Letter to Colombia Santos Imatinib License(1)

8/16/2019 Letter to Colombia Santos Imatinib License(1)

1/18

!"# %&'( )*%&

!+, -+./01.2'

!"#$ $"'( )#$*+) -+./01.2' 34 '(. 5.67890: 34 ;393,=, =.2"'. S02"2:. ;3


2/18

B(. JBUD/ H.:9"+"'032 32 '(. B5F-= QE+..,=,V;393


3/18

F//702E " :320P.+/0'#, Q7/'+"90"

#89 :2;?-+34.//3+ 34 G"K

h"9. G"K =:(339

>=Q

#7@-/A ). 415@827;372/.9I -390:# "21 G.E"9 Q44"0+/

i23K9.1E. A:393E# F2'.+2"'032"9

>=Q

)B/-?/ &117O"+P"+1 B,O, ;("2 =:(339 34 -7890:

O."9'( "21 i.22.1# =:(339 34 j3P,>=Q

C2--/7 :2;527D E3,D !,D &EF JOU ;399"83+"'02E ;.2'.+ 43+

-("+j938"9 Q::.// '3 !.10:02./ -+3E+"<

H0+.:'3+ -7890: ;0'0M.2

>=Q

E-1H. ,-. F. )/76 &,DE3,

H0+.:'3+ JOU >'+.:(' ;.2'.+ 34AL:.99.2:. 43+ Q443+1"89.?036("+'+.:(' >20P.+/0'#

E-1H/661- I-11> :. I2>/-R3+'(."/'.+2 >20P.+/0'# =:(339 34 G"K

-+3E+"< 32 O7!Rj ;393


4/18

,?;5. )1= F/@A?N ,?/>A?6=Q

J120P.+/01"1 1. ?7.23/ Q0+./

=37'( ;.2'+.

,-. F15N/- F/6G/-8/9/-=(.99 5."1.+ 02 F2'.+2"'032"9 H0/67'.

5./397'032I i02Em/ ;399.E. G32132

4/-8Q7 R/5Q6SB/= =6.:0"9 Q1P0/.+ 43+ O."9'( "21

H.P.93620P.+/0'# 34 iK"n797VR"'"9, =37'( Q4+0:"

E-1H. ,-2. E/-52 &1-@BU1V?20P.+/01"1

R":032"9 1. G" -9"'" Q+E.2'02"

!28/6 (1V/H0+.:'3+

i23K9.1E. A:393E# F2'.+2"'032"9

>=Q

)-?V?@392 J2N2V27 -+34.//3+ 34 G"K

B.L"/ Qk! =:((39 34 G"K

S3+' J3+'(I Bp

,-.R.P.R?V/>2727@27!020/'+# 34 O5H F- ;("0+ -+34.//3+RQG=Q5 >20P.+/0'# 34 G"KQ1c72:' g0/0'02E -+34.//3+I >20P.+/0'#

34 ?744"93 ?7/02.// =:(339I R.K h3+`

H0+.:'3+V F2/'0'7'. 34 j938"9 F2'.+2.'

j3P.+2"2:. k Q1P3:":# WjFjQXV

C?50/-G I277/70/-N !H "21 67890: (."9'( :32/79'"2',Q1P0/.+ 32 B5F-= "21 Q::.// '3

!.10:02./ '3 =QH; 20P.+/0'#I

J"/(02E'32I H;

P97G3?2 F1

G3#39" >20P.+/0'# 34 ;(0:"E3 =:(339 34G"K, >=Q

&2GG3/A I. M5977j.3+E0" =37'(.+2 >20P.+/0'#

,-. JBG3 (1;/-G &, &&/@)<M#MEF&Q1c72:' -+34.//3+ H.6"+'


5/18

&?20P.+/01"1 1. 93/ Q21./

?3E3'l ;39320P.+/01"1 -.+7"2" ;"#.'"23 O.+.10"

G020P.+/01"1 1. Q2'03_70"I ;393


6/18

J1L272 E2G-?


7/18

!16X 4?50/-G1 +-1=20P.+/0'# 34 =#12.#

!127 J1V?-2 M1-76-+34.//3+ A20P.+/0'"+0" 1.

;0.2:0"/ 1. 9" ="971 S>;=

E-1H. ]5V2-1 a/-@2 )2-8?/7G1D E3,S":79'"1 1. ;0.2:0"/ A:32q20P.+/01"1 R":032"9

1. ;393


8/18

,2V?@ E?7=17Q83E"13 ;39320P.+/0'# 34 j("2"

G.E32I Q::+"I j("2"

!B272 P282=Q

*2;?A27263/ :BU?7N2H0+.:'3+ -"2VQ4+0:"2 B+."'02- $1827=.203+ S.993K "21 Q1c72:' Q//3:0"'.

-+34.//3+

"' ;397


9/18

( &G?82G"K 6+34 "' '(. O3K"+1 >20P.+/0'#

=:(339 34 G"K

>=Q

4-2328 ,BGH?/5@-+34.//3+ 34 F2'.+2"'032"9 j3P.+2"2:.=:(339 34 G"K>20P.+/0'# 34 G..1/I >i

&2-


10/18

%& 1.


