This document is an excerpt from the EUR-Lex website
Document 52021XC0730(05)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2021 to 30 June 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. junija 2021 do 30. junija 2021 (Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)
Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. junija 2021 do 30. junija 2021 (Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)
PUB/2021/590
UL C 307, 30.7.2021, pp. 1–10
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
30.7.2021 |
SL |
Uradni list Evropske unije |
C 307/1 |
Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. junija 2021 do 30. junija 2021
(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1))
(2021/C 307/01)
— Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja sklepa |
Ime zdravila |
INN (mednarodno nelastniško ime) |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Farmacevtska oblika |
ATC (anatomsko terapevtska kemijska oznaka) |
Datum obvestila |
||
|
17.6.2021 |
Adtralza |
tralokinumab |
|
EU/1/21/1554 |
Raztopina za injiciranje v napolnjeni injekcijski brizgi |
D11AH07 |
18.6.2021 |
||
|
17.6.2021 |
Celsunax |
Ioflupan (123I) |
|
EU/1/21/1560 |
Rztopina za injiciranje |
V09AB03 |
21.6.2021 |
||
|
17.6.2021 |
Evkeeza |
evinakumab |
|
EU/1/21/1551 |
Koncentrat za raztopino za infundiranje |
C10AX |
18.6.2021 |
||
|
17.6.2021 |
Koselugo |
selumetinib |
|
EU/1/21/1552 |
Kapsula, trda |
L01EE04 |
19.6.2021 |
||
|
17.6.2021 |
Onureg |
azacitidin |
|
EU/1/21/1556 |
Filmsko obložene tablete |
L01BC07 |
21.6.2021 |
||
|
21.6.2021 |
Jayempi |
azatioprin |
|
EU/1/21/1557 |
Oralna suspenzija |
L04AX01 |
23.6.2021 |
||
|
24.6.2021 |
Abiraterone Krka |
abirateronacetat |
|
EU/1/21/1553 |
Filmsko obložene tablete |
L02BX03 |
28.6.2021 |
||
|
24.6.2021 |
Enspryng |
satralizumab |
|
EU/1/21/1559 |
Rztopina za injiciranje |
L04AC19 |
29.6.2021 |
— Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
||
|
1.6.2021 |
Cinqaero |
|
EU/1/16/1125 |
3.6.2021 |
||
|
1.6.2021 |
Clopidogrel Taw Pharma |
|
EU/1/09/568 |
2.6.2021 |
||
|
1.6.2021 |
NULOJIX |
|
EU/1/11/694 |
2.6.2021 |
||
|
1.6.2021 |
OPDIVO |
|
EU/1/15/1014 |
2.6.2021 |
||
|
1.6.2021 |
Rebetol |
|
EU/1/99/107 |
3.6.2021 |
||
|
1.6.2021 |
Yervoy |
|
EU/1/11/698 |
2.6.2021 |
||
|
1.6.2021 |
Zejula |
|
EU/1/17/1235 |
24.6.2021 |
||
|
4.6.2021 |
Aripiprazole Zentiva |
|
