This document is an excerpt from the EUR-Lex website
Document C:2019:180:FULL
Official Journal of the European Union, C 180, 24 May 2019
Official Journal of the European Union, C 180, 24 May 2019
Official Journal of the European Union, C 180, 24 May 2019
Display all documents published in this Official Journal
|
ISSN 1977-091X |
||
|
Official Journal of the European Union |
C 180 |
|
|
||
|
English edition |
Information and Notices |
Volume 62 |
|
Contents |
page |
|
|
|
IV Notices |
|
|
|
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
|
|
|
European Commission |
|
|
2019/C 180/01 |
||
|
|
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
|
|
2019/C 180/02 |
|
EN |
|
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
|
24.5.2019 |
EN |
Official Journal of the European Union |
C 180/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
(2019/C 180/01)
|
— |
Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||
|
2.4.2019 |
Idacio |
adalimumab |
|
EU/1/19/1356 |
Solution for injection |
L04AB04 |
4.4.2019 |
||
|
2.4.2019 |
Kromeya |
adalimumab |
|
EU/1/19/1357 |
Solution for injection |
L04AB04 |
4.4.2019 |
||
|
2.4.2019 |
Vizimpro |
dacomitinib |
|
EU/1/19/1354 |
Film-coated tablet |
L01XE47 |
4.4.2019 |
||
|
26.4.2019 |
Dectova |
zanamivir |
|
EU/1/18/1349 |
Solution for infusion |
J05AH01 |
30.4.2019 |
||
|
26.4.2019 |
Ondexxya |
andexanet alfa |
|
EU/1/18/1345 |
Powder for solution for infusion |
V03AB38 |
30.4.2019 |
||
|
26.4.2019 |
Skyrizi |
risankizumab |
|
EU/1/19/1361 |
Solution for injection |
L04AC |
30.4.2019 |
||
|
26.4.2019 |
Zynquista |
sotagliflozin |
|
EU/1/19/1363 |
Film-coated tablet |
A10BK06 |
30.4.2019 |
|
— |
Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
|
2.4.2019 |
Afinitor |
|
EU/1/09/538 |
4.4.2019 |
||
|
2.4.2019 |
Betmiga |
|
EU/1/12/809 |
4.4.2019 |
||
|
2.4.2019 |
Capecitabine Accord |
|
EU/1/12/762 |
4.4.2019 |
||
|
2.4.2019 |
Clopidogrel BGR |
|
EU/1/09/558 |
4.4.2019 |
||
|
2.4.2019 |
Copalia |
|
EU/1/06/372 |
4.4.2019 |
||
|
2.4.2019 |
Dafiro |
|
EU/1/06/371 |
4.4.2019 |
||
|
2.4.2019 |
Deltyba |
|
EU/1/13/875 |
4.4.2019 |
||
|
2.4.2019 |
Eliquis |
|
EU/1/11/691 |
4.4.2019 |
||
|
2.4.2019 |
Empliciti |
|
EU/1/16/1088 |
4.4.2019 |
||
|
2.4.2019 |
Exforge HCT |
|
EU/1/09/569 |
4.4.2019 |
||
|
2.4.2019 |
Gazyvaro |
|
EU/1/14/937 |
4.4.2019 |
||
|
2.4.2019 |
Irbesartan Zentiva |
|
EU/1/06/376 |
4.4.2019 |
||
|
2.4.2019 |
Karvea |
|
