EU/1/16/1139/002 |
2367C |
OCALIVA 10 mg filmom obalené tablety |
tbl flm 30x10 mg (f?.HDPE) |
IEC |
15.12.2018 |
EU/1/16/1139/001 |
2366C |
OCALIVA 5 mg filmom obalené tablety |
tbl flm 30x5 mg (f?.HDPE) |
IEC |
15.12.2018 |
EU/1/13/896/001 |
0171B |
GRANUPAS 4 g gastrorezistentný granulát |
gra ent 1x4 g (vre.papier/LDPE/Al/LDPE) |
EUC-1 |
07.04.2019 |
EU/1/18/1320/001 |
9532C |
Onpattro 2 mg/ml infúzny koncentrát |
con inf 1x5 ml/10 mg (liek.skl.) |
AYL |
27.08.2023 |
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/1/17/1188/001 |
4481C |
Spinraza 12 mg injek?ný roztok |
sol inj 1x5 ml/12 mg (liek.inj.skl.) |
SUO-NL |
30.05.2022 |
EU/1/17/1235/001 |
6171C |
Zejula 100 mg tvrdé kapsuly |
cps dur 84x1x100 mg (blis.PCTFE/PVC/Al) |
TSR |
16.11.2022 |
EU/1/16/1110/001 |
3820C |
Chenodeoxycholic acid Leadiant 250 mg tvrdé kapsuly |
cps dur 100x250 mg (PVC/Al) |
LEI |
10.04.2022 |
EU/1/17/1197/001 |
4740C |
OXERVATE 20 mikrogramov/ml o?ná roztoková instilácia |
int opo 7x1 ml/20 µg (liek.skl.-viacdávk.) |
DMP-3 |
06.07.2022 |
EU/1/08/477/001 |
53852 |
Ceplene 0,5 mg/0,5 ml injek?ného roztoku |
sol inj 14x0,5 ml/0,5 mg (liek.inj.skl.) |
NEI |
|
EU/1/12/787/003 |
4570C |
Revestive 1,25 mg prášok a rozpúš?adlo na injek?ný roztok |
plv iol 28x1,25 mg+28x0,5 ml solv.(liek.inj.skl.+striek.inj.napl.skl.) |
SHP-IE-1 |
|
EU/1/12/787/002 |
4569C |
Revestive 5 mg prášok a rozpúš?adlo na injek?ný roztok |
plv iol 1x5 mg+1x0,5 ml solv.(liek.inj.skl.+striek.inj.napl.skl.) |
SHP-IE-1 |
|
EU/1/12/787/001 |
2568A |
Revestive 5 mg prášok a rozpúš?adlo na injek?ný roztok |
plv iol 28x5 mg+28x0,5 ml solv.(liek.inj.skl.+striek.inj.napl.skl.) |
SHP-IE-1 |
|
EU/1/08/461/002 |
07730 |
Firazyr 30 mg injek?ný roztok v naplnenej injek?nej strieka?ke |
sol inj 3x3 ml/30 mg (striek.skl.napln.) |
SHP-IE-1 |
|
EU/1/08/461/001 |
52459 |
Firazyr 30 mg injek?ný roztok v naplnenej injek?nej strieka?ke |
sol inj 1x3 ml/30 mg (striek.skl.napln.) |
SHP-IE-1 |
|
EU/1/11/667/021 |
7920C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 180x267 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/020 |
7919C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 42x267 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/011 |
3957C |
Esbriet 801 mg filmom obalené tablety |
tbl flm 90x801 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/010 |
3956C |
Esbriet 534 mg filmom obalené tablety |
tbl flm 90x534 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/009 |
3955C |
Esbriet 534 mg filmom obalené tablety |
tbl flm 21x534 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/008 |
3954C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 180 (2x90)x267 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/007 |
3953C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 90x267 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/006 |
3952C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 42 (2x21)x267 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/005 |
