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1. Forxiga 5 mg 2. 5 mg . : 25 mg . , 6.1. 3. (). , , 0,7 cm, "5" "1427" . 4. 4.1 Forxiga 18 2 : , . , , , ( 4.4, 4.5 5.1 ). 4.2 10 mg , , . , , , ( 4.5 4.8). , . Forxiga (
3
[CrCl] < 60 ml/min [eGFR] < 60 ml/min/1,73 m2, 4.4, 4.8, 5.1 5.2). . . , 5 mg. , 10 mg ( 4.4 5.2). ( 65 ) , . ( 4.4 5.2). 75 , . 0 < 18 . . Forxiga . . 4.3 6.1. 4.4 Forxiga 1 . , ( 4.2). ( CrCl < 60 ml/min eGFR < 60 ml/min/1,73 m2), , , , (PTH) , . Forxiga ( CrCl < 60 ml/min eGFR < 60 ml/min/1,73 m2). Forxiga (CrCl < 30 ml/min eGFR < 30 ml/min/1,73 m2) (ESRD). :
( 4.2, 4.8, 5.1 5.2)
, 2 4 . CrCl < 60 ml/min eGFR < 60 ml/min/1,73 m2, .
4
. ( 4.2 5.2). , / , , ( 5.1), . ( 4.5) , .. ( ) , , . , , , (.. , , ) . ( 4.8). 24 10 mg ( 4.8). . . . / , , (AMEA-) 1 (ARB). ( 4.2, 4.4, 4.8 5.1). 65 , , , . , ( 4.8). . 65 , , , ( 4.8).
5
75 . ( 4.2 5.2). - -V . ( 4.8 5.3), , , . , . ( 4.8), . 4 (DPP-4) 1 (GLP-1). , Forxiga . . , Lapp - . 4.5 ( 4.4). , , . , , , ( 4.2 4.8). -5-- 19 (UGT1A9). in vitro , P450 (CYP1) 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP1A2, CYP2B6 CYP3A4. , , .
6
, , , , , , , , , , . ( ), 22% (AUC), 24. . (.. , , ). ( UGT1A9), 55% , 24. . , , , , , , , , , ( P-gp) (S-, CYP2C9), , (INR). 20 mg ( CYP3A4) AUC 19% AUC 31%. . , , . . 4.6 , . ( 5.3). , . , . / . / / , ( 5.3). /. . . , .
7
4.7 Forxiga . , . 4.8 12 , 1.193 10 mg 1.393 . ( ) 10 mg . . 10 mg (0,4%), (0,3%), (0,2%), (0,2%) (0,2%). / . , , . , , (SU) . ( ). . . (). : ( 1/10), ( 1/100 < 1/10), ( 1/1000 < 1/100), ( 1/10.000 < 1/1000), (< 1/10.000), ( ). 1.
*
**
, ,
*
( SU )
, *
*
*
8
*
* *
24- ( ) . . , .., : , , , , , , , , , , , , . : , , . , .., : , , . 10 mg , , : 1,4% -0,4%, HDL 5,5% 3,8%, LDL 2,7% -1,9%, -5,4% -0,7%. 2,15% 10 mg -0,40% . * 2% 10 mg 1% . ** 0,2% 0,1% 3 , 10 mg , . . (< 4%) , . , . ( 4.5). , , 10 mg (6,0%), (2,1%). , , 10 mg (40,3%), (34,0%). (, , ) 0,8% 0,4% ,
9
10 mg , < 0,2% , ( 4.4). , , 4,8% 0,9% , 10 mg , . , . (9,7% 3,4% , ) . 10 mg (4,3% 3,7%, , 4.4). , . . (PTH) PTH , . . , (1,47%) / (1,35%) (. 5.3). , 1 ( , , ) 1 (.. , , ), . / . , . , , . ( 65 ) 65 , 2,5% 1,1% ( 4.4). , , . . 65 , , , 1,5% 0,4% , ( 4.4). 4.9
10
500 mg (50 ). ( 5 500 mg), , QTc. . 100 mg (10 ) 2 2, . , , , , . , , . . 5. 5.1 : , , , ATC: A10BX09 (Ki: 0.55 nM), 2 (SGLT2). SGLT2 , 70 , , , , . SGLT2 , . 2, . , , . ( ) , 24 ' . , , . . . - (HOMA beta-cell) Forxiga. () . . > 1.400 SGLT2 SGLT1, .
