All the information on this site is from our Global Pharmaceutical Database.
S01AA12
tobramycin
For informational purposes only, X-Pharma does not provide medical advice.
SPC/PIL of the products can differ from this general indication.
J01GB01SPC/PIL of the products can differ from this general indication.
S01AA12
North America
Canada (12)
X
United States (45)Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
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X
Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
63122/1
63121/1
63120/1
63121/1
63120/1
ANDA
ANDA
ANDA
ANDA
ANDA
31-10-1994
31-10-1994
31-10-1994
31-10-1994
31-10-1994
63127/1
63118/1
63117/1
63118/1
63117/1
ANDA
ANDA
ANDA
ANDA
ANDA
27-11-1991
29-07-1991
26-04-1991
29-07-1991
26-04-1991
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Europe
Austria (12)
X
Belgium (9)Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
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X
Croatia (4)Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
Product
Pack
Ex-fact
Wholesale
Net retail
Gr. retail
Company
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X
Czechia (10)Product
Pack
Market
Pres.
Dosage
ATC
Company
56 jednodoznih spremnika sa 4 ml otopina
Y
Rx
-
J01GB01
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
56 jednodoznih spremnika sa 4 ml otopina
HR-H-873495110-01
21-10-2019
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X
Denmark (16)Product
Pack
Market
Pres.
Dosage
ATC
Company
300MG/4ML 16X4ML
300MG/4ML 28X4ML
300MG/4ML 4X4ML
300MG/4ML 56X4ML
300MG/4ML 28X4ML
300MG/4ML 4X4ML
300MG/4ML 56X4ML
N
N
N
Y
N
N
Y
inh
J01GB01
300MG/5ML 112X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
N
N
N
N
N
inh
J01GB01
300MG/5ML 112X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
N
N
Y
N
Y
inh
J01GB01
28MG 224(4X56)+5INH
28MG 448(8X56)+10INH
28MG 56+1INH
28MG 448(8X56)+10INH
28MG 56+1INH
Y
N
N
N
N
inh
J01GB01
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
300MG/4ML 16X4ML
300MG/4ML 28X4ML
300MG/4ML 4X4ML
300MG/4ML 56X4ML
300MG/4ML 28X4ML
300MG/4ML 4X4ML
300MG/4ML 56X4ML
15/ 214/07-C
15/ 214/07-C
15/ 214/07-C
15/ 214/07-C
15/ 214/07-C
15/ 214/07-C
15/ 214/07-C
MRP/DCP
MRP/DCP
MRP/DCP
MRP/DCP
MRP/DCP
MRP/DCP
MRP/DCP
300MG/5ML 112X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
15/ 312/03-C
15/ 312/03-C
15/ 312/03-C
15/ 312/03-C
15/ 312/03-C
NP
NP
NP
NP
NP
300MG/5ML 112X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
15/ 312/03-C
15/ 312/03-C
15/ 312/03-C
15/ 312/03-C
15/ 312/03-C
NP
NP
NP
NP
NP
28MG 224(4X56)+5INH
28MG 448(8X56)+10INH
28MG 56+1INH
28MG 448(8X56)+10INH
28MG 56+1INH
EU/1/10/652/002
EU/1/10/652/003
EU/1/10/652/001
EU/1/10/652/003
EU/1/10/652/001
ORP
ORP
ORP
ORP
ORP
Product
Pack
Ex-fact
Wholesale
Net retail
Gr. retail
Company
300MG/4ML 16X4ML
300MG/4ML 28X4ML
300MG/4ML 4X4ML
300MG/4ML 56X4ML
300MG/4ML 28X4ML
300MG/4ML 4X4ML
300MG/4ML 56X4ML
0
0
0
37901,8
0
0
37901,8
43469,62
300MG/5ML 112X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
0
0
38370,51
0
38370,51
43995,51
300MG/5ML 112X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
300MG/5ML 168X5ML
300MG/5ML 56X5ML
0
0
38370,51
0
38370,51
43995,51
28MG 224(4X56)+5INH
28MG 448(8X56)+10INH
28MG 56+1INH
28MG 448(8X56)+10INH
28MG 56+1INH
52235,29
0
0
0
0
59551,8
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X
Hungary (9)Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
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X
Iceland (2)Product
Pack
Market
Pres.
