EN Official Journal of the European Union C 205/7

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2017

(2018/C 205/05)

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 January-30 June 2017, at their meeting on 15 December 2017:

Annex I List of new marketing authorisations Annex II List of renewed marketing authorisations Annex III List of extended marketing authorisations Annex IV List of withdrawn marketing authorisations Annex V List of suspended marketing authorisations

ANNEX I List of new marketing authorisations The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January-30 June 2017: EU Number Product Country Date of authorisation EU/1/11/699 Fampyra (Switch to non-conditional) Liechtenstein 30.6.2017 EU/1/12/771 Zoledronsäure Teva Liechtenstein 30.6.2017 EU/1/15/1049 Cystadrops Liechtenstein 28.2.2017 EU/1/15/1049 Cystadrops Norway 27.1.2017 EU/1/15/1049 CYSTADROPS Iceland 30.1.2017 EU/1/15/1078 Natpar Liechtenstein 30.4.2017 EU/1/15/1078 Natpar Norway 10.5.2017 EU/1/15/1078 Natpar Iceland 15.5.2017 EU/1/16/1086 TAGRISSO (Switch to non-conditional) Liechtenstein 30.4.2017 EU/1/16/1110 Chenodeoxycholic acid Leadiant Norway 20.4.2017 EU/1/16/1110 Chenodeoxycholic acid Leadiant Liechtenstein 30.6.2017 EU/1/16/1110 Chenodeoxycholic acid Leadiant Iceland 9.5.2017 EU/1/16/1133 Emtricitabine/Tenofovir disoproxil Mylan Liechtenstein 28.2.2017 EU/1/16/1133 Emtricitabine/Tenofovir disoproxil Mylan Norway 16.1.2017 EU/1/16/1133 Emtricitabine/Tenofovir disoproxil Mylan Iceland 5.1.2017 EU/1/16/1139 OCALIVA Liechtenstein 30.4.2017 EU/1/16/1140 Darunavir Mylan Liechtenstein 28.2.2017 EU/1/16/1140 Darunavir Mylan Norway 16.1.2017 EU/1/16/1140 Darunavir Mylan Iceland 11.1.2017 EU/1/16/1150 Rekovelle Norway 6.1.2017 EU/1/16/1150 REKOVELLE Iceland 4.1.2017 EU/1/16/1152 Roteas Liechtenstein 30.4.2017 EU/1/16/1152 Roteas Norway 10.5.2017 EU/1/16/1152 Roteas Iceland 10.5.2017 EU/1/16/1153 Tadalafil Generics Liechtenstein 28.2.2017 EU/1/16/1153 Tadalafil Generics Norway 24.1.2017 EU/1/16/1153 Tadalafil Generics Iceland 13.1.2017 EU/1/16/1154 Vemlidy Liechtenstein 28.2.2017 EU/1/16/1154 Vemlidy Norway 1.2.2017 EU/1/16/1154 Vemlidy Iceland 13.1.2017 EU/1/16/1156 ZINPLAVA Liechtenstein 28.2.2017 EU/1/16/1156 ZINPLAVA Norway 26.1.2017 EU/1/16/1156 Zinplava Iceland 24.1.2017 EU/1/16/1157 Suliqua Liechtenstein 28.2.2017 EU/1/16/1157 Suliqua Norway 25.1.2017 EU/1/16/1157 Suliqua Iceland 24.1.2017 EU/1/16/1158 AFSTYLA Liechtenstein 28.2.2017 EU/1/16/1158 AFSTYLA Norway 11.1.2017 EU/1/16/1158 Afstyla Iceland 11.1.2017 EU/1/16/1159 Terrosa Liechtenstein 28.2.2017 EU/1/16/1159 Terrosa