11
2 . 70 g ( 280 kcal/) 10 mg/ 2 12 . 2, 10 mg/ 2 . 2. 2, 10 mg, 12 375 ml/. , . ( 3-7 ) . 24 , -48,3 18,3 micromoles/l (-0,87 -0,33 mg/dl). -, , 5.693 2 Forxiga. 3.939 . 24 , 5 24 78 ( 102 ), 52 . 1,4 16,9 . 51% 12% . 51% , 84% , 10% , 3% 3% . 80% (BMI) 27. -, 24- ( ) Forxiga 2. (p < 0,0001) (HbA1c) ( 2). , HbA1c 102 (-0,63%, -0,18% 10 mg , ).
12
2. 24 (LOCF)
10 mg
N 70 75 HbA1c (%) ( )
(95% )
8,01
-0,89 -0,66*
(-0,96, -0,36)
7,79 -0,23
(%) : HbA1c < 7%
50,8
31,6 (kg)
( )
(95% )
94,13 -3,16 -0,97
(-2,20, 0,25)
88,77 -2,19
LOCF: ( ) - - *p- < 0,0001 52-, Forxiga () (HbA1c > 6,5% 10%). HbA1c 52, , ( 3). (3,5%) 52 (40,8%).
13
3. 52 (LOCF)
+
+ N 400 401
HbA1c (%) ( ) + (95% )
7,69 -0,52
0,00
(-0,11, 0,11)
7,74 -0,52
(kg) ( ) + (95% )
88,44 -3,22
-4,65*
(-5,14, -4,17)
87,60 1,44
LOCF: + *p- < 0,0001 , HbA1c 24 (p < 0,0001, 4 5). , , HbA1c, 24, ( ) 48-. , , HbA1c 102 (-0,78% 0,02% 10 mg , ). 4. 24- (LOCF)
1
(2)
10 mg
10 mg
N 135 137 151 145 HbA1c (%)
( ) (95% CI)
7,92
-0,84
-0,54* (-0,74, -0,34)
8,11
-0,30
8,07
-0,82
-0,68* (-0,86, -0,51)
8,15
-0,13
14
1
(2)
10 mg
10 mg
(%) : HbA1c < 7%
40,6**
25,9
31,7*
13,0
(kg) ( ) (95% )
86,28
-2,86
-1,97* (-2,63, -1,31)
87,74
-0,89
80,56
-2,26
-1,54* (-2,17, -0,92)
80,94
-0,72
1 1500 mg/ 2 4 mg/ LOCF: ( ) - - *p- < 0,0001 + **p- < 0,05 +
15
5. 24 (LOCF) ( )
10 mg +
2
+
2 N 194 193 HbA1c (%)
( ) (95% )
8,58
-0,90
-0,60*
(-0,74, -0,45)
8,46
-0,30
(kg) ( ) (95% )
94,63
-1,67
-1,68*
(-2,19, -1,18)
94,21
0,02
(IU)1 ( ) (95% ) 10% (%)
77,96
-1,16
-6,23* (-8,84, -3,63)
19,6**
73,96
5,08
11,0 LOCF: ( , ) - - *p- < 0,0001 + **p- < 0,05 + 1 ( , , ) (FPG). 2 50% , 50% 1 2 () () () () : , 80% , 12% + , . 10 mg , (-1,64 -1,20 mmol/l [-29,6 -21,7 mg/dl]) (-0,33
16
