topotecan

HYCAMTIN EQ 1MG BASE caps

Y

Rx

oral

L01XX17

HYCAMTIN EQ 4MG BASE/VIAL inj

Y

Rx

INJECTION

L01XX17

TOPOTECAN sol

N
N
N

iv

L01XX17

TOPOTECAN HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) sol

Y

Rx

iv

L01XX17

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) sol

Y

Rx

iv

L01XX17

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) sol

Y

Rx

iv

L01XX17

Hospira

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) sol

Y

Rx

iv

L01XX17

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) sol

Y

Rx

iv

L01XX17

Y

Rx

INJECTION

L01XX17

Y

Rx

INJECTION

L01XX17

Y

Rx

INJECTION

L01XX17

Cipla

Y

Rx

INJECTION

L01XX17

Dr. Reddy's

N
Y

Rx

INJECTION

L01XX17

Y

Rx

INJECTION

L01XX17

Meitheal Pharmaceuticals

N

INJECTION

L01XX17

Y

Rx

INJECTION

L01XX17

Novast Laboratories

Y

Rx

INJECTION

L01XX17

Sagent

HYCAMTIN EQ 0.25MG BASE caps

N

INJECTION

L01XX17

Sun Pharma

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

20981/1

NDA

11-10-2007

HYCAMTIN EQ 1MG BASE caps

20981/2

NDA

11-10-2007

HYCAMTIN EQ 4MG BASE/VIAL inj

20671/1

NDA

28-05-1996

TOPOTECAN sol

200199/3
200199/2
200199/1

NDA
NDA
NDA

25-02-2011
25-02-2011
25-02-2011

TOPOTECAN HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) sol

204406/1

ANDA

06-07-2017

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) sol

204406/2

ANDA

06-07-2017

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) sol

200582/1

NDA

02-02-2011

Hospira

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) sol

206074/1

ANDA

24-11-2017

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) sol

22453/1

NDA

20-12-2012

202351/1

ANDA

26-06-2013

90620/1

ANDA

02-12-2010

91199/1

ANDA

01-12-2010

Cipla

201191/1

ANDA

09-03-2011

Dr. Reddy's

91376/1
91089/1

ANDA
ANDA

29-11-2010
29-11-2010

201166/1

ANDA

08-08-2012

Meitheal Pharmaceuticals

91542/1

ANDA

28-08-2012

206962/1

ANDA

30-11-2016

Novast Laboratories

91284/1

ANDA

26-01-2011

Sagent

202203/1

ANDA

29-08-2013

Sun Pharma

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X Last update: 16-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

Rx

-

L01XX17

Rx

-

L01XX17

HYCAMTIN 1 MG PULVER ZUR HERSTELLUNG EINES SKONZENTRATS sol for inf

Rx

-

L01XX17

HYCAMTIN 4 MG PULVER ZUR HERSTELLUNG EINES SKONZENTRATS sol for inf

Rx

-

L01XX17

POTACTASOL 1 MG PULVER ZUR HERSTELLUNG EINES SKONZENTRATS sol for inf

Rx

-

L01XX17

POTACTASOL 4 MG PULVER ZUR HERSTELLUNG EINES SKONZENTRATS sol for inf

Rx

-

L01XX17

TOPOLIQUID 1 MG/ML conc for sol for inf

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

TOPOTECAN HEXAL 1 MG/ML conc for sol for inf

Rx

-

L01XX17

TOPOTECAN HIKMA 1 MG powd for conc for sol for inf

Rx

-

L01XX17

TOPOTECAN HIKMA 4 MG powd for conc for sol for inf

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

EU/1/96/027/006

18-03-2008

EU/1/96/027/007

18-03-2008

HYCAMTIN 1 MG PULVER ZUR HERSTELLUNG EINES SKONZENTRATS sol for inf

EU/1/96/027/004-005

16-03-2000

HYCAMTIN 4 MG PULVER ZUR HERSTELLUNG EINES SKONZENTRATS sol for inf

EU/1/96/027/001,003

05-11-1997

POTACTASOL 1 MG PULVER ZUR HERSTELLUNG EINES SKONZENTRATS sol for inf

EU/1/10/660/001

06-01-2011

POTACTASOL 4 MG PULVER ZUR HERSTELLUNG EINES SKONZENTRATS sol for inf

EU/1/10/660/002

06-01-2011

TOPOLIQUID 1 MG/ML conc for sol for inf

1-29714

29-09-2010

1-31377

06-07-2012

1-29716

29-09-2010

TOPOTECAN HEXAL 1 MG/ML conc for sol for inf

1-29715

29-09-2010

TOPOTECAN HIKMA 1 MG powd for conc for sol for inf

1-31208

04-04-2012

TOPOTECAN HIKMA 4 MG powd for conc for sol for inf

1-31209

04-04-2012

EU/1/10/633/001-002

10-06-2010

EU/1/09/552/001-002

21-09-2009

EU/1/09/552/003-004

21-09-2009

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X Last update: 22-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