Dosage
ATC
Company
16x single-dose container
28x single-dose container
4x single-dose container
56x single-dose container
28x single-dose container
4x single-dose container
56x single-dose container
N
N
N
Y
N
N
Y
Rx
Rx
Rx
Rx
Rx
Rx
Rx
inh
J01GB01
4x56 blister +5 db. inhalátor
56x blister +1 db. inhalátor
8x56 blister +10 db. inhalátor
56x blister +1 db. inhalátor
8x56 blister +10 db. inhalátor
N
N
N
N
N
Rx
Rx
Rx
Rx
Rx
inh
J01GB01
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
16x single-dose container
28x single-dose container
4x single-dose container
56x single-dose container
28x single-dose container
4x single-dose container
56x single-dose container
OGYI-T-20324/01
OGYI-T-20324/02
OGYI-T-20324/04
OGYI-T-20324/03
OGYI-T-20324/02
OGYI-T-20324/04
OGYI-T-20324/03
29-03-2007
29-03-2007
29-03-2007
29-03-2007
29-03-2007
29-03-2007
29-03-2007
10x1ml amp
10x2ml amp
10x2ml amp
OGYI-T-03682/02
OGYI-T-03682/03
OGYI-T-03682/03
01-01-1980
01-01-1980
01-01-1980
112x5ml amp
168x5ml amp
56x5ml amp
168x5ml amp
56x5ml amp
OGYI-T-08707/02
OGYI-T-08707/03
OGYI-T-08707/01
OGYI-T-08707/03
OGYI-T-08707/01
16-12-2002
16-12-2002
16-12-2002
16-12-2002
16-12-2002
4x56 blister +5 db. inhalátor
56x blister +1 db. inhalátor
8x56 blister +10 db. inhalátor
56x blister +1 db. inhalátor
8x56 blister +10 db. inhalátor
EU/1/10/652/002
EU/1/10/652/001
EU/1/10/652/003
EU/1/10/652/001
EU/1/10/652/003
20-07-2011
20-07-2011
20-07-2011
20-07-2011
20-07-2011
56x amp +1 kézi porlasztós inhalátor
EU/1/18/1350/001
18-02-2019
Product
Pack
Ex-fact
Wholesale
Net retail
Gr. retail
Company
16x single-dose container
28x single-dose container
4x single-dose container
56x single-dose container
28x single-dose container
4x single-dose container
56x single-dose container
0
0
0
468000
0
0
468000
0
0
0
488592
0
0
488592
0
0
0
489582
0
0
489582
0
0
0
514061
0
0
514061
112x5ml amp
168x5ml amp
56x5ml amp
168x5ml amp
56x5ml amp
0
0
468000
0
468000
0
0
488592
0
488592
0
0
489582
0
489582
0
0
514061
0
514061
4x56 blister +5 db. inhalátor
56x blister +1 db. inhalátor
8x56 blister +10 db. inhalátor
56x blister +1 db. inhalátor
8x56 blister +10 db. inhalátor
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
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X
Ireland (6)Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
Product
Pack
Ex-fact
Wholesale
Net retail
Gr. retail
Company
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X
Lithuania (18)Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
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X
Malta (12)Product
Pack
Market
Pres.
