EU/1/17/1235/001 |
6171C |
Zejula 100 mg tvrdé kapsuly |
cps dur 84x1x100 mg (blis.PCTFE/PVC/Al) |
TSR |
16.11.2022 |
EU/1/02/238/001 |
41411 |
Zavesca 100 mg kapsuly |
cps dur 84x100 mg (blis.Aclar/Al) |
JNS |
|
EU/1/16/1121/001 |
1033C |
Zalmoxis |
dis inf 1x10-100 ml (vak etylén-vinyl-acetátový kryogénny (EVA)) |
MFO |
23.08.2019 |
EU/1/07/417/002 |
45775 |
Yondelis 1 mg prášok pre koncentrát pre infúzny roztok |
plc ifc 1x1 mg (liek.inj.skl.) |
PMR |
|
EU/1/07/417/001 |
45774 |
Yondelis 0,25 mg prášok pre koncentrát pre infúzny roztok |
plc ifc 1x0,25 mg (liek.inj.skl.) |
PMR |
|
EU/1/18/1299/001 |
9269C |
YESCARTA |
dis inf 1x68 ml (vak etylénvinylacetátový) |
KIT |
23.08.2023 |
EU/1/17/1224/002 |
5635C |
Xermelo 250 mg filmom obalené tablety |
tbl flm 180x250 mg (blis.PVC/PCTFE/PVC/Al) |
IAA-1 |
18.09.2022 |
EU/1/17/1224/001 |
5634C |
Xermelo 250 mg filmom obalené tablety |
tbl flm 90x250 mg (blis.PVC/PCTFE/PVC/Al) |
IAA-1 |
18.09.2022 |
EU/1/11/727/001 |
0075A |
Xaluprine 20 mg/ml perorálna suspenzia |
sus por 1x100 ml (f?.skl.jantár.+2 striek.inj.PET) |
NLL |
|
EU/1/15/1068/001 |
9135B |
Wakix 4,5 mg filmom obalené tablety |
tbl flm 30x4,5 mg (f?.HDPE) |
BJP-FR |
31.03.2021 |
EU/1/15/1068/002 |
9136B |
Wakix 18 mg filmom obalené tablety |
tbl flm 30x18 mg (f?.HDPE) |
BJP-FR |
31.03.2021 |
EU/1/18/1308/003 |
9535C |
Vyxeos 44 mg/100 mg prášok na koncentrát na infúzny roztok |
plc ifc 5x44 mg/100 mg (liek.inj.skl.) |
JAZ |
23.08.2023 |
EU/1/18/1308/002 |
9534C |
Vyxeos 44 mg/100 mg prášok na koncentrát na infúzny roztok |
plc ifc 2x44 mg/100 mg (liek.inj.skl.) |
JAZ |
23.08.2023 |
EU/1/18/1308/001 |
9533C |
Vyxeos 44 mg/100 mg prášok na koncentrát na infúzny roztok |
plc ifc 1x44 mg/100 mg (liek.inj.skl.) |
JAZ |
23.08.2023 |
EU/1/11/717/002 |
4441B |
Vyndaqel 20 mg mäkké kapsuly |
cps mol 90x20 mg (blis.PVC/Al) |
PFI-BE-3 |
|
EU/1/11/717/001 |
30912 |
Vyndaqel 20 mg mäkké kapsuly |
cps mol 30x20 mg (blis.PVC/Al) |
PFI-BE-3 |
|
EU/1/10/646/006 |
1301A |
VPRIV 400 jednotiek prášok na infúzny roztok |
plv ifo 25x400 U (liek.inj.skl.) |
SHP-IE |
30.08.2020 |
EU/1/10/646/005 |
1300A |
VPRIV 400 jednotiek prášok na infúzny roztok |
plv ifo 5x400 U (liek.inj.skl.) |
SHP-IE |
30.08.2020 |
EU/1/10/646/002 |
23226 |
VPRIV 400 jednotiek prášok na infúzny roztok |
plv ifo 1x400 U (liek.inj.skl.) |
SHP-IE |
30.08.2020 |
EU/1/11/710/005 |
10966 |
Votubia 5 mg tablety |
tbl 100x5 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/004 |
10958 |
Votubia 5 mg tablety |
tbl 30x5 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/015 |
1604B |
Votubia 5 mg dispergovate?né tablety |
tbl dsp 100x5 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/014 |
1603B |
Votubia 5 mg dispergovate?né tablety |
tbl dsp 30x5 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/013 |
1602B |
Votubia 3 mg dispergovate?né tablety |
tbl dsp 100x3 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/012 |
1601B |
Votubia 3 mg dispergovate?né tablety |
tbl dsp 30x3 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/003 |
10957 |
Votubia 2,5 mg tablety |
