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Il-Ġurnal Uffiċjali |
MT Is-serje C |
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C/2024/7468 |
30.12.2024 |
Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Novembru 2024 sa 30 Novembru 2024
(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1) jew L-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill (2) )
(C/2024/7468)
— Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat
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Data tad-deċiżjoni |
Isem tal-prodott mediċinali |
INN (Denominazzjoni Internazzjonali Komuni) |
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq |
Numru tal-entrata fir-Reġistru Komunitarju |
Forma farmaċewtika |
Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) |
Data ta’ notifika |
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13.11.2024 |
Afqlir |
aflibercept |
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EU/1/24/1867 |
Soluzzjoni għall-injezzjoni |
S01LA05 |
14.11.2024 |
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|
13.11.2024 |
Opuviz |
aflibercept |
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EU/1/24/1865 |
Soluzzjoni għall-injezzjoni |
S01LA05 |
18.11.2024 |
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14.11.2024 |
ELAHERE |
mirvetuximab soravtansine |
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EU/1/24/1866 |
Konċentrat għal soluzzjoni għal infużjoni |
L01FX26 |
15.11.2024 |
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14.11.2024 |
Penbraya |
Vaċċin konjugat tal-gruppi meningokokkali A, C, W, Y u vaċċin tal-grupp meningokokkali B (rikombinanti, adsorbit) |
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EU/1/24/1871 |
Trab u suspensjoni għal suspensjoni għall - injezzjoni |
J07AH11 |
15.11.2024 |
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14.11.2024 |
Pomalidomide Teva |
pomalidomide |
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EU/1/24/1868 |
Kapsula, iebsa |
L04AX06 |
15.11.2024 |
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15.11.2024 |
Fluad |
Tilqima tal-influwenza (antiġen tal-wiċċ, inattivata, adjuvanted) |
Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland |
EU/1/24/1878 |
Suspensjoni għall-injezzjoni |
J07BB02 |
19.11.2024 |
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15.11.2024 |
Flucelvax |
Tilqima tal-influwenza (antiġen tal-wiċċ, inattivata, ippreparata f’kolturi taċ-ċelluli) |
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EU/1/24/1879 |
Suspensjoni għall-injezzjoni |
J07BB02 |
26.11.2024 |
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18.11.2024 |
Hympavzi |
marstacimabas |
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EU/1/24/1874 |
Soluzzjoni għall-injezzjoni |
B02BX11 |
19.11.2024 |
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22.11.2024 |
Theralugand |
lutetium (177Lu) chloride |
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EU/1/24/1852 |
Prekursur radjufarmaċewtiku, soluzzjoni |
V10X |
27.11.2024 |
— Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat
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Data tad-deċiżjoni |
Isem tal-prodott mediċinali |
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq |
Numru tal-entrata fir-Reġistru Komunitarju |
Data ta’ notifika |
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4.11.2024 |
Dupixent |
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EU/1/17/1229 |
5.11.2024 |
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4.11.2024 |
Farydak |
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EU/1/15/1023 |
5.11.2024 |
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4.11.2024 |
Hulio |
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EU/1/18/1319 |
6.11.2024 |
||
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4.11.2024 |
Inaqovi |
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EU/1/23/1756 |
6.11.2024 |
||
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4.11.2024 |
Remicade |
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EU/1/99/116 |
5.11.2024 |
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4.11.2024 |
Synjardy |
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EU/1/15/1003 |
5.11.2024 |
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4.11.2024 |
Vipdomet |
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EU/1/13/843 |
5.11.2024 |
||
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13.11.2024 |
Abevmy |
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EU/1/20/1515 |
20.11.2024 |
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13.11.2024 |
Eladynos |
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EU/1/22/1706 |
14.11.2024 |
||
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13.11.2024 |
ELREXFIO |
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EU/1/23/1770 |
15.11.2024 |
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13.11.2024 |
MenQuadfi |
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EU/1/20/1483 |
14.11.2024 |
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13.11.2024 |
Ruxience |
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EU/1/20/1431 |
15.11.2024 |
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13.11.2024 |
TAVLESSE |
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EU/1/19/1405 |