Norway 11.1.2017 EU/1/16/1159 Terrosa Iceland 11.1.2017 EU/1/16/1160 Fiasp Liechtenstein 28.2.2017 EU/1/16/1160 Fiasp Norway 25.1.2017 EU/1/16/1160 Fiasp Iceland 23.1.2017 EU/1/16/1161 Movymia Liechtenstein 28.2.2017 EU/1/16/1161 Movymia Norway 26.1.2017 EU/1/16/1161 Movymia Iceland 24.1.2017 EU/1/16/1162 Lusduna Liechtenstein 28.2.2017 EU/1/16/1162 Lusduna Norway 19.1.2017 EU/1/16/1162 Lusduna Iceland 12.1.2017 EU/1/16/1163 SOLYMBIC Liechtenstein 30.4.2017 EU/1/16/1163 SOLYMBIC Norway 6.4.2017 EU/1/16/1163 Solymbic Iceland 6.4.2017 EU/1/16/1164 AMGEVITA Liechtenstein 30.4.2017 EU/1/16/1164 AMGEVITA Norway 6.4.2017 EU/1/16/1164 Amgevita Iceland 6.4.2017 EU/1/16/1165 LIFMIOR Liechtenstein 28.2.2017 EU/1/16/1165 LIFMIOR Norway 21.2.2017 EU/1/16/1165 Lifmior Iceland 21.2.2017 EU/1/16/1166 Pregabalin Zentiva k.s Liechtenstein 30.4.2017 EU/1/16/1166 Pregabalin Zentiva k.s. Norway 13.3.2017 EU/1/16/1166 Pregabalin Zentiva k.s. Iceland 14.3.2017 EU/1/16/1167 Truxima Liechtenstein 30.4.2017 EU/1/16/1167 Truxima Norway 28.2.2017 EU/1/16/1167 Truxima Iceland 15.3.2017 EU/1/16/1168 Vihuma Liechtenstein 30.4.2017 EU/1/16/1168 Vihuma Norway 17.3.2017 EU/1/16/1168 Vihuma Iceland 10.3.2017 EU/1/16/1169 Alecensa Liechtenstein 28.2.2017 EU/1/16/1169 Alecensa Norway 7.3.2017 EU/1/16/1169 Alecensa Iceland 15.3.2017 EU/1/16/1170 Olumiant Liechtenstein 28.2.2017 EU/1/16/1170 Olumiant Norway 22.2.2017 EU/1/16/1170 OLUMIANT Iceland 21.2.2017 EU/1/16/1171 Ledaga Liechtenstein 30.4.2017 EU/1/16/1171 Ledaga Norway 15.3.2017 EU/1/16/1171 LEDAGA Iceland 14.3.2017 EU/1/17/1172 Jylamvo Liechtenstein 30.4.2017 EU/1/17/1172 Jylamvo Norway 4.4.2017 EU/1/17/1172 Jylamvo Iceland 26.4.2017 EU/1/17/1174 Rolufta Liechtenstein 30.4.2017 EU/1/17/1174 Rolufta Norway 7.4.2017 EU/1/17/1174 Rolufta Iceland 24.3.2017 EU/1/17/1175 Daptomycin Hospira Liechtenstein 30.4.2017 EU/1/17/1175 Daptomycin Hospira Norway 18.4.2017 EU/1/17/1175 Daptomycin Hospira Iceland 7.4.2017 EU/1/17/1176 Yargesa Liechtenstein 30.4.2017 EU/1/17/1176 Yargesa Norway 7.4.2017 EU/1/17/1176 Yargesa Iceland 7.4.2017 EU/1/17/1177 Tadalafil Lilly Liechtenstein 30.4.2017 EU/1/17/1177 Tadalafil Lilly Norway 18.4.2017 EU/1/17/1177 Tadalafil Lilly Iceland 6.4.2017 EU/1/17/1178 Xeljanz Liechtenstein 30.4.2017 EU/1/17/1178 Xeljanz Norway 6.4.2017 EU/1/17/1178 XELJANZ Iceland 6.4.2017 EU/1/17/1180 Varuby Liechtenstein 30.4.2017 EU/1/17/1180 Varuby Norway 10.5.2017 EU/1/17/1180 Varuby Iceland 10.5.2017 EU/1/17/1182 Emtricitabine/Tenofovir disoproxil Krka d.d. Liechtenstein 30.6.2017 EU/1/17/1182 Emtricitabine/Tenofovir disoproxil Krka d.d. Norway 22.5.2017 