2021 11 26 |
LT |
Europos Sąjungos oficialusis leidinys |
C 478/1 |
Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2021 m. spalio 1 d. iki 2021 m. spalio 31 d.
(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį)
(2021/C 478/01)
— Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
||
2021 10 1 |
COVID-19 Vaccine Janssen |
|
EU/1/20/1525 |
2021 10 1 |
||
2021 10 4 |
Docetaxel Accord |
|
EU/1/12/769 |
2021 10 5 |
||
2021 10 4 |
Docetaxel Kabi |
|
EU/1/12/770 |
2021 10 6 |
||
2021 10 4 |
Posaconazole Accord |
|
EU/1/19/1379 |
2021 10 5 |
||
2021 10 4 |
Spikevax |
|
EU/1/20/1507 |
2021 10 4 |
||
2021 10 5 |
Comirnaty |
|
EU/1/20/1528 |
2021 10 5 |
||
2021 10 5 |
Spikevax |
|
EU/1/20/1507 |
2021 10 5 |
||
2021 10 11 |
Copalia |
|
EU/1/06/372 |
2021 10 12 |
||
2021 10 11 |
COVID-19 Vaccine Janssen |
|
EU/1/20/1525 |
2021 10 11 |
||
2021 10 11 |
Dafiro |
|
EU/1/06/371 |
2021 10 12 |
||
2021 10 11 |
Entecavir Mylan |
|
EU/1/17/1227 |
2021 10 12 |
||
2021 10 11 |
Equidacent |
|
EU/1/20/1472 |
2021 11 8 |
||
2021 10 11 |
Exforge |
|
EU/1/06/370 |
2021 10 12 |
||
2021 10 11 |
Onpattro |
|
EU/1/18/1320 |
2021 10 13 |
||
2021 10 11 |
Ovitrelle |
|
EU/1/00/165 |
2021 10 12 |
||
2021 10 11 |
ReFacto AF |
|
EU/1/99/103 |
2021 10 12 |
||
2021 10 11 |
Sifrol |
|
EU/1/97/050 |
2021 10 14 |
||
2021 10 11 |
Vargatef |
|
EU/1/14/954 |
2021 10 27 |
||
2021 10 11 |
Vyndaqel |
|
EU/1/11/717 |
2021 10 12 |
||
2021 10 15 |
Vaxzevria |
|
EU/1/21/1529 |
2021 10 15 |
||
2021 10 19 |
Ammonaps |
|
EU/1/99/120 |
2021 10 20 |
||
2021 10 19 |
Busilvex |
|
EU/1/03/254 |
2021 10 20 |
||
2021 10 19 |
Ceprotin |
|
EU/1/01/190 |
2021 10 20 |
||
2021 10 19 |
Clopidogrel/Acetylsalicylic acid Mylan |
|
EU/1/19/1395 |
2021 10 20 |
||
2021 10 19 |
Duloxetine Mylan |
|
EU/1/15/1010 |
2021 10 21 |
||
2021 10 19 |
Ecalta |
|
EU/1/07/416 |
2021 10 20 |
||
2021 10 19 |
Erelzi |
|
EU/1/17/1195 |
2021 10 20 |
||
2021 10 19 |
Firmagon |
|
EU/1/08/504 |
2021 10 25 |
||
2021 10 19 |
Forsteo |
|
EU/1/03/247 |
2021 10 25 |
||
2021 10 19 |
Gazyvaro |
|
EU/1/14/937 |
2021 10 20 |
||
2021 10 19 |
Gefitinib Mylan |
|
EU/1/18/1321 |
2021 10 20 |
||
2021 10 19 |
Hefiya |
|
EU/1/18/1287 |
2021 10 20 |
||
2021 10 19 |
Imfinzi |
|
EU/1/18/1322 |
2021 10 21 |
||
2021 10 19 |
Inrebic |
|
EU/1/20/1514 |
2021 10 21 |
||
2021 10 19 |
Integrilin |
|
EU/1/99/109 |
2021 10 20 |
||
2021 10 19 |
KEYTRUDA |
|
EU/1/15/1024 |
2021 10 21 |
||
2021 10 19 |
Lopinavir/Ritonavir Mylan |
|
EU/1/15/1067 |
2021 10 21 |
||
2021 10 19 |
Memantine LEK |
|
EU/1/13/826 |
2021 10 21 |
||
2021 10 19 |
Memantine Mylan |
|
EU/1/13/827 |
2021 10 20 |
||
2021 10 19 |
Mirapexin |
|
EU/1/97/051 |
2021 10 21 |
||
2021 10 19 |
Myozyme |
|
EU/1/06/333 |
2021 10 25 |
||
2021 10 19 |
NovoEight |
|
EU/1/13/888 |
2021 10 21 |
||
2021 10 19 |
NovoMix |
|
EU/1/00/142 |
2021 10 21 |
||
2021 10 19 |
Noxafil |
|
EU/1/05/320 |
2021 10 21 |
||
2021 10 19 |
OPDIVO |
|
EU/1/15/1014 |
2021 11 9 |
||
2021 10 19 |
Prasugrel Mylan |
|
EU/1/18/1273 |
2021 10 20 |
||
2021 10 19 |
Rasagiline Mylan |
|
EU/1/16/1090 |
2021 10 20 |
||
2021 10 19 |
REKAMBYS |
|
EU/1/20/1482 |
2021 10 20 |
||
2021 10 19 |
Repaglinide Krka |
|
EU/1/09/579 |