EU/1/97/049 |
4.4.2019 |
||
|
2.4.2019 |
Karvezide |
|
EU/1/98/085 |
4.4.2019 |
||
|
2.4.2019 |
Lumark |
|
EU/1/15/1013 |
4.4.2019 |
||
|
2.4.2019 |
NULOJIX |
|
EU/1/11/694 |
4.4.2019 |
||
|
2.4.2019 |
Opdivo |
|
EU/1/15/1014 |
4.4.2019 |
||
|
2.4.2019 |
Steglatro |
|
EU/1/18/1267 |
4.4.2019 |
||
|
2.4.2019 |
Steglujan |
|
EU/1/18/1266 |
4.4.2019 |
||
|
2.4.2019 |
Sylvant |
|
EU/1/14/928 |
4.4.2019 |
||
|
2.4.2019 |
Vidaza |
|
EU/1/08/488 |
4.4.2019 |
||
|
2.4.2019 |
Yervoy |
|
EU/1/11/698 |
4.4.2019 |
||
|
2.4.2019 |
Zonisamide Mylan |
|
EU/1/16/1093 |
4.4.2019 |
||
|
2.4.2019 |
Zykadia |
|
EU/1/15/999 |
4.4.2019 |
||
|
8.4.2019 |
Actraphane |
|
EU/1/02/229 |
10.4.2019 |
||
|
8.4.2019 |
BiResp Spiromax |
|
EU/1/14/921 |
10.4.2019 |
||
|
8.4.2019 |
Capecitabine medac |
|
EU/1/12/802 |
10.4.2019 |
||
|
8.4.2019 |
DuoResp Spiromax |
|
EU/1/14/920 |
10.4.2019 |
||
|
8.4.2019 |
Iressa |
|
EU/1/09/526 |
10.4.2019 |
||
|
8.4.2019 |
Lantus |
|
EU/1/00/134 |
10.4.2019 |
||
|
8.4.2019 |
Lynparza |
|
EU/1/14/959 |
10.4.2019 |
||
|
8.4.2019 |
M-M-RVAXPRO |
|
EU/1/06/337 |
10.4.2019 |
||
|
8.4.2019 |
Orencia |
|
EU/1/07/389 |
10.4.2019 |
||
|
8.4.2019 |
Riarify |
|
EU/1/18/1275 |
10.4.2019 |
||
|
8.4.2019 |
Ritemvia |
|
EU/1/17/1207 |
10.4.2019 |
||
|
8.4.2019 |
Stribild |
|
EU/1/13/830 |
10.4.2019 |
||
|
8.4.2019 |
Tybost |
|
EU/1/13/872 |
10.4.2019 |
||
|
8.4.2019 |
Viread |
|
EU/1/01/200 |
10.4.2019 |
||
|
8.4.2019 |
Zerit |
|
EU/1/96/009 |
10.4.2019 |
||
|
9.4.2019 |
Esbriet |
|
EU/1/11/667 |
11.4.2019 |
||
|
9.4.2019 |
Ifirmacombi |
|
EU/1/11/673 |
11.4.2019 |
||
|
9.4.2019 |
Rituzena |
|
EU/1/17/1206 |
11.4.2019 |
||
|
9.4.2019 |
Trydonis |
|
EU/1/18/1274 |
11.4.2019 |
||
|
11.4.2019 |
Aprovel |
|
EU/1/97/046 |
15.4.2019 |
||
|
11.4.2019 |
Cervarix |
|
EU/1/07/419 |
15.4.2019 |
||
|
11.4.2019 |
CoAprovel |
|
EU/1/98/086 |
15.4.2019 |
||
|
11.4.2019 |
Copalia HCT |
|
EU/1/09/575 |
15.4.2019 |
||
|
11.4.2019 |
Dafiro HCT |
|
EU/1/09/574 |
15.4.2019 |
||
|
11.4.2019 |
Ebilfumin |
|
EU/1/14/915 |
15.4.2019 |
||
|
11.4.2019 |
Exforge |
|
EU/1/06/370 |
15.4.2019 |
||
|
11.4.2019 |
Irbesartan/Hydrochlorothiazide Teva |
|
EU/1/09/583 |
15.4.2019 |
||
|
11.4.2019 |
Irbesartan Teva |
|
EU/1/09/576 |
15.4.2019 |
||
|
11.4.2019 |
Lamivudine Teva |
|
EU/1/09/566 |
15.4.2019 |
||
|
11.4.2019 |
Leganto |
|
EU/1/11/695 |
15.4.2019 |
||
|
11.4.2019 |
Lokelma |
|
EU/1/17/1173 |
15.4.2019 |
||
|
11.4.2019 |
Neparvis |
|