Dosage
ATC
Company
4 ml N16 single dose container
4 ml N28 single dose container
4 ml N4 single dose container
4 ml N56 single dose container
4 ml N28 single dose container
4 ml N4 single dose container
4 ml N56 single dose container
Rx
Rx
Rx
Rx
Rx
Rx
Rx
inh
J01GB01
N224 (4 x 56) ir 5 inhaliatoriai (mėnesi
N448 (8 x 56) ir 10 inhaliatorių (2 mėne
N56+1 inh blister
N448 (8 x 56) ir 10 inhaliatorių (2 mėne
N56+1 inh blister
Rx
Rx
Rx
Rx
Rx
inh
J01GB01
5 ml N1 container su dropper
5 ml su dropper N1 bottle
container 5 ml su dropper N1 container
5 ml su dropper N1 bottle
container 5 ml su dropper N1 container
Rx
Rx
Rx
Rx
Rx
ocular
S01AA12
N56 ir vartojimo įtaisas amp
Rx
inh
J01GB01
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
4 ml N16 single dose container
4 ml N28 single dose container
4 ml N4 single dose container
4 ml N56 single dose container
4 ml N28 single dose container
4 ml N4 single dose container
4 ml N56 single dose container
LT/1/11/2643/001
LT/1/11/2643/002
LT/1/11/2643/004
LT/1/11/2643/003
LT/1/11/2643/002
LT/1/11/2643/004
LT/1/11/2643/003
NP
NP
NP
NP
NP
NP
NP
20-10-2011
20-10-2011
20-10-2011
20-10-2011
20-10-2011
20-10-2011
20-10-2011
N224 (4 x 56) ir 5 inhaliatoriai (mėnesi
N448 (8 x 56) ir 10 inhaliatorių (2 mėne
N56+1 inh blister
N448 (8 x 56) ir 10 inhaliatorių (2 mėne
N56+1 inh blister
EU/1/10/652/002
EU/1/10/652/003
EU/1/10/652/001
EU/1/10/652/003
EU/1/10/652/001
CP
CP
CP
CP
CP
20-07-2011
20-07-2011
20-07-2011
20-07-2011
20-07-2011
5 ml N1 container su dropper
LT/L/20/1238/001
PI
27-03-2020
5 ml N56 amp
LT/1/16/3931/001
DCP
17-06-2016
3,5 g N1 tube
3,5 g N1 tube
3,5 g N1 tube
LT/L/19/0826/001
LT/L/15/0263/001
LT/L/15/0263/001
PI
PI
PI
06-02-2019
17-04-2015
17-04-2015
5 ml N1 container su dropper
5 ml su dropper N1 bottle
container 5 ml su dropper N1 container
5 ml su dropper N1 bottle
container 5 ml su dropper N1 container
LT/L/14/0233/001
LT/L/12/0091/001
LT/L/19/1095/001
LT/L/12/0091/001
LT/L/19/1095/001
PI
PI
PI
PI
PI
03-11-2014
15-05-2012
25-10-2019
15-05-2012
25-10-2019
5 ml N1 container su dropper
LT/L/16/0377/001
PI
25-05-2016
5 ml su dropper N1 container
LT/1/08/0966/001
NP
17-01-2008
N56 ir vartojimo įtaisas amp
EU/1/18/1350/001
CP
18-02-2019
1,7 ml N56 ir vartojimo įtaisas amp
EU/1/14/932/001
CP
18-03-2015
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X
Poland (28)Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
AA565/61802
30-03-2020
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X
Romania (9)Product
Pack
Market
Pres.