10x

Y

oral

L01XX17

10x

Y

oral

L01XX17

HYCAMTIN 1 MG/ML powd for sol for inf

1 mg
1 mg

-
Y

iv

L01XX17

4 mg
4 mg

-
-

iv

L01XX17

1 mg

-

iv

L01XX17

4 mg

-

iv

L01XX17

TOPOTECAN ACCORD 4 MG powd for conc for sol for inf

4 mg

-

iv

L01XX17

TOPOTECAN ACCORD HEALTHCARE 1 MG/ML conc for sol for inf

1 mL
1 mL
4 mL

Y
-
-

iv

L01XX17

TOPOTECAN ACTAVIS 1 MG powd for conc for sol for inf

1 mg
1 mg

-
-

iv

L01XX17

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

4 mg
4 mg

-
-

iv

L01XX17

TOPOTECAN FRESENIUS KABI 1 MG/ML conc for sol for inf

1 mL
4 mL

-
-

iv

L01XX17

TOPOTECAN FRESENIUS KABI 4 MG powd for conc for sol for inf

4 mg

-

iv

L01XX17

4 mL
4 mL

-
-

iv

L01XX17

TOPOTECAN MYLAN 1 MG/ML conc for sol for inf

2 mL
2 mL
6 mL
6 mL
6 mL

Y
-
-
Y
-

iv

L01XX17

1 mL
1 mL

N
-

iv

L01XX17

4 mL
4 mL

-
-

iv

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

10x

EU/1/96/027/006

CP

10x

EU/1/96/027/007

CP

HYCAMTIN 1 MG/ML powd for sol for inf

1 mg
1 mg

EU/1/96/027/005
EU/1/96/027/004

CP
CP

4 mg
4 mg

EU/1/96/027/003
EU/1/96/027/001

CP
CP

1 mg

EU/1/10/660/001

CP

4 mg

EU/1/10/660/002

CP

TOPOTECAN ACCORD 4 MG powd for conc for sol for inf

4 mg

BE399707

-

TOPOTECAN ACCORD HEALTHCARE 1 MG/ML conc for sol for inf

1 mL
1 mL
4 mL

BE422947
BE422947
BE422956

-
-
-

TOPOTECAN ACTAVIS 1 MG powd for conc for sol for inf

1 mg
1 mg

EU/1/09/536/003
EU/1/09/536/001

CP
CP

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

4 mg
4 mg

EU/1/09/536/004
EU/1/09/536/002

CP
CP

TOPOTECAN FRESENIUS KABI 1 MG/ML conc for sol for inf

1 mL
4 mL

BE442872
BE442881

-
-

TOPOTECAN FRESENIUS KABI 4 MG powd for conc for sol for inf

4 mg

BE381281

-

4 mL
4 mL

EU/1/10/633/002
EU/1/10/633/001

CP
CP

TOPOTECAN MYLAN 1 MG/ML conc for sol for inf

2 mL
2 mL
6 mL
6 mL
6 mL

BE384054
BE384054
BE384072
BE384063
BE384063

-
-
-
-
-

1 mL
1 mL

EU/1/09/552/002
EU/1/09/552/001

CP
CP

4 mL
4 mL

EU/1/09/552/004
EU/1/09/552/003

CP
CP

Product

Pack

Ex-fact

Wholesale

Net retail

Gr. retail

Company

10x

57,96

10x

231,85

HYCAMTIN 1 MG/ML powd for sol for inf

1 mg
1 mg

129,52

4 mg
4 mg

1 mg

4 mg

TOPOTECAN ACCORD 4 MG powd for conc for sol for inf

4 mg

TOPOTECAN ACCORD HEALTHCARE 1 MG/ML conc for sol for inf

1 mL
1 mL
4 mL

25,9

TOPOTECAN ACTAVIS 1 MG powd for conc for sol for inf

1 mg
1 mg

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

4 mg
4 mg

TOPOTECAN FRESENIUS KABI 1 MG/ML conc for sol for inf

1 mL
4 mL

TOPOTECAN FRESENIUS KABI 4 MG powd for conc for sol for inf

4 mg

4 mL
4 mL

TOPOTECAN MYLAN 1 MG/ML conc for sol for inf

2 mL
2 mL
6 mL
6 mL
6 mL

1 mL
1 mL

4 mL
4 mL

TOPOTEKAN ALPHA-MEDICAL 4 MG powd for conc for sol for inf

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X Last update: 17-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

HYCAMTIN* -

Y

Rx

-

L01XX17

POTACTASOL* -

Y

Rx

-

L01XX17

TOPOTECAN HOSPIRA* -

Y

Rx

-

L01XX17

TOPOTECAN TEVA* -

-

Rx

-

L01XX17

1 bočica praškom
5 bočica praškom

Y
Y

Rx
Rx

-

L01XX17

Alpha-Medical

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

TOPOTEKAN ALPHA-MEDICAL 4 MG powd for conc for sol for inf

1 bočica praškom
5 bočica praškom

HR-H-918104024-01
HR-H-918104024-02

21-11-2018
21-11-2018

Alpha-Medical

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X Last update: 17-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