EU/1/17/1182 Emtricitabine/Tenofovir disoproxil KrKa d.d. Iceland 12.5.2017 EU/1/17/1183 Pemetrexed Hospira UK Limited Norway 9.5.2017 EU/1/17/1183 Pemetrexed Hospira UK Limited Iceland 12.5.2017 EU/1/17/1183 Pemetrexed Hospira UK Ltd Liechtenstein 30.6.2017 EU/1/17/1184 Riximyo Liechtenstein 30.6.2017 EU/1/17/1184 Riximyo Norway 26.6.2017 EU/1/17/1185 Rixathon Liechtenstein 30.6.2017 EU/1/17/1185 Rixathon Norway 23.6.2017 EU/1/17/1186 Axumin Liechtenstein 30.6.2017 EU/1/17/1186 Axumin Norway 31.5.2017 EU/1/17/1186 Axumin Iceland 21.6.2017 EU/1/17/1187 Trumenba Liechtenstein 30.6.2017 EU/1/17/1187 Trumenba Norway 9.6.2017 EU/1/17/1187 Trumenba Iceland 21.6.2017 EU/1/17/1188 Spinraza Liechtenstein 30.6.2017 EU/1/17/1188 Spinraza Norway 8.6.2017 EU/1/17/1188 Spinraza Iceland 30.6.2017 EU/1/17/1189 Elmiron Liechtenstein 30.6.2017 EU/1/17/1189 Elmiron Norway 20.6.2017 EU/1/17/1189 Elmiron Iceland 30.6.2017 EU/1/17/1190 Ivabradine Accord Liechtenstein 30.6.2017 EU/1/17/1190 Ivabradine Accord Norway 12.6.2017 EU/1/17/1190 Ivabradine Accord Iceland 7.6.2017 EU/1/17/1191 Dinutuximab beta Apeiron Liechtenstein 30.6.2017 EU/1/17/1191 Dinutuximab beta Apeiron Norway 12.5.2017 EU/1/17/1191 Dinutuximab beta Apeiron Iceland 23.5.2017 EU/1/17/1192 Brineura Liechtenstein 30.6.2017 EU/1/17/1192 Brineura Norway 6.6.2017 EU/1/17/1192 Brineura Iceland 30.6.2017 EU/1/17/1193 Refixia Liechtenstein 30.6.2017 EU/1/17/1193 Refixia Norway 22.6.2017 EU/1/17/1193 Refixia Iceland 30.6.2017 EU/1/17/1194 Febuxostat Mylan Liechtenstein 30.6.2017 EU/1/17/1194 Febuxostat Mylan Norway 26.6.2017 EU/1/17/1195 Erelzi Liechtenstein 30.6.2017 EU/1/17/1196 Kevzara Liechtenstein 30.6.2017 EU/1/17/1201 Skilarence Liechtenstein 30.6.2017 EU/1/17/1202 Ucedane Liechtenstein 30.6.2017 EU/2/16/200 Cepedex Norway 4.1.2017 EU/2/16/201 Halagon Norway 4.1.2017 EU/2/16/201 Halagon Iceland 4.1.2017 EU/2/16/202 Coliprotec F4/F18 Liechtenstein 28.2.2017 EU/2/16/202 Coliprotec F4/F18 Norway 21.2.2017 EU/2/16/202 Coliprotec F4/F18 Iceland 9.3.2017 EU/2/16/203 VarroMed Liechtenstein 28.2.2017 EU/2/16/203 VarroMed Norway 21.2.2017 EU/2/16/203 VarroMed Iceland 15.2.2017 EU/2/16/204 Stronghold Plus Liechtenstein 28.2.2017 EU/2/16/204 Stronghold Plus Norway 27.2.2017 EU/2/16/204 Stronghold Plus Iceland 15.2.2017 EU/2/17/205 CYTOPOINT Liechtenstein 30.4.2017 EU/2/17/205 CYTOPOINT Norway 23.5.2017 EU/2/17/205 CYTOPOINT Iceland 12.5.2017 EU/2/17/206 Credelio Liechtenstein 30.6.2017 EU/2/17/206 Credelio Norway 23.5.2017 EU/2/17/206 Credelio Iceland 12.5.2017 EU/2/17/207 Zulvac BTV Ovis Norway 18.5.2017 EU/2/17/207 Zulvac BTV Ovis Iceland 12.5.2017 EU/2/17/208 Ingelvac PCV FLEX Liechtenstein 30.6.2017 EU/2/17/208 Ingelvac PCV FLEX Norway 8.6.2017 EU/2/17/208 Ingelvac PCV FLEX Iceland 13.6.2017 EU/2/17/209 RESPIPORC FLUpan H1N1 Liechtenstein 30.6.2017 EU/2/17/209 RESPIPORC FLUpan H1N1 Norway 2.6.2017 EU/2/17/209 RESPIPORC FLUpan H1N1 Iceland 13.6.2017 EU/2/17/210 Zeleris Norway 7.6.2017 EU/2/17/210 Zeleris Iceland 19.5.2017

