaros leidimai:
|
ES numeris |
Produktas |
Šalis |
Leidimo suteikimo data |
|
ES/1/02/226 |
InductosOs |
Lichtenšteinas |
2017 6 30 |
|
ES/1/06/362 |
Byetta |
Norvegija |
2017 1 24 |
|
ES/1/06/364 |
Adrovance |
Norvegija |
2017 3 28 |
|
ES/1/06/365 |
Elaprase |
Norvegija |
2016 1 23 |
|
ES/1/06/366 |
Tandemact |
Norvegija |
2017 1 27 |
|
ES/1/07/388 |
Sebivo |
Lichtenšteinas |
2017 2 28 |
|
ES/1/07/388 |
Sebivo |
Norvegija |
2017 1 16 |
|
ES/1/07/388 |
Sebivo |
Islandija |
2017 1 5 |
|
ES/1/07/391 |
Revlimid |
Lichtenšteinas |
2017 2 28 |
|
ES/1/07/391 |
Revlimid |
Norvegija |
2017 2 23 |
|
ES/1/07/391 |
Revlimid |
Islandija |
2017 2 21 |
|
ES/1/07/396 |
Pergoveris |
Lichtenšteinas |
2017 6 30 |
|
ES/1/07/396 |
Pergoveris |
Norvegija |
2017 5 23 |
|
ES/1/07/396 |
Pergoveris |
Islandija |
2017 5 23 |
|
ES/1/07/397 |
Siklos |
Lichtenšteinas |
2017 4 30 |
|
ES/1/07/397 |
Siklos |
Norvegija |
2017 5 5 |
|
ES/1/07/397 |
Siklos |
Islandija |
2017 5 11 |
|
ES/1/07/403 |
Atriance |
Lichtenšteinas |
2017 6 30 |
|
ES/1/07/403 |
Atriance |
Norvegija |
2017 6 26 |
|
ES/1/07/404 |
Flebogamma DIF |
Lichtenšteinas |
2017 4 30 |
|
ES/1/07/404 |
Flebogamma DIF |
Norvegija |
2017 5 10 |
|
ES/1/07/404 |
Flebogamma DIF |
Islandija |
2017 5 11 |
|
ES/1/07/405 |
Rasilez |
Lichtenšteinas |
2017 6 30 |
|
ES/1/07/405 |
Rasilez |
Norvegija |
2017 6 12 |
|
ES/1/07/405 |
Rasilez |
Islandija |
2017 6 6 |
|
ES/1/11/699 |
Fampyra |
Norvegija |
2017 6 20 |
|
ES/1/11/699 |
Fampyra |
Islandija |
2017 6 6 |
|
ES/1/11/749 |
Caprelsa |
Lichtenšteinas |
2017 2 28 |
|
ES/1/11/749 |
Caprelsa |
Norvegija |
2017 3 2 |
|
ES/1/11/749 |
Caprelsa |
Islandija |
2017 2 24 |
|
ES/1/12/752 |
Vepacel |
Lichtenšteinas |
2017 2 28 |
|
ES/1/12/752 |
Vepacel |
Norvegija |
2017 1 19 |
|
ES/1/12/752 |
Vepacel |
Islandija |
2017 1 12 |
|
ES/1/12/757 |
Pioglitazon Teva |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/757 |
Pioglitazone Teva |
Norvegija |
2017 3 21 |
|
ES/1/12/757 |
Pioglitazone Teva |
Islandija |
2017 3 10 |
|
ES/1/12/758 |
Pioglitazon Teva Pharma |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/758 |
Pioglitazone Teva Pharma |
Norvegija |
2017 3 17 |
|
ES/1/12/758 |
Pioglitazone Teva Pharma |
Islandija |
2017 3 10 |
|
ES/1/12/759 |
Zoledronic acid Actavis |
Norvegija |
2017 1 4 |
|
ES/1/12/759 |
Zoledronic acid Actavis |
Islandija |
2017 1 4 |
|
ES/1/12/760 |
Bronchitol |
Lichtenšteinas |
2017 2 28 |
|
ES/1/12/760 |
Bronchitol |
Norvegija |
2017 1 23 |
|
ES/1/12/760 |
Bronchitol |
Islandija |
2017 1 23 |
|
ES/1/12/761 |
Capecitabin Teva |
Lichtenšteinas |
2017 2 28 |
|
ES/1/12/761 |
Capecitabine Teva |
Norvegija |
2017 1 25 |
|
ES/1/12/761 |