tbl 100x2,5 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/002 |
10956 |
Votubia 2,5 mg tablety |
tbl 30x2,5 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/001 |
10952 |
Votubia 2,5 mg tablety |
tbl 10x2,5 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/011 |
1600B |
Votubia 2 mg dispergovate?né tablety |
tbl dsp 100x2 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/010 |
1599B |
Votubia 2 mg dispergovate?né tablety |
tbl dsp 30x2 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/009 |
1598B |
Votubia 2 mg dispergovate?né tablety |
tbl dsp 10x2 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/008 |
8527A |
Votubia 10 mg tablety |
tbl 10x10 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/007 |
10970 |
Votubia 10 mg tablety |
tbl 100x10 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/006 |
10968 |
Votubia 10 mg tablety |
tbl 30x10 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/11/710/016 |
8300C |
Votubia 1 mg dispergovate?né tablety |
tbl dsp 30x1 mg (blis.PA/Al/PVC/Al) |
NEH-IE |
16.11.2020 |
EU/1/14/914/001 |
0258B |
Vimizim 1 mg/ml infúzny koncentrát |
con inf 1x5 ml/5 mg (lie.inj.skl.) |
BAN |
28.04.2019 |
EU/1/08/488/001 |
64369 |
Vidaza 25 mg/ml prášok na injek?nú suspenziu |
plv inu 1x100 mg (liek.inj.skl.) |
CLG-NL |
|
EU/1/17/1219/004 |
8476C |
Verkazia 1 mg/ml o?ná emulzná instilácia |
int ope 120x0,3 ml/0,3 mg |
SOY |
06.07.2023 |
EU/1/17/1219/003 |
8475C |
Verkazia 1 mg/ml o?ná emulzná instilácia |
int ope 90x0,3 ml/0,3 mg |
SOY |
06.07.2023 |
EU/1/17/1219/002 |
8474C |
Verkazia 1 mg/ml o?ná emulzná instilácia |
int ope 60x0,3 ml/0,3 mg |
SOY |
06.07.2023 |
EU/1/17/1219/001 |
8473C |
Verkazia 1 mg/ml o?ná emulzná instilácia |
int ope 30x0,3 ml/0,3 mg |
SOY |
06.07.2023 |
EU/1/13/902/002 |
1457B |
Translarna 250 mg granulát na perorálnu suspenziu |
gru por 30x250 mg (vre.Al) |
PTA-IE |
05.08.2019 |
EU/1/13/902/001 |
1456B |
Translarna 125 mg granulát na perorálnu suspenziu |
gru por 30x125 mg (vre.Al) |
PTA-IE |
05.08.2019 |
EU/1/13/902/003 |
1458B |
Translarna 1000 mg granulát na perorálnu suspenziu |
gru por 30x1000 mg (vre.Al) |
PTA-IE |
05.08.2019 |
EU/1/07/424/001 |
46872 |
Torisel 30 mg koncentrát a rozpúš?adlo na infúzny roztok |
cif fol 1x1,2 ml/30 mg+1x2,2 ml solv. (liek.inj.skl.) |
PFI-BE-3 |
|
EU/1/10/652/003 |
10778 |
TOBI Podhaler 28 mg inhala?ný prášok v tvrdých kapsulách |
plv icd 448(8x56)x28 mg (blis.PVC/PA/Al/PVC-PET/Al + 10 inhalátorov) |
NEH-IE |
|
EU/1/10/652/002 |
10777 |
TOBI Podhaler 28 mg inhala?ný prášok v tvrdých kapsulách |
plv icd 224(4x56)x28 mg (blis.PVC/PA/Al/PVC-PET/Al + 5 inhalátorov) |
NEH-IE |
|
EU/1/10/652/001 |
10776 |
TOBI Podhaler 28 mg inhala?ný prášok v tvrdých kapsulách |
plv icd 56x28 mg (blis.PVC/PA/Al/PVC-PET/Al +1 inhalátor) |
NEH-IE |
|
EU/1/10/622/001 |
89340 |
TEPADINA 15 mg prášok na prípravu koncentrátu na infúzny roztok |
plc ifc 1x15 mg (liek.inj.skl.) |
AES-1 |
|
EU/1/10/622/002 |
89341 |
TEPADINA 100 mg prášok na prípravu koncentrátu na infúzny roztok |
plc ifc 1x100 mg (liek.inj.skl.) |
AES-1 |
|