HYCAMTIN 0,25MG caps, hard

0,25MG 10

N

oral

L01XX17

HYCAMTIN 1MG caps, hard

1MG 10

N

oral

L01XX17

HYCAMTIN 1MG powd for conc for sol for inf

1MG 1
1MG 5

N
N

iv

L01XX17

HYCAMTIN 4MG powd for conc for sol for inf

4MG 1
4MG 5

N
N

iv

L01XX17

POTACTASOL 1MG powd for conc for sol for inf

1MG 1

N

iv

L01XX17

POTACTASOL 4MG powd for conc for sol for inf

4MG 1

N

iv

L01XX17

TOPOTECAN ACCORD 1MG/ML conc for sol for inf

1MG/ML 1X1ML
1MG/ML 1X1ML
1MG/ML 1X4ML
1MG/ML 1X4ML
1MG/ML 5X1ML
1MG/ML 5X1ML
1MG/ML 5X4ML
1MG/ML 5X4ML

N
N
Y
Y
N
N
N
N

iv

L01XX17

TOPOTECAN HOSPIRA 4MG/4ML conc for sol for inf

4MG/4ML 1X4ML
4MG/4ML 5X4ML

N
N

iv

L01XX17

TOPOTECAN PHARMAGEN 4MG powd for conc for sol for inf

4MG 1
4MG 5

Y
N

iv

L01XX17

Pharmagen CZ

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

HYCAMTIN 0,25MG caps, hard

0,25MG 10

EU/1/96/027/006

CP

HYCAMTIN 1MG caps, hard

1MG 10

EU/1/96/027/007

CP

HYCAMTIN 1MG powd for conc for sol for inf

1MG 1
1MG 5

EU/1/96/027/005
EU/1/96/027/004

CP
CP

HYCAMTIN 4MG powd for conc for sol for inf

4MG 1
4MG 5

EU/1/96/027/003
EU/1/96/027/001

CP
CP

POTACTASOL 1MG powd for conc for sol for inf

1MG 1

EU/1/10/660/001

CP

POTACTASOL 4MG powd for conc for sol for inf

4MG 1

EU/1/10/660/002

CP

TOPOTECAN ACCORD 1MG/ML conc for sol for inf

1MG/ML 1X1ML
1MG/ML 1X1ML
1MG/ML 1X4ML
1MG/ML 1X4ML
1MG/ML 5X1ML
1MG/ML 5X1ML
1MG/ML 5X4ML
1MG/ML 5X4ML

44/ 322/12-C
44/ 322/12-C
44/ 322/12-C
44/ 322/12-C
44/ 322/12-C
44/ 322/12-C
44/ 322/12-C
44/ 322/12-C

MRP/DCP
MRP/DCP
MRP/DCP
MRP/DCP
MRP/DCP
MRP/DCP
MRP/DCP
MRP/DCP

TOPOTECAN HOSPIRA 4MG/4ML conc for sol for inf

4MG/4ML 1X4ML
4MG/4ML 5X4ML

EU/1/10/633/001
EU/1/10/633/002

CP
CP

TOPOTECAN PHARMAGEN 4MG powd for conc for sol for inf

4MG 1
4MG 5

44/ 092/15-C
44/ 092/15-C

NP
NP

Pharmagen CZ

Product

Pack

Ex-fact

Wholesale

Net retail

Gr. retail

Company

HYCAMTIN 0,25MG caps, hard

0,25MG 10

0

HYCAMTIN 1MG caps, hard

1MG 10

7049,99

8788,99

HYCAMTIN 1MG powd for conc for sol for inf

1MG 1
1MG 5

0
0

HYCAMTIN 4MG powd for conc for sol for inf

4MG 1
4MG 5

0
16056,05

18958,69

POTACTASOL 1MG powd for conc for sol for inf

1MG 1

0

POTACTASOL 4MG powd for conc for sol for inf

4MG 1

0

TOPOTECAN ACCORD 1MG/ML conc for sol for inf

1MG/ML 1X1ML
1MG/ML 1X1ML
1MG/ML 1X4ML
1MG/ML 1X4ML
1MG/ML 5X1ML
1MG/ML 5X1ML
1MG/ML 5X4ML
1MG/ML 5X4ML

0
0
1818,36
1818,36
0
0
0
0

2431,53
2431,53

TOPOTECAN HOSPIRA 4MG/4ML conc for sol for inf

4MG/4ML 1X4ML
4MG/4ML 5X4ML

0
0

TOPOTECAN PHARMAGEN 4MG powd for conc for sol for inf

4MG 1
4MG 5

3517,97
0

4585,33

Pharmagen CZ

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X Last update: 17-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

-

L01XX17

-

L01XX17

-

L01XX17

-

L01XX17

-

L01XX17

-

L01XX17

TOPOTECAN "ACCORD" 1 MG/ML conc for sol for inf

-

L01XX17

TOPOTECAN "EBEWE" 1 MG/ML conc for sol for inf

-

L01XX17

TOPOTECAN "HOSPIRA" 1 MG/ML conc for sol for inf

-

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

28104153107

CP

18-03-2008

28104153207

CP

18-03-2008

28104028706

CP

12-11-1996

28101801396

CP

12-11-1996

28104752910

CP

06-01-2011

28104753010

CP

06-01-2011

TOPOTECAN "ACCORD" 1 MG/ML conc for sol for inf

28104850110

DCP

30-04-2012

TOPOTECAN "EBEWE" 1 MG/ML conc for sol for inf

28104550009

DCP

20-07-2011

TOPOTECAN "HOSPIRA" 1 MG/ML conc for sol for inf

28104552809

CP

10-06-2010

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X Last update: 17-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