0,18 mmol/l [-6,0 3,3 mg/dl]). 1 , 102. 10 mg 2- 24 , 48. 10 mg , 24 . , , 52 (-4,65 kg ) 102 (-3,07 kg ). 24 182 (DXA), , 10 mg , , DXA . Forxiga . 12 , 10 mg -4,4 mmHg -2,1 mmHg -0,9 mmHg -0,5 mmHg 24. , - . , 36,6% ( ) 70,0% . . : , , () . 1,64% 1,99% . 0,82 (95% [CI]: 0,58, 1,15), Forxiga 2. , 0,79 (95% CI: 0,54, 1,17). (eGFR 30 < 60 ml/min/1,73 m2) (252 eGFR 44 ml/min/1,73 m2). HbA1c 24 -0,44% -0,32%, 10 mg , . HbA1c 9% HbA1c 9.0%, 10 mg HbA1c 24 ( : -2,04% 0,19%
17
10 mg , ) ( : -1,32% 0,53% , ) 2 ( 4.2 ). 5.2 . (Cmax) 2 . Cmax AUC 10 mg 158 ng/ml 628 ng h/ml, . 10 mg 78%. Cmax 50% Tmax 1 , AUC . . , Forxiga . 91% . (.. ). 118 l. 3-O- , . 3-O- . 3-O- UGT1A9, , CYP . (t1/2) 12,9 10 mg . 207 ml/min. , 2% . 50 mg [14C]-, 96%, 75% 21% . , 15% . 0,1 500 mg 24 . (20 mg 7 ), 2 , ( ) 32%, 60% 87% , , 2 . 24
18
85, 52, 18 11 g / 2 , , . . ( Child-Pugh), Cmax AUC 12% 36% , , . . ( C Child-Pugh) Cmax AUC 40% 67% , . ( 65 ) 70 . , . > 70 . . AUCss 22% . , . . , . , . 5.3 , , , . , , , . ( ) / . , 21 90, . 15 . ,
19
. , , . -- , 6 21 , in utero ' . ( ). , ( 1.415 137 , , ). 15 mg/kg/ ( 29 ). , . (NOAEL) , , 19 . - , . . 1.191 . , 1441 . 6. 6.1 (E460i) (E1201) (E551) (E470b) (E1203) (E171) Macrogol 3350 (E553b) (E172) 6.2 . 6.3 3
20
6.4 . 6.5 Alu/Alu. 14, 28 98 30x1 90x1 . . 6.6 . 7. Bristol-Myers Squibb/AstraZeneca EEIG Bristol-Myers Squibb House Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH 8. () 9. / 10. Y : http://www.ema.europa.eu
http://www.ema.europa.eu/
21
1. Forxiga 10 mg 2. 10 mg . : 50 mg . , 6.1. 3. (). , , 1,1 cm x 0,8 cm, "10" "1428" . 4. 4.1 Forxiga 18 2 : , . , , , ( 4.4, 4.5 5.1 ). 4.2 10 mg , , . , , , ( 4.5 4.8). , . Forxiga
22
( [CrCl] < 60 ml/min [eGFR] < 60 ml/min/1,73 m2, 4.4, 4.8, 5.1 5.2). . . , 5 mg. , 10 mg ( 4.4 5.2). ( 65 ) , . ( 4.4 5.2). 75 , . 0 < 18 . . Forxiga . . 4.3 6.1. 4.4 Forxiga 1 . , ( 4.2). ( CrCl < 60 ml/min eGFR < 60 ml/min/1,73 m2), , , , (PTH) , . Forxiga ( CrCl < 60 ml/min eGFR < 60 ml/min/1,73 m2). Forxiga (CrCl < 30 ml/min eGFR < 30 ml/min/1,73 m2) (ESRD). :
( 4.2, 4.8, 5.1 5.2)
, 2 4 .
23
CrCl < 60 ml/min eGFR < 60 ml/min/1,73 m2, .