Capecitabine Teva |
Islandija |
2017 1 23 |
|
ES/1/12/762 |
Capecitabin Accord |
Lichtenšteinas |
2017 2 28 |
|
ES/1/12/762 |
Capecitabine Accord |
Norvegija |
2017 1 25 |
|
ES/1/12/762 |
Capecitabine Accord |
Islandija |
2017 1 23 |
|
ES/1/12/763 |
Ecansya |
Islandija |
2017 1 4 |
|
ES/1/12/764 |
Pixuvri |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/764 |
Pixuvri |
Norvegija |
2017 3 29 |
|
ES/1/12/764 |
Pixuvri |
Islandija |
2017 4 6 |
|
ES/1/12/766 |
SANCUSO |
Lichtenšteinas |
2017 2 28 |
|
ES/1/12/766 |
SANCUSO |
Norvegija |
2017 1 23 |
|
ES/1/12/766 |
SANCUSO |
Islandija |
2017 1 13 |
|
ES/1/12/767 |
Nimenrix |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/767 |
Nimenrix |
Norvegija |
2017 3 14 |
|
ES/1/12/767 |
Nimenrix |
Islandija |
2017 3 14 |
|
ES/1/12/768 |
Riluzol Zentiva |
Lichtenšteinas |
2017 2 28 |
|
ES/1/12/768 |
Riluzole Zentiva |
Norvegija |
2017 1 24 |
|
ES/1/12/768 |
Riluzole Zentiva |
Islandija |
2017 1 13 |
|
ES/1/12/769 |
Docetaxel Accord |
Norvegija |
2017 3 3 |
|
ES/1/12/769 |
Docetaxel Accord |
Islandija |
2017 3 10 |
|
ES/1/12/770 |
Docetaxel Kabi |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/770 |
Docetaxel Kabi |
Norvegija |
2017 3 3 |
|
ES/1/12/770 |
Docetaxel Kabi |
Islandija |
2017 3 10 |
|
ES/1/12/771 |
Zoledronic acid Teva |
Norvegija |
2017 6 20 |
|
ES/1/12/771 |
Zoledronic Acid Teva |
Islandija |
2017 6 6 |
|
ES/1/12/772 |
Zoledronic acid Teva Pharma |
Norvegija |
2017 6 20 |
|
ES/1/12/772 |
Zoledronic acid Teva Pharma |
Islandija |
2017 6 6 |
|
ES/1/12/772 |
Zoledronsäure Teva Pharma |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/773 |
Jakavi |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/773 |
Jakavi |
Norvegija |
2017 5 12 |
|
ES/1/12/773 |
Jakavi |
Islandija |
2017 5 11 |
|
ES/1/12/775 |
NovoThirteen |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/775 |
NovoThirteen |
Norvegija |
2017 6 15 |
|
ES/1/12/775 |
NovoThirteen |
Islandija |
2017 6 7 |
|
ES/1/12/776 |
Fycompa |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/776 |
Fycompa |
Norvegija |
2017 4 18 |
|
ES/1/12/776 |
Fycompa |
Islandija |
2017 4 24 |
|
ES/1/12/777 |
Inlyta |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/777 |
Inlyta |
Norvegija |
2017 6 14 |
|
ES/1/12/777 |
Inlyta |
Islandija |
2017 6 8 |
|
ES/1/12/778 |
Eklira Genuair |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/778 |
Eklira Genuair |
Norvegija |
2017 5 10 |
|
ES/1/12/778 |
Eklira Genuair |
Islandija |
2017 5 10 |
|
ES/1/12/779 |
Zoledronic acid medac |
Islandija |
2017 5 18 |
|
ES/1/12/779 |
Zoledronsäure medac |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/779 |
Zoledronsyre medac |