EU/1/15/1009 |
7.6.2021 |
||
|
4.6.2021 |
Clopidogrel ratiopharm |
|
EU/1/14/975 |
7.6.2021 |
||
|
4.6.2021 |
Hulio |
|
EU/1/18/1319 |
9.6.2021 |
||
|
4.6.2021 |
Irbesartan HCT Zentiva |
|
EU/1/06/377 |
7.6.2021 |
||
|
4.6.2021 |
Isturisa |
|
EU/1/19/1407 |
9.6.2021 |
||
|
4.6.2021 |
Lamivudine Teva |
|
EU/1/09/566 |
7.6.2021 |
||
|
4.6.2021 |
Levetiracetam SUN |
|
EU/1/11/741 |
8.6.2021 |
||
|
4.6.2021 |
Puregon |
|
EU/1/96/008 |
8.6.2021 |
||
|
4.6.2021 |
Synjardy |
|
EU/1/15/1003 |
7.6.2021 |
||
|
14.6.2021 |
Elonva |
|
EU/1/09/609 |
16.6.2021 |
||
|
14.6.2021 |
Levetiracetam Actavis |
|
EU/1/11/713 |
16.6.2021 |
||
|
14.6.2021 |
Levetiracetam ratiopharm |
|
EU/1/11/702 |
16.6.2021 |
||
|
17.6.2021 |
Atripla |
|
EU/1/07/430 |
19.6.2021 |
||
|
17.6.2021 |
AUBAGIO |
|
EU/1/13/838 |
21.6.2021 |
||
|
17.6.2021 |
Bonviva |
|
EU/1/03/265 |
18.6.2021 |
||
|
17.6.2021 |
Cinacalcet Mylan |
|
EU/1/15/1054 |
23.6.2021 |
||
|
17.6.2021 |
Copalia HCT |
|
EU/1/09/575 |
18.6.2021 |
||
|
17.6.2021 |
Dafiro HCT |
|
EU/1/09/574 |
18.6.2021 |
||
|
17.6.2021 |
Deksmedetomidin Accord |
|
EU/1/19/1418 |
21.6.2021 |
||
|
17.6.2021 |
Delstrigo |
|
EU/1/18/1333 |
18.6.2021 |
||
|
17.6.2021 |
Dovprela |
|
EU/1/20/1437 |
18.6.2021 |
||
|
17.6.2021 |
Duloxetine Lilly |
|
EU/1/14/972 |
21.6.2021 |
||
|
17.6.2021 |
Emtriva |
|
EU/1/03/261 |
19.6.2021 |
||
|
17.6.2021 |
Enbrel |
|
EU/1/99/126 |
18.6.2021 |
||
|
17.6.2021 |
Eviplera |
|
EU/1/11/737 |
28.6.2021 |
||
|
17.6.2021 |
Exforge HCT |
|
EU/1/09/569 |
21.6.2021 |
||
|
17.6.2021 |
Fabrazyme |
|
EU/1/01/188 |
18.6.2021 |
||
|
17.6.2021 |
Inovelon |
|
EU/1/06/378 |
20.6.2021 |
||
|
17.6.2021 |
Jardiance |
|
EU/1/14/930 |
21.6.2021 |
||
|
17.6.2021 |
KEYTRUDA |
|
EU/1/15/1024 |
18.6.2021 |
||
|
17.6.2021 |
Kisplyx |
|
EU/1/16/1128 |
20.6.2021 |
||
|
17.6.2021 |
Levetiracetam Teva |
|
EU/1/11/701 |
18.6.2021 |
||
|
17.6.2021 |
Matever |
|
EU/1/11/711 |
18.6.2021 |
||
|
17.6.2021 |
Mysimba |
|
EU/1/14/988 |
21.6.2021 |
||
|
17.6.2021 |
Nitisinone MDK |
|
EU/1/17/1217 |
25.6.2021 |
||
|
17.6.2021 |
Nustendi |
|
EU/1/20/1424 |
2.7.2021 |
||
|
17.6.2021 |
Pioglitazon Teva Pharma |
|
EU/1/12/758 |
2.7.2021 |
||
|
17.6.2021 |
Resolor |
|
EU/1/09/581 |
20.6.2021 |
||
|
17.6.2021 |
Ritemvia |
|
EU/1/17/1207 |
28.6.2021 |
||
|
17.6.2021 |
Sarclisa |
|
EU/1/20/1435 |
18.6.2021 |
||
|
17.6.2021 |
Sialanar |
|
EU/1/16/1135 |
18.6.2021 |
||
