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Document 52021XC1126(04)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2021 to 31 October 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2021. do 31. listopada 2021. (Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2021. do 31. listopada 2021. (Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)
PUB/2021/917
SL C 478, 26.11.2021, p. 1–7
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
26.11.2021 |
HR |
Službeni list Europske unije |
C 478/1 |
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2021. do 31. listopada 2021.
(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))
(2021/C 478/01)
— Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
||
1.10.2021. |
COVID-19 Vaccine Janssen |
|
EU/1/20/1525 |
1.10.2021. |
||
4.10.2021. |
Docetaxel Accord |
|
EU/1/12/769 |
5.10.2021. |
||
4.10.2021. |
Docetaxel Kabi |
|
EU/1/12/770 |
6.10.2021. |
||
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. |
||
5.10.2021. |
Spikevax |
|
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 |
|
EU/1/01/190 |
20.10.2021. |
||
19.10.2021. |
Clopidogrel/Acetylsalicylic acid Mylan |
|
EU/1/19/1395 |
20.10.2021. |
||
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 |
|
EU/1/14/937 |
20.10.2021. |
||
19.10.2021. |
Gefitinib Mylan |
|
EU/1/18/1321 |
20.10.2021. |
||
19.10.2021. |
Hefiya |
|
EU/1/18/1287 |
20.10.2021. |
||
19.10.2021. |
Imfinzi |
|
EU/1/18/1322 |
21.10.2021. |
||
19.10.2021. |
Inrebic |
|
EU/1/20/1514 |
21.10.2021. |
||
19.10.2021. |
Integrilin |
|
EU/1/99/109 |
20.10.2021. |
||
19.10.2021. |
KEYTRUDA |
|
EU/1/15/1024 |
21.10.2021. |
||
19.10.2021. |
Lopinavir/Ritonavir Mylan |
|
EU/1/15/1067 |
21.10.2021. |
||
19.10.2021. |
Memantine LEK |
|
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. |
||
19.10.2021. |
Myozyme |
|
EU/1/06/333 |
25.10.2021. |
||
19.10.2021. |
NovoEight |
|
EU/1/13/888 |
21.10.2021. |
||
19.10.2021. |
NovoMix |
|
EU/1/00/142 |
21.10.2021. |
||
19.10.2021. |
Noxafil |
|
EU/1/05/320 |
21.10.2021. |
||
19.10.2021. |
OPDIVO |
|
EU/1/15/1014 |
9.11.2021. |
||
19.10.2021. |
Prasugrel Mylan |
|
EU/1/18/1273 |
20.10.2021. |
||
19.10.2021. |
Rasagiline Mylan |
|
EU/1/16/1090 |
20.10.2021. |
||
19.10.2021. |
REKAMBYS |
|
EU/1/20/1482 |
20.10.2021. |
||
19.10.2021. |
Repaglinide Krka |
|
EU/1/09/579 |
21.10.2021. |
||
19.10.2021. |
Semglee |
|
EU/1/18/1270 |
20.10.2021. |
||
19.10.2021. |
Spedra |
|
EU/1/13/841 |
21.10.2021. |
||
19.10.2021. |
Sunosi |
|
EU/1/19/1408 |
21.10.2021. |
||
19.10.2021. |
Tasmar |
|
EU/1/97/044 |
21.10.2021. |
||
19.10.2021. |
Tenofovir disoproxil Mylan |
|
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. |
— Povlačenje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
||
11.10.2021. |
Docetaxel Teva |
|
EU/1/09/611 |
12.10.2021. |
||
11.10.2021. |
Equidacent |
|
EU/1/20/1472 |
8.11.2021. |
— Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
||
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. |
Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:
European Medicines Agency |
Domenico Scarlattilaan 6 |
1083 HS Amsterdam |
NETHERLANDS |