Norvegija |
2017 5 22 |
|
ES/1/12/780 |
Jentadueto |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/780 |
Jentadueto |
Norvegija |
2017 4 6 |
|
ES/1/12/780 |
Jentadueto |
Islandija |
2017 4 6 |
|
ES/1/12/781 |
Bretaris Genuair |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/781 |
Bretaris Genuair |
Norvegija |
2017 5 10 |
|
ES/1/12/781 |
Bretaris Genuair |
Islandija |
2017 5 10 |
|
ES/1/12/782 |
Kalydeco |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/782 |
Kalydeco |
Norvegija |
2017 5 19 |
|
ES/1/12/782 |
Kalydeco |
Islandija |
2017 5 11 |
|
ES/1/12/783 |
Zyclara |
Lichtenšteinas |
2017 4 30 |
|
ES/1/12/783 |
Zyclara |
Norvegija |
2017 4 6 |
|
ES/1/12/783 |
Zyclara |
Islandija |
2017 4 7 |
|
ES/1/12/785 |
Zinforo |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/785 |
Zinforo |
Norvegija |
2017 5 19 |
|
ES/1/12/785 |
Zinforo |
Islandija |
2017 5 11 |
|
ES/1/12/786 |
Zoledronic acid Mylan |
Norvegija |
2017 6 26 |
|
ES/1/12/786 |
Zoledronic acid Mylan |
Islandija |
2017 6 7 |
|
ES/1/12/786 |
Zoledronsäure Mylan |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/787 |
Revestive |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/792 |
Dacogen |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/792 |
Dacogen |
Norvegija |
2017 6 1 |
|
ES/1/12/792 |
Dacogen |
Islandija |
2017 6 6 |
|
ES/1/12/802 |
Capecitabin medac |
Lichtenšteinas |
2017 6 30 |
|
ES/1/12/802 |
Capecitabine medac |
Norvegija |
2017 6 26 |
|
ES/1/13/818 |
Bosulif |
Lichtenšteinas |
2017 4 30 |
|
ES/1/13/818 |
Bosulif |
Norvegija |
2017 4 5 |
|
ES/1/13/818 |
Bosulif |
Islandija |
2017 4 7 |
|
ES/1/13/875 |
Deltyba |
Lichtenšteinas |
2017 4 30 |
|
ES/1/13/875 |
Deltyba |
Norvegija |
2017 3 14 |
|
ES/1/13/875 |
Deltyba |
Islandija |
2017 3 14 |
|
ES/1/13/890 |
Cometriq |
Lichtenšteinas |
2017 2 28 |
|
ES/1/13/890 |
Cometriq |
Islandija |
2017 1 23 |
|
ES/1/13/901 |
Sirturo |
Lichtenšteinas |
2017 2 28 |
|
ES/1/13/901 |
Sirturo |
Norvegija |
2017 5 11 |
|
ES/1/13/901 |
SIRTURO |
Islandija |
2017 1 6 |
|
ES/1/13/902 |
Translarna |
Lichtenšteinas |
2017 2 28 |
|
ES/1/13/902 |
Translarna |
Lichtenšteinas |
2017 6 30 |
|
ES/1/13/902 |
Translarna |
Norvegija |
2017 2 1 |
|
ES/1/14/987 |
Holoclar |
Norvegija |
2017 1 4 |
|
ES/1/14/987 |
Holoclar |
Islandija |
2017 1 4 |
|
ES/1/15/999 |
Zykadia |
Lichtenšteinas |
2017 4 30 |
|
ES/1/15/999 |
Zykadia |
Norvegija |
2017 5 30 |
|
ES/1/15/999 |
Zykadia |
Islandija |
2017 4 21 |
|
ES/1/16/1086 |
Tagrisso |
Norvegija |
2017 1 2 |
|
ES/1/16/1089 |
Pandemic influenza vaccine H5N1 MedImmune (Gripo pandemijos vakcina H5N1 MedImmune) |
Islandija |
2017 5 10 |
|
ES/1/16/1089 |