. ( 4.2 5.2). , / , , ( 5.1), . ( 4.5) , .. ( ) , , . , , , (.. , , ) . ( 4.8). 24 10 mg ( 4.8). . . . / , , (AMEA-) 1 (ARB). ( 4.2, 4.4, 4.8 5.1). 65 , , , . , ( 4.8). . 65 , , , ( 4.8).
24
75 . ( 4.2 5.2). - -V . ( 4.8 5.3), , , . , . ( 4.8), . 4 (DPP-4) 1 (GLP-1). , Forxiga . . , Lapp - . 4.5 ( 4.4). , , . , , , ( 4.2 4.8). -5-- 19 (UGT1A9). in vitro , P450 (CYP1) 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP1A2, CYP2B6 CYP3A4. , , .
25
, , , , , , , , , , . ( ), 22% (AUC), 24. . (.. , , ). ( UGT1A9), 55% , 24. . , , , , , , , , , ( P-gp) (S-, CYP2C9), , (INR). 20 mg ( CYP3A4) AUC 19% AUC 31%. . , , . . 4.6 , . ( 5.3). , . , . / . / / , ( 5.3). /. . . , .
26
4.7 Forxiga . , . 4.8 12 , 1.193 10 mg 1.393 . ( ) 10 mg . . 10 mg (0,4%), (0,3%), (0,2%), (0,2%) (0,2%). / . , , . , , (SU) . ( ). . . (). : ( 1/10), ( 1/100 < 1/10), ( 1/1000 < 1/100), ( 1/10.000 < 1/1000), (< 1/10.000), ( ). 1.
*
**
, ,
*
( SU )
, *
*
*
27
*
* *
24- ( ) . . , .., : , , , , , , , , , , , , . : , , . , .., : , , . 10 mg , , : 1,4% -0,4%, HDL 5,5% 3,8%, LDL 2,7% -1,9%, -5,4% -0,7%. 2,15% 10 mg -0,40% . * 2% 10 mg 1% . ** 0,2% 0,1% 3 , 10 mg , . . (< 4%) , . , . ( 4.5). , , 10 mg (6,0%), (2,1%). , , 10 mg (40,3%), (34,0%). (, , ) 0,8% 0,4% ,
28
10 mg , < 0,2% , ( 4.4). , , 4,8% 0,9% , 10 mg , . , . (9,7% 3,4% , ) . 10 mg (4,3% 3,7%, , 4.4). , . . (PTH) PTH , . . , (1,47%) / (1,35%) (. 5.3). , 1 ( , , ) 1 (.. , , ), . / . , . , , . ( 65 ) 65 , 2,5% 1,1% ( 4.4). , , . . 65 , , , 1,5% 0,4% , ( 4.4). 4.9
29
500 mg (50 ). ( 5 500 mg), , QTc. . 100 mg (10 ) 2 2, . , , , , . , , . . 5. 5.1 : , , , ATC: A10BX09 (Ki: 0.55 nM), 2 (SGLT2). SGLT2 , 70 , , , , . SGLT2 , . 2, . , , . ( ) , 24 ' . , , . . . - (HOMA beta-cell) Forxiga. () . . > 1.400 SGLT2 SGLT1, .
30
2 . 70 g ( 280 kcal/) 10 mg/ 2 12 . 2, 10 mg/ 2 . 2. 2, 10 mg, 12 375 ml/. , . ( 3-7 ) . 24 , -48,3 -18,3 micromoles/l (-0,87 -0,33 mg/dl). -, , 5.693 2 Forxiga. 3.939 . 24 , 5 24 78 ( 102 ), 52 . 1,4 16,9 . 51% 12% . 51% , 84% , 10% , 3% 3% . 80% (BMI) 27. -, 24- ( ) Forxiga 2. (p < 0,0001) (HbA1c) ( 2). , HbA1c 102 (-0,63%, -0,18% 10 mg , ).