10x

N

Rx

oral

L01XX17

10x

N

Rx

oral

L01XX17

1x
5x

N
N

Rx
Rx

parenteral

L01XX17

1x17 ml
5x17ml

N
N

Rx
Rx

parenteral

L01XX17

1x1mg glass

N

Rx

parenteral

L01XX17

1x4mg glass

N

Rx

parenteral

L01XX17

1x1ml vial
1x4ml vial
5x1ml vial
5x4ml vial

N
N
N
N

Rx
Rx
Rx
Rx

-

L01XX17

10x3ml vial
10x4ml vial
1x3ml vial
1x4ml vial
5x3ml vial
5x4ml vial

N
N
N
N
N
N

Rx
Rx
Rx
Rx
Rx
Rx

parenteral

L01XX17

1x4ml vial
5x4ml vial

N
N

Rx
Rx

-

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

10x

EU/1/96/027/006

12-11-1996

10x

EU/1/96/027/007

12-11-1996

1x
5x

EU/1/96/027/005
EU/1/96/027/004

12-11-1996
12-11-1996

1x17 ml
5x17ml

EU/1/96/027/003
EU/1/96/027/001

12-11-1996
12-11-1996

1x1mg glass

EU/1/10/660/001

06-01-2011

1x4mg glass

EU/1/10/660/002

06-01-2011

1x1ml vial
1x4ml vial
5x1ml vial
5x4ml vial

OGYI-T-21514/02
OGYI-T-21514/04
OGYI-T-21514/03
OGYI-T-21514/05

09-05-2012
09-05-2012
09-05-2012
09-05-2012

10x3ml vial
10x4ml vial
1x3ml vial
1x4ml vial
5x3ml vial
5x4ml vial

OGYI-T-21729/03
OGYI-T-21729/06
OGYI-T-21729/01
OGYI-T-21729/04
OGYI-T-21729/02
OGYI-T-21729/05

02-06-2011
02-06-2011
02-06-2011
02-06-2011
02-06-2011
02-06-2011

1x4ml vial
5x4ml vial

EU/1/10/633/001
EU/1/10/633/002

10-06-2010
10-06-2010

Product

Pack

Ex-fact

Wholesale

Net retail

Gr. retail

Company

10x

0

10x

174577

182258,39

183248

192410

1x
5x

0
0

1x17 ml
5x17ml

112709
622158

117668,2
649532,95

118658
650523

124591
683049

1x1mg glass

0

1x4mg glass

20000

20880

21870

22964

1x1ml vial
1x4ml vial
5x1ml vial
5x4ml vial

0
0
0
0

10x3ml vial
10x4ml vial
1x3ml vial
1x4ml vial
5x3ml vial
5x4ml vial

0
0
45528
60705
0
0

0
0
47531,23
63376,02
0
0

0
0
48521
64366
0
0

0
0
50947
67584
0
0

1x4ml vial
5x4ml vial

0
273000

0
285012

0
286002

0
300302

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X Last update: 17-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

N

Rx

-

L01XX17

N

Rx

-

L01XX17

N

Rx

-

L01XX17

Y

Rx

-

L01XX17

N

Rx

-

L01XX17

N

Rx

-

L01XX17

N

Rx

-

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

26-03-2008

26-03-2008

12-11-2001

12-05-1998

16-03-2011

16-03-2011

01-09-2010

Product

Pack

Ex-fact

Wholesale

Net retail

Gr. retail

Company

HYCAMTIN 0.25 MG caps, hard

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X Last update: 22-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

-

Rx

oral

L01XX17

-

Rx

oral

L01XX17

HYCAMTIN 1MG/1ML IU powd for sol for inf

-
-

Rx
Rx

iv

L01XX17

-
-

Rx
Rx

-

L01XX17

-

Rx

iv

L01XX17

-

Rx

iv

L01XX17

TOPOTECAN ACCORD 1MG/ML 1 MG/ML conc for sol for inf

N

Rx

iv

L01XX17

-

Rx

iv

L01XX17

HYCAMTIN 0.25 MG caps, hard

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

EU/1/96/027/006

18-03-2008

EU/1/96/027/007

18-03-2008

HYCAMTIN 1MG/1ML IU powd for sol for inf

EU/1/96/027/005
EU/1/96/027/004

16-03-2000
16-03-2000

EU/1/96/027/003
EU/1/96/027/001

15-04-1997
12-11-1996

EU/1/10/660/001

06-01-2011

EU/1/10/660/002

06-01-2011

TOPOTECAN ACCORD 1MG/ML 1 MG/ML conc for sol for inf

PA2315/121/001

04-05-2012

EU/1/10/633/001-2

10-06-2010

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X Last update: 17-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