Pandemic influenza vaccine H5N1 MedImmune (Gripo pandemijos vakcina H5N1 MedImmune) |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1089 |
Pandemic influenza Vaccine H5N1 MedImmune (Gripo pandemijos vakcina H5N1 MedImmune) |
Norvegija |
2017 6 29 |
|
ES/1/16/1101 |
Darzalex |
Lichtenšteinas |
2017 4 30 |
|
ES/1/16/1101 |
Darzalex |
Norvegija |
2017 5 12 |
|
ES/1/16/1101 |
Darzalex |
Islandija |
2017 5 11 |
|
ES/2/07/072 |
Suprelorin |
Lichtenšteinas |
2017 6 30 |
|
ES/2/07/072 |
Suprelorin |
Norvegija |
2017 6 2 |
|
ES/2/07/072 |
Suprelorin |
Islandija |
2017 5 23 |
|
ES/2/11/137 |
Activyl Tick Plus |
Islandija |
2017 1 4 |
|
ES/2/12/139 |
Zulvac 1 + 8 Bovis |
Norvegija |
2017 1 3 |
|
ES/2/12/140 |
Poulvac E. coli |
Lichtenšteinas |
2017 6 30 |
|
ES/2/12/140 |
Poulvac E. Coli |
Islandija |
2017 5 23 |
|
ES/2/12/140 |
Poulvac E.coli |
Norvegija |
2017 5 23 |
|
ES/2/12/141 |
Porcilis ColiClos |
Lichtenšteinas |
2017 4 30 |
|
ES/2/12/141 |
Porcilis ColiClos |
Norvegija |
2017 4 28 |
|
ES/2/12/141 |
Porcilis ColiClos |
Islandija |
2017 4 10 |
|
ES/2/12/142 |
Cardalis |
Lichtenšteinas |
2017 6 30 |
|
ES/2/12/142 |
Cardalis |
Norvegija |
2017 6 28 |
|
ES/2/12/143 |
Nobivac L4 |
Norvegija |
2017 3 20 |
|
ES/2/12/143 |
Nobivac L4 |
Lichtenšteinas |
2017 4 30 |
|
ES/2/12/143 |
Nobivac L4 |
Islandija |
2017 3 24 |
III PRIEDAS
Pratęstų rinkodaros leidimų sąrašas
2017 m. sausio 1 d. – birželio 30 d. EEE ELPA valstybėse pratęsti šie rinkodaros leidimai:
|
ES numeris |
Produktas |
Šalis |
Leidimo suteikimo data |
|
ES/1/03/256/020 |
Humira |
Norvegija |
2017 4 6 |
|
ES/1/03/256/020 |
Humira |
Islandija |
2017 4 10 |
|
ES/1/07/396/004–006 |
Pergoveris |
Norvegija |
2017 5 8 |
|
ES/1/07/396/004–006 |
Pergoveris |
Islandija |
2017 5 23 |
|
ES/1/09/514/021–023 |
Zebinix |
Islandija |
2017 1 4 |
|
ES/1/09/514/024 |
Zebinix |
Norvegija |
2017 1 4 |
|
ES/1/09/564/004 |
Ilaris |
Norvegija |
2017 3 7 |
|
ES/1/09/564/004 |
Ilaris |
Islandija |
2017 3 14 |
|
ES/1/10/641/002 |
Ruconest |
Norvegija |
2017 1 26 |
|
ES/1/10/641/002 |
Ruconest |
Islandija |
2017 1 30 |
|
ES/1/10/655/012–014 |
Brilique |
Norvegija |
2017 5 18 |
|
ES/1/10/655/012–014 |
Brilique |
Islandija |
2017 6 6 |
|
ES/1/11/667/005–011 |
Esbriet |
Norvegija |
2017 5 9 |
|
ES/1/11/667/005–011 |
Esbriet |
Islandija |
2017 5 11 |
|
ES/1/13/860/003 |
Nexium Control |
Norvegija |
2017 6 23 |
|
ES/1/13/892/003–006 |
Tivicay |
Norvegija |
2017 3 2 |
|
ES/1/13/892/003–006 |
Tivicay |
Islandija |
2017 3 13 |
|
ES/1/15/1016/006–007 |
Repatha |
Norvegija |
2017 2 17 |
|
ES/1/15/1016/006–007 |
Repatha |
Islandija |
2017 2 24 |
|
ES/1/15/1074/005 |
Benepali |
Norvegija |
2017 5 31 |
|
ES/1/15/1074/005 |