ANNEX II List of renewed marketing authorisations The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2017: EU Number Product Country Date of authorisation EU/1/02/226 InductosOs Liechtenstein 30.6.2017 EU/1/06/362 Byetta Norway 24.1.2017 EU/1/06/364 Adrovance Norway 28.3.2017 EU/1/06/365 Elaprase Norway 23.1.2016 EU/1/06/366 Tandemact Norway 27.1.2017 EU/1/07/388 Sebivo Liechtenstein 28.2.2017 EU/1/07/388 Sebivo Norway 16.1.2017 EU/1/07/388 Sebivo Iceland 5.1.2017 EU/1/07/391 Revlimid Liechtenstein 28.2.2017 EU/1/07/391 Revlimid Norway 23.2.2017 EU/1/07/391 Revlimid Iceland 21.2.2017 EU/1/07/396 Pergoveris Liechtenstein 30.6.2017 EU/1/07/396 Pergoveris Norway 23.5.2017 EU/1/07/396 Pergoveris Iceland 23.5.2017 EU/1/07/397 Siklos Liechtenstein 30.4.2017 EU/1/07/397 Siklos Norway 5.5.2017 EU/1/07/397 Siklos Iceland 11.5.2017 EU/1/07/403 Atriance Liechtenstein 30.6.2017 EU/1/07/403 Atriance Norway 26.6.2017 EU/1/07/404 Flebogamma DIF Liechtenstein 30.4.2017 EU/1/07/404 Flebogamma DIF Norway 10.5.2017 EU/1/07/404 Flebogamma DIF Iceland 11.5.2017 EU/1/07/405 Rasilez Liechtenstein 30.6.2017 EU/1/07/405 Rasilez Norway 12.6.2017 EU/1/07/405 Rasilez Iceland 6.6.2017 EU/1/11/699 Fampyra Norway 20.6.2017 EU/1/11/699 Fampyra Iceland 6.6.2017 EU/1/11/749 Caprelsa Liechtenstein 28.2.2017 EU/1/11/749 Caprelsa Norway 2.3.2017 EU/1/11/749 Caprelsa Iceland 24.2.2017 EU/1/12/752 Vepacel Liechtenstein 28.2.2017 EU/1/12/752 Vepacel Norway 19.1.2017 EU/1/12/752 Vepacel Iceland 12.1.2017 EU/1/12/757 Pioglitazon Teva Liechtenstein 30.4.2017 EU/1/12/757 Pioglitazone Teva Norway 21.3.2017 EU/1/12/757 Pioglitazone Teva Iceland 10.3.2017 EU/1/12/758 Pioglitazon Teva Pharma Liechtenstein 30.4.2017 EU/1/12/758 Pioglitazone Teva Pharma Norway 17.3.2017 EU/1/12/758 Pioglitazone Teva Pharma Iceland 10.3.2017 EU/1/12/759 Zoledronic acid Actavis Norway 4.1.2017 EU/1/12/759 Zoledronic acid Actavis Iceland 4.1.2017 EU/1/12/760 Bronchitol Liechtenstein 28.2.2017 EU/1/12/760 Bronchitol Norway 23.1.2017 EU/1/12/760 Bronchitol Iceland 23.1.2017 EU/1/12/761 Capecitabin Teva Liechtenstein 28.2.2017 EU/1/12/761 Capecitabine Teva Norway 25.1.2017 EU/1/12/761 Capecitabine Teva Iceland 23.1.2017 EU/1/12/762 Capecitabin Accord