N10 blister

Rx

oral

L01XX17

N10 blister

Rx

oral

L01XX17

Nenurodyta

N10 blister

Rx

oral

L01XX17

N1 vial
N5 vial

Rx
Rx

iv

L01XX17

N1 vial
N5 vial

Rx
Rx

iv

L01XX17

N1 vial

Rx

iv

L01XX17

N1 vial

Rx

iv

L01XX17

1 ml N1 vial
1 ml N5 vial
4 ml N1 vial
4 ml N5 vial

Rx
Rx
Rx
Rx

iv

L01XX17

TOPOTECAN ACTAVIS 1 MG powd for conc for sol for inf

N1 bottle
N5x1 bottle

Rx
Rx

iv

L01XX17

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

N1 bottle
N5x1 bottle

Rx
Rx

iv

L01XX17

4 ml N1 bottle
4 ml N5 bottle

Rx
Rx

iv

L01XX17

1 ml N1 vial
1 ml N5 vial
4 ml N1 vial
4 ml N5 vial

Rx
Rx
Rx
Rx

iv

L01XX17

1 ml N1 bottle
1 ml N5 bottle

Rx
Rx

iv

L01XX17

4 ml N1 bottle
4 ml N5 bottle

Rx
Rx

iv

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

N10 blister

EU/1/96/027/006

CP

18-03-2008

N10 blister

Nominal

Nenurodyta

N10 blister

EU/1/96/027/007

CP

18-03-2008

N1 vial
N5 vial

EU/1/96/027/005
EU/1/96/027/004

CP
CP

12-11-1996
12-11-1996

N1 vial
N5 vial

EU/1/96/027/003
EU/1/96/027/001

CP
CP

12-11-1996
12-11-1996

N1 vial

EU/1/10/660/001

CP

06-01-2011

N1 vial

EU/1/10/660/002

CP

06-01-2011

1 ml N1 vial
1 ml N5 vial
4 ml N1 vial
4 ml N5 vial

LT/1/12/2932/001
LT/1/12/2932/002
LT/1/12/2932/003
LT/1/12/2932/004

DCP
DCP
DCP
DCP

09-05-2012
09-05-2012
09-05-2012
09-05-2012

TOPOTECAN ACTAVIS 1 MG powd for conc for sol for inf

N1 bottle
N5x1 bottle

EU/1/09/536/001
EU/1/09/536/003

CP
CP

24-07-2009
24-07-2009

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

N1 bottle
N5x1 bottle

EU/1/09/536/002
EU/1/09/536/004

CP
CP

24-07-2009
24-07-2009

4 ml N1 bottle
4 ml N5 bottle

EU/1/10/633/001
EU/1/10/633/002

CP
CP

10-06-2010
10-06-2010

1 ml N1 vial
1 ml N5 vial
4 ml N1 vial
4 ml N5 vial

LT/1/11/2388/003
LT/1/11/2388/004
LT/1/11/2388/005
LT/1/11/2388/006

DCP
DCP
DCP
DCP

09-10-2013
09-10-2013
09-10-2013
09-10-2013

1 ml N1 bottle
1 ml N5 bottle

EU/1/09/552/001
EU/1/09/552/002

CP
CP

21-09-2009
21-09-2009

4 ml N1 bottle
4 ml N5 bottle

EU/1/09/552/003
EU/1/09/552/004

CP
CP

21-09-2009
21-09-2009

TOPOTECAN 1MG/ ML (X1ML VIAL) conc for sol for inf

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X Last update: 17-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

Rx

-

L01XX17

TOPOTECAN 1MG/ ML (X4ML VIAL) conc for sol for inf

Rx

-

L01XX17

TOPOTECAN 4MG powd for conc for sol for inf

Rx

-

L01XX17

TOPOTECAN ACCORD 1 MG/ML (1ML VIAL) conc for sol for inf

Rx

-

L01XX17

TOPOTECAN ACCORD 1 MG/ML (4ML VIAL) conc for sol for inf

Rx

-

L01XX17

TOPOTECAN 1MG/ ML (X1ML VIAL) conc for sol for inf

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

MA911/01001

26-09-2013

TOPOTECAN 1MG/ ML (X4ML VIAL) conc for sol for inf

MA911/01002

26-09-2013

TOPOTECAN 4MG powd for conc for sol for inf

MA054/01601

23-11-2009

TOPOTECAN ACCORD 1 MG/ML (1ML VIAL) conc for sol for inf

MA1269/02501

02-03-2012

TOPOTECAN ACCORD 1 MG/ML (4ML VIAL) conc for sol for inf

MA1269/02502

02-03-2012

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X Last update: 17-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