|
17.6.2021 |
TAVLESSE |
|
EU/1/19/1405 |
21.6.2021 |
||
|
17.6.2021 |
Translarna |
|
EU/1/13/902 |
18.6.2021 |
||
|
17.6.2021 |
Trulicity |
|
EU/1/14/956 |
21.6.2021 |
||
|
17.6.2021 |
Xgeva |
|
EU/1/11/703 |
18.6.2021 |
||
|
17.6.2021 |
Xtandi |
|
EU/1/13/846 |
20.6.2021 |
||
|
17.6.2021 |
Yentreve |
|
EU/1/04/280 |
18.6.2021 |
||
|
17.6.2021 |
Zerbaxa |
|
EU/1/15/1032 |
29.6.2021 |
||
|
21.6.2021 |
APTIVUS |
|
EU/1/05/315 |
22.6.2021 |
||
|
21.6.2021 |
Arsenic Trioxide Accord |
|
EU/1/19/1398 |
22.6.2021 |
||
|
21.6.2021 |
BLENREP |
|
EU/1/20/1474 |
22.6.2021 |
||
|
21.6.2021 |
Bortezomib SUN |
|
EU/1/16/1102 |
23.6.2021 |
||
|
21.6.2021 |
Competact |
|
EU/1/06/354 |
8.7.2021 |
||
|
21.6.2021 |
Cymbalta |
|
EU/1/04/296 |
22.6.2021 |
||
|
21.6.2021 |
Darzalex |
|
EU/1/16/1101 |
23.6.2021 |
||
|
21.6.2021 |
Eucreas |
|
EU/1/07/425 |
24.6.2021 |
||
|
21.6.2021 |
EVOTAZ |
|
EU/1/15/1025 |
22.6.2021 |
||
|
21.6.2021 |
Eylea |
|
EU/1/12/797 |
9.7.2021 |
||
|
21.6.2021 |
Fetcroja |
|
EU/1/20/1434 |
22.6.2021 |
||
|
21.6.2021 |
Firmagon |
|
EU/1/08/504 |
23.6.2021 |
||
|
21.6.2021 |
Galvus |
|
EU/1/07/414 |
24.6.2021 |
||
|
21.6.2021 |
Humalog |
|
EU/1/96/007 |
22.6.2021 |
||
|
21.6.2021 |
Jalra |
|
EU/1/08/485 |
24.6.2021 |
||
|
21.6.2021 |
Lemtrada |
|
EU/1/13/869 |
23.6.2021 |
||
|
21.6.2021 |
Levetiracetam Accord |
|
EU/1/11/712 |
22.6.2021 |
||
|
21.6.2021 |
Levetiracetam Actavis Group |
|
EU/1/11/738 |
22.6.2021 |
||
|
21.6.2021 |
LIBTAYO |
|
EU/1/19/1376 |
22.6.2021 |
||
|
21.6.2021 |
LIBTAYO |
|
EU/1/19/1376 |
22.6.2021 |
||
|
21.6.2021 |
Maviret |
|
EU/1/17/1213 |
22.6.2021 |
||
|
21.6.2021 |
Nepexto |
|
EU/1/20/1436 |
24.6.2021 |
||
|
21.6.2021 |
Nordimet |
|
EU/1/16/1124 |
23.6.2021 |
||
|
21.6.2021 |
Ogivri |
|
EU/1/18/1341 |
23.6.2021 |
||
|
21.6.2021 |
Otezla |
|
EU/1/14/981 |
22.6.2021 |
||
|
21.6.2021 |
Pioglitazon Teva |
|
EU/1/12/757 |
22.6.2021 |
||
|
21.6.2021 |
Riarify |
|
EU/1/18/1275 |
22.6.2021 |
||
|
21.6.2021 |
Ribavirin Teva |
|
EU/1/09/509 |
24.6.2021 |
||
|
21.6.2021 |
Ribavirin Teva Pharma BV |
|
EU/1/09/527 |
24.6.2021 |
||
|
21.6.2021 |
Rozlytrek |
|
EU/1/20/1460 |
23.6.2021 |
||
|
21.6.2021 |
Somavert |
|
EU/1/02/240 |
23.6.2021 |
||
|
21.6.2021 |
Targretin |
|
EU/1/01/178 |
22.6.2021 |
||
|
21.6.2021 |
Venclyxto |
|
EU/1/16/1138 |
22.6.2021 |
||
|
21.6.2021 |
Xarelto |
|
EU/1/08/472 |
2.7.2021 |
||
|
21.6.2021 |