Dosage
ATC
Company
16 poj. jednodawkowych 4 ml
28 poj. jednodawkowych 4 ml
56 poj. jednodawkowych 4 ml
28 poj. jednodawkowych 4 ml
56 poj. jednodawkowych 4 ml
Rp
Rp
Rp
Rp
Rp
-
J01GB01
224 caps + 5 inhów
448 caps + 10 inhów
56 caps + 1 inh
448 caps + 10 inhów
56 caps + 1 inh
-
J01GB01
10 butelek 120 ml
10 butelek 80 ml
20 butelek 120 ml
20 butelek 80 ml
10 butelek 80 ml
20 butelek 120 ml
20 butelek 80 ml
Rp
Rp
Rp
Rp
Rp
Rp
Rp
-
J01GB01
112 amp 5 ml
168 amp 5 ml
56 amp 5 ml
168 amp 5 ml
56 amp 5 ml
Rp
Rp
Rp
Rp
Rp
-
J01GB01
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
Rp
Rp
Rp
Rp
Rp
Rp
Rp
-
S01AA12
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
Rp
Rp
Rp
Rp
Rp
Rp
Rp
-
S01AA12
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
16 poj. jednodawkowych 4 ml
28 poj. jednodawkowych 4 ml
56 poj. jednodawkowych 4 ml
28 poj. jednodawkowych 4 ml
56 poj. jednodawkowych 4 ml
12796
12796
12796
12796
12796
MRP
MRP
MRP
MRP
MRP
224 caps + 5 inhów
448 caps + 10 inhów
56 caps + 1 inh
448 caps + 10 inhów
56 caps + 1 inh
CP
CP
CP
CP
CP
10 butelek 120 ml
10 butelek 80 ml
20 butelek 120 ml
20 butelek 80 ml
10 butelek 80 ml
20 butelek 120 ml
20 butelek 80 ml
17627
17627
17627
17627
17627
17627
17627
DCP
DCP
DCP
DCP
DCP
DCP
DCP
112 amp 5 ml
168 amp 5 ml
56 amp 5 ml
168 amp 5 ml
56 amp 5 ml
23837
23837
23837
23837
23837
DCP
DCP
DCP
DCP
DCP
23-03-2022
23-03-2022
23-03-2022
23-03-2022
23-03-2022
1 tube 3,5 g
1 tube 3,5 g
1 tube 3,5 g
1 tube 3,5 g
1 tube 3,5 g
359/17
41/16
138/09
41/16
138/09
PI
PI
PI
PI
PI
31-10-2022
28-01-2021
06-08-2024
28-01-2021
06-08-2024
1 tube 3,5 g
1 tube 3,5 g
1 tube 3,5 g
1 tube 3,5 g
1 tube 3,5 g
107/08
787/15
135/14
787/15
135/14
PI
PI
PI
PI
PI
26-11-2023
22-11-2020
14-03-2024
22-11-2020
14-03-2024
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
65/06
30/16
808/15
261/15
30/16
808/15
261/15
PI
PI
PI
PI
PI
PI
PI
05-11-2021
19-01-2021
10-12-2020
24-05-2020
19-01-2021
10-12-2020
24-05-2020
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
464/13
38/17
263/15
38/17
263/15
PI
PI
PI
PI
PI
28-10-2018
09-02-2022
24-05-2020
09-02-2022
24-05-2020
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
98/14
163/12
92/07
116/14
163/12
92/07
116/14
PI
PI
PI
PI
PI
PI
PI
05-03-2019
28-03-2022
02-01-2018
31-03-2024
28-03-2022
02-01-2018
31-03-2024
1 bottle 5 ml
1 bottle 5 ml
1 bottle 5 ml
324/14
492/13
492/13
PI
PI
PI
05-10-2019
22-11-2023
22-11-2023
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X
Slovenia (24)Product
Pack
Market
Pres.