10 caps

Rpz

-

L01XX17

10 caps

Rpz

-

L01XX17

1 vial
5 vial

Rpz
Rpz

-

L01XX17

1 vial
5 vial

Rpz
Rpz

-

L01XX17

1 vial

Rpz

-

L01XX17

1 vial

Rpz

-

L01XX17

TOPOTECAN ACTAVIS 1 MG powd for conc for sol for inf

1 vial
5 vial

Rpz

-

L01XX17

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

1 vial
5 vial

Rpz

-

L01XX17

1 vial 4 ml
5 vial 4 ml

Rpz
Rpz

-

L01XX17

1 vial 1 ml
1 vial 4 ml
5 vial 1 ml
5 vial 4 ml

Rp
Rp
Rp
Rp

-

L01XX17

1 vial 1 ml
1 vial 2 ml
1 vial 4 ml
5 vial 1 ml
5 vial 2 ml
5 vial 4 ml

Lz
Lz
Lz
Lz
Lz
Lz

-

L01XX17

1 vial
5 vial

Rpz
Rpz

-

L01XX17

1 vial
5 vial

Rpz
Rpz

-

L01XX17

TOPOTECANUM ACCORD 1 MG/ML conc for sol for inf

1 vial 1 ml
1 vial 4 ml
5 vial 1 ml
5 vial 4 ml

Lz
Lz
Lz
Lz

-

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

10 caps

CP

10 caps

CP

1 vial
5 vial

CP
CP

1 vial
5 vial

CP
CP

1 vial

CP

1 vial

CP

TOPOTECAN ACTAVIS 1 MG powd for conc for sol for inf

1 vial
5 vial

CP
CP

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

1 vial
5 vial

CP
CP

1 vial 4 ml
5 vial 4 ml

CP
CP

1 vial 1 ml
1 vial 4 ml
5 vial 1 ml
5 vial 4 ml

21804
21804
21804
21804

DCP
DCP
DCP
DCP

14-02-2019
14-02-2019
14-02-2019
14-02-2019

1 vial 1 ml
1 vial 2 ml
1 vial 4 ml
5 vial 1 ml
5 vial 2 ml
5 vial 4 ml

18922
18922
18922
18922
18922
18922

DCP
DCP
DCP
DCP
DCP
DCP

1 vial
5 vial

CP
CP

1 vial
5 vial

CP
CP

TOPOTECANUM ACCORD 1 MG/ML conc for sol for inf

1 vial 1 ml
1 vial 4 ml
5 vial 1 ml
5 vial 4 ml

20222
20222
20222
20222

DCP
DCP
DCP
DCP

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X Last update: 17-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

blister PVC/PCTFE/Al x 10 caps

-

PR

-

L01XX17

POTACTASOL 4MG PULB. PT. CONC. PT. SOL. PERF.

1fl din sticla x 4 mg pulbere pentru con

-

PR

-

L01XX17

TOPOTECAN ACCORD 1 MG/ML CONC. PT. SOL. PERF.

1 flac. din sticla bruna de tip I, cu ca
1 flac. din sticla bruna de tip I, cu ca
5 flac. din sticla bruna de tip I, cu c
5 flac. din sticla bruna de tip I, cu ca

-
-
-
-

PR
PR
PR
PR

-

L01XX17

TOPOTECAN EBEWE 1 MG/ML CONC. PT. SOL. PERF.

1 flac. din sticla incolora x 1 ml conc.
1 flac. din sticla incolora x 3 ml conc.
1 flac. din sticla incolora x 4 ml conc.
10 flac. din sticla incolora x 1 ml conc
10 flac. din sticla incolora x 3 ml conc
10 flac. din sticla incolora x 4 ml conc
5 flac. din sticla incolora x 1 ml conc.
5 flac. din sticla incolora x 3 ml conc.
5 flac. din sticla incolora x 4 ml conc.

-
-
-
-
-
-
-
-
-

PR
PR
PR
PR
PR
PR
PR
PR
PR

-

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

blister PVC/PCTFE/Al x 10 caps

-

POTACTASOL 4MG PULB. PT. CONC. PT. SOL. PERF.

1fl din sticla x 4 mg pulbere pentru con

-

TOPOTECAN ACCORD 1 MG/ML CONC. PT. SOL. PERF.

1 flac. din sticla bruna de tip I, cu ca
1 flac. din sticla bruna de tip I, cu ca
5 flac. din sticla bruna de tip I, cu c
5 flac. din sticla bruna de tip I, cu ca

-
-
-
-

TOPOTECAN EBEWE 1 MG/ML CONC. PT. SOL. PERF.

1 flac. din sticla incolora x 1 ml conc.
1 flac. din sticla incolora x 3 ml conc.
1 flac. din sticla incolora x 4 ml conc.
10 flac. din sticla incolora x 1 ml conc
10 flac. din sticla incolora x 3 ml conc
10 flac. din sticla incolora x 4 ml conc
5 flac. din sticla incolora x 1 ml conc.
5 flac. din sticla incolora x 3 ml conc.
5 flac. din sticla incolora x 4 ml conc.

-
-
-
-
-
-
-
-
-

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X Last update: 18-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

10 caps blister

N

Rx

oral

L01XX17

10 caps blister

N

Rx

oral

L01XX17

1 vialo
5 vial

N
-

Rx
Rx

iv

L01XX17

1 viala

-

Rx

iv

L01XX17

1 viala

-

Rx

iv

L01XX17

TOPOTEKAN ACCORD 1 MG/ML conc for sol for inf

1 vial (volumen 2 ml) 1 ml conc
1 vial (volumen 5 ml) 4 ml conc

-
N

Rx
Rx

iv

L01XX17

TOPOTEKAN ACCORD 4 MG powd for conc for sol for inf

1 vial praškom

-

Rx

iv

L01XX17

TOPOTEKAN ACTAVIS 1 MG powd for conc for sol for inf

1 vialo

-

Rx

iv

L01XX17

TOPOTEKAN ACTAVIS 4 MG powd for conc for sol for inf

1 vialo

N

Rx

iv

L01XX17

TOPOTEKAN KABI 4 MG powd for conc for sol for inf

1 vial praškom

N

Rx

iv

L01XX17

TOPOTEKAN LOGENEX PHARM 1 MG/ML powd for conc for sol for inf

1 vial powd (1 mg)
1 vial powd (4 mg)
5 vial powd (1 mg)
5 vial powd (4 mg)