31
2. 24 (LOCF)
10 mg
N 70 75 HbA1c (%) ( )
(95% )
8,01
-0,89 -0,66*
(-0,96, -0,36)
7,79 -0,23
(%) : HbA1c < 7%
50,8
31,6 (kg)
( )
(95% )
94,13 -3,16 -0,97
(-2,20, 0,25)
88,77 -2,19
LOCF: ( ) - - *p- < 0,0001 52-, Forxiga () (HbA1c > 6,5% 10%). HbA1c 52, , ( 3). (3,5%) 52 (40,8%).
32
3. 52 (LOCF)
+
+ N 400 401
HbA1c (%) ( ) + (95% )
7,69 -0,52
0,00
(-0,11, 0,11)
7,74 -0,52
(kg) ( ) + (95% )
88,44 -3,22
-4,65*
(-5,14, -4,17)
87,60 1,44
LOCF: + *p- < 0,0001 , HbA1c 24 (p < 0,0001, 4 5). , , HbA1c, 24, ( ) 48-. , , HbA1c 102 (-0,78% 0,02% 10 mg , ). 4. 24- (LOCF)
1
(2)
10 mg
10 mg
N 135 137 151 145 HbA1c (%)
( ) (95% CI)
7,92
-0,84
-0,54* (-0,74, -0,34)
8,11
-0,30
8,07
-0,82
-0,68* (-0,86, -0,51)
8,15
-0,13
33
1
(2)
10 mg
10 mg
(%) : HbA1c < 7%
40,6**
25,9
31,7*
13,0
(kg) ( ) (95% )
86,28
-2,86
-1,97* (-2,63, -1,31)
87,74
-0,89
80,56
-2,26
-1,54* (-2,17, -0,92)
80,94
-0,72
1 1500 mg/ 2 4 mg/ LOCF: ( ) - - *p- < 0,0001 + **p- < 0,05 +
34
5. 24 (LOCF) ( )
10 mg +
2
+
2 N 194 193 HbA1c (%)
( ) (95% )
8,58
-0,90
-0,60*
(-0,74, -0,45)
8,46
-0,30
(kg) ( ) (95% )
94,63
-1,67
-1,68*
(-2,19, -1,18)
94,21
0,02
(IU)1 ( ) (95% ) 10% (%)
77,96
-1,16
-6,23* (-8,84, -3,63)
19,6**
73,96
5,08
11,0 LOCF: ( , ) - - *p- < 0,0001 + **p- < 0,05 + 1 ( , , ) (FPG). 2 50% , 50% 1 2 () () () () : , 80% , 12% + , . 10 mg , (-1,64 -1,20 mmol/l [-29,6 -21,7 mg/dl])
35
(-0,33 0,18 mmol/l [-6,0 3,3 mg/dl]). 1 , 102. 10 mg 2- 24 , 48. 10 mg , 24 . , , 52 (-4,65 kg ) 102 (-3,07 kg ). 24 182 (DXA), , 10 mg , , DXA . Forxiga . 12 , 10 mg -4,4 mmHg -2,1 mmHg -0,9 mmHg -0,5 mmHg 24. , - . , 36,6% ( ) 70,0% . . : , , () . 1,64% 1,99% . 0,82 (95% [CI]: 0,58, 1,15), Forxiga 2. , 0,79 (95% CI: 0,54, 1,17). (eGFR 30 < 60 ml/min/1,73 m2) (252 eGFR 44 ml/min/1,73 m2). HbA1c 24 -0,44% -0,32%, 10 mg , . HbA1c 9% HbA1c 9.0%, 10 mg HbA1c 24 ( : -2,04% 0,19%
36
10 mg , ) ( : -1,32% 0,53% , ) 2 ( 4.2 ). 5.2 . (Cmax) 2 . Cmax AUC 10 mg 158 ng/ml 628 ng h/ml, . 10 mg 78%. Cmax 50% Tmax 1 , AUC . . , Forxiga . 91% . (.. ). 118 l. 3-O- , . 3-O- . 3-O- UGT1A9, , CYP . (t1/2) 12,9 10 mg . 207 ml/min. , 2% . 50 mg [14C]-, 96%, 75% 21% . , 15% . 0,1 500 mg 24 . (20 mg 7 ), 2 , ( ) 32%, 60% 87% , , 2 . 24
37
