All the information on this site is from our Global Pharmaceutical Database.

hydroxycarbamide

North America

Canada (3)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
APO-HYDROXYUREA 500MG caps
Rx
oral
L01XX05
Apotex
HYDREA CAP 500MG caps
Rx
oral
L01XX05
Bristol-Myers Squibb
MYLAN-HYDROXYUREA 500MG caps
Rx
oral
L01XX05
Mylan
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
APO-HYDROXYUREA 500MG caps
02247937
Apotex
HYDREA CAP 500MG caps
00465283
Bristol-Myers Squibb
MYLAN-HYDROXYUREA 500MG caps
02242920
Mylan
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United States (12)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
DROXIA 200MG caps
Y
Rx
oral
L01XX05
Bristol-Myers Squibb
DROXIA 300MG caps
Y
Rx
oral
L01XX05
Bristol-Myers Squibb
DROXIA 400MG caps
Y
Rx
oral
L01XX05
Bristol-Myers Squibb
HYDREA 500MG caps
Y
Rx
oral
L01XX05
Bristol-Myers Squibb
HYDROXYUREA 1GM tabs
N
oral
L01XX05
Barr
HYDROXYUREA 250MG caps
N
N

oral
L01XX05
Barr
HYDROXYUREA 500MG caps
Y
N
Rx
oral
L01XX05
Barr
HYDROXYUREA 500MG caps
Y
Rx
oral
L01XX05
Leading Pharma
HYDROXYUREA 500MG caps
Y
Rx
oral
L01XX05
Par
HYDROXYUREA 500MG caps
N
oral
L01XX05
Roxane
SIKLOS 100MG tabs
Y
Rx
oral
L01XX05
Addmedica
SIKLOS 1GM tabs
Y
Rx
oral
L01XX05
Addmedica
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
DROXIA 200MG caps
16295/2
NDA
25-02-1998
Bristol-Myers Squibb
DROXIA 300MG caps
16295/3
NDA
25-02-1998
Bristol-Myers Squibb
DROXIA 400MG caps
16295/4
NDA
25-02-1998
Bristol-Myers Squibb
HYDREA 500MG caps
16295/1
NDA
01-01-1982
Bristol-Myers Squibb
HYDROXYUREA 1GM tabs
75734/1
ANDA
29-08-2000
Barr
HYDROXYUREA 250MG caps
75020/2
75143/2
ANDA
ANDA
26-06-2000
21-09-2000
Barr
HYDROXYUREA 500MG caps
75020/1
75143/1
ANDA
ANDA
30-07-1998
16-10-1998
Barr
HYDROXYUREA 500MG caps
213438/1
ANDA
08-04-2020
Leading Pharma
HYDROXYUREA 500MG caps
75340/1
ANDA
24-02-1999
Par
HYDROXYUREA 500MG caps
74476/1
ANDA
18-08-1995
Roxane
SIKLOS 100MG tabs
208843/1
NDA
21-12-2017
Addmedica
SIKLOS 1GM tabs
208843/2
NDA
21-12-2017
Addmedica
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Europe

Austria (9)
X
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDROXYCARBAMID HIKMA 500 MG caps, hard
135763
16-09-2014
Hikma
HYDROXYUREA MEDAC 500 MG caps, hard
1-24090
21-05-2001
Medac
LITALIR 500 MG caps
1-23227
28-09-1999
Bristol-Myers Squibb
LITALIR 500 MG caps
1-23227-P1
18-12-2015
EMRAmed
LITALIR 500 MG caps
1-23227-P2
19-07-2016
EurimPharm
LITALIR 500 MG caps
1-23227-P4
25-07-2019
Haemato Pharm
SIKLOS 100 MG fc tabs
EU/1/07/397/002-004
28-02-2011
Addmedica
SIKLOS 1000 MG fc tabs
EU/1/07/397/001
29-06-2007
Addmedica
XROMI 100 MG/ML oral sol
EU/1/19/1366/001
01-07-2019
Nova Laboratories
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Belgium (4)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
HYDREA 500 MG caps, hard
100x
20x
-
Y