Xiliarx |
|
EU/1/08/486 |
24.6.2021 |
||
|
24.6.2021 |
Abasaglar |
|
EU/1/14/944 |
28.6.2021 |
||
|
24.6.2021 |
BLINCYTO |
|
EU/1/15/1047 |
25.6.2021 |
||
|
24.6.2021 |
Glidipion |
|
EU/1/12/756 |
25.6.2021 |
||
|
24.6.2021 |
Hexacima |
|
EU/1/13/828 |
8.7.2021 |
||
|
24.6.2021 |
Ibandronska kislina Accord |
|
EU/1/12/798 |
28.6.2021 |
||
|
24.6.2021 |
Imnovid |
|
EU/1/13/850 |
26.6.2021 |
||
|
24.6.2021 |
KEYTRUDA |
|
EU/1/15/1024 |
1.7.2021 |
||
|
24.6.2021 |
Leflunomide medac |
|
EU/1/10/637 |
28.6.2021 |
||
|
24.6.2021 |
Olanzapine Apotex |
|
EU/1/10/635 |
13.7.2021 |
||
|
24.6.2021 |
OPDIVO |
|
EU/1/15/1014 |
29.6.2021 |
||
|
24.6.2021 |
Pioglitazon Actavis |
|
EU/1/12/755 |
25.6.2021 |
||
|
24.6.2021 |
Protopic |
|
EU/1/02/201 |
2.7.2021 |
||
|
24.6.2021 |
Roteas |
|
EU/1/16/1152 |
29.6.2021 |
||
|
24.6.2021 |
Segluromet |
|
EU/1/18/1265 |
29.6.2021 |
||
|
24.6.2021 |
Tandemact |
|
EU/1/06/366 |
8.7.2021 |
||
|
24.6.2021 |
Veklury |
|
EU/1/20/1459 |
28.6.2021 |
||
|
24.6.2021 |
Yervoy |
|
EU/1/11/698 |
25.6.2021 |
||
|
25.6.2021 |
Triumeq |
|
EU/1/14/940 |
2.7.2021 |
||
|
28.6.2021 |
Accofil |
|
EU/1/14/946 |
1.7.2021 |
||
|
28.6.2021 |
Hexyon |
|
EU/1/13/829 |
29.6.2021 |
||
|
28.6.2021 |
Isentress |
|
EU/1/07/436 |
29.6.2021 |
||
|
28.6.2021 |
Spherox |
|
EU/1/17/1181 |
1.7.2021 |
||
|
28.6.2021 |
Vidaza |
|
EU/1/08/488 |
29.6.2021 |
— Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
||
|
14.6.2021 |
Ulipristal Acetate Gedeon Richter |
|
EU/1/18/1309 |
13.7.2021 |
||
|
21.6.2021 |
Lextemy |
|
EU/1/20/1516 |
23.6.2021 |
||
|
21.6.2021 |
Pioglitazon Teva Pharma |
|
EU/1/12/758 |
22.6.2021 |
||
|
21.6.2021 |
Ritemvia |
|
EU/1/17/1207 |
2.7.2021 |
||
|
22.6.2021 |
Ribavirin Teva |
|
EU/1/09/509 |
24.6.2021 |
||
|
22.6.2021 |
Ribavirin Teva Pharma BV |
|
EU/1/09/527 |
24.6.2021 |
— Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
||
|
1.6.2021 |
Reconcile |
|
EU/2/08/080 |
2.6.2021 |
||
|
4.6.2021 |
Comfortis |
|
EU/2/10/115 |
14.6.2021 |
||
|
14.6.2021 |
Bovilis Blue-8 |
|
EU/2/17/218 |
18.6.2021 |
||
|
22.6.2021 |
Porcilis ColiClos |
|
EU/2/12/141 |
23.6.2021 |
||
|
22.6.2021 |
RESPIPORC FLUpan H1N1 |
|
EU/2/17/209 |
23.6.2021 |
||
|
22.6.2021 |
Stronghold Plus |
|
EU/2/16/204 |
13.7.2021 |
Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:
|
European Medicines Agency |
|
Domenico Scarlattilaan 6 |
|
1083 HS Amsterdam |
|
NIZOZEMSKA |