EU/1/16/1103 |
15.4.2019 |
||
|
11.4.2019 |
Pemetrexed Lilly |
|
EU/1/15/1034 |
15.4.2019 |
||
|
11.4.2019 |
Pregabalin Zentiva |
|
EU/1/15/1021 |
15.4.2019 |
||
|
11.4.2019 |
Spherox |
|
EU/1/17/1181 |
15.4.2019 |
||
|
11.4.2019 |
Starlix |
|
EU/1/01/174 |
15.4.2019 |
||
|
11.4.2019 |
Truxima |
|
EU/1/16/1167 |
15.4.2019 |
||
|
11.4.2019 |
Zutectra |
|
EU/1/09/600 |
15.4.2019 |
||
|
15.4.2019 |
Ecansya |
|
EU/1/12/763 |
17.4.2019 |
||
|
15.4.2019 |
Entresto |
|
EU/1/15/1058 |
17.4.2019 |
||
|
15.4.2019 |
Ifirmasta |
|
EU/1/08/480 |
17.4.2019 |
||
|
15.4.2019 |
Irbesartan HCT Zentiva |
|
EU/1/06/377 |
17.4.2019 |
||
|
15.4.2019 |
Yargesa |
|
EU/1/17/1176 |
17.4.2019 |
||
|
17.4.2019 |
Amlodipine/ Valsartan Mylan |
|
EU/1/16/1092 |
24.4.2019 |
||
|
17.4.2019 |
Caelyx |
|
EU/1/96/011 |
24.4.2019 |
||
|
17.4.2019 |
Cimzia |
|
EU/1/09/544 |
24.4.2019 |
||
|
17.4.2019 |
Clopidogrel Apotex |
|
EU/1/09/568 |
24.4.2019 |
||
|
17.4.2019 |
Clopidogrel HCS |
|
EU/1/10/651 |
24.4.2019 |
||
|
17.4.2019 |
Cuprymina |
|
EU/1/12/784 |
24.4.2019 |
||
|
17.4.2019 |
Miglustat Dipharma |
|
EU/1/18/1346 |
24.4.2019 |
||
|
17.4.2019 |
Pandemic influenza vaccine H5N1 AstraZeneca |
|
EU/1/16/1089 |
24.4.2019 |
||
|
17.4.2019 |
Rydapt |
|
EU/1/17/1218 |
24.4.2019 |
||
|
17.4.2019 |
Semglee |
|
EU/1/18/1270 |
24.4.2019 |
||
|
17.4.2019 |
SonoVue |
|
EU/1/01/177 |
24.4.2019 |
||
|
17.4.2019 |
Zubsolv |
|
EU/1/17/1233 |
24.4.2019 |
||
|
24.4.2019 |
Orphacol |
|
EU/1/13/870 |
26.4.2019 |
||
|
26.4.2019 |
Aimovig |
|
EU/1/18/1293 |
30.4.2019 |
||
|
26.4.2019 |
Ameluz |
|
EU/1/11/740 |
30.4.2019 |
||
|
26.4.2019 |
Kyprolis |
|
EU/1/15/1060 |
30.4.2019 |
||
|
26.4.2019 |
Lonquex |
|
EU/1/13/856 |
30.4.2019 |
||
|
26.4.2019 |
Nuwiq |
|
EU/1/14/936 |
30.4.2019 |
||
|
26.4.2019 |
Oncaspar |
|
EU/1/15/1070 |
30.4.2019 |
||
|
26.4.2019 |
Picato |
|
EU/1/12/796 |
30.4.2019 |
||
|
26.4.2019 |
RotaTeq |
|
EU/1/06/348 |
30.4.2019 |
||
|
26.4.2019 |
Spectrila |
|
EU/1/15/1072 |
30.4.2019 |
||
|
29.4.2019 |
Abilify |
|
EU/1/04/276 |
1.5.2019 |
||
|
29.4.2019 |
ABILIFY MAINTENA |
|
EU/1/13/882 |
1.5.2019 |
||
|
29.4.2019 |
Aripiprazole Sandoz |
|
EU/1/15/1029 |
2.5.2019 |
||
|
29.4.2019 |
Humira |
|
EU/1/03/256 |
2.5.2019 |
||
|
29.4.2019 |
Kaletra |
|
EU/1/01/172 |
2.5.2019 |
||
|
29.4.2019 |
Lemtrada |
|
EU/1/13/869 |
2.5.2019 |
||
|
29.4.2019 |
Maviret |
|
EU/1/17/1213 |
2.5.2019 |
||
|
29.4.2019 |
Miglustat Gen.Orph |
|
EU/1/17/1232 |
