ISSN 1977-0952 |
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Eiropas Savienības Oficiālais Vēstnesis |
C 478 |
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Izdevums latviešu valodā |
Informācija un paziņojumi |
64. gadagājums |
Saturs |
Lappuse |
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IV Paziņojumi |
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EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
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Eiropas Komisija |
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2021/C 478/01 |
LV |
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IV Paziņojumi
EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI
Eiropas Komisija
26.11.2021 |
LV |
Eiropas Savienības Oficiālais Vēstnesis |
C 478/1 |
Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2021. gada 1. oktobra līdz 2021. gada 31. oktobrim
(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 (1))
(2021/C 478/01)
— Tirdzniecības atļaujas grozīšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas
Lēmuma datums |
Zāļu nosaukums |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Paziņojuma datums |
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1.10.2021. |
COVID-19 Vaccine Janssen |
|
EU/1/20/1525 |
1.10.2021. |
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4.10.2021. |
Docetaxel Accord |
|
EU/1/12/769 |
5.10.2021. |
||
4.10.2021. |
Docetaxel Kabi |
|
EU/1/12/770 |
6.10.2021. |
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4.10.2021. |
Posaconazole Accord |
|
EU/1/19/1379 |
5.10.2021. |
||
4.10.2021. |
Spikevax |
|
EU/1/20/1507 |
4.10.2021. |
||
5.10.2021. |
Comirnaty |
|
EU/1/20/1528 |
5.10.2021. |
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5.10.2021. |
Spikevax |
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EU/1/20/1507 |
5.10.2021. |
||
11.10.2021. |
Copalia |
|
EU/1/06/372 |
12.10.2021. |
||
11.10.2021. |
COVID-19 Vaccine Janssen |
|
EU/1/20/1525 |
11.10.2021. |
||
11.10.2021. |
Dafiro |
|
EU/1/06/371 |
12.10.2021. |
||
11.10.2021. |
Entecavir Mylan |
|
EU/1/17/1227 |
12.10.2021. |
||
11.10.2021. |
Equidacent |
|
EU/1/20/1472 |
8.11.2021. |
||
11.10.2021. |
Exforge |
|
EU/1/06/370 |
12.10.2021. |
||
11.10.2021. |
Onpattro |
|
EU/1/18/1320 |
13.10.2021. |
||
11.10.2021. |
Ovitrelle |
|
EU/1/00/165 |
12.10.2021. |
||
11.10.2021. |
ReFacto AF |
|
EU/1/99/103 |
12.10.2021. |
||
11.10.2021. |
Sifrol |
|
EU/1/97/050 |
14.10.2021. |
||
11.10.2021. |
Vargatef |
|
EU/1/14/954 |
27.10.2021. |
||
11.10.2021. |
Vyndaqel |
|
EU/1/11/717 |
12.10.2021. |
||
15.10.2021. |
Vaxzevria |
|
EU/1/21/1529 |
15.10.2021. |
||
19.10.2021. |
Ammonaps |
|
EU/1/99/120 |
20.10.2021. |
||
19.10.2021. |
Busilvex |
|
EU/1/03/254 |
20.10.2021. |
||
19.10.2021. |
Ceprotin |
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EU/1/01/190 |
20.10.2021. |
||
19.10.2021. |
Clopidogrel/Acetylsalicylic acid Mylan |
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EU/1/19/1395 |
20.10.2021. |
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19.10.2021. |
Duloxetine Mylan |
|
EU/1/15/1010 |
21.10.2021. |
||
19.10.2021. |
Ecalta |
|
EU/1/07/416 |
20.10.2021. |
||
19.10.2021. |
Erelzi |
|
EU/1/17/1195 |
20.10.2021. |
||
19.10.2021. |
Firmagon |
|
EU/1/08/504 |
25.10.2021. |
||
19.10.2021. |
Forsteo |
|
EU/1/03/247 |
25.10.2021. |
||
19.10.2021. |
Gazyvaro |
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EU/1/14/937 |
20.10.2021. |
||
19.10.2021. |
Gefitinib Mylan |
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EU/1/18/1321 |
20.10.2021. |
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19.10.2021. |
Hefiya |
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EU/1/18/1287 |
20.10.2021. |
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19.10.2021. |
Imfinzi |
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EU/1/18/1322 |
21.10.2021. |
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19.10.2021. |
Inrebic |
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EU/1/20/1514 |
21.10.2021. |
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19.10.2021. |
Integrilin |
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EU/1/99/109 |
20.10.2021. |
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19.10.2021. |
KEYTRUDA |
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EU/1/15/1024 |
21.10.2021. |
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19.10.2021. |
Lopinavir/Ritonavir Mylan |
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EU/1/15/1067 |
21.10.2021. |
||
19.10.2021. |
Memantine LEK |
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EU/1/13/826 |
21.10.2021. |
||
19.10.2021. |
Memantine Mylan |
|
EU/1/13/827 |
20.10.2021. |
||
19.10.2021. |
Mirapexin |
|
EU/1/97/051 |
21.10.2021. |
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19.10.2021. |
Myozyme |
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EU/1/06/333 |