Liechtenstein 28.2.2017 EU/1/12/762 Capecitabine Accord Norway 25.1.2017 EU/1/12/762 Capecitabine Accord Iceland 23.1.2017 EU/1/12/763 Ecansya Iceland 4.1.2017 EU/1/12/764 Pixuvri Liechtenstein 30.4.2017 EU/1/12/764 Pixuvri Norway 29.3.2017 EU/1/12/764 Pixuvri Iceland 6.4.2017 EU/1/12/766 SANCUSO Liechtenstein 28.2.2017 EU/1/12/766 SANCUSO Norway 23.1.2017 EU/1/12/766 Sancuso Iceland 13.1.2017 EU/1/12/767 Nimenrix Liechtenstein 30.4.2017 EU/1/12/767 Nimenrix Norway 14.3.2017 EU/1/12/767 Nimenrix Iceland 14.3.2017 EU/1/12/768 Riluzol Zentiva Liechtenstein 28.2.2017 EU/1/12/768 Riluzole Zentiva Norway 24.1.2017 EU/1/12/768 Riluzole Zentiva Iceland 13.1.2017 EU/1/12/769 Docetaxel Accord Norway 3.3.2017 EU/1/12/769 Docetaxel Accord Iceland 10.3.2017 EU/1/12/770 Docetaxel Kabi Liechtenstein 30.4.2017 EU/1/12/770 Docetaxel Kabi Norway 3.3.2017 EU/1/12/770 Docetaxel Kabi Iceland 10.3.2017 EU/1/12/771 Zoledronic acid Teva Norway 20.6.2017 EU/1/12/771 Zoledronic Acid Teva Iceland 6.6.2017 EU/1/12/772 Zoledronic acid Teva Pharma Norway 20.6.2017 EU/1/12/772 Zoledronic acid Teva Pharma Iceland 6.6.2017 EU/1/12/772 Zoledronsäure Teva Pharma Liechtenstein 30.6.2017 EU/1/12/773 Jakavi Liechtenstein 30.6.2017 EU/1/12/773 Jakavi Norway 12.5.2017 EU/1/12/773 Jakavi Iceland 11.5.2017 EU/1/12/775 NovoThirteen Liechtenstein 30.6.2017 EU/1/12/775 NovoThirteen Norway 15.6.2017 EU/1/12/775 NovoThirteen Iceland 7.6.2017 EU/1/12/776 Fycompa Liechtenstein 30.4.2017 EU/1/12/776 Fycompa Norway 18.4.2017 EU/1/12/776 Fycompa Iceland 24.4.2017 EU/1/12/777 Inlyta Liechtenstein 30.6.2017 EU/1/12/777 Inlyta Norway 14.6.2017 EU/1/12/777 Inlyta Iceland 8.6.2017 EU/1/12/778 Eklira Genuair Liechtenstein 30.4.2017 EU/1/12/778 Eklira Genuair Norway 10.5.2017 EU/1/12/778 Eklira Genuair Iceland 10.5.2017 EU/1/12/779 Zoledronic acid medac Iceland 18.5.2017 EU/1/12/779 Zoledronsäure medac Liechtenstein 30.6.2017 EU/1/12/779 Zoledronsyre medac Norway 22.5.2017 EU/1/12/780 Jentadueto Liechtenstein 30.4.2017 EU/1/12/780 Jentadueto Norway 6.4.2017 EU/1/12/780 Jentadueto Iceland 6.4.2017 EU/1/12/781 Bretaris Genuair Liechtenstein 30.4.2017 EU/1/12/781 Bretaris Genuair Norway 10.5.2017 EU/1/12/781 Bretaris Genuair Iceland 10.5.2017 EU/1/12/782 Kalydeco Liechtenstein 30.6.2017 EU/1/12/782 Kalydeco Norway 19.5.2017 EU/1/12/782 Kalydeco Iceland 11.5.2017 EU/1/12/783 Zyclara Liechtenstein 30.4.2017 EU/1/12/783 Zyclara Norway 6.4.2017 EU/1/12/783 Zyclara Iceland 7.4.2017 EU/1/12/785 Zinforo Liechtenstein 30.6.2017 EU/1/12/785 Zinforo Norway 19.5.2017 EU/1/12/785 Zinforo Iceland 11.5.2017 EU/1/12/786 Zoledronic acid Mylan Norway 26.6.2017 