Dosage
ATC
Company
12 plicuri din Al; fiecare plic contine
4 plicuri din Al; fiecare plic contine 7
8 plicuri din Al; fiecare plic contine 7
4 plicuri din Al; fiecare plic contine 7
8 plicuri din Al; fiecare plic contine 7
-
-
-
-
-
PRF
PRF
PRF
PRF
PRF
-
J01GB01
112 fiole ambalate in pungi de folie lam
168 fiole ambalate in pungi de folie lam
56 fiole ambalate in pungi de folie lami
168 fiole ambalate in pungi de folie lam
56 fiole ambalate in pungi de folie lami
-
-
-
-
-
PRF
PRF
PRF
PRF
PRF
-
J01GB01
56 de fiole de unica folosinta din PJD a
-
PRF
-
J01GB01
1 flac. din PEJD, prevazut cu picurator
-
PRF
-
S01AA12
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
12 plicuri din Al; fiecare plic contine
4 plicuri din Al; fiecare plic contine 7
8 plicuri din Al; fiecare plic contine 7
4 plicuri din Al; fiecare plic contine 7
8 plicuri din Al; fiecare plic contine 7
-
-
-
-
-
112 fiole ambalate in pungi de folie lam
168 fiole ambalate in pungi de folie lam
56 fiole ambalate in pungi de folie lami
168 fiole ambalate in pungi de folie lam
56 fiole ambalate in pungi de folie lami
-
-
-
-
-
56 de fiole de unica folosinta din PJD a
-
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X
Spain (21)Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
56 vsebniki 4 ml inhalacijske sol
842-164/2019
-
09-04-2019
09-04-2020
56 enoodmernimi vsebniki 4 ml sol
842-10/2019
-
24-01-2019
24-01-2020
10 amp 2 ML RAZTOPINE ZA INJICIRANJE
4261-462/2012
-
27-08-2012
27-08-2013
4 škatle 56 kapsul, 5 inhalatorjev
EU/1/10/652/002
CP
23-04-2012
1 amp 2 ml sol
842-424/2019
-
05-11-2019
05-11-2020
5 vial 2 ml sol
4261-416/2012
-
03-08-2012
03-08-2013
plastenko 5 ml sol
5363-U-I-1555/08
NP
12-06-2012
01-07-2012
01-07-2012
Product
Pack
Ex-fact
Wholesale
Net retail
Gr. retail
Company
60 vial 2 ml sol
2 ml sol (zloženka stekleničko 2 ml sol
stekleničko 2 ml sol (80mg/2ml)
1 vial 2 ml sol
1ml sol (zloženka stekleničko 1 ml sol (
kapalna steklenička 10 ml sol
ampula 1 x 80 mg/2ml
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.
X
Sweden (10)Product
Pack
Market
Pres.
Dosage
ATC
Company
1 vial of 2 ml
100 vials of 2 ml
100 vials of 2 ml
-
-
-
Rx
Rx
Rx
iv/im
J01GB01
1 vial of 2 ml
100 vials of 2 ml
100 vials of 2 ml
Y
Y
Y
Rx
Rx
Rx
VÍA INTRAVENOSA, VÍA INTRAMUSCULAR
J01GB01
1 bottle of 100 ml
50 bolsas of 100 ml
50 frascos of 100 ml
50 bolsas of 100 ml
50 frascos of 100 ml
-
-
-
-
-
Rx
Rx
Rx
Rx
Rx
iv
J01GB01
1 vial of 2 ml
100 vials of 2 ml
100 vials of 2 ml
Y
Y
Y
Rx
Rx
Rx
iv/im
J01GB01
1 tube of 3,5 g
Y
Rx
ocular
S01AA12
20 envases unidosis of 0,25 ml
Y
Rx
ocular
S01AA12
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
1 vial of 2 ml
100 vials of 2 ml
100 vials of 2 ml
54935
54935
54935
01-06-1981
01-06-1981
01-06-1981
1 vial of 2 ml
100 vials of 2 ml
100 vials of 2 ml
65261
65261
65261
24-03-2003
24-03-2003
24-03-2003
1 bottle of 100 ml
50 bolsas of 100 ml
50 frascos of 100 ml
50 bolsas of 100 ml
50 frascos of 100 ml
62009
62009
62009
62009
62009
01-05-1998
01-05-1998
01-05-1998
01-05-1998
01-05-1998
1 vial of 2 ml
100 vials of 2 ml
100 vials of 2 ml
65262
65262
65262
27-02-2003
27-02-2003
27-02-2003
1 tube of 3,5 g
57593
01-04-1988
20 envases unidosis of 0,25 ml
77752
16-07-2013
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.
X
Switzerland (9)Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
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.
X
Product
Pack
Market
Pres.
Dosage
ATC
Company
Product
Pack
Reg. Nr.
Reg. Type
Reg. Date
Reg. Valid
Revocation
Company
58751 1
Hauptzulassung
28-05-2009
27-05-2024
60565 1
Hauptzulassung
01-02-2012
31-01-2022
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.
