12 April 2018 EMA/231687/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: etoposide
Procedure no.: PSUSA/00001333/201708
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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
CELLTOP 100 mg –
not available
BE172846
BAXTER SA
BE
not available
BE172846
BAXTER SA
BE
not available
BE172846
BAXTER SA
BE
not available
BE172855
BAXTER SA
BE
Celltop 25 mg, capsule
not available
34009 365 759 7 4
BAXTER SAS
FR
Celltop 25 mg, capsule
not available
34009 365 760 5 6
BAXTER SAS
FR
Celltop 25 mg, capsule
not available
34009 365 761 1 7
BAXTER SAS
FR
CELLTOP 25 mg, capsules
not available
BE172855
BAXTER SA
BE
not available
BE172855
BAXTER SA
BE
not available
BE172864
BAXTER SA
BE
Infusionslösung CELLTOP 100 mg – oplossing voor infusie CELLTOP 100 mg – solution pour perfusion. CELLTOP 25 mg – Weichkapseln
molles CELLTOP 25 mg, zachte capsules CELLTOP 50 mg – Weichkapseln
List of nationally authorised medicinal products EMA/231687/2018
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Celltop 50 mg, capsule
not available
34009 365 755 1 6
BAXTER SAS
FR
Celltop 50 mg, capsule
not available
34009 365 756 8 4
BAXTER SAS
FR
Celltop 50 mg, capsule
not available
34009 365 757 4 5
BAXTER SAS
FR
Celltop 50 mg, capsule
not available
34009 365 758 0 6
BAXTER SAS
FR
CELLTOP 50 mg, capsules
not available
BE172864
BAXTER SA
BE
not available
BE172864
BAXTER SA
BE
not available
BE338301
TEVA PHARMA BELGIUM
BE
molles CELLTOP 50 mg, zachte capsules EPOSIN 20 mg/ml concentraat voor
N.V./S.A
oplossing voor infusie EPOSIN 20 mg/ml
not available
BE170651
concentraat voor
TEVA PHARMA BELGIUM
BE
N.V./S.A
oplossing voor infusie EPOSIN 20 mg/ml
not available
Konzentrat zur
BE170651
TEVA PHARMA BELGIUM
BE
N.V./S.A
Herstellung einer Infusionslösung
List of nationally authorised medicinal products EMA/231687/2018
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
EPOSIN 20 mg/ml
not available
BE338301
TEVA PHARMA BELGIUM
BE
Konzentrat zur
N.V./S.A
Herstellung einer Infusionslösung. EPOSIN 20 mg/ml
not available
AMM 1316/09010013
solution à diluer
TEVA PHARMA BELGIUM
LU
N.V./S.A
injectable EPOSIN 20 mg/ml
not available
BE170651
solution à diluer pour
TEVA PHARMA BELGIUM
BE
N.V./S.A
perfusion EPOSIN 20 mg/ml
not available
BE338301
solution à diluer pour
TEVA PHARMA BELGIUM
BE
N.V./S.A
perfusion. Etopofos 100 mg pulver
not available
12512
BRISTOL-MYERS SQUIBB AB
SE
not available
PL 11184/0052
BRISTOL-MYERS SQUIBB
UK
till infusionsvätska, lösning Etopophos 100mg Powder for Solution for Injection ETOPOPHOS® 100 mg,
PHARMACEUTICALS LIMITED not available
559 651-7
BRISTOL-MYERS SQUIBB
FR
not available
559 650-0
BRISTOL-MYERS SQUIBB
FR
not available
559 652-3
BRISTOL-MYERS SQUIBB
FR
lyophilisat pour usage parentéral ETOPOPHOS® 100 mg, lyophilisat pour usage parentéral ETOPOPHOS® 100 mg, lyophilisat pour usage parentéral
List of nationally authorised medicinal products EMA/231687/2018
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
ETOPOPHOS® 100 mg,
not available
559 654-6
BRISTOL-MYERS SQUIBB
FR
not available
559 655-2
BRISTOL-MYERS SQUIBB
FR
not available
35021.00.00
BRISTOL-MYERS SQUIBB
DE
lyophilisat pour usage parentéral ETOPOPHOS® 100 mg, lyophilisat pour usage parentéral Etopophos® 100 mg, Pulver zur Herstellung
GMBH & CO. KGAA
einer Infusionslösung Etopophos® 1000 mg,
not available
35021.02.00
Pulver zur Herstellung
BRISTOL-MYERS SQUIBB
DE
GMBH & CO. KGAA
einer Infusionslösung Etoposid Ebewe 20
not available
1-21568
EBEWE PHARMA
AT
not available
PL 40378/0155
TORRENT PHARMA GMBH
UK
not available
PL 40378/0155
TORRENT PHARMA GMBH
UK
not available
PL 40378/0155
TORRENT PHARMA GMBH
UK
not available
PL 40378/0155
TORRENT PHARMA GMBH
UK
mg/ml - Konzentrat zur Herstellung einer Infusionslösung Etoposide 20 mg/ml concentrate for solution for infusion Etoposide 20 mg/ml concentrate for solution for infusion Etoposide 20 mg/ml concentrate for solution for infusion Etoposide 20 mg/ml concentrate for solution for infusion
List of nationally authorised medicinal products EMA/231687/2018
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Etoposide Mylan 20
not available
NL 22079
MYLAN S.A.S
FR
not available
UP/I-530-09/13-02/60
PFIZER CROATIA D.O.O.