oral
L01XX05
Bristol-Myers Squibb
SIKLOS 100 MG fc tabs
120x
60x
90x
-
Y
-


oral
L01XX05
Addmedica
SIKLOS 1000 MG fc tabs
30x
-
oral
L01XX05
Addmedica
XROMI 100 MG/ML oral sol
1x, 150 mL, 2x
-
oral
L01XX05
Nova Laboratories
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDREA 500 MG caps, hard
100x
20x
BE048851
BE048851
-
-
Bristol-Myers Squibb
SIKLOS 100 MG fc tabs
120x
60x
90x
EU/1/07/397/004
EU/1/07/397/004
EU/1/07/397/003
CP
CP
CP
Addmedica
SIKLOS 1000 MG fc tabs
30x
EU/1/07/397/001
CP
Addmedica
XROMI 100 MG/ML oral sol
1x, 150 mL, 2x
EU/1/19/1366/001
CP
Nova Laboratories
Product
Pack
Ex-fact
Wholesale
Net retail
Gr. retail
Company
HYDREA 500 MG caps, hard
100x
20x
3,69
Bristol-Myers Squibb
SIKLOS 100 MG fc tabs
120x
60x
90x
73,01
Addmedica
SIKLOS 1000 MG fc tabs
30x
Addmedica
XROMI 100 MG/ML oral sol
1x, 150 mL, 2x
Nova Laboratories
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Croatia (3)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
LITALIR 500 MG TVRDA caps, hard
100 caps u bočici
Y
Rx
-
L01XX05
Bristol-Myers Squibb
SIKLOS* -
-
Rx
-
L01XX05
XROMI* -
-
Rx
-
L01XX05
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
LITALIR 500 MG TVRDA caps, hard
100 caps u bočici
HR-H-923595891-01
30-06-2017
Bristol-Myers Squibb
SIKLOS* -
XROMI* -
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Czechia (3)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
LITALIR 500MG caps, hard
500MG 100
Y
oral
L01XX05
Bristol-Myers Squibb
SIKLOS 1000MG fc tabs
1000MG 30
N
oral
L01XX05
Addmedica
SIKLOS 100MG fc tabs
100MG 120
100MG 60
100MG 90
N
N
N
oral
L01XX05
Addmedica
XROMI 100MG/ML oral sol
100MG/ML 1X150ML+ADAP+2STŘ
N
oral
L01XX05
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
LITALIR 500MG caps, hard
500MG 100
44/ 652/93-C
NP
Bristol-Myers Squibb
SIKLOS 1000MG fc tabs
1000MG 30
EU/1/07/397/001
CP
Addmedica
SIKLOS 100MG fc tabs
100MG 120
100MG 60
100MG 90
EU/1/07/397/004
EU/1/07/397/002
EU/1/07/397/003
CP
CP
CP
Addmedica
XROMI 100MG/ML oral sol
100MG/ML 1X150ML+ADAP+2STŘ
EU/1/19/1366/001
CP
Product
Pack
Ex-fact
Wholesale
Net retail
Gr. retail
Company
LITALIR 500MG caps, hard
500MG 100
415,46
602,99
Bristol-Myers Squibb
SIKLOS 1000MG fc tabs
1000MG 30
0
Addmedica
SIKLOS 100MG fc tabs
100MG 120
100MG 60
100MG 90
0
0
0
Addmedica
XROMI 100MG/ML oral sol
100MG/ML 1X150ML+ADAP+2STŘ
0
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Denmark (6)
X
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDREA 500 MG caps, hard
28103759904
PI
17-05-2005
Paranova
HYDROXYUREA "MEDAC" 500 MG caps, hard
28103179700
MRP
19-03-2001
Medac
ORIBAMIDE 500 MG caps, hard
28106109718
DCP
29-03-2019
Orifarm
SIKLOS 100 MG fc tabs
28104653710
CP
28-02-2011
Addmedica
SIKLOS 1000 MG fc tabs
28103865905
CP
29-06-2007
Addmedica
XROMI 100 MG/ML oral sol
28106086718
CP
01-07-2019
Nova Laboratories
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Hungary (4)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
LITALIR 500 MG caps, hard
100x glass
Y
Rx
oral
L01XX05
Bristol-Myers Squibb
SIKLOS 100 MG fc tabs
120x bottle
60x bottle
90x bottle
N
N
N
Rx
Rx
Rx
-
L01XX05
Addmedica
SIKLOS 1000 MG fc tabs
30x bottle
N
Rx
-
L01XX05
Addmedica
XROMI 100 MG/ML oral sol
1x150ml hdpe container
N
Rx
-
L01XX05
Nova Laboratories
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
LITALIR 500 MG caps, hard
100x glass
OGYI-T-01878/01
01-01-1992
Bristol-Myers Squibb
SIKLOS 100 MG fc tabs
120x bottle
60x bottle
90x bottle
EU/1/07/397/004
EU/1/07/397/002
EU/1/07/397/003
28-02-2011
28-02-2011
28-02-2011
Addmedica
SIKLOS 1000 MG fc tabs
30x bottle
EU/1/07/397/001
29-06-2007
Addmedica
XROMI 100 MG/ML oral sol
1x150ml hdpe container
EU/1/19/1366/001
01-07-2019
Nova Laboratories
Product
Pack
Ex-fact
Wholesale
Net retail
Gr. retail
Company
LITALIR 500 MG caps, hard
100x glass
5751
6004,04
6994
7344
Bristol-Myers Squibb
SIKLOS 100 MG fc tabs
120x bottle
60x bottle
90x bottle
0
0
0
0
0
0
0
0
0
0
0
0
Addmedica
SIKLOS 1000 MG fc tabs
30x bottle
0
0
0
0
Addmedica
XROMI 100 MG/ML oral sol
1x150ml hdpe container
0
0
0
0
Nova Laboratories
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Iceland (4)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
HYDROXYUREA MEDAC 500 MG caps, hard
Y
Rx
-
L01XX05
Medac
SIKLOS 100 MG fc tabs
N
Rx
-
L01XX05
Addmedica
SIKLOS 1000 MG fc tabs
N
Rx
-
L01XX05
Addmedica
XROMI 100 MG/ML oral sol
N
Rx
-
L01XX05
Nova Laboratories
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDROXYUREA MEDAC 500 MG caps, hard
02-09-2015
Medac
SIKLOS 100 MG fc tabs
25-03-2011
Addmedica
SIKLOS 1000 MG fc tabs
19-07-2007
Addmedica
XROMI 100 MG/ML oral sol
01-07-2019
Nova Laboratories
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Ireland (4)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