18.11.2024 |
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13.11.2024 |
Vaxelis |
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EU/1/15/1079 |
14.11.2024 |
||
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13.11.2024 |
Zynlonta |
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EU/1/22/1695 |
14.11.2024 |
||
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14.11.2024 |
Fingolimod Mylan |
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EU/1/21/1573 |
15.11.2024 |
||
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14.11.2024 |
Fulphila |
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EU/1/18/1329 |
27.11.2024 |
||
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14.11.2024 |
Givlaari |
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EU/1/20/1428 |
19.11.2024 |
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14.11.2024 |
Incruse Ellipta |
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EU/1/14/922 |
15.11.2024 |
||
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14.11.2024 |
KIMMTRAK |
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EU/1/22/1630 |
18.11.2024 |
||
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14.11.2024 |
Laventair Ellipta |
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EU/1/14/899 |
15.11.2024 |
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14.11.2024 |
Lenalidomide Mylan |
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EU/1/20/1490 |
15.11.2024 |
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14.11.2024 |
Lumeblue |
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EU/1/20/1470 |
15.11.2024 |
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14.11.2024 |
Lumykras |
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EU/1/21/1603 |
15.11.2024 |
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14.11.2024 |
Rolufta Ellipta |
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EU/1/17/1174 |
15.11.2024 |
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14.11.2024 |
Spevigo |
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EU/1/22/1688 |
15.11.2024 |
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14.11.2024 |
Sugammadex Mylan |
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EU/1/21/1583 |
15.11.2024 |
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14.11.2024 |
Tarceva |
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EU/1/05/311 |
20.11.2024 |
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14.11.2024 |
Tecovirimat SIGA |
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EU/1/21/1600 |
19.11.2024 |
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14.11.2024 |
Uptravi |
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EU/1/15/1083 |
15.11.2024 |
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14.11.2024 |
Yescarta |
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EU/1/18/1299 |
15.11.2024 |
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18.11.2024 |
Akynzeo |
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EU/1/15/1001 |
19.11.2024 |
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18.11.2024 |
Apixaban Accord |
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EU/1/20/1458 |
19.11.2024 |
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18.11.2024 |
Cosentyx |
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EU/1/14/980 |
19.11.2024 |
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18.11.2024 |
Erleada |
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EU/1/18/1342 |
19.11.2024 |
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18.11.2024 |
Isturisa |
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EU/1/19/1407 |
19.11.2024 |
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18.11.2024 |
Krazati |
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EU/1/23/1744 |
19.11.2024 |
||
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18.11.2024 |
Lupkynis |
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EU/1/22/1678 |
19.11.2024 |
||
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18.11.2024 |
Nevanac |
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EU/1/07/433 |
19.11.2024 |
||
|
18.11.2024 |
Nilemdo |
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EU/1/20/1425 |
27.11.2024 |
||
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18.11.2024 |
Nustendi |
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EU/1/20/1424 |
27.11.2024 |
||
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18.11.2024 |
Orgovyx |
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EU/1/22/1642 |
19.11.2024 |
||
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18.11.2024 |
Ozawade |
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EU/1/21/1546 |
19.11.2024 |
||
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18.11.2024 |
Praluent |
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EU/1/15/1031 |
19.11.2024 |
||
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18.11.2024 |
Pylclari |
|
EU/1/23/1746 |
21.11.2024 |
||
|
18.11.2024 |
Simulect |
|
EU/1/98/084 |
19.11.2024 |
||
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18.11.2024 |
Xolair |
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EU/1/05/319 |
19.11.2024 |
||
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19.11.2024 |
Victoza |