25.10.2021. |
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19.10.2021. |
NovoEight |
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EU/1/13/888 |
21.10.2021. |
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19.10.2021. |
NovoMix |
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EU/1/00/142 |
21.10.2021. |
||
19.10.2021. |
Noxafil |
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EU/1/05/320 |
21.10.2021. |
||
19.10.2021. |
OPDIVO |
|
EU/1/15/1014 |
9.11.2021. |
||
19.10.2021. |
Prasugrel Mylan |
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EU/1/18/1273 |
20.10.2021. |
||
19.10.2021. |
Rasagiline Mylan |
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EU/1/16/1090 |
20.10.2021. |
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19.10.2021. |
REKAMBYS |
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EU/1/20/1482 |
20.10.2021. |
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19.10.2021. |
Repaglinide Krka |
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EU/1/09/579 |
21.10.2021. |
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19.10.2021. |
Semglee |
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EU/1/18/1270 |
20.10.2021. |
||
19.10.2021. |
Spedra |
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EU/1/13/841 |
21.10.2021. |
||
19.10.2021. |
Sunosi |
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EU/1/19/1408 |
21.10.2021. |
||
19.10.2021. |
Tasmar |
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EU/1/97/044 |
21.10.2021. |
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19.10.2021. |
Tenofovir disoproxil Mylan |
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EU/1/16/1129 |
20.10.2021. |
||
19.10.2021. |
Torisel |
|
EU/1/07/424 |
20.10.2021. |
||
19.10.2021. |
Vaborem |
|
EU/1/18/1334 |
20.10.2021. |
||
19.10.2021. |
Vfend |
|
EU/1/02/212 |
21.10.2021. |
||
19.10.2021. |
Vocabria |
|
EU/1/20/1481 |
20.10.2021. |
||
19.10.2021. |
Xydalba |
|
EU/1/14/986 |
20.10.2021. |
||
19.10.2021. |
Zessly |
|
EU/1/18/1280 |
20.10.2021. |
||
22.10.2021. |
Adempas |
|
EU/1/13/907 |
5.11.2021. |
||
22.10.2021. |
Alofisel |
|
EU/1/17/1261 |
28.10.2021. |
||
22.10.2021. |
Betaferon |
|
EU/1/95/003 |
5.11.2021. |
||
22.10.2021. |
Biktarvy |
|
EU/1/18/1289 |
27.10.2021. |
||
22.10.2021. |
Clopidogrel ratiopharm |
|
EU/1/14/975 |
26.10.2021. |
||
22.10.2021. |
Hyrimoz |
|
EU/1/18/1286 |
25.10.2021. |
||
22.10.2021. |
Idacio |
|
EU/1/19/1356 |
25.10.2021. |
||
22.10.2021. |
Imcivree |
|
EU/1/21/1564 |
26.10.2021. |
||
22.10.2021. |
Inflectra |
|
EU/1/13/854 |
25.10.2021. |
||
22.10.2021. |
Jardiance |
|
EU/1/14/930 |
25.10.2021. |
||
22.10.2021. |
Retacrit |
|
EU/1/07/431 |
25.10.2021. |
||
22.10.2021. |
Steglatro |
|
EU/1/18/1267 |
25.10.2021. |
||
22.10.2021. |
Veltassa |
|
EU/1/17/1179 |
9.11.2021. |
||
22.10.2021. |
Zepatier |
|
EU/1/16/1119 |
25.10.2021. |
||
25.10.2021. |
Clopidogrel Taw Pharma |
|
EU/1/09/559 |
26.10.2021. |
||
25.10.2021. |
Clopidogrel Viatris |
|
EU/1/09/568 |
1.11.2021. |
||
25.10.2021. |
Firazyr |
|
EU/1/08/461 |
27.10.2021. |
||
25.10.2021. |
Forxiga |
|
EU/1/12/795 |
26.11.2021. |
||
25.10.2021. |
Latuda |
|
EU/1/14/913 |
26.10.2021. |
||
25.10.2021. |
Nerlynx |
|
EU/1/18/1311 |
10.11.2021. |
||
25.10.2021. |
Segluromet |
|
EU/1/18/1265 |
28.10.2021. |
||
25.10.2021. |
Zyllt |
|
EU/1/09/553 |
27.10.2021. |
||
28.10.2021. |
Clopidogrel Krka |
|
EU/1/09/556 |
2.11.2021. |
||
28.10.2021. |
Clopidogrel TAD |
|
EU/1/09/555 |
3.11.2021. |
||
28.10.2021. |
Darunavir Mylan |
|
EU/1/16/1140 |
5.11.2021. |
||
28.10.2021. |
Mysildecard |
|
EU/1/16/1134 |
29.10.2021. |
||
28.10.2021. |
Ontozry |
|
EU/1/21/1530 |
29.10.2021. |
||
28.10.2021. |
Tyverb |
|
EU/1/07/440 |
29.10.2021. |
||
28.10.2021. |
Voriconazole Accord |
|
EU/1/13/835 |
29.10.2021. |
||
29.10.2021. |
Spikevax |
|
EU/1/20/1507 |
29.10.2021. |
— Tirdzniecības atļaujas izņemšana no aprites (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)
Lēmuma datums |
Zāļu nosaukums |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Paziņojuma datums |
||
11.10.2021. |
Docetaxel Teva |
|
EU/1/09/611 |
12.10.2021. |
||
11.10.2021. |
Equidacent |
|
EU/1/20/1472 |
8.11.2021. |
— Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas
Lēmuma datums |
Zāļu nosaukums |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Paziņojuma datums |
||
18.10.2021. |
Oxyglobin |
|
EU/2/99/015 |
5.11.2021. |
||
25.10.2021. |
Activyl Tick Plus |
|
EU/2/11/137 |
26.10.2021. |
||
25.10.2021. |
Canigen L4 |
|
EU/2/15/183 |
26.10.2021. |
||
25.10.2021. |
Nobilis IB Primo QX |
|
EU/2/14/174 |
27.10.2021. |
||
25.10.2021. |
Tulissin |
|
EU/2/20/252 |
28.10.2021. |
||
25.10.2021. |
Vectra 3D |
|
EU/2/13/156 |
26.10.2021. |
Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:
European Medicines Agency |
Domenico Scarlattilaan 6 |
1083 HS Amsterdam |
NETHERLANDS |