HYDREA 500 MG HARD caps, hard
Y
Rx
oral
L01XX05
Bristol-Myers Squibb
SIKLOS 100 MG fc tabs
-
Rx
oral
L01XX05
Addmedica
SIKLOS 1000 MG fc tabs
-
Rx
oral
L01XX05
Addmedica
XROMI 100 MG/ML oral sol
-
Rx
oral
L01XX05
Nova Laboratories
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDREA 500 MG HARD caps, hard
PA0002/027/001
01-04-1979
Bristol-Myers Squibb
SIKLOS 100 MG fc tabs
EU/1/07/397/002-004
28-02-2011
Addmedica
SIKLOS 1000 MG fc tabs
EU/1/07/397/001
Addmedica
XROMI 100 MG/ML oral sol
EU/1/19/1366/001
01-07-2019
Nova Laboratories
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Lithuania (7)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
HYDREA 500 MG caps, hard
N100 bottle
Rx
oral
L01XX05
Bristol-Myers Squibb
HYDREA 500 MG caps, hard
N100 blister
Rx
oral
L01XX05
Lex ano
HYDREA 500 MG caps, hard
N100 blister
Rx
oral
L01XX05
Limedika
LITALIR 500 MG caps, hard
N100 nenurodyta
oral
L01XX05
Nenurodyta
SIKLOS 100 MG fc tabs
N120 bottle
N60 bottle
N90 bottle
Rx
Rx
Rx
oral
L01XX05
Addmedica
SIKLOS 1000 MG fc tabs
N30 blister
Rx
oral
L01XX05
Addmedica
XROMI 100 MG/ML oral sol
150 ml, adapteris ir 3 ml ir 12 ml dozav
Rx
oral
L01XX05
Nova Laboratories
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDREA 500 MG caps, hard
N100 bottle
LT/1/98/0429/001
NP
22-10-1998
Bristol-Myers Squibb
HYDREA 500 MG caps, hard
N100 blister
LT/L/12/0102/001
PI
03-07-2012
Lex ano
HYDREA 500 MG caps, hard
N100 blister
LT/L/17/0472/001
PI
06-03-2017
Limedika
LITALIR 500 MG caps, hard
N100 nenurodyta
Nominal
Nenurodyta
SIKLOS 100 MG fc tabs
N120 bottle
N60 bottle
N90 bottle
EU/1/07/397/004
EU/1/07/397/002
EU/1/07/397/003
CP
CP
CP
28-02-2011
28-02-2011
28-02-2011
Addmedica
SIKLOS 1000 MG fc tabs
N30 blister
EU/1/07/397/001
CP
29-07-2007
Addmedica
XROMI 100 MG/ML oral sol
150 ml, adapteris ir 3 ml ir 12 ml dozav
EU/1/19/1366/001
CP
01-07-2019
Nova Laboratories
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Malta (2)
X
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDREA HARD 500MG caps, hard
AA244/10602
05-11-2018
P&D Pharmaceuticals
HYDROXYCARBAMIDE MEDAC 500MG , HARD caps, hard
AA565/51501
19-08-2019
Central Procurement & Supplies Unit
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Poland (5)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
HYDROXYCARBAMID TEVA 500 MG caps
100 caps container
100 caps w butelce
Rp
Rp
-
L01XX05
Teva
HYDROXYUREA MEDAC 500 MG caps, hard
100 caps
50 caps
Rp
Rp
-
L01XX05
Medac
SIKLOS 100 MG fc tabs
120 tabs
60 tabs
90 tabs
-
L01XX05
Addmedica
SIKLOS 1000 MG fc tabs
30 tabs
Rpz
-
L01XX05
Addmedica
XROMI 100 MG/ML oral sol
1 bottle
-
L01XX05
Nova Laboratories
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDROXYCARBAMID TEVA 500 MG caps
100 caps container
100 caps w butelce
02312
02312
NP
NP
Teva
HYDROXYUREA MEDAC 500 MG caps, hard
100 caps
50 caps
09449
09449
NP
NP
Medac
SIKLOS 100 MG fc tabs
120 tabs
60 tabs
90 tabs
CP
CP
CP
Addmedica
SIKLOS 1000 MG fc tabs
30 tabs
CP
Addmedica
XROMI 100 MG/ML oral sol
1 bottle
CP
Nova Laboratories
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Romania (1)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
HYDREA 500 MG caps
x 1 flac. din sticla bruna x 100 caps
-
PRF
-
L01XX05
Bristol-Myers Squibb
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDREA 500 MG caps
x 1 flac. din sticla bruna x 100 caps
-
Bristol-Myers Squibb
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Slovenia (1)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
LITALIR 500 MG caps, hard
steklenico 100 caps
N
Rx
oral
L01XX05
Bristol-Myers Squibb
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
LITALIR 500 MG caps, hard
steklenico 100 caps
10024-128/2014-2
NP
06-01-2015
Bristol-Myers Squibb
Product
Pack
Ex-fact
Wholesale
Net retail
Gr. retail
Company
LITALIR 500 MG caps, hard
steklenico 100 caps
49,17
Bristol-Myers Squibb
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Spain (3)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
HYDREA 500 MG caps, hard
20 caps
Y
Rx
oral
L01XX05
Bristol-Myers Squibb
SIKLOS 1.000 MG fc tabs
30 tabs
Y
Rx
oral
L01XX05
Addmedica
SIKLOS 100 MG fc tabs
60 tabs
Y
Rx
oral
L01XX05
Addmedica
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDREA 500 MG caps, hard
20 caps
61633
01-05-1998
Bristol-Myers Squibb
SIKLOS 1.000 MG fc tabs
30 tabs
07397001
25-06-2010
Addmedica
SIKLOS 100 MG fc tabs
60 tabs
07397002
18-01-2012
Addmedica
Would you like to in or out-license dossiers? Do you have Marketing Authorization to sell? Would you like to sell or aquire companies? This is the right place for you to find new business opportunities in the pharmaceutical industry.