-
-
-
-

Rx
Rx
Rx
Rx

iv

L01XX17

Logenex Pharm

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

10 caps blister

EU/1/96/027/006

CP

23-04-2012

10 caps blister

EU/1/96/027/007

CP

23-04-2012

1 vialo
5 vial

EU/1/96/027/003
EU/1/96/027/001

CP
CP

23-04-2012
23-04-2012

1 viala

EU/1/10/660/001

CP

23-04-2012

1 viala

EU/1/10/660/002

CP

23-04-2012

TOPOTEKAN ACCORD 1 MG/ML conc for sol for inf

1 vial (volumen 2 ml) 1 ml conc
1 vial (volumen 5 ml) 4 ml conc

103-178/2018-3
103-178/2018-3

DCP
DCP

27-03-2019
27-03-2019

TOPOTEKAN ACCORD 4 MG powd for conc for sol for inf

1 vial praškom

103-21/2015-3

DCP

02-11-2015

TOPOTEKAN ACTAVIS 1 MG powd for conc for sol for inf

1 vialo

EU/1/09/536/001

CP

11-01-2019

11-07-2020

TOPOTEKAN ACTAVIS 4 MG powd for conc for sol for inf

1 vialo

EU/1/09/536/002

CP

11-01-2019

11-07-2020

TOPOTEKAN KABI 4 MG powd for conc for sol for inf

1 vial praškom

1011-148/2014-6

DCP

30-05-2018

30-11-2019

TOPOTEKAN LOGENEX PHARM 1 MG/ML powd for conc for sol for inf

1 vial powd (1 mg)
1 vial powd (4 mg)
5 vial powd (1 mg)
5 vial powd (4 mg)

103-119/2014-2
103-119/2014-2
103-119/2014-2
103-119/2014-2

DCP
DCP
DCP
DCP

03-11-2014
03-11-2014
03-11-2014
03-11-2014

03-01-2015
03-01-2015
03-01-2015
03-01-2015

Logenex Pharm

Product

Pack

Ex-fact

Wholesale

Net retail

Gr. retail

Company

10 caps blister

10 caps blister

1 vialo
5 vial

1 viala

1 viala

TOPOTEKAN ACCORD 1 MG/ML conc for sol for inf

1 vial (volumen 2 ml) 1 ml conc
1 vial (volumen 5 ml) 4 ml conc

138,37

TOPOTEKAN ACCORD 4 MG powd for conc for sol for inf

1 vial praškom

TOPOTEKAN ACTAVIS 1 MG powd for conc for sol for inf

1 vialo

TOPOTEKAN ACTAVIS 4 MG powd for conc for sol for inf

1 vialo

TOPOTEKAN KABI 4 MG powd for conc for sol for inf

1 vial praškom

TOPOTEKAN LOGENEX PHARM 1 MG/ML powd for conc for sol for inf

1 vial powd (1 mg)
1 vial powd (4 mg)
5 vial powd (1 mg)
5 vial powd (4 mg)

Logenex Pharm

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X Last update: 23-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

10 caps

Y

Rx

oral

L01XX17

10 caps

Y

Rx

oral

L01XX17

HYCAMTIN 4 MG POLVO powd for conc for sol for inf

5 vials

Y

Rx

iv

L01XX17

1 vial of 4 ml

Y

Rx

iv

L01XX17

TOPOTECAN ACCORD 4 MG powd for conc for sol for inf

1 vial

-

Rx

iv

L01XX17

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

1 vial

-

Rx

iv

L01XX17

TOPOTECAN FARMALIDER 1 MG powd for conc for sol for inf

1 vial

-

Rx

iv

L01XX17

TOPOTECAN FARMALIDER 4 MG powd for conc for sol for inf

1 vial

-

Rx

iv

L01XX17

TOPOTECAN HOSPIRA 4MG/4 ML conc for sol for inf

5 vials of 4 ml

Y

Rx

iv

L01XX17

5 vials of 4 ml

-

Rx

iv

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

10 caps

96027006

03-04-2008

10 caps

96027007

03-04-2008

HYCAMTIN 4 MG POLVO powd for conc for sol for inf

5 vials

96027001

01-03-1997

1 vial of 4 ml

76570

02-10-2012

TOPOTECAN ACCORD 4 MG powd for conc for sol for inf

1 vial

72892

20-10-2010

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

1 vial

09536002

25-09-2009

TOPOTECAN FARMALIDER 1 MG powd for conc for sol for inf

1 vial

78445

11-02-2014

TOPOTECAN FARMALIDER 4 MG powd for conc for sol for inf

1 vial

78428

03-02-2014

TOPOTECAN HOSPIRA 4MG/4 ML conc for sol for inf

5 vials of 4 ml

10633002

20-09-2010

5 vials of 4 ml

09552004

21-12-2009

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X Last update: 18-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