2.5.2019 |
||
|
29.4.2019 |
Natpar |
|
EU/1/15/1078 |
1.5.2019 |
||
|
29.4.2019 |
Norvir |
|
EU/1/96/016 |
2.5.2019 |
||
|
29.4.2019 |
Repatha |
|
EU/1/15/1016 |
1.5.2019 |
||
|
30.4.2019 |
Zydelig |
|
EU/1/14/938 |
3.5.2019 |
|
— |
Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
|
2.4.2019 |
Numient |
|
EU/1/15/1044 |
4.4.2019 |
||
|
10.4.2019 |
Rituzena |
|
EU/1/17/1206 |
12.4.2019 |
||
|
11.4.2019 |
Topotecan Teva |
|
EU/1/09/552 |
15.4.2019 |
||
|
15.4.2019 |
Airexar Spiromax |
|
EU/1/16/1123 |
17.4.2019 |
|
— |
Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||
|
17.4.2019 |
Chanhold |
selamectin |
|
EU/2/19/236 |
Spot-on solution |
QP54AA05 |
24.4.2019 |
||
|
23.4.2019 |
Forceris |
toltrazuril/gleptoferron |
|
EU/2/19/235 |
Suspension for injection |
QP51AJ51 |
25.4.2019 |
||
|
26.4.2019 |
Felisecto Plus |
selamectin/sarolaner |
|
EU/2/19/238 |
Spot-on solution |
QP54AA55 |
30.4.2019 |
||
|
26.4.2019 |
ReproCyc ParvoFLEX |
Porcine parvovirosis vaccine (inactivated) |
|
EU/2/19/237 |
Suspension for injection |
QI09AA02 |
30.4.2019 |
|
— |
Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
|
8.4.2019 |
Versican Plus DHPPi/L4 |
|
EU/2/14/164 |
10.4.2019 |
||
|
8.4.2019 |
Versican Plus DHPPi/L4R |
|
EU/2/14/163 |
10.4.2019 |
||
|
8.4.2019 |
Versican Plus L4 |
|
EU/2/14/171 |
10.4.2019 |
||
|
11.4.2019 |
Convenia |
|
EU/2/06/059 |
15.4.2019 |
||
|
11.4.2019 |
Suvaxyn PRRS MLV |
|
EU/2/17/215 |
15.4.2019 |
||
|
11.4.2019 |
Versican Plus Pi/L4 |
|
EU/2/14/172 |
15.4.2019 |
||
|
23.4.2019 |
Innovax-ILT |
|
EU/2/15/182 |
25.4.2019 |
||
|
26.4.2019 |
ERYSENG PARVO |
|
EU/2/14/167 |
30.4.2019 |
||
|
26.4.2019 |
ProZinc |
|
EU/2/13/152 |
30.4.2019 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
|
European Medicines Agency |
|
Domenico Scarlattilaan 6 |
|
1083 HS Amsterdam |
|
NEDERLAND |
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
|
24.5.2019 |
EN |
Official Journal of the European Union |
C 180/16 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
(2019/C 180/02)
|
— |
Issuing, maintenance or modification of a national marketing authorisation |
|
Date of the decision |
Name(s) of the medicinal product |
INN (International Non-Proprietary Name) |
Holder(s) of the marketing authorisation |
Member State concerned |
Date of notification |
|
2.4.2019 |
Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group |
sartan |
Not applicable |
Not applicable |
3.4.2019 |