3951C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 21x267 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/019 |
4593C |
Esbriet 801 mg filmom obalené tablety |
tbl flm 252 [3 (4x21)]x801 mg (blis.PVC/Aclar/PCTFE) |
HLR-DE |
|
EU/1/11/667/018 |
4592C |
Esbriet 801 mg filmom obalené tablety |
tbl flm 84 (4x21)x801 mg (blis.PVC/Aclar/PCTFE) |
HLR-DE |
|
EU/1/11/667/017 |
4591C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 252 [3 (4x21)]x267 mg (blis.PVC/Aclar/PCTFE) |
HLR-DE |
|
EU/1/11/667/016 |
4590C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 63 (1x21 a 2x21)x267 mg (blis.PVC/Aclar/PCTFE) |
HLR-DE |
|
EU/1/14/937/001 |
1191B |
Gazyvaro 1 000 mg infúzny koncentrát |
con inf 1x40 ml (liek inj.skl.) |
HLR-DE |
23.07.2019 |
EU/1/11/667/015 |
4586C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 168 (8x21)x267 mg (blis.PVC/Aclar/PCTFE) |
HLR-DE |
|
EU/1/11/667/014 |
4584C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 84 (4x21)x267 mg (blis.PVC/Aclar/PCTFE) |
HLR-DE |
|
EU/1/11/667/013 |
4583C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 42 (2x21)x267 mg (blis.PVC/Aclar/PCTFE) |
HLR-DE |
|
EU/1/11/667/012 |
4582C |
Esbriet 267 mg filmom obalené tablety |
tbl flm 21 (1x21)x267 mg (blis.PVC/Aclar/PCTFE) |
HLR-DE |
|
EU/1/11/667/003 |
06330 |
Esbriet 267 mg tvrdé kapsuly |
cps dur 270x267 mg (f?.HDPE) |
HLR-DE |
|
EU/1/11/667/002 |
06329 |
Esbriet 267 mg tvrdé kapsuly |
cps dur 252x1x267 mg (blis.PVC/PE/PCTFE/Al-jednotk.bal.) |
HLR-DE |
|
EU/1/11/667/001 |
06324 |
Esbriet 267 mg tvrdé kapsuly |
cps dur 63 (7x3+7x6)x267 mg (blis.PVC/PE/PCTFE/Al) |
HLR-DE |
|
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/1/07/422/015 |
7818C |
Tasigna 50 mg tvrdé kapsuly |
cps dur 120 (3x40)x50 mg (blis.PVC/PVDC/Al) |
NEH-IE |
|
EU/1/18/1297/001 |
8935C |
Kymriah |
dis inf 1-3 (vak etylénvinylacetátový (EVA)) |
NEH-IE |
23.08.2023 |
EU/1/17/1218/001 |
5606C |
Rydapt 25 mg mäkké kapsuly |
cps mol 112 (4x28)x25 mg (blis.PA/Al/PVC-Al) |
NEH-IE |
18.09.2022 |
EU/1/17/1218/002 |
7166C |
Rydapt 25 mg mäkké kapsuly |
cps mol 56 (2x28)x25 mg (blis.PA/Al/PVC-Al) |
NEH-IE |
18.09.2022 |
EU/1/07/422/014 |
0296C |
Tasigna 200 mg tvrdé kapsuly |
cps dur 392(14x28)x200 mg (blis.PVC/PVDC/Al) |
NEH-IE |
|
EU/1/07/422/013 |
0295C |
Tasigna 150 mg tvrdé kapsuly |
cps dur 392(14x28)x150 mg (blis.PVC/PVDC/Al) |
NEH-IE |
|
EU/1/15/1023/009 |
5865B |
Farydak 20 mg tvrdé kapsuly |
cps dur 24x20 mg (blis.PVC/PCTFE/Al) |
NEH-IE |
28.08.2020 |
EU/1/15/1023/008 |
5864B |
Farydak 20 mg tvrdé kapsuly |
cps dur 12x20 mg (blis.PVC/PCTFE/Al) |
NEH-IE |
28.08.2020 |
EU/1/15/1023/007 |
5860B |
Farydak 20 mg tvrdé kapsuly |
cps dur 6x20 mg (blis.PVC/PCTFE/Al) |
NEH-IE |
28.08.2020 |
EU/1/15/1023/006 |
5856B |
Farydak 15 mg tvrdé kapsuly |
cps dur 24x15 mg (blis.PVC/PCTFE/Al) |
NEH-IE |
28.08.2020 |
EU/1/15/1023/005 |
5855B |
Farydak 15 mg tvrdé kapsuly |
cps dur 12x15 mg (blis.PVC/PCTFE/Al) |
NEH-IE |
28.08.2020 |