EU/1/12/786 Zoledronic acid Mylan Iceland 7.6.2017 EU/1/12/786 Zoledronsäure Mylan Liechtenstein 30.6.2017 EU/1/12/787 Revestive Liechtenstein 30.6.2017 EU/1/12/792 Dacogen Liechtenstein 30.6.2017 EU/1/12/792 Dacogen Norway 1.6.2017 EU/1/12/792 Dacogen Iceland 6.6.2017 EU/1/12/802 Capecitabin medac Liechtenstein 30.6.2017 EU/1/12/802 Capecitabine medac Norway 26.6.2017 EU/1/13/818 Bosulif Liechtenstein 30.4.2017 EU/1/13/818 Bosulif Norway 5.4.2017 EU/1/13/818 Bosulif Iceland 7.4.2017 EU/1/13/875 Deltyba Liechtenstein 30.4.2017 EU/1/13/875 Deltyba Norway 14.3.2017 EU/1/13/875 Deltyba Iceland 14.3.2017 EU/1/13/890 Cometriq Liechtenstein 28.2.2017 EU/1/13/890 Cometriq Iceland 23.1.2017 EU/1/13/901 Sirturo Liechtenstein 28.2.2017 EU/1/13/901 Sirturo Norway 11.5.2017 EU/1/13/901 SIRTURO Iceland 6.1.2017 EU/1/13/902 Translarna Liechtenstein 28.2.2017 EU/1/13/902 Translarna Liechtenstein 30.6.2017 EU/1/13/902 Translarna Norway 1.2.2017 EU/1/14/987 Holoclar Norway 4.1.2017 EU/1/14/987 Holoclar Iceland 4.1.2017 EU/1/15/999 Zykadia Liechtenstein 30.4.2017 EU/1/15/999 Zykadia Norway 30.5.2017 EU/1/15/999 Zykadia Iceland 21.4.2017 EU/1/16/1086 Tagrisso Norway 2.1.2017 EU/1/16/1089 Pandemic influenza vaccine H5N1 MedImmune Iceland 10.5.2017 EU/1/16/1089 Pandemic influenza vaccine H5N1 MedImmune Liechtenstein 30.4.2017 EU/1/16/1089 Pandemic Influenza Vaccine H5N1 MedImmune Norway 29.6.2017 EU/1/16/1101 Darzalex Liechtenstein 30.4.2017 EU/1/16/1101 Darzalex Norway 12.5.2017 EU/1/16/1101 Darzalex Iceland 11.5.2017 EU/2/07/072 Suprelorin Liechtenstein 30.6.2017 EU/2/07/072 Suprelorin Norway 2.6.2017 EU/2/07/072 Suprelorin Iceland 23.5.2017 EU/2/11/137 Activyl Tick Plus Iceland 4.1.2017 EU/2/12/139 Zulvac 1+8 Bovis Norway 3.1.2017 EU/2/12/140 Poulvac E. coli Liechtenstein 30.6.2017 EU/2/12/140 Poulvac E. Coli Iceland 23.5.2017 EU/2/12/140 Poulvac E.coli Norway 23.5.2017 EU/2/12/141 Porcilis ColiClos Liechtenstein 30.4.2017 EU/2/12/141 Porcilis ColiClos Norway 28.4.2017 EU/2/12/141 Porcilis ColiClos Iceland 10.4.2017 EU/2/12/142 Cardalis Liechtenstein 30.6.2017 EU/2/12/142 Cardalis Norway 28.6.2017 EU/2/12/143 Nobivac L4 Norway 20.3.2017 EU/2/12/143 Nobivac L4 Liechtenstein 30.4.2017 EU/2/12/143 Nobivac L4 Iceland 24.3.2017