Benepali |
Islandija |
2017 6 7 |
|
ES/1/97/047/009 |
BeneFIX |
Norvegija |
2017 3 22 |
|
ES/1/97/047/009 |
BeneFIX |
Islandija |
2017 4 7 |
|
ES/2/04/042/015–018 |
Novem |
Islandija |
2017 6 6 |
|
ES/2/08/083/006–009 |
EQUIOXX |
Norvegija |
2017 2 9 |
|
ES/2/08/083/006–009 |
Equioxx |
Islandija |
2017 2 15 |
IV PRIEDAS
Panaikintų rinkodaros leidimų sąrašas
2017 m. sausio 1 d. – birželio 30 d. EEE ELPA valstybėse panaikinti šie rinkodaros leidimai:
|
ES numeris |
Produktas |
Šalis |
Panaikinimo data |
|
ES/1/00/137 |
Avandia |
Lichtenšteinas |
2017 2 28 |
|
ES/1/03/258 |
Avandamet |
Lichtenšteinas |
2017 2 28 |
|
ES/1/06/373 |
Imprida |
Lichtenšteinas |
2017 4 30 |
|
ES/1/06/373 |
Imprida |
Norvegija |
2017 4 19 |
|
ES/1/06/373 |
Imprida |
Islandija |
2017 4 21 |
|
ES/1/07/385 |
Focetria |
Lichtenšteinas |
2017 2 28 |
|
ES/1/08/500 |
Fablyn |
Lichtenšteinas |
2017 2 28 |
|
ES/1/09/512 |
Removab |
Lichtenšteinas |
2017 6 30 |
|
ES/1/09/512 |
Removab |
Norvegija |
2017 6 23 |
|
ES/1/09/512 |
Removab |
Islandija |
2017 6 12 |
|
ES/1/09/532 |
Clopidogrel Acino |
Lichtenšteinas |
2017 2 28 |
|
ES/1/09/532 |
Clopidogrel Acino |
Norvegija |
2017 2 9 |
|
ES/1/09/532 |
Clopidogrel Acino |
Islandija |
2017 2 3 |
|
ES/1/09/561 |
Clopidogrel Teva Pharma |
Lichtenšteinas |
2017 6 30 |
|
ES/1/09/561 |
Clopidogrel Teva Pharma |
Norvegija |
2017 6 28 |
|
ES/1/10/657 |
Prepandemic Influenza |
Lichtenšteinas |
2017 2 28 |
|
ES/1/11/720 |
Incivo |
Islandija |
2017 2 3 |
|
ES/1/11/721 |
Paglitaz |
Lichtenšteinas |
2017 2 28 |
|
ES/1/14/942 |
Clopidogrel/Acetylsalicylsäure Teva |
Lichtenšteinas |
2017 2 28 |
|
ES/1/14/948 |
Budesonide/Formoterol Teva |
Norvegija |
2017 1 19 |
|
ES/1/14/948 |
Budesonide/Formoterol Teva |
Islandija |
2017 1 5 |
|
ES/1/14/949 |
Vylaer Spiromax |
Lichtenšteinas |
2017 2 28 |
|
ES/1/14/949 |
Vylaer Spiromax |
Norvegija |
2017 1 19 |
|
ES/1/14/949 |
Vylaer Spiromax |
Islandija |
2017 1 13 |
|
ES/1/14/950 |
Budesonide/Formoterol Teva Pharma B.V. |
Norvegija |
2017 1 19 |
|
ES/1/14/950 |
Budesonide/Formoterol Teva Pharma B.V. |
Islandija |
2017 1 5 |
|
ES/1/15/1022 |
Unituxin |
Norvegija |
2017 4 19 |
|
ES/1/15/1022 |
Unituxin |
Islandija |
2017 4 6 |
|
ES/1/15/995 |
DUTREBIS |
Lichtenšteinas |
2017 4 30 |
|
ES/1/15/995 |
DUTREBIS |
Norvegija |
2017 5 9 |
|
ES/1/15/995 |
DUTREBIS |
Islandija |
2017 5 11 |
|
ES/2/11/127 |
RECUVYRA |
Islandija |
2017 2 3 |
V PRIEDAS
Sustabdytų rinkodaros leidimų sąrašas
2017 m. sausio 1 d. – birželio 30 d. EEE ELPA valstybėse sustabdyti šie rinkodaros leidimai:
|
ES numeris |
Produktas |
Šalis |
Leidimo sustabdymo data |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|