2021 10 21 |
||
2021 10 19 |
Semglee |
|
EU/1/18/1270 |
2021 10 20 |
||
2021 10 19 |
Spedra |
|
EU/1/13/841 |
2021 10 21 |
||
2021 10 19 |
Sunosi |
|
EU/1/19/1408 |
2021 10 21 |
||
2021 10 19 |
Tasmar |
|
EU/1/97/044 |
2021 10 21 |
||
2021 10 19 |
Tenofovir disoproxil Mylan |
|
EU/1/16/1129 |
2021 10 20 |
||
2021 10 19 |
Torisel |
|
EU/1/07/424 |
2021 10 20 |
||
2021 10 19 |
Vaborem |
|
EU/1/18/1334 |
2021 10 20 |
||
2021 10 19 |
Vfend |
|
EU/1/02/212 |
2021 10 21 |
||
2021 10 19 |
Vocabria |
|
EU/1/20/1481 |
2021 10 20 |
||
2021 10 19 |
Xydalba |
|
EU/1/14/986 |
2021 10 20 |
||
2021 10 19 |
Zessly |
|
EU/1/18/1280 |
2021 10 20 |
||
2021 10 22 |
Adempas |
|
EU/1/13/907 |
2021 11 5 |
||
2021 10 22 |
Alofisel |
|
EU/1/17/1261 |
2021 10 28 |
||
2021 10 22 |
Betaferon |
|
EU/1/95/003 |
2021 11 5 |
||
2021 10 22 |
Biktarvy |
|
EU/1/18/1289 |
2021 10 27 |
||
2021 10 22 |
Clopidogrel ratiopharm |
|
EU/1/14/975 |
2021 10 26 |
||
2021 10 22 |
Hyrimoz |
|
EU/1/18/1286 |
2021 10 25 |
||
2021 10 22 |
Idacio |
|
EU/1/19/1356 |
2021 10 25 |
||
2021 10 22 |
Imcivree |
|
EU/1/21/1564 |
2021 10 26 |
||
2021 10 22 |
Inflectra |
|
EU/1/13/854 |
2021 10 25 |
||
2021 10 22 |
Jardiance |
|
EU/1/14/930 |
2021 10 25 |
||
2021 10 22 |
Retacrit |
|
EU/1/07/431 |
2021 10 25 |
||
2021 10 22 |
Steglatro |
|
EU/1/18/1267 |
2021 10 25 |
||
2021 10 22 |
Veltassa |
|
EU/1/17/1179 |
2021 11 9 |
||
2021 10 22 |
Zepatier |
|
EU/1/16/1119 |
2021 10 25 |
||
2021 10 25 |
Clopidogrel Taw Pharma |
|
EU/1/09/559 |
2021 10 26 |
||
2021 10 25 |
Clopidogrel Viatris |
|
EU/1/09/568 |
2021 11 1 |
||
2021 10 25 |
Firazyr |
|
EU/1/08/461 |
2021 10 27 |
||
2021 10 25 |
Forxiga |
|
EU/1/12/795 |
2021 11 26 |
||
2021 10 25 |
Latuda |
|
EU/1/14/913 |
2021 10 26 |
||
2021 10 25 |
Nerlynx |
|
EU/1/18/1311 |
2021 11 10 |
||
2021 10 25 |
Segluromet |
|
EU/1/18/1265 |
2021 10 28 |
||
2021 10 25 |
Zyllt |
|
EU/1/09/553 |
2021 10 27 |
||
2021 10 28 |
Clopidogrel Krka |
|
EU/1/09/556 |
2021 11 2 |
||
2021 10 28 |
Clopidogrel TAD |
|
EU/1/09/555 |
2021 11 3 |
||
2021 10 28 |
Darunavir Mylan |
|
EU/1/16/1140 |
2021 11 5 |
||
2021 10 28 |
Mysildecard |
|
EU/1/16/1134 |
2021 10 29 |
||
2021 10 28 |
Ontozry |
|
EU/1/21/1530 |
2021 10 29 |
||
2021 10 28 |
Tyverb |
|
EU/1/07/440 |
2021 10 29 |
||
2021 10 28 |
Voriconazole Accord |
|
EU/1/13/835 |
2021 10 29 |
||
2021 10 29 |
Spikevax |
|
EU/1/20/1507 |
2021 10 29 |
— Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis)
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
||
2021 10 11 |
Docetaxel Teva |
|
EU/1/09/611 |
2021 10 12 |
||
2021 10 11 |
Equidacent |
|
EU/1/20/1472 |
2021 11 8 |
— Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
||
2021 10 18 |
Oxyglobin |
|
EU/2/99/015 |
2021 11 5 |
||
2021 10 25 |
Activyl Tick Plus |
|
EU/2/11/137 |
2021 10 26 |
||
2021 10 25 |
Canigen L4 |
|
EU/2/15/183 |
2021 10 26 |
||
2021 10 25 |
Nobilis IB Primo QX |
|
EU/2/14/174 |
2021 10 27 |
||
2021 10 25 |
Tulissin |
|
EU/2/20/252 |
2021 10 28 |
||
2021 10 25 |
Vectra 3D |
|
EU/2/13/156 |
2021 10 26 |
Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:
European Medicines Agency |
Domenico Scarlattilaan 6 |
1083 HS Amsterdam |
NETHERLANDS |