ANNEX III List of extended marketing authorisations The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2017: EU Number Product Country Date of authorisation EU/1/03/256/020 Humira Norway 6.4.2017 EU/1/03/256/020 Humira Iceland 10.4.2017 EU/1/07/396/004-006 Pergoveris Norway 8.5.2017 EU/1/07/396/004-006 Pergoveris Iceland 23.5.2017 EU/1/09/514/021-023 Zebinix Iceland 4.1.2017 EU/1/09/514/024 Zebinix Norway 4.1.2017 EU/1/09/564/004 Ilaris Norway 7.3.2017 EU/1/09/564/004 Ilaris Iceland 14.3.2017 EU/1/10/641/002 Ruconest Norway 26.1.2017 EU/1/10/641/002 Ruconest Iceland 30.1.2017 EU/1/10/655/012-014 Brilique Norway 18.5.2017 EU/1/10/655/012-014 Brilique Iceland 6.6.2017 EU/1/11/667/005-011 Esbriet Norway 9.5.2017 EU/1/11/667/005-011 Esbriet Iceland 11.5.2017 EU/1/13/860/003 Nexium Control Norway 23.6.2017 EU/1/13/892/003-006 Tivicay Norway 2.3.2017 EU/1/13/892/003-006 Tivicay Iceland 13.3.2017 EU/1/15/1016/006-007 Repatha Norway 17.2.2017 EU/1/15/1016/006-007 Repatha Iceland 24.2.2017 EU/1/15/1074/005 Benepali Norway 31.5.2017 EU/1/15/1074/005 Benepali Iceland 7.6.2017 EU/1/97/047/009 BeneFIX Norway 22.3.2017 EU/1/97/047/009 BeneFIX Iceland 7.4.2017 EU/2/04/042/015-018 Novem Iceland 6.6.2017 EU/2/08/083/006-009 EQUIOXX Norway 9.2.2017 EU/2/08/083/006-009 Equioxx Iceland 15.2.2017

ANNEX IV List of withdrawn marketing authorisations The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January-30 June 2017: EU Number Product Country Date of withdrawal EU/1/00/137 Avandia Liechtenstein 28.2.2017 EU/1/03/258 Avandamet Liechtenstein 28.2.2017 EU/1/06/373 Imprida Liechtenstein 30.4.2017 EU/1/06/373 Imprida Norway 19.4.2017 EU/1/06/373 Imprida Iceland 21.4.2017 EU/1/07/385 Focetria Liechtenstein 28.2.2017 EU/1/08/500 Fablyn Liechtenstein 28.2.2017 EU/1/09/512 Removab Liechtenstein 30.6.2017 EU/1/09/512 Removab Norway 23.6.2017 EU/1/09/512 Removab Iceland 12.6.2017 EU/1/09/532 Clopidogrel Acino Liechtenstein 28.2.2017 EU/1/09/532 Clopidogrel Acino Norway 9.2.2017 EU/1/09/532 Clopidogrel Acino Iceland 3.2.2017 EU/1/09/561 Clopidogrel Teva Pharma Liechtenstein 30.6.2017 EU/1/09/561 Clopidogrel Teva Pharma Norway 28.6.2017 EU/1/10/657 Prepandemic Influenza Liechtenstein 28.2.2017 EU/1/11/720 Incivo Iceland 3.2.2017 EU/1/11/721 Paglitaz Liechtenstein 28.2.2017 EU/1/14/942 Clopidogrel/Acetylsalicylsäure Teva Liechtenstein 28.2.2017 EU/1/14/948 Budesonide/Formoterol Teva Norway 19.1.2017 EU/1/14/948 Budesonide/Formoterol Teva Iceland 5.1.2017 EU/1/14/949 Vylaer Spiromax Liechtenstein 28.2.2017 EU/1/14/949 Vylaer Spiromax Norway 19.1.2017 EU/1/14/949 Vylaer Spiromax Iceland 13.1.2017 EU/1/14/950 Budesonide/Formoterol Teva Pharma B.V. Norway 19.1.2017 EU/1/14/950 Budesonide/Formoterol Teva Pharma B.V. Iceland 5.1.2017 EU/1/15/1022 Unituxin Norway 19.4.2017 EU/1/15/1022 Unituxin Iceland 6.4.2017 EU/1/15/995 DUTREBIS Liechtenstein 30.4.2017 EU/1/15/995 DUTREBIS Norway 9.5.2017 EU/1/15/995 DUTREBIS Iceland 11.5.2017 EU/2/11/127 RECUVYRA Iceland 3.2.2017