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EU/1/09/529 |
26.11.2024 |
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22.11.2024 |
Anoro Ellipta |
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EU/1/14/898 |
25.11.2024 |
||
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22.11.2024 |
Beovu |
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EU/1/19/1417 |
25.11.2024 |
||
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22.11.2024 |
Briviact |
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EU/1/15/1073 |
26.11.2024 |
||
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22.11.2024 |
Bylvay |
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EU/1/21/1566 |
29.11.2024 |
||
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22.11.2024 |
Cablivi |
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EU/1/18/1305 |
25.11.2024 |
||
|
22.11.2024 |
Ebymect |
|
EU/1/15/1051 |
25.11.2024 |
||
|
22.11.2024 |
Rybelsus |
|
EU/1/20/1430 |
26.11.2024 |
||
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22.11.2024 |
SANCUSO |
|
EU/1/12/766 |
28.11.2024 |
||
|
22.11.2024 |
Saxenda |
|
EU/1/15/992 |
26.11.2024 |
||
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22.11.2024 |
Scintimun |
|
EU/1/09/602 |
27.11.2024 |
||
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22.11.2024 |
Vaxneuvance |
|
EU/1/21/1591 |
26.11.2024 |
||
|
22.11.2024 |
Yselty |
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EU/1/21/1606 |
25.11.2024 |
||
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25.11.2024 |
Hepcludex |
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EU/1/20/1446 |
26.11.2024 |
||
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25.11.2024 |
Kevzara |
|
EU/1/17/1196 |
26.11.2024 |
||
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25.11.2024 |
Kisqali |
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EU/1/17/1221 |
26.11.2024 |
||
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25.11.2024 |
Menveo |
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EU/1/10/614 |
26.11.2024 |
||
|
25.11.2024 |
Orgalutran |
|
EU/1/00/130 |
27.11.2024 |
||
|
25.11.2024 |
Supemtek |
|
EU/1/20/1484 |
28.11.2024 |
||
|
25.11.2024 |
Tevimbra |
|
EU/1/23/1758 |
26.11.2024 |
||
|
25.11.2024 |
Tigecycline Accord |
|
EU/1/19/1394 |
26.11.2024 |
||
|
28.11.2024 |
Azacitidine Betapharm |
|
EU/1/19/1416 |
4.12.2024 |
||
|
28.11.2024 |
Besponsa |
|
EU/1/17/1200 |
29.11.2024 |
||
|
28.11.2024 |
Deferasirox Accord |
|
EU/1/19/1412 |
29.11.2024 |
||
|
28.11.2024 |
QUVIVIQ |
|
EU/1/22/1638 |
3.12.2024 |
||
|
28.11.2024 |
Xigduo |
|
EU/1/13/900 |
29.11.2024 |
||
|
29.11.2024 |
Ameluz |
|
EU/1/11/740 |
4.12.2024 |
||
|
29.11.2024 |
Azacitidine Mylan |
|
EU/1/20/1426 |
2.12.2024 |
||
|
29.11.2024 |
Mircera |
|
EU/1/07/400 |
3.12.2024 |
||
|
29.11.2024 |
Tasigna |
|
EU/1/07/422 |
2.12.2024 |
— Irtirar ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)
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Data tad-deċiżjoni |
Isem tal-prodott mediċinali |
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq |
Numru tal-entrata fir-Reġistru Komunitarju |
Data ta’ notifika |
||
|
25.11.2024 |
Extavia |
|
EU/1/08/454 |
26.11.2024 |
||
|
25.11.2024 |
PreHevbri |
|
EU/1/22/1641 |
27.11.2024 |
— Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill; L-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill): Aċċettat
|
Data tad-deċiżjoni |
Isem tal-prodott mediċinali |
INN (Denominazzjoni Internazzjonali Komuni) |
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq |
Numru tal-entrata fir-Reġistru Komunitarju |
Forma farmaċewtika |
Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) |
Data ta’ notifika |
||
|
22.11.2024 |
BRAVECTO TriUNO |
Fluralaner / Moxidectin / Pyrantel |
|
EU/2/24/325 |
Pilloli li tomgħodhom |
QP54AB52 |
28.11.2024 |
||
|
22.11.2024 |
DuOtic |
Betamethasone acetate / Terbinafine |
|
EU/2/24/327 |
Ġel għall-widnejn |
QS02CA90 |
25.11.2024 |
||
|
22.11.2024 |
VAXXON ND CLONE |
vaċċin ħaj tal-marda Newcastle |
|
EU/2/24/326 |
lijofilizzat u solvent għal sospensjoni fl-għajnejn u fl-imnieħer għat-tiġieġ |
QI01AD06 |
27.11.2024 |
— Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill; L-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill): Aċċettat
|
Data tad-deċiżjoni |
Isem tal-prodott mediċinali |
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq |
Numru tal-entrata fir-Reġistru Komunitarju |
Data ta’ notifika |
||
|
22.11.2024 |
Bovilis Nasalgen-C |
|
EU/2/23/294 |
25.11.2024 |
||
|
22.11.2024 |
Inflacam |
|
EU/2/11/134 |
26.11.2024 |
||
|
22.11.2024 |
Poulvac Procerta HVT-IBD |
|
EU/2/23/300 |
26.11.2024 |
||
|
25.11.2024 |
Eluracat |
|
EU/2/23/297 |
26.11.2024 |
||
|
25.11.2024 |
Enteroporc Coli AC |
|
EU/2/20/262 |
26.11.2024 |
||
|
25.11.2024 |
Mometamax Ultra |
|
EU/2/22/289 |
3.12.2024 |
||
|
25.11.2024 |
Rheumocam |
|
EU/2/07/078 |
28.11.2024 |
||
|
28.11.2024 |
CLYNAV |
|
EU/2/16/197 |
29.11.2024 |
Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:
|
European Medicines Agency |
|
Domenico Scarlattilaan 6 |
|
1083 HS Amsterdam |
|
NETHERLANDS |
(1) ĠU L 136, 30.4.2004, p. 1, ELI: https://data.europa.eu/eli/reg/2004/726/oj.
(2) ĠU L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.
ELI: http://data.europa.eu/eli/C/2024/7468/oj
ISSN 1977-0987 (electronic edition)