HR
not available
56.108
BRISTOL-MYERS SQUIBB SA
ES
not available
7280/2014/01
BRISTOL-MYERS SQUIBB
RO
mg/ml, solution à diluer pour perfusion ETOPOSIDE Pfizer 20 mg/ml koncentrat za otopinu za infuziju VEPESID 100 mg cápsulas blandas VEPESID 100 mg capsule moi
GYOGYSZERKERESKEDELMI KFT.
VEPESID 100 mg capsule
not available
BE117433
molle VEPESID 100 mg capsule
not available
2009100547-0126419
not available
024639041
LU
BRISTOL-MYERS SQUIBB
IT
S.R.L. not available
H/93/01630/001
kapsule Vepesid 100 mg,
BRISTOL-MYERS SQUIBB BELGIUM S.A.
molli Vepesid 100 mg mehke
BE
BELGIUM S.A.
molle VEPESID 100 mg capsule
BRISTOL-MYERS SQUIBB
BRISTOL-MYERS SQUIBB
SI
SPOL. S R.O. not available
capsules, zacht
List of nationally authorised medicinal products EMA/231687/2018
RVG 08543
BRISTOL-MYERS SQUIBB
NL
B.V.
Page 6/8
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
VEPESID 50 mg cápsulas
not available
56.488
BRISTOL-MYERS SQUIBB SA
ES
not available
7279/2014/01
BRISTOL-MYERS SQUIBB
RO
blandas VEPESID 50 mg capsule moi
GYOGYSZERKERESKEDELMI KFT.
VEPESID 50 mg capsule
not available
024639039
molli Vepesid 50 mg kapsel,
BRISTOL-MYERS SQUIBB
IT
S.R.L. not available
10950
BRISTOL-MYERS SQUIBB AB
FI
not available
10950
BRISTOL-MYERS SQUIBB AB
FI
not available
10415
BRISTOL-MYERS SQUIBB AB
SE
not available
RVG 10375
BRISTOL-MYERS SQUIBB
NL
mjuk Vepesid 50 mg kapseli, pehmeä Vepesid 50 mg mjuka kapslar Vepesid 50 mg, capsules, zacht Vepesid Soft Capsules
B.V. not available
PA 48/22/1
100 mg Vepesid Soft Capsules
BRISTOL-MYERS SQUIBB
IE
HOLDINGS LIMITED not available
100 mg
List of nationally authorised medicinal products EMA/231687/2018
PL 0125/0124
BRISTOL-MYERS SQUIBB
UK
HOLDINGS LIMITED
Page 7/8
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Vepesid Soft Capsules 50
not available
PA 48/22/3
BRISTOL-MYERS SQUIBB
IE
mg Vepesid Soft Capsules 50
HOLDINGS LIMITED not available
PL 0125/0153
mg Vepesid, 100 mg
BRISTOL-MYERS SQUIBB
UK
HOLDINGS LIMITED not available
319400
pehmekapslid
BRISTOL-MYERS SQUIBB
EE
GYOGYSZERKERESKEDELMI KFT.
Vepesid, kapsler, bløde
not available
12190
BRISTOL-MYERS SQUIBB AB
DK
Vepesid® K 100 mg
not available
13218.00.01
BRISTOL-MYERS SQUIBB
DE
GMBH & CO. KGAA Vepesid® K 50 mg
not available
13218.01.01
BRISTOL-MYERS SQUIBB
DE
GMBH & CO. KGAA Vepesid-Kapseln
not available
17.994
BRISTOL-MYERS SQUIBB
AT
GESMBH
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