85, 52, 18 11 g / 2 , , . . ( Child-Pugh), Cmax AUC 12% 36% , , . . ( C Child-Pugh) Cmax AUC 40% 67% , . ( 65 ) 70 . , . > 70 . . AUCss 22% . , . . , . , . 5.3 , , , . , , , . ( ) / . , 21 90, . 15 . ,
38
. , , . -- , 6 21 , in utero ' . ( ). , ( 1.415 137 , , ). 15 mg/kg/ ( 29 ). , . (NOAEL) , , 19 . - , . . 1.191 . , 1441 . 6. 6.1 (E460i) (E1201) (E551) (E470b) (E1203) (E171) Macrogol 3350 (E553b) (E172) 6.2 . 6.3 3
39
6.4 . 6.5 Alu/Alu. 14, 28 98 30x1 90x1 . . 6.6 . 7. Bristol-Myers Squibb/AstraZeneca EEIG Bristol-Myers Squibb House Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH 8. () 9. / 10. Y : http://www.ema.europa.eu
http://www.ema.europa.eu/
40
.
.
.
41
. Bristol Myers Squibb S.r.l. Contrada Fontana del Ceraso IT-03012 Anagni (FR) . . .
1.8.1 . () 1.8.2 (CHMP). CHMP , (). , :
, ,
60 ( ),
.
.
42
H
43
A.
44
5 mg 1. Forxiga 5 mg 2. () () 5 mg 3. . . 4. 14 28 30x1 90x1 98 5. () . 6. , . 7. () () (), () 8.
45
9. 10. , 11. Bristol-Myers Squibb/AstraZeneca EEIG Bristol-Myers Squibb House Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH 12. () 13. 14. . 15. 16. BRAILLE Forxiga 5 mg
46
10 mg 1. Forxiga 10 mg 2. () () 10 mg 3. . . 4. 14 28 30x1 90x1 98 5. () . 6.
, . 7. () () (), () 8.
47
9. 10. , 11. Bristol-Myers Squibb/AstraZeneca EEIG Bristol-Myers Squibb House Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH 12. () 13. 14. . 15. 16. BRAILLE Forxiga 10 mg
48
BLISTER BLISTERS 5 mg 1. Forxiga 5 mg 2. Bristol-Myers Squibb/AstraZeneca EEIG 3. EXP 4. Lot 5.
49
BLISTER BLISTERS 10 mg 1. Forxiga 10 mg 2. Bristol-Myers Squibb/AstraZeneca EEIG 3. EXP 4. Lot 5.
50
BLISTER BLISTERS 5 mg 1. Forxiga 5 mg 2. Bristol-Myers Squibb/AstraZeneca EEIG 3. EXP 4. Lot 5.
51
BLISTER BLISTERS 10 mg 1. Forxiga 10 mg 2. Bristol-Myers Squibb/AstraZeneca EEIG 3. EXP 4. Lot 5.
52
B.
53
:
Forxiga 5 mg Forxiga 10 mg
. - . . - , , . - ' .
. , .
- , . .
: 1. Forxiga 2. Forxiga 3. Forxiga 4. 5. Forxiga 6. 1. Forxiga Forxiga . " ". . () . Forxiga " 2" ( 18 ). " 2" . 2, , . . Forxiga . Forxiga
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54
2. Forxiga Forxiga:
( 6). , Forxiga: " 1"
, . " " ,
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55
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. . . . . ,
. .
56
Forxiga . . . , , . , . , , Forxiga. Forxiga Forxiga , . . Forxiga . 12 ,
Forxiga . .