Sweden (11)
X
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDREA 500 MG caps, hard
Nationell decentral eller ömsesidig
14-01-1999
Bristol-Myers Squibb
HYDREA 500 MG caps, hard
PI
29-11-2002
31-12-2010
EuroPharma Sverige
HYDREA 500 MG caps, hard
PI
PI
PI
18-02-2004
11-02-2004
02-11-2001
31-12-2012
31-12-2012
31-12-2012
Orifarm
HYDREA 500 MG caps, hard
PI
PI
28-12-2001
11-01-2002
31-01-2011
Paranova
HYDROXIKARBAMID ORIFARM 500 MG caps, hard
PI
31-01-2018
Orifarm
HYDROXYUREA MEDAC 500 MG caps, hard
Nationell decentral eller ömsesidig
09-10-1998
Medac
HYDROXYUREA ORIFARM 500 MG caps, hard
PI
18-02-2008
31-12-2011
Orifarm
ORIBAMIDE 500 MG caps, hard
Nationell decentral eller ömsesidig
08-04-2019
Orifarm
SIKLOS 100 MG fc tabs
CP
28-02-2011
Addmedica
SIKLOS 1000 MG fc tabs
CP
29-06-2007
Addmedica
XROMI 100 MG/ML oral sol
CP
01-07-2019
Nova Laboratories
Would you like to in or out-license dossiers? Do you have Marketing Authorization to sell? Would you like to sell or aquire companies? This is the right place for you to find new business opportunities in the pharmaceutical industry.

Switzerland (3)
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
HYDROXYCARBAMID DEVATIS 500 MG caps
-
A
-
L01XX05
Devatis
HYDROXYCARBAMID LABATEC 500 MG caps
-
-
-
A
A
A
-
L01XX05
Labatec Pharma
LITALIR caps
-
A
-
L01XX05
Bristol-Myers Squibb
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
HYDROXYCARBAMID DEVATIS 500 MG caps
67491 1
Hauptzulassung
28-10-2019
27-10-2024
Devatis
HYDROXYCARBAMID LABATEC 500 MG caps
66131 1
66131 1
66131 1
Hauptzulassung
Hauptzulassung
Hauptzulassung
30-06-2016
30-06-2016
30-06-2016
29-06-2021
29-06-2021
29-06-2021
Labatec Pharma
LITALIR caps
52958 1
Hauptzulassung
27-04-1995
Bristol-Myers Squibb
Would you like to in or out-license dossiers? Do you have Marketing Authorization to sell? Would you like to sell or aquire companies? This is the right place for you to find new business opportunities in the pharmaceutical industry.


Data source