TOPOTECAN ACCORD 4 MG powd for conc for sol for inf

Rx

-

L01XX17

TOPOTECAN ACTAVIS 1 MG powd for conc for sol for inf

Rx

-

L01XX17

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

Rx

-

L01XX17

TOPOTECAN EAGLE 15 MG/5 ML conc for sol for inf

Rx

-

L01XX17

TOPOTECAN EAGLE 3 MG/1 ML conc for sol for inf

Rx

-

L01XX17

Rx

-

L01XX17

TOPOTECAN FRESENIUS KABI 1 MG/ML conc for sol for inf

Rx

-

L01XX17

TOPOTECAN FRESENIUS KABI 4 MG powd for conc for sol for inf

Rx

-

L01XX17

Rx

-

L01XX17

TOPOTECAN MARTINDALE PHARMA 1 MG powd for conc for sol for inf

Rx

-

L01XX17

TOPOTECAN MARTINDALE PHARMA 4 MG powd for conc for sol for inf

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

Rx

-

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

CP

18-03-2008

CP

18-03-2008

CP

12-11-1996

CP

12-11-1996

CP

06-01-2011

CP

06-01-2011

Nationell decentral eller ömsesidig

02-08-2012

TOPOTECAN ACCORD 4 MG powd for conc for sol for inf

Nationell decentral eller ömsesidig

08-07-2011

19-10-2016

TOPOTECAN ACTAVIS 1 MG powd for conc for sol for inf

CP

24-07-2009

11-01-2019

TOPOTECAN ACTAVIS 4 MG powd for conc for sol for inf

CP

24-07-2009

11-01-2019

TOPOTECAN EAGLE 15 MG/5 ML conc for sol for inf

CP

22-12-2011

01-10-2014

TOPOTECAN EAGLE 3 MG/1 ML conc for sol for inf

CP

22-12-2011

01-10-2014

Nationell decentral eller ömsesidig

25-02-2011

TOPOTECAN FRESENIUS KABI 1 MG/ML conc for sol for inf

Nationell decentral eller ömsesidig

07-11-2013

30-11-2014

TOPOTECAN FRESENIUS KABI 4 MG powd for conc for sol for inf

Nationell decentral eller ömsesidig

29-04-2011

12-09-2017

CP

10-06-2010

TOPOTECAN MARTINDALE PHARMA 1 MG powd for conc for sol for inf

Nationell decentral eller ömsesidig

29-10-2010

31-12-2011

TOPOTECAN MARTINDALE PHARMA 4 MG powd for conc for sol for inf

Nationell decentral eller ömsesidig

29-10-2010

31-12-2011

Nationell decentral eller ömsesidig

21-10-2011

31-08-2014

CP

21-09-2009

11-04-2019

CP

21-09-2009

11-04-2019

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X Last update: 25-05-2020

Product

Pack

Market

Pres.

Dosage

ATC

Company

HYCAMTIN 0.25 MG caps

-

A

-

L01XX17

-

A

-

L01XX17

HYCAMTIN 1 MG lyophil

-

A

-

L01XX17

HYCAMTIN 4 MG lyophil

-
-

A
A

-

L01XX17

TOPOTECAN ACCORD 1 MG conc for sol for inf

-

A

-

L01XX17

TOPOTECAN ACCORD 4 MG conc for sol for inf

-
-

A
A

-

L01XX17

TOPOTECAN FRESENIUS 1 MG/1 ML Infusionskonzentrat

-

A

-

L01XX17

TOPOTECAN FRESENIUS 4 MG/4 ML Infusionskonzentrat

-

A

-

L01XX17

TOPOTECAN LABATEC 1 MG powd for sol for inf

-

A

-

L01XX17

TOPOTECAN LABATEC 4 MG powd for sol for inf

-

A

-

L01XX17

TOPOTECAN-GSK 0.25 MG caps

-

A

-

L01XX17

TOPOTECAN-GSK 1 MG caps

-

A

-

L01XX17

TOPOTECAN-GSK 1 MG lyophil

-

A

-

L01XX17

TOPOTECAN-GSK 4 MG lyophil

-

A

-

L01XX17

Product

Pack

Reg. Nr.

Reg. Type

Reg. Date

Reg. Valid

Revocation

Company

HYCAMTIN 0.25 MG caps

58589 1

Hauptzulassung

14-04-2009

13-04-2024

58589 2

Hauptzulassung

14-04-2009

13-04-2024

HYCAMTIN 1 MG lyophil

53857 2

Hauptzulassung

16-10-1996

03-04-2021

HYCAMTIN 4 MG lyophil

53857 1
53857 1

Hauptzulassung
Hauptzulassung

16-10-1996
16-10-1996

03-04-2021
03-04-2021

TOPOTECAN ACCORD 1 MG conc for sol for inf

66810 1

Hauptzulassung

15-03-2019

14-03-2024

TOPOTECAN ACCORD 4 MG conc for sol for inf

66810 2
66810 2

Hauptzulassung
Hauptzulassung

15-03-2019
15-03-2019

14-03-2024
14-03-2024

TOPOTECAN FRESENIUS 1 MG/1 ML Infusionskonzentrat

65286 1

Exportzulassung

17-12-2014

TOPOTECAN FRESENIUS 4 MG/4 ML Infusionskonzentrat

65286 2

Exportzulassung

17-12-2014

TOPOTECAN LABATEC 1 MG powd for sol for inf

65085 1

Exportzulassung

10-12-2013

09-12-2023

TOPOTECAN LABATEC 4 MG powd for sol for inf

65085 2

Exportzulassung

10-12-2013

09-12-2023

TOPOTECAN-GSK 0.25 MG caps

66158 1

Exportzulassung

18-02-2016

17-02-2021

TOPOTECAN-GSK 1 MG caps

66158 2

Exportzulassung

18-02-2016

17-02-2021

TOPOTECAN-GSK 1 MG lyophil

66157 1

Exportzulassung

18-02-2016

17-02-2021

TOPOTECAN-GSK 4 MG lyophil

66157 2

Exportzulassung

18-02-2016

17-02-2021