12 , . .
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57
: ( 1 10 ) ()
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. ,
"EXP" "". .
. .
. .
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58
() Forxiga 5 mg 5 mg () Forxiga 10 mg 10 mg : : (E460i), ( 2
" Forxiga "), (E1201), (E551), (E470b).
: (E1203), (E171), macrogol 3350, (E553b), (E172).
Forxiga Forxiga 5 mg
0,7 cm. "5" "1427".
Forxiga 10 mg 1,1 x 0,8 cm. "10" "1428".
Forxiga 5 mg Forxiga 10 mg 14, 28, 98 30x1 90x1 . . Bristol-Myers Squibb/AstraZeneca EEIG Bristol-Myers Squibb House Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH Bristol-Myers Squibb Company Contrada Fontina del Ceraso IT-03012 Anagni (FR)
59
, : Belgi/Belgique/Belgien Bristol-Myers Squibb Belgium S.A./N.V. Tl/Tel: + 32 2 352 76 11
Luxembourg/Luxemburg Bristol-Myers Squibb Belgium S.A./N.V. Tl/Tel: + 32 2 352 76 11
Bristol-Myers Squibb Gygyszerkereskedelmi Kft. Te.: + 359 800 12 400
Magyarorszg Bristol-Myers Squibb Gygyszerkereskedelmi Kft. Tel.: + 36 1 301 9700
esk republika Bristol-Myers Squibb spol. s r.o. Tel: + 420 221 016 111
Malta Bristol-Myers Squibb S.R.L. Tel: + 39 06 50 39 61
Danmark Bristol-Myers Squibb Tlf: + 45 45 93 05 06
Nederland Bristol-Myers Squibb BV Tel: + 31 34 857 42 22
Deutschland Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 49 89 121 42 0
Norge Bristol-Myers Squibb Norway LTD Tlf: + 47 67 55 53 50
Eesti Bristol-Myers Squibb Gygyszerkereskedelmi Kft. Tel: + 372 6827 400
sterreich Bristol-Myers Squibb GesmbH Tel: + 43 1 60 14 30
Bristol-Myers Squibb A.E. : + 30 210 6074300
Polska Bristol-Myers Squibb Polska Sp. z o.o. Tel.: + 48 22 5796666
Espaa Bristol-Myers Squibb, S.A. Tel: + 34 91 456 53 00
Portugal Bristol-Myers Squibb Farmacutica Portuguesa, S.A. Tel: + 351 21 440 70 00
France Bristol-Myers Squibb SARL Tl: + 33 (0)810 410 500
Romnia Bristol-Myers Squibb Gygyszerkereskedelmi Kft. Tel: + 40 (0)21 272 16 00
Ireland Bristol-Myers Squibb Pharmaceuticals Ltd Tel: + 353 (1 800) 749 749
Slovenija Bristol-Myers Squibb spol. s r.o. Tel: + 386 1 236 47 00
sland Vistor HF Smi: + 354 535 7000
Slovensk republika Bristol-Myers Squibb spol. s r.o. Tel: + 421 2 59298411
Italia Bristol-Myers Squibb S.R.L. Tel: + 39 06 50 39 61
Suomi/Finland OY Bristol-Myers Squibb (Finland) AB Puh/Tel: + 358 9 251 21 230
Bristol-Myers Squibb A.E.
Sverige Bristol-Myers Squibb AB
60
: + 357 800 92666
Tel: + 46 8 704 71 00
Latvija Bristol-Myers Squibb Gygyszerkereskedelmi Kft. Tel: + 371 6750 21 85
United Kingdom Bristol-Myers Squibb Pharmaceuticals Ltd Tel: + 44 (0800) 731 1736
Lietuva Bristol-Myers Squibb Gygyszerkereskedelmi Kft. Tel: + 370 5 2790 762
: http://www.ema.europa.eu --------------------------------------------------------------------------------------------------------------------------
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