11/18

G" H.:9"+":0q2 1. 9" U+E"20M":0q2 !7210"9 1.9 ;3=Q B+"1. -+3=Q[B-Q[/YB.L'[/,"/6d"%*\e ;393


12/18

R3P"+'0/ (" +.:("M"13 9" 34.+'" 1. 2.E3:0":0q2 6+367./'" 63+ ;393=Q

)B/-?/ &117O"+P"+1 B,O, ;("2 =:(339 34 -7890:

O."9'( "21 i.22.1# =:(339 34 j3P,

>=Q

C2--/7 :2;527D E3,D !,D &EF JOU ;399"83+"'02E ;.2'.+ 43+

-("+j938"9 Q::.// '3 !.10:02./ -+3E+"<

H0+.:'3+ -7890: ;0'0M.2

>=Q

E-1H. ,-. F. )/76 &,DE3,H0+.:'3+ JOU >'+.:(' ;.2'.+ 34

AL:.99.2:. 43+ Q443+1"89.

?036("+'+.:(' >20P.+/0'#

E-1H/661- I-11> :. I2>/-R3+'(."/'.+2 >20P.+/0'# =:(339 34 G"K

-+3E+"< 32 O7!Rj ;393


13/18

QiU -("+20P.+/0'# !.10:"9 ;.2'+. j+3202E.2I

j938"9 O."9'( >20'I >20P.+/0'# 34

j+3202E.2, B(. R.'(.+9"21/,

P2-516 P1--/2>20P.+/01"1 1. ?7.23/ Q0+./

=37'( ;.2'+.

,-. F15N/- F/6G/-8/9/-

=(.99 5."1.+ 02 F2'.+2"'032"9 H0/67'.5./397'032I i02Em/ ;399.E. G32132

4/-8Q7 R/5Q6SB/= =6.:0"9 Q1P0/.+ 43+ O."9'( "21

H.P.93620P.+/0'# 34 iK"n797VR"'"9, =37'( Q4+0:"

E-1H. ,-2. E/-52 &1-@BU1V?20P.+/01"1

R":032"9 1. G" -9"'" Q+E.2'02"

!28/6 (1V/H0+.:'3+

i23K9.1E. A:393E# F2'.+2"'032"9

>=Q

)-?V?@392 J2N2V27

-+34.//3+ 34 G"KB.L"/ Qk! =:((39 34 G"K

S3+' J3+'(I Bp

,-.R.P.R?V/>2727@27!020/'+# 34 O5H F- ;("0+ -+34.//3+

RQG=Q5 >20P.+/0'# 34 G"K

Q1c72:' g0/0'02E -+34.//3+I >20P.+/0'#34 ?744"93 ?7/02.// =:(339I R.K h3+`

H0+.:'3+V F2/'0'7'. 34 j938"9 F2'.+2.'j3P.+2"2:. k Q1P3:":# WjFjQXV

C?50/-G I277/70/-N !H "21 67890: (."9'( :32/79'"2',

Q1P0/.+ 32 B5F-= "21 Q::.// '3

!.10:02./ '3 =QH; 20P.+/0'#IJ"/(02E'32I H;

P97G3?2 F1G3#39" >20P.+/0'# 34 ;(0:"E3 =:(339 34

G"K, >=Q

&2GG3/A I. M5977j.3+E0" =37'(.+2 >20P.+/0'#

,-. JBG3 (1;/-G &, &&/@)<

M#MEF&Q1c72:' -+34.//3+ H.6"+'


14/18

M-27 WB?N5/9;9020:"9 -+34.//3+ 34 G"KI H0+.:'3+I

O."9'( "21 O7=Q

&?20P.+/01"1 1. 93/ Q21./

?3E3'l ;39320P.+/01"1 -.+7"2" ;"#.'"23 O.+.10"

G020P.+/01"1 1. Q2'03_70"I ;393


15/18

(B?6 !1-N/ F/-7Q7@/= M5^-/=D &,DE3,-+34./3+ Q/3:0"13 ="971 -v890:"

>20P.+/01"1 1. 93/ Q21./VS":79'"1 1.

!.10:02", ?3E3'lI ;393


16/18

$?72 (?65/G3 +U/@2 )1;1>20P.+/01"1 R":032"9

!.10:3

#@-?272 &/7@1=2 JB?=

5./."+:(.+ U/K"913 ;+7M S3721"'032 xS03:+7MI ?+"M09

!16X 4?50/-G1 +-1=20P.+/0'# 34 =#12.#

!127 J1V?-2 M1-76-+34.//3+ A20P.+/0'"+0" 1.

;0.2:0"/ 1. 9" ="971 S>;=

E-1H. ]5V2-1 a/-@2 )2-8?/7G1D E3,S":79'"1 1. ;0.2:0"/ A:32q20P, R":032"9 1. ;39,

&2-?2 P-?6G?72 (2G1--/a,S, =3:0.1"1 ;393


17/18

$2@?2 :23B2=27N1-390'q93E"

;39320P.+/0'# 34 j("2"

G.E32I Q::+"I j("2"

!B272 P282=Q

*2;?A27263/ :BU?7N2H0+.:'3+ -"2VQ4+0:"2 B+."'


18/18

#>02- $1827=.203+ S.993K "21 Q1c72:' Q//3:0"'.

-+34.//3+

"' ;397i

&2-

Documents

Letter to Colombia Santos Imatinib License(1)